阅读说明：本技术 一种注意缺陷多动障碍治疗药物的鉴别方法 (A kind of discrimination method of attention deficit hyperactivity disorder therapeutic agent ) 是由 付立家 付建家 马筠 赵敏姿 于 2018-05-16 设计创作，主要内容包括：本发明公开了一种注意缺陷多动障碍治疗药物的鉴别方法,注意缺陷多动障碍治疗药物由以下组份构成：太子参,熟地黄,枸杞子,五味子,远志,石菖蒲和茯苓；鉴别方法包括定性鉴别太子参,熟地黄,枸杞子,五味子,远志,石菖蒲和茯苓的步骤,以及定量检测五味子和熟地黄的步骤。本发明采用了专属性较高的方法简单易行,准确可靠,精确度高。本发明能很好的控制该组合物的质量,保证用药的安全性,从而确保其临床疗效。(The invention discloses a kind of discrimination method of attention deficit hyperactivity disorder therapeutic agent, attention deficit hyperactivity disorder therapeutic agent is made of following component: radix pseudostellariae, Rehmannia glutinosa, fructus lycii, Schisandra chinensis, Radix Polygalae, rhizoma acori graminei and Poria cocos；The step of the step of discrimination method includes Qualitive test radix pseudostellariae, Rehmannia glutinosa, fructus lycii, Schisandra chinensis, Radix Polygalae, rhizoma acori graminei and Poria cocos and quantitative detection Schisandra chinensis and Rehmannia glutinosa.Present invention employs the higher method of specificity is simple and easy, accurately and reliably, accuracy is high.The present invention can control the quality of the composition well, guarantee the safety of medication, so that it is guaranteed that its clinical efficacy.)

1. a kind of discrimination method of attention deficit hyperactivity disorder therapeutic agent, it is characterised in that: attention deficit hyperactivity disorder treatment Drug is made of following component: radix pseudostellariae, Rehmannia glutinosa, fructus lycii, Schisandra chinensis, Radix Polygalae, rhizoma acori graminei and Poria cocos；

The discrimination method includes the steps that identifying radix pseudostellariae in accordance with the following methods: taking this product 1g, grinds, add methanol 20ml temperature Leaching shakes 30 minutes, filtering, and filtrate recycling design is to residue is done to obtain, and residue adds methanol 1ml to make to dissolve, as test solution； Radix pseudostellariae control medicinal material 1g separately is taken, is made in the same way of control medicinal material solution；Thin-layered chromatography test is carried out, it is molten to draw test sample respectively Each 1 μ l of liquid, control medicinal material solution puts respectively on same silica gel g thin-layer plate, is n-butanol-ice vinegar of 4:1:1 with volume ratio Acid-water is solvent, and silica gel g thin-layer plate, which is set in the expansion cylinder of solvent presaturation 15 minutes, to be unfolded, and takes out, dries, sprays With 0.2V% ethanol solution of ninhydrin, it is clear to be heated to spot development at 105 DEG C, inspects in the sunlight；In sample chromatogram, In On position corresponding with reference medicine chromatography, the spot of same color is shown；

Alternatively, the discrimination method includes the steps that identifying radix pseudostellariae in accordance with the following methods:

This product 1g is taken, chloroform 25ml is added, is heated to reflux 1 hour, discards chloroform liquid, medical fluid volatilizes solvent, adds water 0.5ml, stirring is wet, adds water-saturated n-butanol 10ml, is ultrasonically treated 30 minutes, and Aspirate supernatant adds 25ml ammonia solution, shakes up, Layering is placed, takes upper liquid to be evaporated to obtain residue, residue adds methanol 1ml to dissolve, as test solution；Separately take radix pseudostellariae comparison medicine Material 1g, is made in the same way of control medicinal material solution；TLC test is carried out, draws test solution, 10 μ of control medicinal material solution respectively L, point are chloroform-ethyl acetate-first of 15:40:22:10 with 10 DEG C of volume ratios arranged below on same silica G plate Alcohol-subsurface layer solution is unfolded as solvent, takes out, dries；10V% ethanol solution of sulfuric acid is sprayed, it is aobvious that spot is heated at 105 DEG C Color is clear, inspects in the sunlight；In sample chromatogram, on position corresponding with reference medicine chromatography, the spot of same color is shown Point.

2. the discrimination method of attention deficit hyperactivity disorder therapeutic agent according to claim 1, which is characterized in that the mirror Other method further includes the steps that identifying radix rehmanniae preparata in accordance with the following methods: taking this product 1g, grinds, add methanol 20ml, is ultrasonically treated 30 points Clock, filtering, filtrate recycling design is to residue is done to obtain, and residue adds methanol 1ml to make to dissolve, as test solution；Separately take radix rehmanniae preparata pair According to medicinal material 1g, it is made in the same way of control medicinal material solution；Carry out TLC test, draw each 5 μ l of above two solution, put respectively in On same silica gel g thin-layer plate, using toluene-ethyl acetate-formic acid of volume ratio 20:5:0.5 as solvent, it is unfolded, takes out, dry in the air Dry, with vanillin-sulfuric acid solution-ethanol solution of volume ratio 4:1, the vanillin-sulfuric acid solution is 2V% vanillin-sulfuric acid for spray Solution, it is clear to be heated to spot development at 105 DEG C, inspects in the sunlight；In sample chromatogram, corresponding to reference medicine chromatography Position on, show same color spot.

3. the discrimination method of attention deficit hyperactivity disorder therapeutic agent according to claim 2, which is characterized in that the mirror Other method further includes the steps that identifying Schisandra chinensis in accordance with the following methods: taking this product 1g, grinds, add chloroform 20ml, heat back Stream 30 minutes, filtering, filtrate recycling design is to residue is done to obtain, and residue adds chloroform 1ml to make to dissolve, as test solution； Schisandra chinensis control medicinal material 1g separately is taken, is made in the same way of control medicinal material solution；TLC test is carried out, it is each to draw above two solution 2 μ l are put respectively on same silica GF254 lamellae, with petroleum ether-Ethyl formate-of 30~60 DEG C of volume ratio 15:5:1 Formic acid upper solution is solvent, is unfolded, and takes out, dries, set and inspect under 254nm ultraviolet lamp；In sample chromatogram, with it is right According on the corresponding position of medicinal material chromatography, the fluorescence spot of same color is shown.

4. the discrimination method of attention deficit hyperactivity disorder therapeutic agent according to claim 3, which is characterized in that the mirror Other method further includes the steps that identifying Radix Polygalae in accordance with the following methods: taking this product 1g, grinds, add 70V% methanol 20ml, is ultrasonically treated 30 minutes, filtering, filtrate was evaporated, and residue adds methanol 1ml to make to dissolve, as test solution；Radix Polygalae control medicinal material 1g separately is taken, together Control medicinal material solution is made in method；TLC test is carried out, each 2 μ l of above two solution is drawn, puts respectively thin in same silica G On laminate, using volume ratio 7:3:1 chloroform-methanol-water lower layer's solution as solvent, it is unfolded, takes out, dry, set 365nm It is inspected under ultraviolet lamp；In sample chromatogram, on position corresponding with reference medicine chromatography, the fluorescent spot of same color is shown Point.

5. the discrimination method of attention deficit hyperactivity disorder therapeutic agent according to claim 4, which is characterized in that the mirror Other method further includes the steps that identifying rhizoma acori graminei in accordance with the following methods: taking this product 0.5g, grinds, add 60~90 DEG C of petroleum ethers 20ml is heated to reflux 1 hour, filtering, filtrate recycling design to dry that residue, residue add 60~90 DEG C of petroleum ether 1ml to make to dissolve, As test solution；Rhizoma acori graminei control medicinal material 1g separately is taken, is made in the same way of control medicinal material solution；TLC test is carried out, is inhaled Each 2 μ l of above two solution is taken, is put respectively on same silica gel g thin-layer plate, is exhibition with volume ratio 4:1 petroleum ether-ethyl acetate Agent is opened, is unfolded, takes out, dries, is placed about 1 hour, is set and inspected under 365nm ultraviolet lamp；In sample chromatogram, with comparison medicine Wood color is composed on corresponding position, and the fluorescence spot of same color is shown.

6. the discrimination method of attention deficit hyperactivity disorder therapeutic agent according to claim 5, which is characterized in that the mirror Other method further includes the steps that identifying Poria cocos in accordance with the following methods: taking this product 1g, grinds, add diethyl ether 50ml, is ultrasonically treated 10 points Clock, filtering, filtrate recycling design is to residue is done to obtain, and residue adds methanol 1ml to make to dissolve, as test solution；Separately take Poria cocos pair According to medicinal material 1g, it is made in the same way of control medicinal material solution；Carry out TLC test, draw each 2 μ l of above two solution, put respectively in On same silica gel g thin-layer plate, using volume ratio 20:5:0.5 toluene-ethyl acetate-formic acid as solvent, it is unfolded, takes out, dry, With vanillin-sulfuric acid solution-ethanol solution of volume ratio 4:1, the vanillin-sulfuric acid solution is that 2V% vanillin-sulfuric acid is molten for spray It is clear to be heated to spot development at 105 DEG C for liquid；In sample chromatogram, on position corresponding with reference medicine chromatography, show identical The spot of color.

7. the discrimination method of attention deficit hyperactivity disorder therapeutic agent according to claim 6, which is characterized in that the mirror Other method further includes the steps that measuring Rehmannia glutinosa content in accordance with the following methods: Rehmannia glutinosa passes through high effective liquid chromatography for measuring；With Octadecylsilane chemically bonded silica is filler；Using volume ratio 16:84 acetonitrile -0.1V% acetic acid as mobile phase；Detection wavelength is 334nm；Number of theoretical plate is calculated by acteoside peak is more than or equal to 5000；The preparation of reference substance solution, takes acteoside pair It is appropriate according to product, it is accurately weighed, it sets in 50ml measuring bottle, with flowing phased soln and is diluted to scale, shakes up to get reference substance solution； Test solution preparation, takes this product 2g, sets in 25ml measuring bottle, add methanol appropriate, is ultrasonically treated (power 250W, frequency 40KHz) It 20 minutes, lets cool, adds methanol dilution to scale, shake up, filter to get test solution；Measuring method, it is accurate respectively to draw control Product solution and each 20 μ l of test solution inject hplc determination.

8. the discrimination method of attention deficit hyperactivity disorder therapeutic agent according to claim 7, which is characterized in that the mirror Other method further includes the steps that measuring Schisandra chinensis content in accordance with the following methods: Schisandra chinensis passes through high effective liquid chromatography for measuring；With Octadecylsilane chemically bonded silica is filler；Using volume ratio 65:35 methanol-water as mobile phase；Detection wavelength is 250nm； Number of theoretical plate is calculated by schizandrin peak is more than or equal to 2000；The preparation of reference substance solution takes schizandrin reference substance suitable Amount, it is accurately weighed, it sets in 10ml measuring bottle, scale is dissolved and be diluted to methanol, is shaken up to get reference substance solution；Test sample is molten Liquid is prepared, and this product 1g is taken, accurately weighed, is set in 25ml measuring bottle, is added methanol appropriate, is ultrasonically treated 15 minutes, is let cool, add methanol dilute It releases to scale, shakes up, filter up to test solution；Measuring method, accurate absorption reference substance solution and test solution are each respectively 10 μ l inject hplc determination.

9. the discrimination method of attention deficit hyperactivity disorder therapeutic agent according to claim 1-8, feature exist In attention deficit hyperactivity disorder therapeutic agent is made of following component: 300~400 parts by weight of radix pseudostellariae, Rehmannia glutinosa 300~400 Parts by weight, 200~300 parts by weight of fructus lycii, 200~300 parts by weight of Schisandra chinensis, 200~300 parts by weight of Radix Polygalae, rhizoma acori graminei 200 ~300 parts by weight, 300~400 parts by weight of Poria cocos.

10. the discrimination method of attention deficit hyperactivity disorder therapeutic agent according to claim 1-8, feature exist In being made of the component of following weight proportion: radix pseudostellariae 380, Rehmannia glutinosa 380, fructus lycii 228, Schisandra chinensis 228, Radix Polygalae 228, Rhizoma acori graminei 228, Poria cocos 380.

Technical field

The invention belongs to children ADHD therapeutic agent technical fields, more particularly to attention deficit hyperactivity disorder medicine The discrimination method of object.

Background technique

Attention deficit hyperactivity disorder (ADHD), common a kind of mental handicape childhood China is known as hyperactivity, is.Table Now for age and developmental level be disproportionate absent minded and attention the time is of short duration, hyperactivity hyperkinesia and impulsion, be often accompanied by Difficulty of learning, conduct disorder and maladjustment.

Drug can improve attention deficit, reduce activity level, improve school grade to a certain extent, improve suffer from a short time The relationship of person and kinsfolk.First kind drug is central stimulant, mainly methylphenidate and its controlled release tablet, commodity fame and gain he Woods.Low dosage helps to improve attention, and high dose can improve more dynamic, impulsion symptoms, reduce behavioral problem.Central stimulant 6 years old or more patient is only limitted to use.Because there is central excitation effect, should not use at night, drug side-effect has loss of appetite, loses Dormancy, headache, irritated and irritability etc. still cannot determine whether to influence growth and development.Central stimulant may induce or making patients Symptom is twitched, comorbidity tic disorder patient is it is not recommended that use.Second class drug is that selective norepinephrine reuptake inhibits Agent represents drug atomoxetine, and atomoxetine curative effect is suitable with methylphenidate, and adverse reaction is few, and tolerance is good, has been cited as The first-line treatment drug of ADHD.Feature: being administered once daily, and curative effect sustainable 24 hours；It takes for a long time, without additive；The medicine rises The effect time is slower than central stimulant, could generally occur curative effect after starting medication 1~2 week, not be suitable for needing acute The ADHD patient for the treatment of.The most common adverse reaction is gastrointestinal reaction, need to be taken medicine after the meal.

Attention deficit hyperactivity disorder patient can be treated using the Chinese materia medica preparation that attention deficit hyperactivity disorder is treated, is being applied When can obtain higher cure rate.But lack the method for quality control to said preparation, it cannot be guaranteed that the safety of clinical application has Effect, is unfavorable for the standardized production of drug, does not also meet the trend of modernization Chinese medicine development.

Summary of the invention

The object of the present invention is to provide a kind of discrimination methods of attention deficit hyperactivity disorder therapeutic agent.

The technical scheme to solve the above technical problems is that a kind of mirror of attention deficit hyperactivity disorder therapeutic agent Other method, attention deficit hyperactivity disorder therapeutic agent are made of following component: radix pseudostellariae, Rehmannia glutinosa, fructus lycii, Schisandra chinensis, far Will, rhizoma acori graminei and Poria cocos；

The discrimination method includes the steps that identifying radix pseudostellariae in accordance with the following methods: taking this product 1g, grinds, add methanol 20ml temperature Leaching shakes 30 minutes, filtering, and filtrate recycling design is to residue is done to obtain, and residue adds methanol 1ml to make to dissolve, as test solution； Radix pseudostellariae control medicinal material 1g separately is taken, is made in the same way of control medicinal material solution；Thin-layered chromatography test is carried out, it is molten to draw test sample respectively Each 1 μ l of liquid, control medicinal material solution puts respectively on same silica gel g thin-layer plate, is n-butanol-ice vinegar of 4:1:1 with volume ratio Acid-water is solvent, and silica gel g thin-layer plate, which is set in the expansion cylinder of solvent presaturation 15 minutes, to be unfolded, and takes out, dries, sprays With 0.2V% ethanol solution of ninhydrin, it is clear to be heated to spot development at 105 DEG C, inspects in the sunlight；In sample chromatogram, In On position corresponding with reference medicine chromatography, the spot of same color is shown；

Alternatively, the discrimination method includes the steps that identifying radix pseudostellariae in accordance with the following methods:

This product 1g is taken, chloroform 25ml is added, is heated to reflux 1 hour, discards chloroform liquid, medical fluid volatilizes solvent, adds water 0.5ml, stirring is wet, adds water-saturated n-butanol 10ml, is ultrasonically treated 30 minutes, and Aspirate supernatant adds 25ml ammonia solution, shakes up, Layering is placed, takes upper liquid to be evaporated to obtain residue, residue adds methanol 1ml to dissolve, as test solution；Separately take radix pseudostellariae comparison medicine Material 1g, is made in the same way of control medicinal material solution；TLC test is carried out, draws test solution, 10 μ of control medicinal material solution respectively L, point are chloroform-ethyl acetate-first of 15:40:22:10 with 10 DEG C of volume ratios arranged below on same silica G plate Alcohol-subsurface layer solution is unfolded as solvent, takes out, dries；10V% ethanol solution of sulfuric acid is sprayed, it is aobvious that spot is heated at 105 DEG C Color is clear, inspects in the sunlight；In sample chromatogram, on position corresponding with reference medicine chromatography, the spot of same color is shown Point.

The discrimination method of present invention attention deficit hyperactivity disorder therapeutic agent as described above, further, the identification side Method further includes the steps that identifying radix rehmanniae preparata in accordance with the following methods: taking this product 1g, grinds, add methanol 20ml, is ultrasonically treated 30 minutes, mistake Filter, filtrate recycling design is to residue is done to obtain, and residue adds methanol 1ml to make to dissolve, as test solution；Separately take radix rehmanniae preparata control medicinal material 1g is made in the same way of control medicinal material solution；TLC test is carried out, each 5 μ l of above two solution is drawn, is put respectively in same silicon On glue G lamellae, using toluene-ethyl acetate-formic acid of volume ratio 20:5:0.5 as solvent, be unfolded, take out, dry, spray with Vanillin-sulfuric acid solution-ethanol solution of volume ratio 4:1, the vanillin-sulfuric acid solution are 2V% vanillin-sulfuric acid solution, In 105 DEG C to be heated to spot development clear, inspects in the sunlight；In sample chromatogram, in position corresponding with reference medicine chromatography On, show the spot of same color.

The discrimination method of present invention attention deficit hyperactivity disorder therapeutic agent as described above, further, the identification side Method further includes the steps that identifying Schisandra chinensis in accordance with the following methods: taking this product 1g, grinds, add chloroform 20ml, be heated to reflux 30 Minute, filtering, filtrate recycling design is to residue is done to obtain, and residue adds chloroform 1ml to make to dissolve, as test solution；Separately take Schisandra chinensis control medicinal material 1g, is made in the same way of control medicinal material solution；TLC test is carried out, each 2 μ l of above two solution is drawn, It is put respectively on same silica GF254 lamellae, with petroleum ether-Ethyl formate-formic acid of 30~60 DEG C of volume ratio 15:5:1 Upper solution is solvent, is unfolded, and takes out, dries, set and inspect under 254nm ultraviolet lamp；In sample chromatogram, with comparison medicine Wood color is composed on corresponding position, and the fluorescence spot of same color is shown.

The discrimination method of present invention attention deficit hyperactivity disorder therapeutic agent as described above, further, the identification side Method further includes the steps that identifying Radix Polygalae in accordance with the following methods: taking this product 1g, grinds, add 70V% methanol 20ml, is ultrasonically treated 30 points Clock, filtering, filtrate are evaporated, and residue adds methanol 1ml to make to dissolve, as test solution；Separately take Radix Polygalae control medicinal material 1g, same to legal system At control medicinal material solution；TLC test is carried out, each 2 μ l of above two solution is drawn, is put respectively in same silica gel g thin-layer plate On, using volume ratio 7:3:1 chloroform-methanol-water lower layer's solution as solvent, it is unfolded, takes out, dry, it is ultraviolet to set 365nm It is inspected under light lamp；In sample chromatogram, on position corresponding with reference medicine chromatography, the fluorescence spot of same color is shown.

The discrimination method of present invention attention deficit hyperactivity disorder therapeutic agent as described above, further, the identification side Method further includes the steps that identifying rhizoma acori graminei in accordance with the following methods: taking this product 0.5g, grinds, add 60~90 DEG C of petroleum ether 20ml, add Heat reflux 1 hour, filtering, filtrate recycling design is to residue is done to obtain, and residue adds 60~90 DEG C of petroleum ether 1ml to make to dissolve, as confession Test sample solution；Rhizoma acori graminei control medicinal material 1g separately is taken, is made in the same way of control medicinal material solution；TLC test is carried out, is drawn above-mentioned Each 2 μ l of two kinds of solution puts respectively on same silica gel g thin-layer plate, using volume ratio 4:1 petroleum ether-ethyl acetate as solvent, opens up It opens, takes out, dry, place about 1 hour, set and inspected under 365nm ultraviolet lamp；In sample chromatogram, with reference medicine chromatography On corresponding position, the fluorescence spot of same color is shown.

The discrimination method of present invention attention deficit hyperactivity disorder therapeutic agent as described above, further, the identification side Method further includes the steps that identifying Poria cocos in accordance with the following methods: taking this product 1g, grinds, add diethyl ether 50ml, is ultrasonically treated 10 minutes, mistake Filter, filtrate recycling design is to residue is done to obtain, and residue adds methanol 1ml to make to dissolve, as test solution；Separately take Poria cocos control medicinal material 1g is made in the same way of control medicinal material solution；TLC test is carried out, each 2 μ l of above two solution is drawn, is put respectively in same silicon On glue G lamellae, using volume ratio 20:5:0.5 toluene-ethyl acetate-formic acid as solvent, it is unfolded, takes out, dry, spray with body Vanillin-sulfuric acid solution-ethanol solution of the product than 4:1, the vanillin-sulfuric acid solution is 2V% vanillin-sulfuric acid solution, 105 It is clear DEG C to be heated to spot development；In sample chromatogram, on position corresponding with reference medicine chromatography, the spot of same color is shown Point.

The discrimination method of present invention attention deficit hyperactivity disorder therapeutic agent as described above, further, the identification side Method further includes the steps that measuring Rehmannia glutinosa content in accordance with the following methods: Rehmannia glutinosa passes through high effective liquid chromatography for measuring；With 18 Alkyl silane bonded silica gel is filler；Using volume ratio 16:84 acetonitrile -0.1V% acetic acid as mobile phase；Detection wavelength is 334nm；Number of theoretical plate is calculated by acteoside peak is more than or equal to 5000；The preparation of reference substance solution, takes acteoside pair It is appropriate according to product, it is accurately weighed, it sets in 50ml measuring bottle, with flowing phased soln and is diluted to scale, shakes up to get reference substance solution； Test solution preparation, takes this product 2g, sets in 25ml measuring bottle, add methanol appropriate, is ultrasonically treated (power 250W, frequency 40KHz) It 20 minutes, lets cool, adds methanol dilution to scale, shake up, filter to get test solution；Measuring method, it is accurate respectively to draw control Product solution and each 20 μ l of test solution inject hplc determination.

The discrimination method of present invention attention deficit hyperactivity disorder therapeutic agent as described above, further, the identification side Method further includes the steps that measuring Schisandra chinensis content in accordance with the following methods: Schisandra chinensis passes through high effective liquid chromatography for measuring；With 18 Alkyl silane bonded silica gel is filler；Using volume ratio 65:35 methanol-water as mobile phase；Detection wavelength is 250nm；It is theoretical Plate number is calculated by schizandrin peak is more than or equal to 2000；The preparation of reference substance solution takes schizandrin reference substance appropriate, essence It is close weighed, it sets in 10ml measuring bottle, scale is dissolved and be diluted to methanol, is shaken up to get reference substance solution；Test solution is matched System, takes this product 1g, accurately weighed, sets in 25ml measuring bottle, adds methanol appropriate, is ultrasonically treated 15 minutes, lets cool, add methanol dilution extremely Scale shakes up, and filters up to test solution；Measuring method, it is accurate respectively to draw reference substance solution and each 10 μ l of test solution Inject hplc determination.

The discrimination method of present invention attention deficit hyperactivity disorder therapeutic agent as described above, further, it is noted that defect is more Dynamic treating dysfunction drug is made of following component: 300~400 parts by weight of radix pseudostellariae, 300~400 parts by weight of Rehmannia glutinosa, fructus lycii 200~300 parts by weight, 200~300 parts by weight of Schisandra chinensis, 200~300 parts by weight of Radix Polygalae, 200~300 parts by weight of rhizoma acori graminei, 300~400 parts by weight of Poria cocos.

The discrimination method of present invention attention deficit hyperactivity disorder therapeutic agent as described above, further, by following weight The component of proportion is constituted: radix pseudostellariae 380, Rehmannia glutinosa 380, fructus lycii 228, Schisandra chinensis 228, Radix Polygalae 228, rhizoma acori graminei 228, Poria cocos 380。

The beneficial effects of the present invention are:

Present invention employs the higher methods of specificity to radix pseudostellariae, Rehmannia glutinosa, fructus lycii, Schisandra chinensis, Radix Polygalae, rhizoma acori graminei and Fu Siberian cocklebur carries out Qualitive test, and method of quality control is simple and easy, and accurately and reliably, accuracy is high.The present invention can control the group well The quality for closing object, guarantees the safety of medication, so that it is guaranteed that its clinical efficacy.

Specific embodiment

The embodiment recorded herein is specific specific embodiment of the invention, for illustrating design of the invention, Be it is explanatory and illustrative, should not be construed as the limitation to embodiment of the present invention and the scope of the invention.Except what is recorded herein Outside embodiment, those skilled in the art can also based on the claim of this application book and specification disclosure of that using aobvious and The other technical solutions being clear to, these technical solutions include using any obvious to making for the embodiment recorded herein The technical solution of substitutions and modifications.

Attention deficit hyperactivity disorder therapeutic agent is made of following component: radix pseudostellariae, Rehmannia glutinosa, fructus lycii, Schisandra chinensis, far Will, rhizoma acori graminei and Poria cocos；For example it is to be noted that the mostly dynamic treating dysfunction drug of defect is made of following component: 300~400 weight of radix pseudostellariae Amount part, 300~400 parts by weight of Rehmannia glutinosa, 200~300 parts by weight of fructus lycii, 200~300 parts by weight of Schisandra chinensis, Radix Polygalae 200~ 300 parts by weight, 200~300 parts by weight of rhizoma acori graminei, 300~400 parts by weight of Poria cocos.

For formula as below: attention deficit hyperactivity disorder therapeutic agent is made of the component of following weight proportion, radix pseudostellariae 380, Rehmannia glutinosa 380, fructus lycii 228, Schisandra chinensis 228, Radix Polygalae 228, rhizoma acori graminei 228, Poria cocos 380.

The preparation method of attention deficit hyperactivity disorder therapeutic agent the following steps are included:

Step 1, Schisandra chinensis is extracted with ethyl alcohol, is concentrated after filtrate recycling ethanol, and the first extract is ground into after being dried under reduced pressure Fine powder；

Preferably, the detailed process of step 1 are as follows: Schisandra chinensis is crushed, is the heating of 60% ethyl alcohol with the mass percent of 10 times of quality Three times, 2 hours every time, filtering, merging filtrate recycled ethyl alcohol to refluxing extraction, and concentration is dried under reduced pressure, crush to extract First extract fine powder.

Step 2, rhizoma acori graminei steam distillation, aqueous solution and the dregs of a decoction after obtaining volatile oil, distillation；Volatile oil is pasted with ring Spermatophore closes, and crushed after being dried is at the second extract fine powder；

Preferably, the detailed process of step 2 are as follows: rhizoma acori graminei extracts volatile oil with steam distillation, volatile oil with cyclodextrin encapsulated, It is dried, crushed into fine powder；The another device preservation of aqueous solution after distillation, the dregs of a decoction add 8 times of amount water to decoct 1 hour time, filtration, filtrate and steaming Aqueous solution after evaporating merges, the solution for standby after merging.

Step 3, radix pseudostellariae, radix rehmanniae preparata, fructus lycii, Poria cocos, Radix Polygalae add water to cook, and obtain filtrate；

Preferably, the detailed process of step 3 are as follows: radix pseudostellariae, radix rehmanniae preparata, fructus lycii, Poria cocos, Radix Polygalae add 12 times of quality water decoct 3 times, it is every Secondary 1.5 hours, filtering, merging filtrate.

Step 4, the filtrate decompression that aqueous solution and step 3 after the distillation obtained to step 2 obtain is concentrated, and ethyl alcohol is added and stirs Standing is mixed, supernatant is taken, recycling ethyl alcohol and being concentrated under reduced pressure is thick paste, and thick paste is dried under reduced pressure and is ground into third extract fine powder；

Preferably, the detailed process of step 4 are as follows: the solution after merging obtained by step 2 merges with step 3 gained filtrate, depressurizes dense Relative density is the clear cream of 1.00~1.30g/ml under the conditions of being reduced to 60 DEG C, adds ethyl alcohol to make alcohol content 60wt%, stirs evenly, and is stood； Supernatant is taken, the thick paste that relative density is 1.10~1.40g/ml under the conditions of recycling ethyl alcohol and being concentrated under reduced pressure into 60 DEG C, thick paste subtracts It press dry dry and is ground into third extract fine powder.

Step 5, the first extract fine powder, the second extract fine powder, third extract fine powder and additive are mixed and are pelletized, Dry attention deficit hyperactivity disorder therapeutic agent.

900 ADHD children patients, about 80 patients of each experimental group are treated using said medicine.Make It is three times per day warmly taken after meal with 1 course for the treatment of Chinese medicine of the invention, 12 grams every time, 2 weeks as a treatment course.It is lacked using above-mentioned attention Attention deficit hyperactivity disorder patient can be treated by falling into more dynamic treating dysfunction drugs, can obtain higher cure rate in application, Up to 92.5%.

Inventor's discovery some patientss in the experimentation for carrying out effect of drugs have side effect generation, are embodied in trouble Person has a stomach upset after the tablet has been ingested, dry, and inventor's discovery is in the drug of addition endothelium corneum gigeriae galli, production without side-effects after patient's medication It is raw, it is preferred that the additive amount of endothelium corneum gigeriae galli is 100 to 300 parts by weight.Such as attention deficit hyperactivity disorder therapeutic agent is by with the following group Part is constituted: radix pseudostellariae 380, Rehmannia glutinosa 380, fructus lycii 228, Schisandra chinensis 228, Radix Polygalae 228, rhizoma acori graminei 228, in Poria cocos 380, chicken Gold 160.Preparation method is same as the previously described embodiments.

Reagent source used in following detection process is following (it is percent by volume that percentage, which does not fill bright): methanol, Chromatographic grade, >=99.9%；N-butanol, chromatographic grade, >=99.7% (GC)；Glacial acetic acid, ACS, >=99.7%；Ninhydrin is hydration indenes three Ketone, >=98.0% (UV)；Chloroform, >=99.5%；N-butanol, 99.5% (GC)；Ammonia solution, 40% preparation of liquor ammoniae fortis dilution； Ethyl acetate, >=99.5%；Sulfuric acid 75wt%；Toluene, >=99.5%；Formic acid, GC, > 99%；Vanillic aldehyde, 99%；Ethyl alcohol, >=99.0%； Petroleum ether, chromatographic grade, bp30-60 DEG C；Ethyl formate, >=99.5% (GC)；Acetonitrile, > 99.5% (GC)；Acetic acid, 1mol/l.

The discrimination method of attention deficit hyperactivity disorder therapeutic agent the following steps are included:

Step 1

Identify radix pseudostellariae in accordance with the following methods: taking this product 1g, grind, methanol 20ml temperature is added to soak, shakes 30 minutes, filtering, filtrate Recycling design is to residue is done to obtain, and residue adds methanol 1ml to make to dissolve, as test solution；Radix pseudostellariae control medicinal material 1g separately is taken, together Control medicinal material solution is made in method；Thin-layered chromatography test is carried out, draws test solution, each 1 μ l of control medicinal material solution respectively, point Other point on same silica gel g thin-layer plate, using volume ratio for 4:1:1 n-butanol-glacial acetic acid-water as solvent, silica gel g thin-layer plate It sets in the expansion cylinder of solvent presaturation 15 minutes and is unfolded, take out, dry, spray with 0.2V% ethanol solution of ninhydrin, In 105 DEG C to be heated to spot development clear, inspects in the sunlight；In sample chromatogram, in position corresponding with reference medicine chromatography On, show the spot of same color；

Alternatively, the discrimination method includes the steps that identifying radix pseudostellariae in accordance with the following methods:

This product 1g is taken, chloroform 25ml is added, is heated to reflux 1 hour, discards chloroform liquid, medical fluid volatilizes solvent, adds water 0.5ml, stirring is wet, adds water-saturated n-butanol 10ml, is ultrasonically treated 30 minutes, and Aspirate supernatant adds 25ml ammonia solution, shakes up, Layering is placed, takes upper liquid to be evaporated to obtain residue, residue adds methanol 1ml to dissolve, as test solution；Separately take radix pseudostellariae comparison medicine Material 1g, is made in the same way of control medicinal material solution；TLC test is carried out, draws test solution, 10 μ of control medicinal material solution respectively L, point are chloroform-ethyl acetate-first of 15:40:22:10 with 10 DEG C of volume ratios arranged below on same silica G plate Alcohol-subsurface layer solution is unfolded as solvent, takes out, dries；10V% ethanol solution of sulfuric acid is sprayed, it is aobvious that spot is heated at 105 DEG C Color is clear, inspects in the sunlight；In sample chromatogram, on position corresponding with reference medicine chromatography, the spot of same color is shown Point.

Step 2

Identify radix rehmanniae preparata in accordance with the following methods: taking this product 1g, grind, add methanol 20ml, be ultrasonically treated 30 minutes, filtering, filtrate is returned Solvent is received to residue is done to obtain, residue adds methanol 1ml to make to dissolve, as test solution；Separately take radix rehmanniae preparata control medicinal material 1g, same to legal system At control medicinal material solution；TLC test is carried out, each 5 μ l of above two solution is drawn, is put respectively in same silica gel g thin-layer plate On, using toluene-ethyl acetate-formic acid of volume ratio 20:5:0.5 as solvent, it is unfolded, takes out, dry, sprays with volume ratio 4:1 Vanillin-sulfuric acid solution-ethanol solution, the vanillin-sulfuric acid solution be 2V% vanillin-sulfuric acid solution, 105 DEG C heat It is clear to spot development, it inspects in the sunlight；In sample chromatogram, on position corresponding with reference medicine chromatography, show identical The spot of color.

Step 3

Identify Schisandra chinensis in accordance with the following methods: taking this product 1g, grind, add chloroform 20ml, be heated to reflux 30 minutes, filters, Filtrate recycling design is to residue is done to obtain, and residue adds chloroform 1ml to make to dissolve, as test solution；Separately Schisandra chinensis is taken to compare Medicinal material 1g, is made in the same way of control medicinal material solution；TLC test is carried out, each 2 μ l of above two solution is drawn, puts respectively in same On one silica GF254 lamellae, it is with petroleum ether-Ethyl formate-formic acid upper solution of 30~60 DEG C of volume ratio 15:5:1 Solvent is unfolded, and takes out, dries, set and inspect under 254nm ultraviolet lamp；In sample chromatogram, corresponding to reference medicine chromatography Position on, show same color fluorescence spot.

Step 4

Identify Radix Polygalae in accordance with the following methods: taking this product 1g, grind, add 70V% methanol 20ml, be ultrasonically treated 30 minutes, filters, filter Liquid is evaporated, and residue adds methanol 1ml to make to dissolve, as test solution；Radix Polygalae control medicinal material 1g separately is taken, is made in the same way of control medicinal material Solution；TLC test is carried out, each 2 μ l of above two solution is drawn, is put respectively on same silica gel g thin-layer plate, with volume Lower layer's solution than 7:3:1 chloroform-methanol-water is solvent, is unfolded, and takes out, dries, set and examine under 365nm ultraviolet lamp Depending on；In sample chromatogram, on position corresponding with reference medicine chromatography, the fluorescence spot of same color is shown.

Step 5

Identify rhizoma acori graminei in accordance with the following methods: taking this product 0.5g, grinds, add 60~90 DEG C of petroleum ether 20ml, it is small to be heated to reflux 1 When, filtering, filtrate recycling design is to residue is done to obtain, and residue adds 60~90 DEG C of petroleum ether 1ml to make to dissolve, as test solution； Rhizoma acori graminei control medicinal material 1g separately is taken, is made in the same way of control medicinal material solution；TLC test is carried out, it is each to draw above two solution 2 μ l put respectively on same silica gel g thin-layer plate, using volume ratio 4:1 petroleum ether-ethyl acetate as solvent, are unfolded, take out, dry in the air It is dry, it places about 1 hour, sets and inspected under 365nm ultraviolet lamp；In sample chromatogram, in position corresponding with reference medicine chromatography On, show the fluorescence spot of same color.

Step 6

Identify Poria cocos in accordance with the following methods: taking this product 1g, grind, add diethyl ether 50ml, is ultrasonically treated 10 minutes, and filtering, filtrate is returned Solvent is received to residue is done to obtain, residue adds methanol 1ml to make to dissolve, as test solution；Separately take Poria cocos control medicinal material 1g, same to legal system At control medicinal material solution；TLC test is carried out, each 2 μ l of above two solution is drawn, is put respectively in same silica gel g thin-layer plate On, using volume ratio 20:5:0.5 toluene-ethyl acetate-formic acid as solvent, it is unfolded, takes out, dry, sprays with volume ratio 4:1's Vanillin-sulfuric acid solution-ethanol solution, the vanillin-sulfuric acid solution are 2V% vanillin-sulfuric acid solution, are heated at 105 DEG C Spot development is clear；In sample chromatogram, on position corresponding with reference medicine chromatography, the spot of same color is shown.

Step 7

Measure Rehmannia glutinosa content in accordance with the following methods: Rehmannia glutinosa passes through high effective liquid chromatography for measuring；With octadecylsilane key Conjunction silica gel is filler；Using volume ratio 16:84 acetonitrile -0.1V% acetic acid as mobile phase；Detection wavelength is 334nm；Number of theoretical plate It is calculated by acteoside peak and is more than or equal to 5000；The preparation of reference substance solution takes acteoside reference substance appropriate, and precision claims It is fixed, it sets in 50ml measuring bottle, with flowing phased soln and is diluted to scale, shakes up to get reference substance solution；Test solution preparation, This product 2g is taken, is set in 25ml measuring bottle, adds methanol appropriate, ultrasonic treatment (power 250W, frequency 40KHz) 20 minutes lets cool, adds first Alcohol is diluted to scale, shakes up, and filters to get test solution；Measuring method, accurate absorption reference substance solution and test sample are molten respectively Each 20 μ l of liquid injects hplc determination.

Step 8

Measure Schisandra chinensis content in accordance with the following methods: Schisandra chinensis passes through high effective liquid chromatography for measuring；With octadecylsilane key Conjunction silica gel is filler；Using volume ratio 65:35 methanol-water as mobile phase；Detection wavelength is 250nm；Number of theoretical plate presses the five tastes Sub- alcohol first peak, which calculates, is more than or equal to 2000；The preparation of reference substance solution takes schizandrin reference substance appropriate, accurately weighed, sets In 10ml measuring bottle, scale is dissolved and be diluted to methanol, is shaken up to get reference substance solution；Test solution is prepared, and this product is taken 1g, it is accurately weighed, it sets in 25ml measuring bottle, adds methanol appropriate, be ultrasonically treated 15 minutes, let cool, add methanol dilution to scale, shake It is even, it filters up to test solution；Measuring method, it is accurate respectively to draw reference substance solution and each 10 μ l injection liquid phase of test solution Chromatograph measurement.

Each technical characteristic of above-mentioned disclosure is not limited to disclosed and other feature combination, and those skilled in the art are also Can carry out other combinations between each technical characteristic according to the purpose of invention, be subject to realize the present invention purpose.