阅读说明：本技术 一种用于治疗早中期老年痴呆病的中药组合物及其制备方法 (A Chinese medicinal composition for treating senile dementia of early and middle stages, and its preparation method ) 是由 周迅 于 2020-06-09 设计创作，主要内容包括：本发明涉及一种用于治疗早、中期老年痴呆的中药组合物及制备方法,它是由下述重量份的原料制备而成：杜仲1-5份三七1-5份黄芪1-5丹参1-5当归1-5份川芎1-5份。本发明与现有技术相比所产生的有益效果是：(1)本发明为纯中药酒剂,各种药材配伍相宜,具有强阴益精,使气宣通,益气安神,利窍去湿之功效,能有效改善脑神经、脑血管和脑血液循环功能,其有增强机体免疫功能、增强造血功能。改善物质代谢、增强性腺功能、抗应激、延缓衰老等作用,用于治疗老年性痴呆症。(2)本发明疗效好、未见毒副作用,安全可靠,可长期使用,其制备方法科学合理。(The invention relates to a traditional Chinese medicine composition for treating early and middle-term senile dementia and a preparation method thereof, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 1-5 parts of eucommia bark, 1-5 parts of pseudo-ginseng, 1-5 parts of astragalus root, 1-5 parts of salvia miltiorrhiza, 1-5 parts of angelica sinensis and 1-5 parts of ligusticum wallichii. Compared with the prior art, the invention has the following beneficial effects: (1) the invention is a pure traditional Chinese medicine wine, and various medicinal materials are compatible, so the wine has the effects of strengthening yin and replenishing vital essence, enabling qi to be conducted, tonifying qi and soothing nerves, and benefiting orifices and removing dampness, can effectively improve the functions of cranial nerves, cerebral vessels and cerebral blood circulation, and has the functions of enhancing the immunity of the organism and enhancing the hematopoiesis. Improving metabolism, improving gonadal function, resisting stress, and delaying aging, and can be used for treating senile dementia. (2) The invention has good curative effect, no toxic or side effect, safety and reliability, can be used for a long time, and has scientific and reasonable preparation method.)

1. A Chinese medicinal composition for treating senile dementia in early and middle stages and its preparation method are provided,

the traditional Chinese medicine composition is composed of the following traditional Chinese medicine components in parts by weight:

1-5 parts of eucommia bark, 1-5 parts of pseudo-ginseng, 1-5 parts of astragalus root, 1-5 parts of salvia miltiorrhiza, 1-5 parts of angelica,

1-5 parts of ligusticum wallichii.

2. The Chinese medicinal composition for treating senile dementia in early and middle stages as claimed in claim 1, and its preparation method

The preparation method is characterized by comprising the following traditional Chinese medicine components in parts by weight:

3-5 parts of eucommia bark, 3-5 parts of pseudo-ginseng, 3-5 parts of astragalus root, 3-5 parts of salvia miltiorrhiza, 3-5 parts of angelica,

3-5 parts of ligusticum wallichii.

3. The Chinese medicinal composition according to claim 1 for treating senile dementia in early and middle stages

The preparation method is characterized in that the dosage of the white spirit is 8 to 50 parts, and the brown sugar is 0.01 to 0.05 part.

4. The Chinese medicinal composition for treating senile dementia in early and middle stages as claimed in claim 3

The preparation method is characterized by comprising the following process steps:

the above medicinal materials are prepared into decoction pieces according to the method specified in pharmacopoeia, and six medicinal materials in the formula are prepared according to the method

Weighing the raw medicinal materials according to the weight parts, placing the raw medicinal materials into a container, adding 50-degree white spirit for soaking, and soaking every 24 hours

Stirring once, and filtering residues after 7 days to obtain the product;

or soaking in 50% ethanol for 24 hr, reflux extracting twice, filtering the extractive solution, and recovering ethanol;

adding Chinese liquor, and concocting to 5-60% (v/v) wine.

5. The Chinese medicinal composition for treating senile dementia in early and middle stages as claimed in claim 1, and its preparation method

The preparation method is characterized in that the quality control method of the composition is to control the following quality indexes according to

And (3) high performance liquid chromatography determination:

(1) the content of Eucommiae cortex in per 10ml of the product is not less than 0.008mg calculated by chlorogenic acid (C16H 18O 9);

(2) the content of radix astragali in 10ml of the product is not less than 20 μ g, calculated as astragaloside IV (C41H 68014);

(3) the product contains 10ml of Notoginseng radix extract containing ginsenoside Rg1 (C42H 72O 14), ginsenoside Rb1(C54H 92O 23),

The total amount of ginsenoside Re (C48H 82O 18) and notoginsenoside R1 (C47H 80O 18) is not small enough

At 9.5m g.

6. A Chinese medicinal composition for treating senile dementia in early and middle stages and its preparation method are provided,

the invention can also be prepared into oral dosage forms such as tablets, capsules, powder and the like except for medicinal liquor.

Technical Field

The invention belongs to the field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating senile dementia in early and middle stages and a preparation method thereof.

Background

Senile dementia, i.e. degenerative change of brain function, is a common symptom after people enter middle-aged and elderly people, and with the continuous development of the process, the symptoms of associated organ failure, uncontrollable after repeated infection, malignant change of tissue cells of the associated organs and the like appear, and finally, patients die. The death is the result of normal death outside the hospital in most of human beings.

The brain function degeneration is the accurate definition of the clinical of senile dementia (Alzheimer's disease), and doctors of all countries are studying the treatment method of the disease, so far, there is no specific treatment medicine, especially for the late stage patients, some central nervous tissues related to peripheral organ tissues in the cranium are partially lost or completely lost, the electromagnetic pulse connected with the peripheral organ tissues is greatly weakened or can not generate the electromagnetic pulse to reach the peripheral organ and tissues, so the late stage patients have certain effect after treatment, some functions are improved, but because the brain tissues which are subjected to organic change are irreversible, the curative effect is limited, only the survival condition is improved and the survival time is prolonged to a certain extent. Therefore, the degenerative change of brain function of middle-aged and elderly people should be manual intervention in early and middle stages, and the significance is great. The early-mid-term degenerative changes in asian brain function, often occur in the age of 50-60 years, perhaps earlier.

The degenerative change of brain function of human brain is associated with the difficulty of supplying nutrients required by brain tissue, and after the long-term persistent supply difficulty occurs, the degenerative change of brain function begins to occur, and the inflection point is the appearance of menopause. Blood supply to brain tissue is one of the keys.

The inventor finds the medicine capable of treating the degenerative change of the brain function of the middle-aged and elderly people in the traditional Chinese medicine treatment based on the biological electromagnetism theory and by combining the traditional theory of the traditional Chinese medicine, and obtains a surprising effect in the verification through a reasonable formula.

Disclosure of Invention

The invention provides a traditional Chinese medicine composition for treating early and middle-term senile dementia and a preparation method thereof.

The invention also provides a quality control method of the composition.

The technical scheme adopted by the invention for solving the technical problems is as follows:

a traditional Chinese medicine composition for treating early and middle-term senile dementia is prepared from the following raw materials in parts by weight:

1-5 parts of eucommia bark, 1-5 parts of pseudo-ginseng, 1-5 parts of astragalus root, 1-5 parts of salvia miltiorrhiza, 1-5 parts of angelica and 1-5 parts of ligusticum wallichii.

8-50 parts of white spirit and 0.01-0.05 part of brown sugar.

Preferably, the traditional Chinese medicine composition comprises the following traditional Chinese medicine components in parts by weight:

3-5 parts of eucommia bark, 3-5 parts of pseudo-ginseng, 3-5 parts of astragalus membranaceus, 3-5 parts of salvia miltiorrhiza, 3-5 parts of angelica sinensis and 3-5 parts of ligusticum wallichii.

8-50 parts of white spirit and 0.01-0.05 part of brown sugar.

The traditional Chinese medicine composition disclosed by the invention is characterized in that the content (g/v) of raw medicinal materials in the composition is 0.5-12%.

The alcohol content of the traditional Chinese medicine composition is 5-60% (v/v) in the composition.

Aiming at the characteristics of gradual attenuation of electroencephalogram and magnetic pulse signals, microcirculation disturbance of body tissues and the like of the senile dementia in early and middle stages, the invention takes traditional Chinese medicines of eucommia bark, pseudo-ginseng, astragalus root, salvia miltiorrhiza, angelica and ligusticum wallichii as compositions, and the compositions are prepared by soaking the traditional Chinese medicines in white spirit to treat the disease.

The invention takes traditional Chinese medicines of eucommia bark, pseudo-ginseng, astragalus root, salvia miltiorrhiza, angelica and ligusticum wallichii as the prescription for treating the senile dementia in early and middle stages, but the effect is more obvious after the traditional Chinese medicines are prepared into the wine.

The traditional Chinese medicine composition for treating senile dementia, disclosed by the invention, has the following medicinal material effects:

eucommia ulmoides: the product is prepared by peeling dried bark of Eucommia ulmoides Oliv. of Eucommiaceae for 4-6 months, scraping off coarse bark, piling up to give purple brown inner skin, and sun drying. It has the actions of tonifying liver and kidney, strengthening tendons and bones, and preventing abortion. Can be used for treating deficiency of liver and kidney, soreness of waist and knees, weakness of bones and muscles, dizziness, pregnant hemorrhage, and threatened abortion.

Pseudo-ginseng: is prepared from dried root and rhizome of Panax notoginseng (Burk.) F.H.Chen of Araliaceae, by cleaning, drying, and grinding into fine powder. It has the actions of dissipating blood stasis, stopping bleeding, subduing swelling and alleviating pain. Can be used for treating hemoptysis, hematemesis, sail blood, hematochezia, metrorrhagia, traumatic hemorrhage, thoracico-abdominal pain, and traumatic swelling and pain.

Astragalus root: the product is Astragalus membranaceus (Astragalus membranaceus) bgeracus (bgeraceae) belonging to Leguminosae

(Fisch.) dried root of either Hsiao or Astragalus membranaceus bgas Astragalum brannaceus (Fisch.) by bge. It has the effects of invigorating qi, invigorating yang, consolidating superficial resistance, arresting sweating, inducing diuresis, relieving swelling, promoting production of body fluid, nourishing blood, activating stagnancy, relieving arthralgia, expelling pus, healing sore, and promoting granulation. Can be used for treating deficiency of vital energy, asthenia, anorexia, constipation peaceful, collapse of middle-jiao energy, chronic diarrhea, rectocele, hematochezia, spontaneous perspiration, qi deficiency, edema, internal heat, diabetes, blood deficiency, hemiplegia, arthralgia, numbness, carbuncle, cellulitis, and intractable ulcer.

Red sage root: the product is dried root and rhizome of Salvia Miltiorrhiza bge of Labiatae. It has the actions of activating blood and resolving stasis, unblocking meridians to alleviate pain, clearing heart fire and relieving restlessness, cooling blood and resolving carbuncle. Can be used for treating thoracic obstruction, heart pain, abdominal pain, hypochondriac pain, abdominal mass, pain due to heat arthralgia, vexation, insomnia, menoxenia, dysmenorrhea, amenorrhea, sore , and swelling and pain.

Chinese angelica: the product is dried root of Angelica sinensis (oliv.) Diels) of Umbelliferae. Collected in late autumn, removed fibrous root and silt, bundled into small bundles after water is slightly evaporated, put on a shed, and smoked by firework. It has the actions of tonifying blood, activating blood, regulating menstruation, moistening intestines and relaxing bowels. Can be used for treating blood deficiency, sallow complexion, giddiness, palpitation, menoxenia, amenorrhea, dysmenorrhea, asthenia cold, abdominal pain, rheumatalgia, traumatic injury, superficial infection, pyocutaneous disease, intestinal dryness, and constipation. The wine angelica sinensis can activate blood and promote menstruation. Can be used for treating amenorrhea, dysmenorrhea, rheumatalgia, and traumatic injury.

Ligusticum wallichii: the product is dried rhizome of Ligusticum chuanxiong Hort of Umbelliferae. In summer, when the node disc on the stem is prominent and is purple, the stem is dug, silt is removed, and the stem is dried after being dried and then fibril roots are removed. It has the actions of activating blood and qi, dispelling wind and alleviating pain. Can be used for treating thoracic obstruction, cardialgia, stabbing pain in chest and hypochondrium, traumatic injury, menoxenia, amenorrhea, dysmenorrhea, abdominal pain due to cicatrix, headache, and rheumatalgia.

White spirit: is solid white spirit, and the raw material is corn. And (3) wine quality standard: GB/T10781.

The invention relates to an optimized prescription of Guizhou province, Qian, West and northern folk minority nationality through further argumentation of modern pharmacology, which is prepared by the following steps:

eucommia ulmoides: the chemical components comprise lignans, phenylpropanoids, iridoids, vitamin C, vitamin E, vitamin B, and carotenoid; it has regulating effects on immune system, endocrine system, central nervous system, circulatory system and urinary system, and cortex Eucommiae can excite pituitary-adrenal cortex system and enhance adrenal cortex function.

Pseudo-ginseng: the chemical components of the health-care food comprise flavone, pseudo-ginseng polysaccharide, volatile oil, sterol components, pseudo-ginseng saponins, inorganic ions, amino acids and the like. Wherein, 17 amino acids, 77 volatile oils and 24 notoginsenoside are separated. It has hemostatic, blood circulation promoting and blood tonifying effects; has effects of promoting recovery of urinary system gland and urethra inflammation; has analgesic and memory improving effects on central nervous system animal experiment; has effects of reducing blood lipid, resisting arrhythmia, reducing oxygen consumption of myocardium, relaxing blood vessel smooth muscle, reducing peripheral resistance, lowering blood pressure, lowering blood viscosity, resisting thrombi, relieving ischemic brain injury, improving cerebral blood circulation, and protecting brain tissue; has effects in improving immunity, resisting tissue edema, and promoting repair of damaged tissue; in addition, it also has antitumor activity and hepatoprotective effect.

Astragalus root: the chemical components of the health-care food comprise flavonoids, sucrose, glucuronic acid, astragalus polysaccharide A, B, C, D, mucilage, a plurality of amino acids, bitter gourmet, astragalus saponin, betaine, choline, folic acid, flavan compounds and a plurality of trace elements such as selenium, silicon, zinc, cobalt, copper, molybdenum and the like. It has effects in enhancing immunity and hematopoiesis. Improving metabolism, improving gonadal function, resisting stress, and delaying aging. Radix astragali also has effects in tonifying heart, regulating blood pressure, resisting viral myocarditis, protecting liver, and resisting ulcer.

Red sage root: the chemical components mainly comprise fat-soluble diterpenoid components and water-soluble phenolic acid components, and also comprise other components such as flavonoids, triterpenes, sterols and the like. It has effects in tonifying heart, dilating coronary artery and peripheral blood vessel, resisting thrombosis, and improving microcirculation; promoting tissue repair and regeneration; other ingredients also have liver protecting, antibacterial, and blood lipid reducing effects.

Chinese angelica: the chemical components mainly contain neutral oil components such as beta-pinene, alpha-pinene, camphene and the like. Contains acidic oil components such as p-methylbenzyl alcohol and 5-methoxy-2, 3-xylenol, organic acid, saccharide, vitamins, amino acids, etc. It has the function of bidirectional regulating uterine smooth muscle; the fluid extract has effects of resisting myocardial ischemia, resisting arrhythmia, dilating coronary artery, and increasing coronary blood flow; the angelica powder has the functions of reducing blood fat and protecting the arteriosclerotic aortic lesion to a certain extent; the angelica total acid not only has the function of improving the cellular immune function, but also has the function of promoting humoral immunity, and the angelica polysaccharide also has the function of enhancing the immunity; ligustilide as effective component in radix Angelicae sinensis has analgesic effect on central nervous system; the angelica has antibacterial effects on in vitro dysentery, typhoid, paratyphoid, escherichia coli, diphtheria bacillus, vibrio cholerae, alpha and beta hemolytic streptococcus and the like; ligustilide as radix Angelicae sinensis has antiasthmatic effect; in addition, radix Angelicae sinensis has effects of protecting liver, resisting tumor, resisting radiation, resisting inflammation, protecting kidney, resisting oxidation, and correcting protein metabolism disorder.

Ligusticum wallichii: the chemical components mainly comprise alkaloid (such as ligustrazine), volatile oil (mainly including ligustilide, xiang xuan alkene, etc.), phenols (such as ferulic acid), lactone, vitamin A, folic acid, sucrose, sterol, fatty oil, etc. It has effects in dilating coronary artery, increasing coronary blood flow, improving myocardial blood oxygen supply, and reducing myocardial oxygen consumption; dilating cerebral vessels, reducing vascular resistance, remarkably increasing blood flow of brain and limbs, and improving microcirculation; can reduce the surface activity of blood platelet, inhibit blood platelet aggregation, and prevent thrombosis; the neutral component of the ferulic acid promotes in small dose and inhibits the uterine smooth muscle in large dose; the water decoction has a sedative effect on the central nervous system of animals and has an obvious and lasting antihypertensive effect; can accelerate the absorption of local hematoma of fracture and promote the formation of callus; has effect in resisting vitamin E deficiency; can inhibit multiple bacilli; has antihistaminic and choleretic effects.

Compared with the prior art, the traditional Chinese medicine composition for treating the early-senile dementia and the middle-aged and the senile dementia and the preparation method thereof have the following beneficial effects:

1. the invention is a pure traditional Chinese medicine composition, has the effects of strengthening yin and replenishing vital essence, enabling qi to be conducted, tonifying qi and soothing nerves, benefiting orifices and removing dampness, can effectively improve the functions of cranial nerves, cerebral vessels and cerebral blood circulation, and has the functions of enhancing the immunity of organisms and enhancing hematopoiesis. Improving metabolism, improving gonadal function, resisting stress, and delaying aging, and can be used for treating senile dementia.

2. The invention has good curative effect, small toxic and side effect, safety and reliability, can be used for a long time, and has scientific and reasonable preparation method.

Detailed Description

The preparation method of the traditional Chinese medicine composition for treating the senile dementia in the early and middle stages comprises the following steps:

the method comprises the following steps: all the medicinal materials are prepared into decoction pieces according to a method specified in pharmacopoeia, the six medicinal materials are placed in a container, 50-degree white spirit is added for soaking, the mixture is stirred once every 24 hours, and after 7 days, residue is filtered to obtain the traditional Chinese medicine decoction pieces.

The product is a medicinal liquor, and 100ml of the medicinal liquor contains 1.5 g of eucommia bark.

The second method comprises the following steps: all the medicinal materials are prepared into decoction pieces by the method specified in pharmacopoeia, soaking in 50% ethanol for 24 hr, reflux extracting twice, filtering the extractive solution, recovering ethanol, adding Chinese liquor, and concocting to obtain decoction pieces

And (5) brewing the wine to 60 degrees.

The product is a medicinal liquor, and each 100ml of the product contains 1.5 g of eucommia ulmoides oliv raw medicinal materials.

The preparation process of the medicine is completely Chinese medicine, and chemical raw material components or other auxiliary materials are not added.

A method of preparing any of the compositions of the invention, the method comprising one or more of the following identification methods:

(1) vacuum removing water and ethanol at 60 deg.C, adding 10ml methanol, heating under reflux for 1 hr, filtering, and concentrating the filtrate to 1ml to obtain sample solution. And preparing 2g of eucommia ulmoides control medicinal material into control medicinal material solution by the same method. According to a thin-layer chromatography (general rule 0502) test, 5 mu l of each of the two solutions is sucked and respectively poured on the same silica gel G thin-layer plate, an upper layer solution of toluene-ethyl acetate-70% ethanol-formic acid (5.5: 1.5: 1: 0.6) is used as a developing agent, and the solution is developed, taken out, dried and inspected under ultraviolet light (365 nm). The same blue fluorescence main spot appears on the chromatogram of the test solution at the position corresponding to the chromatogram of the reference solution.

(2) Vacuum removing water and ethanol at 60 deg.C, adding 25ml methanol, ultrasonic treating for 30 min, cooling, filtering, recovering solvent from filtrate to dryness, dissolving residue with 20ml water, shaking with water saturated n-butanol for 2 times (25 ml each time), mixing n-butanol solutions, recovering solvent to dryness, and dissolving residue with 2ml methanol to obtain test solution. Taking 0.3G of pseudo-ginseng as a reference medicinal material, adding 10ml of methanol, heating and refluxing for 20 minutes, filtering, concentrating the filtrate to 2ml, using the solution of the reference medicinal material as a test of thin layer chromatography, sucking each 24 of the two solutions, respectively dropping the two solutions on a same silica gel G thin layer plate, taking an upper layer solution of n-butyl alcohol-ethyl acetate-water (4: 1: 5) as a developing agent, developing, taking out, drying in the air, spraying a 10% sulfuric acid ethanol solution, heating at 105 ℃ until spots are clear in color, and respectively inspecting under sunlight and ultraviolet light (365 nm). In the chromatogram of the test solution, spots with the same color appear in the corresponding positions of the chromatogram of the reference medicinal material under sunlight; the fluorescent spots of the same color appear under ultraviolet light.

(3) Collecting 100ml of the product, removing water and ethanol at 60 ℃ in vacuum, adding 30ml of ethanol, heating and refluxing for 20 minutes, filtering, recovering solvent from the filtrate until the solvent is dry, adding 20ml of 0.3% sodium hydroxide solution into the residue to dissolve the residue, adjusting the pH value to 5-6 with dilute hydrochloric acid, shaking and extracting with ethyl acetate for 2 times, 20ml each time, collecting ethyl acetate solution, filtering with filter paper paved with a proper amount of anhydrous sodium sulfate, recovering solvent from the filtrate until the filtrate is dry, and adding ethyl acetate lml into the residue to dissolve the residue to obtain a sample solution. Preparing a reference medicinal material lg of astragalus mongholicus, and preparing a reference medicinal material solution by the same method. According to a thin layer chromatography test, sucking 5 μ l of each of the two solutions, respectively dropping on the same silica gel G thin layer plate, developing with chloroform-methanol (10: 1) as developing agent, taking out, air drying, fumigating with ammonia vapor, and inspecting under ultraviolet light (365 nm). In the chromatogram of the test solution, fluorescent spots with the same color appear at the corresponding positions of the chromatogram of the reference solution.

(4) Also comprises the following steps:

the chlorogenic acid of Eucommiae cortex is determined by high performance liquid chromatography (general rule 0512).

Octadecylsilane chemically bonded silica is used as a filler in chromatographic conditions and system applicability tests; acetonitrile-1% glacial acetic acid solution (10: 90) is used as a mobile phase; the detection wavelength was 327 nm. The number of theoretical plates is not less than 800 calculated according to chlorogenic acid peak.

Preparation of control solution A suitable amount of chlorogenic acid control was precisely weighed, placed in a brown measuring flask, and 50% methanol was added to make a solution containing 5 μ g per lm.

Preparing sample solution by taking 80ml of the product, removing water and ethanol at 60 ℃ under vacuum, precisely adding 50ml of 50% methanol, weighing, performing ultrasonic treatment (power 500W and frequency 40 kHz) for 45 minutes, cooling, weighing again, supplementing lost weight with 50% methanol, shaking up, filtering, and taking the subsequent filtrate.

The determination method comprises precisely sucking 10 μ l of each of the reference solution and the sample solution, injecting into liquid chromatograph, and determining.

The content of Eucommiae cortex in per 10ml of the product is not less than 0.008mg calculated by chlorogenic acid (C16H 18O 9).

Notoginseng radix is determined by high performance liquid chromatography (general rule 0512).

Octadecylsilane chemically bonded silica is used as a filler in chromatographic conditions and system applicability tests;

acetonitrile is taken as a mobile phase A, water is taken as a mobile phase B, and gradient elution is carried out according to the specification in the following table; the detection wavelength was 203 nm. The number of theoretical plates is not less than 4000 according to the peak of notoginsenoside R1.

Time (min) mobile phase A (%) mobile phase B (%)

0- 1219 81

12- 6019→36 81→64

Preparing reference solution by taking ginsenoside Rg1 reference, ginsenoside Rb1 reference,

Accurately weighing appropriate amount of ginsenoside Re reference substance and notoginsenoside R1 reference substance, and adding methanol to obtain a solution containing ginsenoside Rg1200 μ g and ginsenoside Rg per 1ml_Rb1200 mug of ginsenoside Re 50 mug and notoginsenoside_R1Mixing the solution with 50 mu g to obtain the product.

Preparing test solution by taking 10ml of the product, placing the product in a conical flask with a plug, removing water and ethanol at 60 ℃ in vacuum, precisely adding 25ml of 50% ethanol, sealing the plug, weighing, carrying out ultrasonic treatment (power 300W, frequency 45kHz) for 30 minutes, cooling, weighing again, supplementing the lost weight with 50% ethanol, shaking up, filtering, and taking the subsequent filtrate to obtain the product.

The determination method precisely absorbs 10 μ l of the reference solution and 10-20 μ l of the test solution respectively, and injects

And (5) performing determination by using a liquid chromatograph to obtain the product.

The product contains ginsenoside Rg1 (C) per 10ml₄₂H₇₂O₁₄) Ginsenoside Rb1 (C)₅₄H₉₂O₂₃) Ginsenoside Re (C)₄₈H₈₂O₁₈) And notoginsenoside R1 (C)₄₇H₈₀O₁₈) Should not be less than 9.5mg in total.

Radix astragali was measured by high performance liquid chromatography (general rule 0512).

Octadecylsilane chemically bonded silica is used as a filler in chromatographic conditions and system applicability tests; acetonitrile-water (32:68) is used as a mobile phase; detection by an evaporative light scattering detector. The number of theoretical plates is not less than 4000 calculated according to astragaloside IV peak.

Preparation of control solution A proper amount of astragaloside IV control is precisely weighed, and added with methanol to obtain solution containing 0.2mg per lml.

Preparing a test solution, taking 35ml of the test solution, placing the test solution in a conical flask with a plug, removing water and ethanol in vacuum at 60 ℃, adding 40ml of methanol, carrying out ultrasonic treatment (power 300W and frequency 45kHz) for 60 minutes, cooling, filtering, washing the conical flask and filter paper by using a small amount of methanol in a split mode, combining filtrate and washing liquor, drying by distillation, adding 20ml of water into residues for dissolving, shaking and extracting by using water-saturated n-butyl alcohol for 4 times, 40ml each time, combining n-butyl alcohol liquid, washing by using ammonia test solution for 2 times, 40ml each time, discarding ammonia liquid, recovering a solvent from the n-butyl alcohol liquid until the residues are dry, adding an appropriate amount of methanol into the residues for dissolving, transferring the residues into a 5ml measuring flask, adding methanol to the scale, and shaking to obtain the.

The determination method comprises precisely sucking 5 μ l and 10 μ l of reference solution and 15 μ l of test solution, respectively, injecting into liquid chromatograph, determining, and calculating with logarithmic equation by external standard two-point method.

The content of radix astragali in per 10ml of the product is not less than 20 μ g, calculated as astragaloside (C41H68O14)

The alcohol amount should be 5-60% (general 0711).

The total solid is measured precisely to obtain 50ml of the product, and checked according to the Law (general rule 0185 first Law). The total solid content of the product should not be less than 0.150% (g/ml).

Other regulations (general rule 0185) are in line with the wine.

The above-mentioned embodiments are merely illustrative of the preferred embodiments of the present invention, and do not limit the scope of the present invention, and variations and modifications of the technical solution of the present invention by those skilled in the art without departing from the spirit of the present invention should fall within the protective scope defined by the claims of the present invention.

The composition is administered orally with water in an empty stomach to relieve irritation of gastric mucosa; 25 ml-75 ml before meal, but not more than individual alcohol tolerance, is administered 1-3 times a day for 30 days as a treatment course. The product can be stored for a long time and then a little precipitate appears, which is normal, and the product can be taken after being shaken up.

Other effects the traditional Chinese medicine formula of the invention has treatment effects on the brain function retrogression of the middle-aged and the elderly, and also has the following functions: improving microcirculation and softening blood vessels; accelerating wound tissue healing, improving tissue dehydration condition, etc.

It should be noted that:

strictly forbidding taking of the medicine in excess of the alcohol tolerance of the user;

fasting greasy food during treatment;

it is forbidden for pregnant women, women in menstrual period, and children;

patients with serious hepatic and renal insufficiency and patients with serious hypertension are forbidden;

it is forbidden for patients allergic to alcohol;

patients with acute or subacute bacterial and viral infections are prohibited;

patients taking cephalosporin and furan antibiotics and other contraindications with contraindications to alcohol;

it is not taken with sour, raw, astringent, tea, etc. to avoid affecting the therapeutic effect.