阅读说明：本技术 治疗糖尿病的铁皮石斛组合物及其制备方法和应用 (Dendrobium officinale composition for treating diabetes and preparation method and application thereof ) 是由 徐雯欣 黎姗 严姝苓 袁丽 徐涛 范浩宇 于 2021-09-13 设计创作，主要内容包括：本发明公开了一种治疗糖尿病的石斛组合物,其原料由以下重量份的成分组成：铁皮石斛10～12份、藏红花5～10份、三七15～18份、甘草15～16份、麦冬10～12份。本发明还同时提供了上述治疗糖尿病的石斛组合物的制备方法,包括以下步骤：原料先进行醇提,再进行水提,醇提液和水提所得的上清液混合,减压浓缩,获得干膏,将干膏粉碎,得到治疗糖尿病的石斛组合物。本发明的石斛组合物能用于治疗糖尿病。(The invention discloses a dendrobium nobile composition for treating diabetes, which is prepared from the following raw materials in parts by weight: 10-12 parts of dendrobium officinale, 5-10 parts of saffron crocus, 15-18 parts of pseudo-ginseng, 15-16 parts of liquorice and 10-12 parts of radix ophiopogonis. The invention also provides a preparation method of the dendrobium composition for treating diabetes, which comprises the following steps: the raw materials are firstly extracted by alcohol and then extracted by water, the supernatant fluid obtained by extracting the alcohol extract and the water is mixed, and then the mixture is concentrated under reduced pressure to obtain dry paste, and the dry paste is crushed to obtain the dendrobium composition for treating diabetes. The dendrobium composition can be used for treating diabetes.)

1. The dendrobium composition for treating diabetes is characterized by comprising the following raw materials in parts by weight: 10-12 parts of dendrobium officinale, 5-10 parts of saffron crocus, 15-18 parts of pseudo-ginseng, 15-16 parts of liquorice and 10-12 parts of radix ophiopogonis.

2. The dendrobe composition for treating diabetes according to claim 1, wherein the dendrobe composition is prepared from the following raw materials in parts by weight: 10 parts of dendrobium officinale, 5 parts of saffron crocus, 15 parts of pseudo-ginseng, 15 parts of liquorice and 10 parts of radix ophiopogonis.

3. The method for preparing the dendrobium composition for treating diabetes according to claim 1 or 2, which comprises the following steps:

1) adding ethanol solution into the raw materials according to the material-liquid ratio of 1g of raw materials to 5-8 ml of ethanol solution, and performing ethanol extraction at 70-95 ℃ for 30-200 minutes to obtain ethanol extract and filter residue respectively;

the volume concentration of ethanol in the ethanol solution is 75-95%;

2) adding purified water into the filter residue obtained in the step 1) according to the material-liquid ratio of 1g of raw material to 10-15 ml, and carrying out water extraction at 80-100 ℃, wherein the water extraction time is 30-120 minutes, so as to obtain a water extract;

standing the water extract at room temperature, cooling for 6-8 hours, and taking supernatant;

3) mixing the alcohol extract obtained in the step 1) with the supernatant obtained in the step 2), concentrating under reduced pressure to obtain dry paste, and crushing the dry paste to obtain the dendrobium nobile composition for treating diabetes.

4. The method for preparing the dendrobium composition for treating diabetes according to claim 3, wherein the dendrobium composition comprises the following components in percentage by weight: the dendrobium composition is prepared into tablets, granules, capsules or honeyed pills.

5. The method for preparing the dendrobium composition for treating diabetes according to claim 3 or 4, wherein the dendrobium composition comprises the following components:

the alcohol extraction frequency of the step 1) is 1-4, the alcohol extraction time of each time is 30-50 minutes, and the alcohol is filtered by a screen with the filter diameter less than or equal to 3 mm;

the water extraction frequency of the step 2) is 1-2, the water extraction time of each time is 30-60 minutes, and the water is filtered by a screen with the filter diameter not more than 2 mm.

6. The method for preparing the dendrobium composition for treating diabetes according to claim 5, wherein the dendrobium composition comprises the following components in percentage by weight:

the step 1):

adding ethanol solution into the raw materials according to the material-liquid ratio of 1g raw materials/6 ml ethanol solution, and performing ethanol extraction at 85 ℃ for 2 times, wherein the ethanol extraction time is 40 minutes each time; combining all the alcohol extract solutions; the volume concentration of ethanol in the ethanol solution is 75 percent;

the step 2):

adding purified water into the filter residue obtained in the step 1) according to the material-liquid ratio of 1g of raw material/10-12 ml, carrying out water extraction at 90 ℃, wherein the water extraction frequency is 1 time, the water extraction time is 45 minutes each time, standing and cooling the obtained water extraction liquid at room temperature for 6-8 hours, and taking supernatant.

7. Use of the dendrobe composition prepared by the method according to any one of claims 3 to 6 in preparation of a medicament for treating diabetes.

8. Use according to claim 7, characterized in that: the diabetes is type I diabetes, type II diabetes and secondary diabetes.

Technical Field

The invention relates to the field of medicines, and particularly relates to a dendrobium nobile composition for treating diabetes, and a preparation method and application thereof.

Background

Diabetes has become a common disease and a frequently encountered disease with mortality rate second to cancer, AIDS and cardiovascular diseases in many countries in the world, and about 1 hundred million diabetics exist in China at present and are the second largest diabetic country in the world; clinically, the type II diabetes, which is called non-insulin-dependent diabetes, is also called adult-onset diabetes, frequently occurs after the age of 35-40 years, and is slow in onset and hidden, and some patients are found in health examination or other diseases. The ability of insulin production in patients with type II diabetes is not completely lost, and some patients even produce excessive insulin, but the action effect of the insulin is greatly reduced, so that the insulin in the patients is relatively deficient; can stimulate the secretion of insulin in vivo through some oral medicines, but still some patients need insulin treatment like type I diabetic patients in the later period; the main objectives of diabetes therapy include: correct metabolic disorders, eliminate symptoms, maintain good living and working abilities: preventing various acute or chronic complications and accompanying symptoms, prolonging life, and reducing disability rate and death; in the existing hypoglycemic drugs used clinically, various western medicines have certain limitations and serious adverse reactions, such as hypoglycemia, lactic acidosis and the like, while the traditional Chinese medicines lack hypoglycemic preparations which are definite in curative effect, definite in medicinal mechanism and easy to accept by clinicians and patients, so far, no medicine can completely cure diabetes, and western medicines can only control blood sugar.

Dendrobium officinale, also called Equisetum nigrum, is a traditional and rare traditional Chinese medicine in China, has the effects of nourishing yin, promoting the production of body fluid, clearing heat, protecting liver, invigorating spleen, benefiting stomach, regulating immunity and the like, can be used for treating diseases such as fever body fluid deficiency, stomach yin deficiency, persistent asthenic fever after disease, yin deficiency and fire excess, and the like, contains dendrobium polysaccharides as the main medicinal component, dendrobine, flavone and some trace elements in addition, pharmacological research finds that DOP has pharmacological effects of resisting oxidation and aging, treating asthma, reducing blood sugar, improving immunity and the like, and is commonly used for clinical treatment of qi-yin deficiency type T2DM in recent years.

The invention CN110585363A discloses a substitutional tea with the function of reducing three highs and a preparation method thereof, and the substitutional tea comprises the following raw materials: lalang grass rhizome, leaves of spring jujube, lotus leaves, mung bean skins, black tea, fragrant solomonseal rhizome, dendrobium officinale, grape seeds, panax japonicus, radix scrophulariae, mulberry, Chinese dodder, ginseng leaves, ginseng, oldenlandia diffusa, honeysuckle, saffron, liquorice, red bean skins, astragalus membranaceus, pseudo-ginseng, lotus seeds and radix scrophulariae. Can reduce the formation of blood coagulation factors, has the functions of resisting thrombus, resisting oxidation, neutralizing acid-base balance, removing blood and vessel wall garbage and the like, can reduce the blood fat index by 20-60 percent, balance blood pressure and obviously reduce three highs. No mention is made in its entirety about the reduction of blood glucose.

CN107912546A invention discloses a lucid ganoderma, dendrobe and red sage root black tea for reducing high blood pressure, high blood sugar, high blood fat and high blood fat, and a processing technology thereof, and the lucid ganoderma, dendrobe and red sage root black tea comprises the following raw materials: main materials: fresh black tea leaves, purple lucid ganoderma slices, dendrobium officinale slices, purple flower salvia miltiorrhiza, saffron crocus and eucommia male flowers; auxiliary materials: fructus crataegi slice, herba Apocyni Veneti, herba Gynostemmatis, Ginseng radix, radix Panacis Quinquefolii, Cordyceps, cornu Cervi Pantotrichum, nidus Collocaliae, rhizoma Gastrodiae, Hippocampus, Stichopus japonicus, colla Corii Asini, Cistanchis herba, herba Cynomorii, herba Epimedii, maca, cyclocarya paliurus, radix Puerariae, rhizoma Polygonati, semen Cassiae, folium Ginkgo, Notoginseng radix, herba Taxilli, stigma Maydis, flos Lonicerae, Poria, fructus Lycii, radix astragali, folium Nelumbinis, Prunellae Spica, folium kaki, flos Pruni mume, flos Hibisci Luffae, radix Arctii, Pu her tea, black tea, green tea, white tea, oolong tea, and yellow tea; neutralizing materials: pericarpium Citri Tangerinae, fructus Hordei vulgaris, folium Mori, Glycyrrhrizae radix, flos Chrysanthemi, and flos Rosae Rugosae.

Disclosure of Invention

The invention aims to solve the technical problem of providing a dendrobium nobile composition with good curative effect for treating diabetes and a preparation method and application thereof.

In order to solve the technical problems, the invention provides a dendrobium nobile composition for treating diabetes, which comprises the following raw materials in parts by weight: 10-12 parts of dendrobium officinale, 5-10 parts of saffron crocus, 15-18 parts of pseudo-ginseng, 15-16 parts of liquorice and 10-12 parts of radix ophiopogonis.

As an improvement of the dendrobium composition for treating diabetes, the dendrobium composition comprises the following raw materials in parts by weight: 10 parts of dendrobium officinale, 5 parts of saffron crocus, 15 parts of pseudo-ginseng, 15 parts of liquorice and 10 parts of radix ophiopogonis.

The invention also provides a preparation method of the dendrobium composition for treating diabetes, which comprises the following steps:

1) adding ethanol solution into the raw materials according to the material-liquid ratio of 1g of raw materials to 5-8 ml of ethanol solution, and performing ethanol extraction at 70-95 ℃ for 30-200 minutes to respectively obtain ethanol extract (ethanol extract) and filter residue;

the volume concentration of ethanol in the ethanol solution is 75-95%;

description of the drawings: the raw materials are firstly cleaned and drained according to a conventional mode, and then alcohol extraction is carried out;

2) adding purified water into the filter residue obtained in the step 1) according to a material-liquid ratio of 1g of raw material/10-15 ml, and performing water extraction at 80-100 ℃ (namely, heating with slow fire to keep the filter residue slightly boiling), wherein the water extraction time is 30-120 minutes, so as to obtain a water extraction solution;

standing the water extract at room temperature, cooling for 6-8 hours, and taking supernatant;

3) mixing the alcohol extract obtained in the step 1) and the supernatant obtained in the step 2), concentrating under reduced pressure (so as to remove all ethanol and most water) to obtain dry paste (the water content of the dry paste is less than or equal to 10%), and crushing the dry paste (crushing and sieving by a 120-mesh sieve) to obtain the dendrobium composition for treating diabetes.

The improvement of the preparation method of the dendrobium composition for treating diabetes comprises the following steps: the dendrobium composition is prepared into tablets, granules, capsules or honeyed pills.

The preparation method of the dendrobium composition for treating diabetes is further improved as follows:

the alcohol extraction frequency of the step 1) is 1-4, the alcohol extraction time of each time is 30-50 minutes, and the alcohol is filtered by a screen with the filter diameter less than or equal to 3 mm;

description of the drawings: when the extraction times exceed 1 time, the filter residue obtained by alcohol extraction and filtration is used for replacing the raw material to repeatedly carry out alcohol extraction; combining all the alcohol extract solutions; refrigerating the alcohol extract at 4 ℃ for later use;

the water extraction frequency of the step 2) is 1-2, the water extraction time of each time is 30-60 minutes, and the water is filtered by a screen with the filter diameter less than or equal to 2 mm;

description of the drawings: when the extraction times exceed 1 time, the filter residue obtained by water extraction and filtration is used for replacing the filter residue obtained in the step 1) for repeated water extraction; all the water extract solutions are combined and then subjected to subsequent standing and cooling.

The preparation method of the dendrobium composition for treating diabetes is further improved as follows:

the step 1):

adding ethanol solution into the raw materials according to the material-liquid ratio of 1g raw materials/6 ml ethanol solution, and performing ethanol extraction at 85 ℃ for 2 times, wherein the ethanol extraction time is 40 minutes each time; combining all the alcohol extract solutions; the volume concentration of ethanol in the ethanol solution is 75 percent;

the step 2):

adding purified water into the filter residue obtained in the step 1) according to the material-liquid ratio of 1g of raw material/10-12 ml, carrying out water extraction at 90 ℃, wherein the water extraction frequency is 1 time, the water extraction time is 45 minutes each time, standing and cooling the obtained water extraction liquid at room temperature for 6-8 hours, and taking supernatant.

The invention also provides application of the dendrobium composition prepared by the method in preparation of a medicament for treating diabetes.

As an improvement of the application of the invention: the diabetes is type I diabetes, type II diabetes and secondary diabetes.

The pharmacological actions of the raw materials in the invention comprise:

dendrobium officinale: the dendrobium officinale is an orchid family herbaceous plant, and the stem of the dendrobium officinale is used as a medicine, is sweet in taste and slightly cold in nature, has the effects of promoting the production of body fluid, nourishing the stomach, nourishing yin, clearing heat, moistening lung, tonifying kidney, improving eyesight and strengthening waist, and has an obvious effect on people with yin deficiency and weakness. Dendrobium officinale has the effect of nourishing yin, and is suitable for people with yin deficiency and body fluid injury, dry mouth, dry nose and dry eyes. It contains various pharmacological components beneficial to human health, such as polysaccharide, alkaloid, amino acid, trace elements, etc. The dendrobium officinale also contains amino acids necessary for human bodies and is rich in microelements necessary for human bodies, such as copper, iron, zinc, calcium, potassium, magnesium and the like. Due to numerous pharmacological actions of dendrobium officinale, the dendrobium officinale has the effects of digesting systems, circulating systems, relieving heat, alleviating pain, resisting inflammation and the like.

Saffron: saffron is a bulbous herbaceous plant of crocus of iridaceae, has strong effects of promoting blood circulation to remove blood stasis and resolving stagnation to eliminate stagnation, and has been used clinically. The dry stigma of saffron is sweet in taste and mild in nature; heart and liver meridian entered; promoting blood circulation, cooling blood, removing toxic substances, resolving stagnation, and tranquilizing mind; can be used for treating amenorrhea, puerperal stagnation, toxic heat, speckle, melancholy, stuffiness, palpitation, and mania; modern pharmacology indicates that saffron has the effects of promoting blood circulation to remove blood stasis, resisting cancer in a broad spectrum, strengthening immunity and treating cardiovascular and cerebrovascular diseases. In recent years, research shows that saffron has good anticancer activity and almost no toxic or side effect.

Pseudo-ginseng: notoginseng radix is Araliaceae plant, and has slightly bitter taste, warm nature, liver, stomach, heart and small intestine channels, has effects of stopping bleeding, dispelling blood stasis, relieving swelling and pain, tonifying deficiency, strengthening body, enhancing immunity and inhibiting tumor, and is mainly prepared from soap compounds for treating hemoptysis, traumatic hemorrhage, and traumatic injury with swelling and pain. In recent years, modern pharmacological research shows that the health-care tea can soften blood vessels, promote blood circulation, reduce blood fat, promote blood circulation, nourish face, treat coronary heart disease, resist heart pain, resist thrombus, diabetes and other diseases after being taken for a long time; the evaluation on the aspect of treating blood diseases is high.

Licorice root: the Glycyrrhrizae radix is Leguminosae plant, and its effective components mainly include licoflavone, glycyrrhizic acid, glycyrrhetinic acid, and Glycyrrhiza polysaccharide. The Glycyrrhrizae radix has effects of resisting oxidation, resisting virus, resisting tumor, invigorating spleen, invigorating qi, clearing heat and toxic substances, eliminating phlegm, relieving cough, relieving spasm and pain, etc., and can be used for treating spleen and stomach weakness, listlessness debilitation, cardiopalmus short breath, cough with excessive phlegm, abdominal cavity, extremity spasm and pain, carbuncle swelling and sore toxin, etc., and relieving drug toxicity, pungency and immunoregulation etc. The honey-fried licorice root is a processed product of liquorice and has sweet taste and mild property; the medicine has the effects of invigorating spleen, replenishing qi, moistening lung, relieving cough, relieving drug property, clearing away heat and toxic materials; can be used for treating weakness of spleen and stomach, deficiency of middle-warmer energy, cough, and asthma.

Radix ophiopogonis: liliaceae Ophiopogon genus perennial evergreen herb, sweet, slightly bitter, slightly cold in nature; entering stomach, lung and heart meridians; moistening lung, clearing heart fire, clearing heat, promoting fluid production, eliminating phlegm, relieving vomit, and treating cough; can be used for treating dry cough due to lung dryness, tuberculosis due to yin deficiency, pharyngitis, pharyngalgia, thirst due to body fluid consumption, internal heat, diabetes, vexation, insomnia, and constipation due to intestinal dryness; modern pharmacological research shows that radix ophiopogonis mainly contains ophiopogonin, steroid saponin, alkaloid, sitosterol, glucose, amino acid, vitamin and the like, and has the effects of resisting fatigue, removing free radicals, improving cellular immune function and reducing blood sugar; radix Ophiopogonis has tranquilizing, hypnotic, myocardial ischemia resisting, and heart rhythm resisting effects, and can be used in medicine for treating diabetes and secondary diabetes.

The invention is not suitable for patients with gestational diabetes because the invention is matched with the liquorice and the saffron.

The use method and the dosage of the invention are as follows: the dendrobium nobile lindl composition is orally taken, and the dosage of each person is about 3-9 g.

Compared with the prior art, the invention has the following technical advantages:

the combination of the selected traditional Chinese medicines is based on the understanding and treatment principle of the traditional Chinese medicine on the pathogenesis of diabetes, and by referring to the modern pharmacological research results, through mutual cooperation of all raw medicines, combination of all the medicines, and compatibility of the selected medicinal materials are appropriate, so that the traditional Chinese medicine and modern medical and pharmaceutical theories are met, the weight parts of all the raw medicines are optimized, the insulin content of experimental type II diabetic rats can be obviously improved, the insulin resistance can be relieved, and meanwhile, the effects of regulating the blood lipid metabolism disorder of experimental diabetic nephropathy rats and improving the kidney injury are achieved; clinical tests show that taking type II diabetes as an example, the total effective rate of the traditional Chinese medicine composition for treating type II diabetes patients is more than 95%, the traditional Chinese medicine composition has significant difference with a metformin hydrochloride tablet control group, and is superior to metformin hydrochloride tablets in the aspects of improving clinical symptoms of type II diabetes and regulating lipid metabolism; the invention has simple raw materials, simple and convenient preparation method and low cost, is used for preparing the medicine for treating II diabetes and secondary diabetes, and has good curative effect and quick response.

In conclusion, when the dendrobium composition is used for treating diabetes, the dendrobium composition has the advantages of good curative effect, quick response, small toxic and side effects, convenience in preparation, capability of improving the immunity of the organism, comprehensively conditioning metabolic disorders, having a certain repairing effect on pancreatic tissue damage, capability of inhibiting the expression of the mRNA of the insulinase gene, small side effects, no drug dependence of patients and the like.

Detailed Description

The invention will be further described with reference to specific examples, but the scope of the invention is not limited thereto:

example 1, a dendrobium composition;

the dendrobium composition comprises the following raw materials in parts by weight: 10 parts of dendrobium officinale, 5 parts of saffron crocus, 15 parts of pseudo-ginseng, 15 parts of liquorice and 10 parts of radix ophiopogonis.

The preparation method comprises the following steps in sequence:

1) removing impurities from the raw materials, cleaning and draining in a conventional manner;

then according to the material-liquid ratio of 1g of raw material/6 ml of ethanol solution (75% ethanol aqueous solution by volume concentration), adding the ethanol solution into the raw material, and carrying out ethanol extraction at 85 ℃ for 2 times, wherein the ethanol extraction time is 40 minutes each time; filtering with a screen with a filter diameter of 3mm after each alcohol extraction;

during the 2 nd alcohol extraction, the filter residue obtained by filtering after the first alcohol extraction is used for replacing the raw material to repeatedly carry out the alcohol extraction; merging the 2 times of alcohol extraction liquid; refrigerating the alcohol extract at 4 ℃ for later use;

2) adding purified water into the filter residue obtained in the step 1) (filter residue obtained by secondary alcohol extraction) according to a material-liquid ratio of 1g of raw material/10-12 ml, performing water extraction at 90 ℃ (heating the filter residue with slow fire to keep the filter residue slightly boiling), wherein the water extraction frequency is 1 time, the water extraction time is 45 minutes each time, and filtering the filter residue with a screen with the filter diameter of 2mm after the water extraction is finished to obtain a water extraction solution; and cooling and standing the water extract at room temperature for 6-8 h, and taking supernatant.

3) Mixing the alcohol extract obtained in the step 1) and the supernatant obtained in the step 2), concentrating under reduced pressure at 70 ℃ under the pressure of 0.1MPa for 120 minutes to remove all ethanol and most water to obtain dry extract (the water content of the dry extract is less than or equal to 10 percent), and crushing the dry extract (crushing and sieving with a 120-mesh sieve) to obtain the dendrobium composition for treating diabetes.

About 28g of dendrobium composition can be obtained by 100g of raw materials.

Finally, the dendrobium composition is prepared into tablets, granules, capsules or honeyed pills according to a conventional method.

Example 2, the raw material formula of example 1 is changed into 8 parts of dendrobium officinale, 3 parts of saffron crocus, 9 parts of pseudo-ginseng, 10 parts of liquorice and 8 parts of radix ophiopogonis, and the balance is equal to example 1.

Example 3, the raw material formula of example 1 is changed into 15 parts of dendrobium officinale, 8 parts of saffron crocus, 12 parts of pseudo-ginseng, 16 parts of liquorice and 12 parts of radix ophiopogonis, and the balance is equal to example 1.

Experiment 1, clinical study of stage II diabetic patients

The dendrobium composition prepared in the embodiments 1-3 of the invention is used for treating patients with stage II diabetes, the patients are divided into 3 groups, each group comprises 30 cases, and 30 cases of metformin hydrochloride treatment are used as a control group.

The specific experimental method is as follows:

1. materials and methods

1) 120 patients were divided into 30 treatment groups of 1-3 groups and 30 control groups, and each group had age, sex, course of disease, weight, fasting plasma glucose (FBG) and 2-hour blood glucose after breakfast, and had no obvious difference through statistical treatment and had comparability.

2) The diagnostic standard fasting blood sugar is more than or equal to 7.0mmol/L (or the random blood sugar is more than or equal to 11.1mmol/L), or the blood sugar is more than or equal to 11.1mmol 1/L after 2h of oral glucose tolerance test.

3) Treatment and observation methods

The treatment method comprises the following steps: all patients stop taking all the medicines with the functions of reducing blood sugar and blood fat. On the basis of diet control, exercise and diabetes education, the control group is administered with 0.5g metformin hydrochloride tablet, and is orally administered 2 times a day (1 tablet each time); 1-3 groups of treatment are given with the medicine (the dendrobium composition) of the invention, and the medicine is orally taken three times a day, 2 capsules are taken each time, and the amount of the dendrobium composition as an effective component in each capsule is 1.5 g;

each group is treated for 3 courses of treatment, with 4 weeks as 1 course.

② observation of clinical symptom score, FBG, glycated hemoglobin (HbAlc), Total Cholesterol (TC), Triglyceride (TG), low-density lipoprotein cholesterol (LDL-C).

Thirdly, the statistical method adopts t test for the measurement data and x test for the counting data²And (6) checking.

4) The standard of curative effect judgment refers to the standard of curative effect in the guiding principle of on-site research of new traditional Chinese medicines:

the effect is shown: the symptom integral is reduced by more than or equal to 70 percent, FBG is normal or reduced by more than 40 percent, HbAlc is normal or reduced by more than 30 percent, and TC, TG and LDL-C are improved by more than 30 percent or recovered to be normal;

the method has the following advantages: the symptom integral is reduced by more than or equal to 30 percent, FBG is normal or reduced by more than 20 percent, HbAlc is normal or reduced by more than 10 percent, and TC, TG and LDL-C are improved compared with those before treatment but are not enough to show the effect standard;

and (4) invalidation: clinical symptoms change or aggravate or are less than 30%, and laboratory indexes are unchanged or increased.

2. Results

1) 1 treatment group has 23 cases of obvious effect, 6 cases of effect and 1 case of no effect, and the total effective rate is 96 percent.

The treatment of 2 groups has 21 cases with obvious effect, 6 cases with effective effect and 3 cases with ineffective effect, and the total effective rate is 90 percent.

The treatment of 3 groups has 19 cases with obvious effect, 7 cases with effect and 4 cases with no effect, and the total effective rate is 87%.

The control group has 18 effective cases, 6 effective cases and 6 ineffective cases, and the total effective rate is 80 percent.

2) For the HbAlc detection standard, see Table 1 below:

TABLE 1

The total effective rates of all groups are compared, the treatment group is superior to the control group, wherein the treatment group 1 has the optimal effect, and the invention has extremely high cure rate and effective rate under the mutual compatibility of all raw materials.

Clinical symptom score the improvement of clinical indexes before and after treatment of each group is shown in table 1; compared before and after treatment, the treatment groups 1-3 have very significant difference (P is less than 0.01), and the control group has statistical significance (P is less than 0.05); after each group of treatment, the traditional Chinese medicine composition has significant difference (P <0.01), and the traditional Chinese medicine composition is better than western medicines in the aspect of improving the clinical symptoms of stage II diabetes.

Comparative example 1, the formulation of example 1 was changed to: 10 parts of dendrobium officinale, 17 parts of pseudo-ginseng, 17 parts of liquorice and 11 parts of radix ophiopogonis. The rest is equivalent to embodiment 1.

Experiment 2, the dendrobium compositions obtained in examples 1 to 3 and comparative example 1 were subjected to the following rat experiments:

after a plurality of experimental rats are prepared into type II diabetic rats, 60 rats with obvious symptoms and proper weight (about 160-200 g) are selected and grouped into 10 cases of treatment groups 1-3 and 10 cases of control groups (control drugs), 10 cases of comparative example 1 and 10 cases of nonsense drugs. In the experiment, the dendrobium compositions obtained in the examples 1 to 3 and the comparative example 1 are prepared into the required concentration by water, the daily dosage is 4g of the dendrobium composition/kg, and the stomach is irrigated once a day; metformin hydrochloride was drenched into the control group.

Before administration, the difference of the sex, the weight, the fasting blood sugar (FBG) and the blood sugar 2 hours after the feed in each group is not obvious after statistical treatment, and the feed has comparability; metformin hydrochloride is used as a control group of the drivers, and Fasting Blood Glucose (FBG) before the drivers and HbAlc 2 hours after the feeds are measured in each group. The results obtained are shown in Table 2 below:

TABLE 2

Treatment 1 group had the best treatment effect. The invention can obviously reduce the fasting plasma glucose (FBG) of experimental type II diabetes and can play a role in reducing the glycated protein (HbAlc) of rats.

Finally, it should be noted that: the above examples are only for illustrating the technical solutions of the present invention, and not for limiting the same; although the present invention is described in detail with reference to the foregoing embodiments, it should be understood by those of ordinary skill in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some of the technical features may be equally replaced; the modifications or substitutions can make the technical scheme more perfect, and do not make the essence of the corresponding technical scheme depart from the spirit and scope of the technical scheme of the embodiment of the invention.