CN104815166B - A kind of Chinese medicine composition for treating diabetes and its preparation and application - Google Patents

Abstract

The invention relates to a traditional Chinese medicine composition, in particular to a traditional Chinese medicine composition for treating diabetes and its preparation and application, belonging to the field of traditional Chinese medicine. The traditional Chinese medicine composition for treating diabetes of the present invention, its raw material composition comprises cornus, ginseng, raw land, sealwort, astragalus, white peony root, medlar, anemarrhena, root ginseng, coptis, black plum, guava peel, oyster, silver Bupleurum, Huhuanglian, Danshen, Guijianyu, Aloe Vera, Polygonum cuspidatum. The traditional Chinese medicine composition of the invention nourishes qi and nourishes yin, clears away heat and promotes fluid production. It is used for type II diabetes with dryness, heat, body fluid and deficiency of both qi and yin. Symptoms include excessive thirst, frequent urination, elimination of grains and good hunger, gradual thinning, fatigue, spontaneous sweating, night sweats, dysphoria and fever, and turbid urine. Constipation etc.

Description

A kind of traditional Chinese medicine composition for treating diabetes and its preparation and application

technical field

The invention relates to a traditional Chinese medicine composition, in particular to a traditional Chinese medicine composition for treating diabetes and its preparation and application, belonging to the field of traditional Chinese medicine.

Background technique

Diabetes (diabetes) is a metabolic disease characterized by hyperglycemia. Together with hypertension and hyperlipidemia, it is called the "three highs". Various pathogenic factors such as mental factors act on the body to cause a series of metabolic disorder syndromes such as sugar, protein, fat, water and electrolytes caused by hypofunction of pancreatic islets and insulin resistance. Especially "adult-onset diabetes" has a particularly high infection rate among middle-aged people over the age of forty. The long-term high blood sugar in diabetes leads to chronic damage and dysfunction of various tissues, especially the eyes, kidneys, heart, blood vessels, and nerves.

Diabetes is divided into type I diabetes, type II diabetes, gestational diabetes and other special types of diabetes. Type I diabetes and type II diabetes are usually concerned and studied more:

① Type I diabetes is an autoimmune disease. Autoimmune diseases are caused by the body's immune system attacking itself. In diabetics, the immune system attacks and kills the beta cells of the pancreas that secrete their own insulin. As a result, the pancreas does not produce enough insulin. Due to the lack of insulin secretion, patients need to rely on exogenous insulin supplements to maintain life.

②Type II diabetes is adult-onset diabetes, which usually occurs after the age of 35-40, accounting for more than 90% of diabetic patients. The ability to produce insulin in the patient's body is not completely lost, and some patients even produce too much insulin in the body, but the effect of insulin is greatly reduced, so the insulin in the patient's body is relatively deficient.

Type II diabetes has stronger genetic and environmental factors, and shows significant heterogeneity. Its typical cases may show symptoms such as polyuria, polydipsia, polyphagia, and weight loss, that is, "three more and one less". Poor control will lead to complications, leading to failure of the kidneys, eyes, feet and other parts of the disease, and can not be cured.

Nowadays, the most commonly used treatment method is to take hypoglycemic drugs such as metformin, which treats the symptoms but not the root cause. It can only lower blood sugar but not treat blood sugar. Long-term use will not only bring burden to the patient's body, but also easily cause drug resistance in the patient's body.

TCM treatment of diabetes pays attention to overall regulation, and is obviously superior to Western medicine in improving symptoms and other aspects. It is suitable for non-insulin-dependent diabetes mellitus (namely type II diabetes mellitus), so it is necessary to develop a traditional Chinese medicine composition for treating diabetes mellitus.

Contents of the invention

The invention aims at the deficiency of existing western medicine in treating diabetes, and provides a traditional Chinese medicine composition for treating diabetes.

The technical solution of the present invention to solve the above-mentioned technical problems is as follows: a kind of Chinese medicine composition for treating diabetes, its raw material composition and proportioning are as follows:

28-32 parts by weight of cornus; 36-42 parts by weight of ginseng root; 28-32 parts by weight of raw land; 28-32 parts by weight of sealwort; 42 parts by weight; Anemarrhena 28-32 parts by weight; Yuanshen 28-32 parts by weight; Coptidis 36-42 parts by weight; Black plum 28-32 parts by weight; Guava peel 36-42 parts by weight; Silver Bupleurum 18-22 parts by weight; Coptis chinensis 28-32 parts by weight; Salvia miltiorrhiza 28-32 parts by weight; Guijianyu 36-42 parts by weight; Aloe vera 14-16 parts by weight; Polygonum cuspidatum 28-32 parts by weight.

Preferably, the raw material composition and proportioning ratio of the traditional Chinese medicine composition for treating diabetes are as follows: 30 parts by weight of cornus; 40 parts by weight of ginseng root; 30 parts by weight of rhizoma rhizome; Parts by weight: 40 parts by weight of medlar; 30 parts by weight of Anemarrhena; 30 parts by weight of Yuanshen; 40 parts by weight of Coptidis; 30 parts by weight of black plum; 30 parts by weight of berberine; 30 parts by weight of salvia miltiorrhiza; 40 parts by weight of ghost arrow feather; 15 parts by weight of aloe; 30 parts by weight of knotweed.

Further, the traditional Chinese medicine composition is prepared into capsules, granules, pills, or decoctions by adding or not adding auxiliary materials.

The adjuvant is a variety of commonly used pharmaceutical adjuvants and/or excipients, including (but not limited to) sugars (such as lactose, glucose and sucrose), starches (such as corn starch and potato starch), cellulose and derivatives thereof substances (such as sodium carboxymethylcellulose, ethylcellulose, and methylcellulose), tragacanth powder, malt, gelatin, talc, solid lubricants (such as stearic acid and magnesium stearate), calcium sulfate, Vegetable oils such as peanut oil, cottonseed oil, sesame oil, olive oil, corn oil, and cocoa butter, polyols (such as propylene glycol, glycerin, sorbitol, mannitol, and polyethylene glycol), alginic acid, emulsifiers (such as Tween), Wetting agent (such as sodium lauryl sulfate), coloring agent, flavoring agent, tableting agent, stabilizer, antioxidant, preservative, pyrogen-free water, isotonic saline solution and phosphate buffer, etc. Excipients can improve the stability, activity and bioavailability of the formula as needed, or produce acceptable taste or smell when taken orally.

In the traditional Chinese medicine composition of the present invention, the cornus in the prescription nourishes the liver and kidneys, consolidates astringent essence; The combination of the three medicines has the effects of nourishing yin and replenishing qi, clearing away heat and promoting body fluid, and is a king medicine. The minister uses sealwort and astragalus to nourish the kidneys and lungs, strengthen the spleen and replenish qi; white peony root and wolfberry to nourish the liver and kidney yin; Anemarrhena, root ginseng, and coptis to clear away dryness and heat in the lungs and stomach and nourish yin to enhance the power of the king's medicine. Black plum astringes yin to promote fluid and quench thirst; guava peel and oyster astringe and solidify astringent; Yin Bupleurum and Huhuanglian enter yin to clear deficiency and heat; salvia miltiorrhiza and ghost arrow feather promote blood circulation and remove blood stasis; aloe vera and polygonum cuspidatum purify laxative and are adjuvant medicines.

The second aspect of the present invention discloses a preparation method of the aforementioned traditional Chinese medicine composition for treating diabetes, which is a decocting method, comprising the following steps:

1) Soaking: according to the formula of the traditional Chinese medicine composition, put the raw materials into 8 to 10 times the amount of cold water and soak for 20 to 40 minutes;

2) Decoction: decoct the soaked medicinal materials on high heat, turn to low heat and decoct for 40-60 minutes, then filter and separate to obtain medicinal residues and filtrate;

3) Second decoction: Add 4 to 6 times the amount of water to the dregs of the previous step, decoct on high heat, turn to low heat and decoct for 30 to 40 minutes, filter to get the filtrate;

4) Combine the filtrates of step 2) and step 3), evaporate and concentrate at low temperature to a relative density of 1.05-1.15, and obtain a decoction of the traditional Chinese medicine composition.

The present invention also discloses another preparation method of a traditional Chinese medicine composition for treating diabetes, which is a water extraction and alcohol precipitation method, comprising the following steps:

①Decoction: According to the formula of the traditional Chinese medicine composition, add 8 to 10 times the amount of water to the raw materials, heat and decoct for 1 to 2 hours; after solid-liquid separation, add 4 to 6 times the amount of water, heat and decoct for 1 to 2 hours For 1.5 hours, combine the filtrates of the two decoctions;

② Concentrate the filtrate by low-temperature evaporation to a relative density of 1.15-1.2. Under stirring conditions, slowly add 2 times the amount of 95% v/v ethanol solution, stir for 18-25 minutes, cool down for 36-60 hours, and pour out the supernatant liquid, filtered;

③Recover ethanol by distillation, continue to evaporate and concentrate to a relative density of 1.25-1.35, place it for 20-28 hours to complete the precipitation, filter, and evaporate the filtrate to a thick paste at low temperature;

④ Add auxiliary materials to the thick paste in the previous step to make a soft material, mix well, make granules, and dry to obtain granules of the traditional Chinese medicine composition.

The last aspect of the present invention discloses the application of the aforementioned traditional Chinese medicine composition in the preparation of medicaments for treating type Ⅱ diabetes.

The beneficial effects of the present invention are: the traditional Chinese medicine composition of the present invention nourishes qi and nourishes yin, clears away heat and promotes body fluid. It is used for type II diabetes with dryness, heat, body fluid and deficiency of both qi and yin. Symptoms include excessive thirst, frequent urination, elimination of grains and good hunger, gradual thinning, fatigue, spontaneous sweating, night sweats, dysphoria and fever, and turbid urine. Constipation etc.

Detailed ways

The principles and features of the present invention are described below, and the examples given are only used to explain the present invention, and are not intended to limit the scope of the present invention.

The preparation of embodiment 1 Chinese medicine composition decoction

1. Traditional Chinese medicine composition formula

30g of cornus, 40g of ginseng, 30g of raw land; 30g of sealwort, 20g of astragalus, 20g of white peony, 40g of medlar, 30g of anemarrhena, 30g of ginseng, 40g of coptis; 30g of black plum, 40g of guava skin, 30g of oyster, silver wood Hu 20g, Hu Huanglian 30g, Danshen 30g, ghost arrow feather 40g, aloe vera 15g, knotweed 30g.

2. Preparation method

1) Put the above-mentioned medicinal materials in a steel steamer, use about 8 times the amount of cold water as the medicinal materials, and soak for 30 minutes;

2) Decoct the soaked medicinal materials with strong fire, turn to warm fire and cook for 50 minutes, and filter out the medicinal liquid;

3) After filtering out the medicinal liquid, add 5 times the amount of cold water to boil again, turn to warm fire and boil for 40 minutes, and filter out the medicinal liquid;

4) Merge, mix and filter the medicinal solution in the above step 2) and step 3), and concentrate the filtrate by low-temperature evaporation to a decoction with a relative density of 1.1.

The preparation of embodiment 2 Chinese medicine composition granules

1. Traditional Chinese medicine composition formula

28g of cornus, 42g of ginseng, 28g of raw land; 32g of sealwort, 22g of astragalus, 18g of white peony, 36g of medlar, 32g of anemarrhena, 28g of ginseng, 36g of coptis; 28g of black plum, 42g of guava skin, 32g of oyster, silver chai Hu 18g, Hu Huanglian 28g, Salvia miltiorrhiza 28g, ghost arrow feather 42g, aloe vera 14g, knotweed 32g.

2. Preparation method

① Add about 10 times the amount of water to the above medicinal materials for the first time, heat and decoct for 1.5 hours; add about 4 times the amount of water for the second time, heat and decoct for 1.5 hours, combine the filtrates, and filter.

②Concentrate the filtrate by low-temperature evaporation to a relative density of 1.15. With full stirring, slowly add 2 times the amount of 95% ethanol, stir for 20 minutes, cool down for 48 hours, pour out the supernatant, and filter.

③ Recover ethanol by distillation, continue to evaporate and concentrate to a relative density of 1.3, place in a cold place for 24 hours to make the precipitation complete, filter, evaporate the filtrate to a thick paste at low temperature, and set aside.

④ Put the thick paste in a container, add dextrin (the mass ratio of dextrin to thick paste is 1:2) and ethanol solution with a volume concentration of 70% to make a soft material, mix well, make granules, and dry to obtain Traditional Chinese medicine composition granules.

The preparation of embodiment 3 Chinese medicine composition capsules

1. Traditional Chinese medicine composition formula

32g of cornus, 36g of ginseng, 32g of raw land; 28g of sealwort, 18g of astragalus, 22g of white peony, 42g of medlar, 28g of anemarrhena, 32g of ginseng, 42g of coptis; 32g of black plum, 36g of guava skin, 28g of oyster, silver wood Hu 22g, Hu Huanglian 32g, Salvia 32g, Guijian Yu 36g, Aloe Vera 16g, Polygonum cuspidatum 28g.

2. Preparation method

①Dry the above medicinal materials, mix them evenly, and grind them into fine powder, all of which should pass through a No. 6 sieve.

②Put the above-mentioned medicinal material powder into No. 1 capsule under dry conditions, each weighing 0.5 grams.

Embodiment 4 Chinese medicine composition treats the animal test of diabetes

1. Construction of animal model of type Ⅱ diabetes mellitus

Select healthy 7-week-old male SD rats to give a high-fat diet (the high-fat and high-sugar feed formula adopted by the high-fat diet is: lard 15%, sucrose 20%, cholesterol 5%, common mouse feed 60%, all are quality percentage content) after 8 weeks, intraperitoneal injection of streptozotocin (0.5% streptozotocin 30mg/kg, 0.1mmol/L citrate buffer, pH4.4), after 7 days of injection, type Ⅱ diabetes mellitus was successfully prepared 50 rats.

2. Experimental methods and results

10 untreated SD rats were used as the blank control group; 10 of the 50 successfully constructed type II diabetic rats were randomly selected as the model control group, and the remaining model rats were randomly and equally divided into two groups. Object group (traditional Chinese medicine composition of the present invention), and glyburide group (glibenclamide tablets, purchased from Guangdong Sancai Pharmaceutical Group Co., Ltd.). The Chinese medicine group was intragastrically administered once a day (10ml/kg of the Chinese medicine composition decoction prepared in Example 1), the glyburbide group was administered daily (7.8mg/kg), and the model control group and the blank control group were administered respectively. Volume of normal saline (administered 1mL per 100g), continuous medication for 30d. On the 15th day and 30th day after taking the medicine, respectively, they fasted for 12 hours and measured their blood sugar once. The results are shown in Table 1.

Table 1 The influence of traditional Chinese medicine composition on mouse blood sugar

Compared with the model control group, *P<0.05, **P<0.01.

It can be seen from the above table 1 that, compared with the model control group, the traditional Chinese medicine composition of the present invention can significantly reduce the blood sugar of streptozotocin-induced type II diabetic rats, and has a significant effect on the treatment of diabetes.

The effect of embodiment 5 Chinese medicine composition clinical treatment diabetes

1. Case selection:

The cases were selected according to the WHO diabetes diagnostic criteria, all of them were II diabetic patients, and they met the dialectical criteria of deficiency of both qi and yin in the "Guiding Principles for Clinical Research of New Chinese Medicines for Diabetes (Diabetes)".

A total of 300 patients were admitted and randomly divided into a treatment group and a control group: 120 cases in the treatment group, including 60 males and 60 females, aged 38-65 years, with a course of 3-15 years; the severity of the disease: 23 cases were mild, Moderate in 64 cases, severe in 33 cases. The control group consisted of 120 cases, including 63 males and 57 females, aged 38 to 65 years, with a course of disease of 3 to 15 years; disease severity: 24 cases were mild, 68 cases were moderate, and 28 cases were severe.

2. Treatment method:

Both groups controlled diet as required. The treatment group oral Chinese medicine composition decoction 200-250ml of embodiment 1, every day 2 times, drink 30min before lunch and dinner; Control group oral Xiaoke pill (Guangzhou Zhongyi Pharmaceutical Co., Ltd.), each 8, each 3 times a day, take with warm water 30 minutes before breakfast, lunch and dinner. The course of treatment for both groups was 60 days.

3. Formulate standards for curative effect

Refer to the curative effect judging criteria in the "Guiding Principles for Clinical Research of New Drugs of Traditional Chinese Medicine in the Treatment of Diabetes (Diabetes)" formulated by the Ministry of Health.

4. Treatment results:

The results of the treatment effects are shown in Table 2 below.

Table 2 Chinese medicine composition therapeutic effect

group total number of cases markedly effective efficient invalid total effective rate therapy group 120 40 60 20 83.3% control group 120 44 61 15 87.5%

It can be seen that the effect of the traditional Chinese medicine composition of the present invention is close to the curative effect of the existing diabetes treatment drugs. For improving the clinical total effective rate of thirst and polydipsia, eliminating gluten and hunger, polyuria, lassitude and fatigue, spontaneous sweating and night sweating, dysphoria and fever, turbid urine, constipation, etc., the treatment group is better than the control group, revealing that the traditional Chinese medicine composition The curative effect of the capsule is better than that of the control group.

The above descriptions are only preferred embodiments of the present invention, and are not intended to limit the present invention. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principles of the present invention shall be included in the protection of the present invention. within range.

Claims (6)

1. A traditional Chinese medicine composition for treating diabetes, its raw material composition and proportioning are as follows: 28-32 parts by weight of cornus; 36-42 parts by weight of ginseng root; 28-32 parts by weight of raw land; 28-32 parts by weight of sealwort; Radix Astragali 18-22 parts by weight; Radix Paeoniae Alba 18-22 parts by weight; Lycium barbarum 36-42 parts by weight; Anemarrhena 28-32 parts by weight; Parts by weight; 36-42 parts by weight of guava peel; 28-32 parts by weight of oyster; 18-22 parts by weight of Yin Bupleurum; 14-16 parts by weight of aloe; 28-32 parts by weight of knotweed. 2. The Chinese medicine composition according to claim 1, characterized in that, the raw material composition and proportioning of the Chinese medicine composition are as follows: 30 parts by weight of cornus; 40 parts by weight of ginseng root; 30 parts by weight of rehmannia root; Parts by weight; 20 parts by weight of Radix Astragali; 20 parts by weight of Radix Paeoniae Alba; 40 parts by weight of Lycium barbarum; 30 parts by weight of Zhimu; 30 parts by weight; 20 parts by weight of Yin Bupleurum; 30 parts by weight of Coptis chinensis; 30 parts by weight of Salvia miltiorrhiza; 40 parts by weight of ghost arrow feather; 15 parts by weight of aloe; 3. The Chinese medicine composition according to claim 1 or 2, characterized in that, the Chinese medicine composition is made into capsules, granules, pills, or decoctions by adding or not adding auxiliary materials. 4. The preparation method of the Chinese medicine composition for treating diabetes according to any one of claims 1-3, which is a decocting method, comprising the following steps: 1) Soaking: according to the formula of the traditional Chinese medicine composition, put the raw materials into 8 to 10 times the amount of cold water and soak for 20 to 40 minutes; 2) Decoction: decoct the soaked medicinal materials on high heat, turn to low heat and decoct for 40-60 minutes, then filter and separate to obtain medicinal residues and filtrate; 3) Second decoction: Add 4 to 6 times the amount of water to the dregs of the previous step, decoct on high heat, turn to low heat and decoct for 30 to 40 minutes, filter to get the filtrate; 4) Combine the filtrates of step 2) and step 3), evaporate and concentrate at low temperature to a relative density of 1.05-1.15, and obtain a decoction of the traditional Chinese medicine composition. 5. The preparation method of the Chinese medicine composition for treating diabetes according to any one of claims 1-3, which is a water extraction and alcohol precipitation method, comprising the following steps: ①Decoction: According to the formula of the traditional Chinese medicine composition, add 8 to 10 times the amount of water to the raw materials, heat and decoct for 1 to 2 hours; after solid-liquid separation, add 4 to 6 times the amount of water, heat and decoct for 1 to 2 hours For 1.5 hours, combine the filtrates of the two decoctions; ② Concentrate the filtrate by low-temperature evaporation to a relative density of 1.15-1.2. Under stirring conditions, slowly add 2 times the amount of 95% v/v ethanol solution, stir for 18-25 minutes, cool down for 36-60 hours, and pour out the supernatant liquid, filtered; ③Recover ethanol by distillation, continue to evaporate and concentrate to a relative density of 1.25-1.35, place it for 20-28 hours to complete the precipitation, filter, and evaporate the filtrate to a thick paste at low temperature; ④ Add auxiliary materials to the thick paste in the previous step to make a soft material, mix well, make granules, and dry to obtain granules of the traditional Chinese medicine composition. 6. The application of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of medicaments for treating type II diabetes.