CN103599343B - A kind of pharmaceutical composition for the treatment of diabetes and its production and use - Google Patents

Abstract

The invention provides a pharmaceutical composition for treating diabetes, which is a preparation prepared from raw materials in the following weight proportions: 10-60 parts of Coptidis Rhizoma, 10-60 parts of Radix Asparagus, 10-60 parts of Rehmannia glutinosa, ebony plum 10-60 parts, 5-20 parts of ginseng, 2-12 parts of cinnamon. The invention also provides the preparation method and application of the pharmaceutical composition. The test of the present invention shows that the pharmaceutical composition of the present invention has precise compatibility, can effectively lower blood sugar, and its pharmacodynamic activity is significantly better than that of classic prescription Lianmei Decoction and Jiaotai Pill, providing a new choice for clinical medication for treating diabetes.

Description

A kind of pharmaceutical composition for treating diabetes and its preparation method and application

technical field

The invention relates to a pharmaceutical composition for treating diabetes and its preparation method and application.

Background technique

Diabetes is a combination of sugar, protein, fat, water, and A series of metabolic disorder syndromes such as electrolytes, the pathological mechanism is mainly insulin secretion defect or insulin action defect. The main features are hyperglycemia, diabetes, polyuria, polydipsia, polyphagia, weight loss, and fatigue. Diabetes is mainly divided into four categories, namely type 1 diabetes, type 2 diabetes, other specific types of diabetes and gestational diabetes. In recent years, diabetes has become the third major disease that seriously endangers human health after tumors and cardiovascular and cerebrovascular diseases. The number of people with diabetes worldwide is increasing year by year. In 2008, there were 43 million diabetic patients in my country, with an increase of about 1.2 million people every year, and an increase of about 3,000 people every day, becoming the country with the largest number of diabetic patients in the world. Among them, type 2 diabetes accounts for about 95% of diabetic patients. Therefore, increasing the prevention and treatment of diabetes, especially type 2 diabetes, has become a top priority.

At present, the drug treatment of type 2 diabetes is mostly based on western medicine. There are mainly the following types of hypoglycemic drugs, such as insulin secretion enhancers, whose representative drugs are glimepiride and glibenclamide (xanthylurea drugs); biguanides, whose representative drug is metformin; insulin sensitizers, whose representative drugs are Troglitazone, rosiglitazone, and pioglitazone (thiazolidinediones); small intestinal α-glucosidase inhibitors, representative drugs include Baisupine (acarbose); aldose reductase inhibitors, representative drugs are Torrestat and epalrestat; non-xanthyl urea insulin secretagogues, representative drugs are repaglinide, nateglinide, etc. Western medicines for the treatment of type 2 diabetes have the advantage of effectively controlling postprandial blood sugar, but long-term use can easily lead to tolerance and cause serious side effects on the body.

Traditional Chinese medicine has certain advantages in the treatment of diabetes: less toxic and side effects, suitable for long-term use; wide source of medicine, not easy to develop tolerance. In recent years, more than 60 kinds of single traditional Chinese medicines with hypoglycemic effect have been discovered in China, and many Chinese patent medicines for hypoglycemia have been developed successively. Its production process, the patent discloses a Chinese patent medicine for treating diabetes, which contains the following raw materials: Ophiopogon japonicus, Asparagus, Scrophulariaceae, Coptis chinensis, Alisma, Poria, Digupi, Astragalus, Cornus officinalis, Lycium barbarum, Dried rehmannia glutinosa , rehmannia glutinosa, trichosanthum pollen, ginseng, pilose antler, and white silkworm, which can enhance the body's sensitivity to insulin, lower blood sugar, blood lipids, regulate organs, and nourish the liver and kidney. Patent application number: 97100874.4, invention name: formula and production method of Kebixiao pills and Kebixiao ointment. This application also provides a medicine for treating diabetes by combining internal and external treatment. A, Schisandra, Digupi, Rehmannia glutinosa, Rehmannia glutinosa, Asparagus, Ophiopogon japonicus, Black plum meat, Polygonum multiflorum, Codonopsis, Coptidis, Scrophulariaceae, Astragalus, Poria, Anemarrhena, Alisma, Sophora, Pueraria, Yam, Duckweed grass, mussel powder, pig pancreas and more than 20 herbs. Lu Xiong et al. found that Jiaotai Pills (Huanglian: Cinnamon = 1:1) had the effect of lowering blood sugar and serum triglycerides in the rat model of type 2 diabetes fed with high-sugar and high-fat diet combined with low-dose streptozotocin injection. However, it has no significant effect on body weight and insulin levels, and its mechanism may be related to the improvement of insulin sensitivity (Lu Xiong, et al., Experimental Research on the Hypoglycemic Effect of Jiaotai Pills, Liaoning Journal of Traditional Chinese Medicine, Volume 34, Issue 9, 2007).

Contents of the invention

The object of the present invention is to provide a pharmaceutical composition for treating diabetes and its preparation method and application.

The invention provides a pharmaceutical composition for treating diabetes, which is a preparation prepared from raw materials comprising the following weight ratios:

10-60 parts of coptis, 10-60 parts of asparagus, 10-60 parts of rehmannia glutinosa, 10-60 parts of black plum, 5-20 parts of ginseng, and 2-12 parts of cinnamon.

Further, it is a preparation prepared from raw materials comprising the following weight ratios:

30 parts of coptis, 6 parts of cinnamon, 15 parts of ginseng, 30 parts of asparagus, 30 parts of rehmannia glutinosa, and 30 parts of dark plum.

Furthermore, it is a preparation prepared from raw materials with the following weight ratio:

Coptidis 25-35 parts, cinnamon 4-8 parts, ginseng 12-18 parts, asparagus 25-35 parts, rehmannia glutinosa 25-35 parts, ebony plum 25-35 parts.

Preferably, it is a preparation prepared from raw materials in the following weight ratio:

30 parts of coptis, 6 parts of cinnamon, 15 parts of ginseng, 30 parts of asparagus, 30 parts of rehmannia glutinosa, and 30 parts of dark plum.

Further, the rehmannia glutinosa is selected from raw rehmannia glutinosa.

In the medicinal composition, Coptis chinensis, bitter cold and hypoglycemic, is the monarch drug; ebony, sour, hypoglycemic and promotes fluid; Shengdi, clearing heat and cooling blood, nourishing yin and promoting fluid; asparagus, nourishing yin and promoting fluid; a total of ministerial drugs; ginseng, protecting pancreatic islets Cells, nourishing vital energy; cinnamon, warming and nourishing vitality, restricting the bitter and cold nature and flavor of Coptis chinensis; shared with Coptidis chinensis, it communicates with the heart and kidney, and is an adjuvant drug. After the above-mentioned medicines are compatible, they play a synergistic effect, and the drug effect is significantly enhanced.

The present invention also provides the application of the above-mentioned medicine in the preparation of medicine or/and health care product for lowering blood sugar.

Further, the medicine or/and health product is a medicine or/and health product for treating or preventing diabetes.

Furthermore, the diabetes is type 2 diabetes.

The test of the present invention shows that the pharmaceutical composition of the present invention has precise compatibility, can effectively lower blood sugar, and its pharmacodynamic activity is significantly better than that of classic prescription Lianmei Decoction and Jiaotai Pill, providing a new choice for clinical medication for treating diabetes.

Detailed ways

The preparation of embodiment 1 pharmaceutical composition of the present invention

Take 30g of Coptis chinensis, 6g of cinnamon, 15g of ginseng, 30g of asparagus, 30g of rehmannia glutinosa, and 30g of black plum; add 8 times the amount of water and decoct 3 times, each time for 0.5h, combine the decoction, filter, and after the filtrate is concentrated, add appropriate amount Soluble starch, granulated.

The preparation of embodiment 2 pharmaceutical composition of the present invention

Take 30g of Coptis chinensis, 6g of cinnamon, 15g of ginseng, 30g of asparagus, 30g of rehmannia glutinosa, and 30g of ebony plum; add 8 times the amount of water and decoct 3 times, each time for 0.5h, combine the decoction, filter, concentrate the filtrate, and dry, Add an appropriate amount of microcrystalline cellulose, mix well, and pack into capsules.

The preparation of embodiment 3 pharmaceutical composition of the present invention

Take 35g of Coptis chinensis, 4g of cinnamon, 12g of ginseng, 25g of asparagus, 25g of rehmannia glutinosa, and 25g of ebony plum, add 80% v/v ethanol for reflux extraction twice, and use the alcohol extract for later use; Combine the water decoction; recover ethanol from the ethanol extract, combine with the water decoction, concentrate, add appropriate soluble starch, and granulate to obtain granules.

Embodiment 4 Preparation of the pharmaceutical composition of the present invention

Take 25g of Coptis chinensis, 8g of cinnamon, 18g of ginseng, 35g of asparagus, 35g of rehmannia glutinosa, and 35g of black plum, grind into powder, sieve, add appropriate amount of microcrystalline cellulose, mix well, and pack into capsules to obtain capsules.

The beneficial effects of the present invention will be specifically described below through test examples.

Therapeutic effect of test example 1 diabetes

1. Experimental drug

Coptidis group: take appropriate amount of Coptidis single herbs

Dark plum group: take an appropriate amount of single herbal medicine of dark plum

Jiaotai pill group: coptis: cinnamon = 30:30

Lianmei soup group: Yunlian: Wumei: Ophiopogon japonicus: Habitat: donkey-hide gelatin=30:45:45:45:30

Coptidis + ebony group: Coptidis: ebony = 30:30

Habitat + asparagus + coptis + ebony group, habitat: asparagus: coptis: ebony = 30:30:30:30

Habitat + Asparagus + Coptidis + Black Plum + Ginseng + Cinnamon Group, Habitat: Asparagus: Coptidis: Dark Plum = 30:30:30:30:15:6

The above-mentioned medicinal materials of each group were decocted for 3 times with 8 times of water respectively, and the decoctions were combined, concentrated in an appropriate amount, and set aside for later use, which was the test drug.

2. Test method

The experiment was divided into 8 groups, 12 Wistar rats in each group, and the model was established by intraperitoneal injection of STZ55mg/Kg. Except for the model group, all treated rats were given Chinese medicine for 8 weeks (W), and the dose of each Chinese medicine group was 20mg/Kg (the dose was calculated based on the original medicine). Fasting blood glucose (FPG) and 2h postprandial blood glucose (2hPG) were detected.

3. Test results

See table below.

Table 1

Statistical software SPSS16.0, statistical method: one-way variance comparison. statistical results:

Coptidis+black plum group compared with Coptidis group, P<0.05;

Coptidis+black plum group compared with dark plum group, P<0.01;

Coptidis+black plum group compared with Lianmei decoction group, P>0.05;

The comparison between Shengdi + Asparagus + Coptidis + Wumei group and Coptidis group, P<0.01;

Shengdi + Asparagus + Coptidis + Wumei group compared with Wumei group, P<0.01;

Compared with Lianmei decoction, Shengdi + Asparagus + Coptis chinensis + Wumei group, P<0.05;

Shengdi + Asparagus + Coptidis + Wumei group compared with Jiaotai Pill group, P>0.05;

The comparison between Shengdi + Asparagus + Coptidis + Black Plum + Ginseng + Cinnamon group and Lianmei Decoction group, P<0.05;

Shengdi + asparagus + coptis + black plum + ginseng + cinnamon group compared with Jiaotai pill group, P<0.05;

Shengdi + asparagus + coptis + black plum + ginseng + cinnamon group compared with the coptis group, P<0.01;

Shengdi + asparagus + coptis + ebony + ginseng + cinnamon group compared with ebony group, P<0.01;

P<0.01 between the model group and each group.

It can be seen from the above results that:

(1) In the present invention, after the joint use of Coptis chinensis and ebony plum, its hypoglycemic effect is obviously better than that of Coptis chinensis and ebony plum, which shows that the combination of the two has played a synergistic effect; at the same time, compared with the classic Fanglianmei decoction, the present invention Coptidis ebony group significantly reduced the medicinal taste, and changed the compatible dosage of Coptis chinensis and ebony plum, and its medicinal activity was equivalent to that of Lianmei decoction.

(2) After the combination of Coptis chinensis and black plum with Shengdi and Asparagus in the present invention, its hypoglycemic effect is obviously better than that of single medicine, indicating that the above-mentioned compatibility has played a synergistic effect; at the same time, compared with the classic Fang Lianmei soup, its meal The blood glucose level in the next 2 hours was lower, and the comparison between the groups was statistically significant (p<0.05), indicating that the composition of the present invention has a stronger medicinal effect.

(3) The hypoglycemic effect of Coptis chinensis and ebony plum combined with Shengdi, Asparagus, ginseng and cinnamon in the present invention is significantly better than that of the classic prescription Lianmei Decoction and Jiaotai Pills, indicating that the above-mentioned medicines have played a synergistic effect after being compatible. The effect is significantly enhanced.

The test of the present invention shows that the pharmaceutical composition of the present invention has precise compatibility, can effectively lower blood sugar, and its pharmacodynamic activity is significantly better than that of classic prescription Lianmei Decoction and Jiaotai Pill, providing a new choice for clinical medication for treating diabetes.

Claims (8)

1. treat a pharmaceutical composition for diabetes, it is characterized in that: it is the preparation be prepared from by the crude drug of following weight proportion:

Rhizoma Coptidis 25-35 part, Cortex Cinnamomi 4-8 part, Radix Ginseng 12-18 part, Radix Asparagi 25-35 part, Radix Rehmanniae 25-35 part, Fructus Mume 25-35 part.

2. pharmaceutical composition according to claim 1, is characterized in that: it is the preparation be prepared from by the crude drug of following weight proportion:

Rhizoma Coptidis 30 parts, Cortex Cinnamomi 6 parts, Radix Ginseng 15 parts, Radix Asparagi 30 parts, Radix Rehmanniae 30 parts, Fructus Mume 30 parts.

3. pharmaceutical composition according to claim 1 and 2, is characterized in that: described Radix Rehmanniae is selected from Radix Rehmanniae.

4. pharmaceutical composition according to claim 1 and 2, is characterized in that: described preparation is oral formulations.

5. the preparation method of pharmaceutical composition described in claim 1-4 any one, is characterized in that: it comprises following operating procedure:

(1) each crude drug is taken by weight ratio;

(2) each crude drug directly pulverized or add water or/and after ethanol extraction, adding adjuvant conventional in pharmacy or health product or complementary composition, be prepared into conventional preparation.

6. the pharmaceutical composition described in claim 1-4 any one at the hypoglycemic medicine of preparation or/and purposes in health product.

7. purposes according to claim 6, is characterized in that: described medicine is or/and health product are that treatment or the medicine that prevents diabetes are or/and health product.

8. purposes according to claim 6, is characterized in that: described diabetes are type 2 diabetes mellitus.