CN103494916B - Traditional Chinese medicine composition with effect of reducing blood sugar, as well as preparation method and application thereof - Google Patents

Abstract

The invention discloses a traditional Chinese medicine composition with the effect of lowering blood sugar. The active ingredients contained in the composition are prepared from the following raw materials in parts by weight: 30-40 parts of Yamato red, 15-25 parts of motherwort, and 8-12 parts of peach kernels , 15-25 parts of fish eye grass, 15-25 parts of citrus aurantium, 15-25 parts of poria cocos and 8-12 parts of licorice, the dosage forms are granules, tablets, oral liquid, capsules, and the preparation method is also disclosed as adding water to decoct Boiling, concentrating, ethanol precipitation, spray drying, adding auxiliary materials to prepare the required preparation, and also discloses its application in the preparation of drugs with hypoglycemic effect.

Description

A kind of traditional Chinese medicine composition with effect of lowering blood sugar and its preparation method and application

technical field

The invention relates to a traditional Chinese medicine composition, in particular to a traditional Chinese medicine composition with hypoglycemic effect and its preparation method and application.

Background technique

Diabetes is a group of metabolic diseases characterized by hyperglycemia. Hyperglycemia is caused by defective insulin secretion or impaired biological action, or both. 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. In addition to insulin, the current clinical treatment of type 2 drugs is mainly oral hypoglycemic drugs, which are roughly divided into sulfonylureas, biguanides, traditional Chinese medicine preparations, other hypoglycemic drugs and auxiliary drugs. However, the side effects of these oral chemicals are mainly manifested in the damage to the blood phase, liver function, and kidney function, which will cause diabetic cardiovascular and cerebrovascular complications, prone to hypoglycemia, irritating to the gastrointestinal tract, and producing anorexia , nausea, vomiting and even diarrhea. Therefore, it is urgent to choose high-efficiency and long-term use without any toxic and side effects, reliable curative effect, and convenient hypoglycemic drugs to take. Chinese medicine has certain curative effect for treating diabetes. The efficacy of traditional Chinese medicine preparations in treating diabetes is not significant, and the advantages of traditional Chinese medicine in treating diabetes cannot be brought into play.

Contents of the invention

Purpose of the invention: In order to solve the above problems, the purpose of the present invention is to provide a Chinese medicine composition with hypoglycemic effect and its preparation method and application.

Technical scheme: the purpose of the present invention is achieved by the following scheme:

A traditional Chinese medicine composition with hypoglycemic effect, which is prepared by extracting the following raw materials in parts by weight: 30-40 parts of Yamato red, 15-25 parts of motherwort, 8-12 parts of peach kernel, 15-25 parts of fish eye grass, citrus aurantium 15-25 parts of fenugreek, 15-25 parts of poria cocos and 8-12 parts of licorice.

The above-mentioned traditional Chinese medicine composition with hypoglycemic effect is prepared by extracting the following raw materials in parts by weight: 35 parts of Yamato red, 20 parts of motherwort, 10 parts of peach kernel, 20 parts of fish eye grass, 20 parts of Citrus aurantium, and 20 parts of poria cocos And licorice 10 parts.

The dosage forms of the above-mentioned traditional Chinese medicine composition with hypoglycemic effect are granules, tablets, oral liquids, and capsules.

The above method of the traditional Chinese medicine composition with hypoglycemic effect, the preparation steps are: take Yamato red, motherwort, peach kernel, fish eye grass, citrus aurantium, poria cocos and licorice medicinal materials, add water to decoct twice, combine the decoction, and concentrate to 65°C When the relative density is 1.10-1.20, add ethanol, stir, so that the alcohol content reaches 65-85% by volume percentage, stand still, filter, and the relative density of the filtrate is 1.20-1.30 when the filtrate is concentrated under reduced pressure to 65 ° C and recovers ethanol Concentrated liquid, the concentrated liquid is added with auxiliary materials to make oral liquid, or the concentrated liquid is spray-dried and added with auxiliary materials to make granules, tablets or capsules.

For the preparation method of the above-mentioned traditional Chinese medicine composition with hypoglycemic effect, the decocting conditions are as follows: the amount of water added for the first time is 8-12 times the weight of the medicinal materials, decocted for 1-2 hours, and the amount of water added for the second time is 6-10 times the weight of the medicinal materials. Double the amount, decoct for 1-2h.

For the preparation method of the above-mentioned traditional Chinese medicine composition with hypoglycemic effect, the spray drying conditions are as follows: the inlet air temperature is 90-110°C, the outlet air temperature is 80-90°C, the material temperature is 80-90°C, and the atomization pressure is 0.2 -0.5MPa, the spray speed is 1-10ml/s.

Application of the above-mentioned traditional Chinese medicine composition with hypoglycemic effect in the preparation of a drug with hypoglycemic effect.

Beneficial effect:

1. From the perspective of TCM theory, TCM considers diabetes as the syndrome of "diabetes", which is listed as Jueyin disease in Treatise on Febrile Diseases. As the monarch drug, the fish eye grass clears away heat and detoxifies, dampness-reducing, and trifoliate oranges promote qi and reduce phlegm. They are ministerial drugs together. Poria cocos invigorates the spleen and stomach, and licorice harmonizes other drugs. It is an adjuvant drug. , heat-clearing, promoting fluid, expectorant effect, for the treatment of diabetes.

2. The prescription design of the present invention is reasonable and the compatibility is strict.

3. The composition of the present invention is made of natural Chinese medicinal materials, has no toxic and side effects, and is cheap.

Detailed ways

Below by embodiment form, above-mentioned content of the present invention is described in further detail again, but this should not be interpreted as the scope of the above-mentioned theme of the present invention being limited to following examples, all technologies realized based on the above-mentioned content of the present invention all belong to this invention the scope of the invention.

1, in conjunction with specific embodiment, the present invention is further described as follows:

The weight ratio listed in the table below takes the required raw materials of the present invention, unit: g

the Daiwa Red Motherwort peach kernel fish eye grass Citrus aurantium Poria cocos licorice Example 1 30 25 8 25 15 25 8 Example 2 35 20 10 20 20 20 10 Example 3 35 20 10 20 20 20 10 Example 4 40 15 12 15 25 15 15

In the present invention, Dahehong is Maohangzishao plant of the genus Fabaceae, and its root is used as medicine. Fisheye grass is the whole herb of Asteraceae small fisheye grass or Chrysanthemum chrysanthemum fisheye grass, and the rest are all pharmacopoeia varieties.

2. Preparation Example

The ratio of raw materials in the above table is an example, including the following steps:

Embodiment 1: the preparation of granule

Weigh and mix the medicinal materials according to the amount of each medicinal material in the above table, add water to decoct twice, add water for the first time to 8 times the weight of the medicinal materials, decoct for 1.5 hours, add water for the second time to 6 times the weight of the medicinal materials, and decoct for 1 hour , combined decoction, filtered, the filtrate was concentrated to a relative density of 1.10 (65°C), added an appropriate amount of ethanol to make the alcohol content (volume fraction) reach 65%, stirred, left to stand for 24 hours, filtered, the filtrate recovered ethanol and concentrated to The concentrated solution with a relative density of 1.20 (65°C) is spray-dried (conditions are that the inlet air temperature is 100°C, the outlet air temperature is 80°C, the material temperature is 70°C, the atomization pressure is 0.2 MPa, and the spray speed is 5ml/ s.), crushed into dry extract powder, then add appropriate amount of dextrin, mix evenly, moisten with appropriate amount of 80% ethanol, make soft material, granulate through 14 mesh sieve, dry at 70°C, granulate with 60 mesh to obtain granules agent.

Embodiment 2: the preparation of tablet

Weigh and mix the medicinal materials according to the amount of each medicinal material in the above table, add water to decoct twice, add water for the first time to 10 times the weight of the medicinal materials, decoct for 2 hours, add water for the second time to 8 times the weight of the medicinal materials, decoct for 1 hour, and combine Decoction, filter, concentrate the filtrate to a relative density of 1.15 (65°C), add an appropriate amount of ethanol to make the alcohol content (volume fraction) reach 75%, stir, let stand for 24 hours, filter, recover ethanol from the filtrate and concentrate to a relative density 1.25 (65°C) concentrated solution, spray-dried (conditions are that the inlet air temperature is 120°C, the outlet air temperature is 90°C, the material temperature is 80°C, the atomization pressure is 0.3 MPa, and the spray speed is 7.5/s. ), crushed into dry extract powder, then add an appropriate amount of powdered sugar, mix well, moisten with an appropriate amount of 80% ethanol, make a soft material, pass through a 30-mesh sieve to granulate, dry at 70-80°C, and granulate with a 60-mesh sieve , tableting, sugar-coating, sub-packaging, outer packaging, and passing the inspection to obtain the finished product.

Embodiment 3: the preparation of oral liquid

Weigh and mix the medicinal materials according to the amount of each medicinal material in the above table, add water to decoct twice, add water for the first time to 12 times the weight of the medicinal materials, decoct for 2 hours, add water for the second time to 10 times the weight of the medicinal materials, and decoct for 2 hours, Combine the decoctions, filter, concentrate the filtrate to a relative density of 1.20 (65°C), add an appropriate amount of ethanol to make the alcohol content (volume fraction) reach 85%, stir, let stand for 24 hours, filter, recover the ethanol from the filtrate and concentrate to a relative The concentrated solution with a density of 1.30 (65° C.) is added with sucrose and 0.1% propionic acid or 0.1% to 0.25% sodium benzoate as preservatives to obtain a finished oral solution.

Embodiment 4: the preparation of capsule

Weigh and mix the medicinal materials according to the amount of each medicinal material in the above table, add water to decoct twice, add water for the first time to 10 times the weight of the medicinal materials, decoct for 1.5 hours, add water for the second time to 8 times the weight of the medicinal materials, and decoct for 1.5 hours h, combine the decoctions, filter, concentrate the filtrate to a relative density of 1.15 (65°C), add an appropriate amount of ethanol to make the alcohol content (volume fraction) reach 75%, stir, let stand for 24 hours, filter, recover the ethanol from the filtrate and concentrate Concentrate to a relative density of 1.25 (65°C), spray-dried (conditions are that the inlet air temperature is 120°C, the outlet air temperature is 90°C, the material temperature is 90°C, the atomization pressure is 0.4 MPa, and the spray speed is 7.5 / s.), crushed into dry extract powder, passed through a No. 6 sieve, and then filled into No. 1 capsule to obtain the finished product.

3. Pharmacodynamic study on lowering blood sugar

The Chinese medicine composition with hypoglycemic effect of the present invention has obvious hypoglycemic effect, further illustrates the effect of the present invention with experiment below:

Experimental animals: male Kunming mice (20±2g), provided by Shanghai Slack Experimental Animal Co., Ltd., production license: SCXK (Shanghai) 2007-0005.

Experimental drug: the oral liquid of this Chinese medicine composition was prepared according to the method of the above-mentioned oral liquid embodiment.

Weigh 35g of medicinal materials Dahehong, 20g of motherwort, 10g of peach kernel, 20g of fisheye grass, 20g of Citrus aurantium, 20g of poria cocos and 10g of licorice, mix them, add water to decoct twice, add water for the first time to 12 times the weight of the medicinal materials, and decoct for 2 hours , add water for the second time to 10 times the weight of the medicinal material, decoct for 2 hours, combine the decoction, filter, and concentrate the filtrate to a relative density of 1.20 (65°C), add an appropriate amount of ethanol to make the alcohol content (volume fraction) reach 85%, Stir, stand still for 24 hours, filter, recover ethanol from the filtrate and concentrate to a concentrated solution with a relative density of 1.30 (65°C), add sucrose and 0.1% propionic acid or 0.1% to 0.25% sodium benzoate as preservatives, and obtain oral liquid 10 sticks of finished product, specification: 10mL/stick (equivalent to 13.5g of crude drug), batch number: 20120815. Xiaoke Wan, a product of Guangzhou Zhongyi Pharmaceutical Co., Ltd., batch number 20120410, the specification is 30g/bottle, 120 capsules per bottle, 10 capsules is 2.5g. Dosage: According to the "Equivalent Dose Ratio Table Between Humans and Animals Converted According to Body Surface", the daily dosage for a 70 kg person is 67.5g, and the daily dosage for each 20g mouse is 67.5*0.0026=0.1755g, Because each 10mL of oral liquid contains 13.5g of crude drug, that is, the dosage of each mouse is 0.13ml, so it is determined that the small dose is 0.1ml oral liquid, and the middle dose and high dose are 0.2ml and 0.4mL respectively. , the amount of crude drug contained in the oral liquid administered to each 20g mouse per day is 0.135g, 0.27g, and 0.54g, respectively, based on the weight of the mouse, the low dose, medium dose, and high dose are respectively 6.75g crude drug amount/kg , 13.5g crude drug amount/kg and 27g crude drug amount/kg.

Positive drug Xiaoke pill, product of Guangzhou Zhongyi Pharmaceutical Co., Ltd., batch number 20120310, specification 30g/bottle, 120 capsules per bottle, 10 capsules is 2.5g, patients generally use 10 capsules each time, twice a day, that is, people The daily dose is 5g, which is equivalent to 5*0.0026=0.013g per 20g mouse, calculated per kilogram of mice, that is, the positive drug group is given Xiaoke Wan 0.65g/kg.

Instruments and reagents: Alloxan (C ₄ H ₂ N ₂ O ₄ ·H ₂ O, molecular weight 160.08), blood glucose meter, automatic biochemical analyzer, 721 spectrophotometer, microplate reader, balance.

After one day of adaptive feeding, 10 mice were randomly selected as the normal group, and the other 90 animals were fasted for 3-5 hours, and the fasting blood glucose was measured as the basal blood glucose value of the batch of animals. Then the animals were fasted for 24 hours (free drinking water), intraperitoneally injected with alloxan (freshly prepared before use) 130mg/kg to build a model, and after 5 days, the animals were fasted for 5 hours, and their blood sugar was measured. A blood sugar value of 10-25mmol/L was a hyperglycemia model. success animal.

Select 40 hyperglycemia model animals, group them according to the blood glucose level after fasting for 3-5 hours, randomly select 1 model control group and 4 dosage groups (the difference between the groups is not more than 1.1mmol/L), 10 animals in each group, The dose group was given different concentrations of test samples, and the model control group was given solvent. For 30 consecutive days, the fasting blood glucose was measured (fasting was the same as before the experiment), and the blood glucose and blood glucose reduction percentages of animals in each group were compared.

Effect ((X ± D) of the present invention on hyperglycemia model mouse blood sugar drop

Compared with the normal group ***p<0.001, compared with the model group ###p<0.001, compared with the positive drug group ^￥ p<0.05.

The medicament of the present invention has hypoglycemic effect on hyperglycemic mice, and compared with the model group, the blood sugar level significantly decreases after the experiment, indicating that the present invention has hypoglycemic effect. Compared with the positive medicine group, the high-dose group of the medicine of the present invention has a significant difference in blood sugar drop, indicating that the effect of the medicine of the present invention is better than that of the positive medicine.

Claims (6)

1. one kind has the Chinese medicine composition of effect of lowering blood sugar, it is characterized in that being extracted by following raw materials in part by weight medicine being prepared from: large and red 30-40 part, Herba Leonuri 15-25 part, Semen Persicae 8-12 part, Herba Houttuyniae 15-25 part, Fructus Aurantii Immaturus 15-25 part, Poria 15-25 part and Radix Glycyrrhizae 8-12 part, preparation method step is: get large and red, Herba Leonuri, Semen Persicae, Herba Houttuyniae, Fructus Aurantii Immaturus, Poria and licorice medicinal materials merge, decoct with water twice, collecting decoction, when being concentrated into 65 DEG C, relative density is 1.10-1.20, add ethanol, stir, make alcohol content by volume percentage calculation reach 65-85%, leave standstill, filter, during filtrate reduced in volume to 65 DEG C, relative density is 1.20-1.30 and reclaims ethanol to obtain concentrated solution, concentrated solution is added adjuvant and makes oral liquid, or by concentrated solution spraying dry, add adjuvant, make granule, tablet or capsule.

2. a kind of Chinese medicine composition with effect of lowering blood sugar as claimed in claim 1, is characterized in that being extracted by following raw materials in part by weight medicine being prepared from: large and red 35 parts, Herba Leonuri 20 parts, 10 parts, Semen Persicae, Herba Houttuyniae 20 parts, Fructus Aurantii Immaturus 20 parts, 20 parts, Poria and 10 parts, Radix Glycyrrhizae.

3. there is the Chinese medicine composition of effect of lowering blood sugar as claimed in claim 1 or 2, it is characterized in that dosage form is granule, tablet, oral liquid, capsule.

4. there is the preparation method of the Chinese medicine composition of effect of lowering blood sugar as claimed in claim 1, it is characterized in that, decocting condition is: amount of water is the 8-12 times amount of medical material weight for the first time, decocts 1-2h, second time amount of water is the 6-10 times amount of medical material weight, decocts 1-2h.

5. there is the preparation method of the Chinese medicine composition of effect of lowering blood sugar as claimed in claim 1, it is characterized in that, described spray drying condition is: inlet temperature is 90-110 DEG C, leaving air temp is 80-90 DEG C, temperature of charge is 80-90 DEG C, atomizing pressure is 0.2-0.5 MPa, and spray velocity is 1-10ml/s.

6. the Chinese medicine composition as claimed in claim 1 or 2 with effect of lowering blood sugar is preparing the application had in effect of lowering blood sugar medicine.