CN113384644A

CN113384644A - A Chinese medicinal composition and its preparation method

Info

Publication number: CN113384644A
Application number: CN202110865627.3A
Authority: CN
Inventors: 吴洪宇
Original assignee: Individual
Current assignee: Individual
Priority date: 2021-07-29
Filing date: 2021-07-29
Publication date: 2021-09-14

Abstract

The invention discloses a Chinese medicinal composition for improving complications and regulating blood sugar and a preparation method thereof, wherein the raw materials of the composition comprise astragalus, Chinese yam, American ginseng, pumpkin powder, dark plum, kudzu root, gordon euryale seed, sea buckthorn, schisandra chinensis, spina date seed, liquorice and chromium gluconate, and the prepared Chinese medicinal composition is rich in islet activating factors, can promote islet beta cell repair and regeneration and improve islet function, thereby increasing secretion of endogenous insulin, enhancing utilization of glucose by peripheral tissues, promoting synthesis of glycogen, reducing blood sugar, enabling glucose metabolism to enter normal circulation, and simultaneously promoting fat synthesis and inhibiting lipodieresis by endogenous insulin.

Description

A Chinese medicinal composition and its preparation method

Technical Field

The invention relates to the technical field of traditional Chinese medicine compositions, in particular to a traditional Chinese medicine composition and a preparation method thereof.

Background

Diabetes is a disease of endocrine metabolism, and hyperglycemia is a common main marker of diabetes. Sugar, protein, fat, and secondary water and electrolyte disorders are caused by absolute or relative insufficiency of insulin secretion and decreased sensitivity of beta cells to insulin. Clinically, it is manifested as polydipsia, polyuria, polydipsia, polyphagia, fatigue and emaciation. However, a significant proportion of the diseases, even most of them, do not have the above symptoms, and are only found in a full body picture or in the presence of complications. Ketoacidosis or other types of acute metabolic disorders can occur when diabetes is severe. The common complications include acute infection, pulmonary tuberculosis, atherosclerosis, renal and retinal microvascular lesions, neuropathy and the like.

At present, about dozens of diabetes drugs produced in China are classified into insulin, biguanides, sulfonylureas and Chinese medicinal preparations according to the chemical structure and action principle of the drugs.

(1) Insulin is mainly used for type I diabetes, although the curative effect is reliable, the dosage form is single (only injection), the price is high, the insulin resistance can be generated after long-term use, the curative effect is reduced, the symptoms rebound immediately after the medicine is stopped, and adverse reactions such as hypoglycemia, allergy and the like easily occur, so that the use is painful and inconvenient (intramuscular injection);

(2) the double arcs mainly increase the utilization of peripheral tissues to glucose and inhibit the absorption of gastrointestinal tracts to the glucose, the treatment object is type II diabetes, gastrointestinal tract reaction, acidemia lacticum and malnutrition are easy to cause, and the double arcs are stopped in many countries and have certain clinical application in China;

(3) sulfonylureas lower blood glucose. The medicine is discharged from the liver along with the bile through the kidney, and the medicine is easy to generate medicine resistance and damage the liver and the kidney after long-term administration;

(4) the food blood sugar regulator has insignificant effect of the alpha glucose glycol inhibitor and is applied less.

Therefore, how to provide a medicine for nourishing liver and kidney, tonifying qi and promoting the production of body fluid. The technical problems to be solved by the technical personnel in the field are the traditional Chinese medicine composition for polydipsia, diuresis, polyphagia, emaciation, tiredness and hypodynamia, soreness and weakness of waist and knees, blood sugar and urine sugar rise, improvement of complications and blood sugar regulation and the preparation method thereof.

Disclosure of Invention

In view of the above, the present invention aims to provide a Chinese medicinal composition for improving complications and regulating blood sugar and a preparation method thereof, wherein the prepared Chinese medicinal composition is rich in islet activating factors, and can promote islet beta cell repair and regeneration, improve islet function, increase secretion of endogenous insulin, enhance glucose utilization of peripheral tissues, promote glycogen synthesis, reduce blood sugar, promote glucose metabolism to enter normal circulation, and promote fat synthesis and inhibit lipodieresis of endogenous insulin.

In order to achieve the purpose, the invention adopts the following technical scheme:

a traditional Chinese medicine composition comprises the following raw materials in parts by weight:

32-48 parts of astragalus membranaceus, 32-48 parts of Chinese yam, 20-30 parts of American ginseng, 20-30 parts of pumpkin powder, 20-30 parts of dark plum fruit, 16-24 parts of kudzu root, 16-24 parts of gordon euryale seed, 16-24 parts of sea-buckthorn, 16-24 parts of schisandra chinensis, 16-24 parts of spina date seed, 5-9 parts of liquorice and 0.04-0.06 part of chromium gluconate.

Further, the traditional Chinese medicine composition comprises the following raw materials in parts by weight:

40 parts of astragalus, 40 parts of Chinese yam, 25 parts of American ginseng, 25 parts of pumpkin powder, 25 parts of dark plum fruit, 20 parts of kudzuvine root, 20 parts of gordon euryale seed, 20 parts of sea-buckthorn, 20 parts of Chinese magnoliavine fruit, 20 parts of spina date seed, 7 parts of liquorice and 0.05 part of chromium gluconate.

A preparation method of a traditional Chinese medicine composition comprises the following steps:

(1) weighing the raw materials for later use;

(2) cleaning the raw materials, removing impurities, and drying at 66-70 deg.C;

(3) breaking cell wall of fructus Cucurbitae Moschatae powder, semen Ziziphi Spinosae, semen euryales, fructus Schisandrae chinensis and Glycyrrhrizae radix, and sieving to obtain fine powder A;

(4) mixing radix Puerariae, radix astragali, rhizoma Dioscoreae, mume fructus, fructus Hippophae and radix Panacis Quinquefolii, extracting, making into paste, drying, pulverizing, and sieving to obtain fine powder B;

(5) mixing the fine powder A, the fine powder B and the chromium gluconate uniformly, and preparing the finished product according to the required dosage form.

Preferably, a wall breaking machine is adopted in the wall breaking treatment in the step (3), and the rotating speed is 40000-45000 r/min; the time is 1-2 min.

Preferably, the extraction in the step (4) is to put the kudzuvine root, the astragalus root, the Chinese yam, the dark plum fruit, the sea-buckthorn and the American ginseng into a multifunctional extraction tank, add 11 times of water for reflux extraction for 2.5 to 3 hours, add 9 times of water for reflux extraction for 1.5 to 2 hours to the dregs of a decoction, and obtain an extracting solution.

Preferably, the step (4) of preparing the paste is that the extract is filtered by a centrifuge, and is concentrated under reduced pressure to a thick paste with the relative density of 1.32-1.34 measured at 70 ℃, and then is dried at 80-85 ℃.

The medicinal mechanism of the raw material composition is as follows:

in the formula, the astragalus and the Chinese yam are used as monarch drugs, wherein the astragalus is sweet in taste and slightly warm in nature and can enter lung and spleen channels to tonify middle-jiao and Qi. Cloud of famous physicians' bibliography: it is used to treat deficiency of husband, fatigue, emaciation, thirst, abdominal pain, dysentery, qi invigorating, and yin qi benefiting. The book of the Western medicine of the medical science and the records of the Zhongzhao nationality is also cloud: astragalus root can tonify lung qi and tonify the kidney water, so that qi can generate water by itself. Chinese yam is sweet in taste and neutral in nature, enters lung, spleen and kidney meridians, and can tonify kidney, tonify yang, invigorate spleen and tonify kidney, and is recorded in the book Ben Cao Zheng (materia Medica): chinese yam can invigorate spleen, tonify deficiency, nourish essence and strengthen kidney, and treat consumptive disease and injuries of five organs and seven organs. Cloud of the book of Yi Xue Zhong Can xi Lu: it is indicated for diabetes by taking rhizoma Dioscoreae alone. It can tonify spleen and kidney, stop frequent urination … …, promote lung qi to generate water, quench thirst, and treat Yuye decoction, which is mainly rhizoma Dioscoreae, and is effective in repeated tests. Radix astragali is compatible with rhizoma Dioscoreae. Not only the spleen and the kidney are supplemented, but also the qi and the yin can be supplemented;

in the formula, the American ginseng and the pumpkin powder are used as ministerial drugs, and the American ginseng is sweet in taste, slightly bitter in taste and expect in nature. The "records of the Western medicine of the medical science Zhongzhao" (cloud of medicine): "can supplement qi system and blood system", it is a cold and tonifying herb. Pumpkin is sweet in taste and warm in nature, can tonify middle-jiao and Qi, and is said to be 'transverse-moving and old in channel and promote urination' in Yunnan herbal medicine. The combination of the two medicines can enhance the effects of the monarch drug in reinforcing kidney, nourishing yin, invigorating spleen and replenishing qi;

in the recipe, radix Puerariae is added to the recipe, which is sweet in taste and mild in nature, and the recipe is as follows in Ben Cao Zheng Yi (materia Medica): the qi which can grow the spleen and stomach and clear yang enters the spleen and stomach to grow the spleen and stomach and clear yang to transfer body fluid, so that the thirst can be self-stopped if the body fluid is distributed for four times. Dark plum is sour in taste and mild in nature, and can astringe body fluid to quench thirst, so it is called phlegm-eliminating, thirst-quenching and juice-collecting in Ben Cao Shi Yi (A supplement to the materia Medica). The spina date seed is sour in taste, neutral in nature, capable of nourishing the liver, calming the heart and soothing the nerves and arresting sweating. The famous physicians bibliography is as follows: "mainly vexing heart and insomnia, pain in the upper and lower umbilicus, prolonged blood circulation, sweating due to debility and polydipsia, tonifying the middle-jiao, benefiting liver qi, strengthening tendons and bones, assisting yin qi, and making people fertile and healthy. The three ingredients are combined to help the Chinese yam to tonify spleen and stomach, nourish yin and astringe yin and fluid;

the pumpkin is warm in nature and sweet in taste, can tonify middle-jiao and Qi, can prevent and treat various diseases, and is proved by clinic: after the pumpkin powder is taken, 70-90% of healthy people and non-insulin-dependent diabetes mellitus patients have blood sugar reduction, after the non-insulin-dependent diabetes mellitus patients take the pumpkin powder, hunger sensation disappears, and the blood sugar reduction effect of the pumpkin powder is higher than the insulin increasing effect, so the pumpkin powder is high-quality health food for the diabetes mellitus patients.

The composition is supplemented with the chromium gluconate, the incidence rate of diabetes in areas with serious trivalent chromium deficiency is high, and the diabetes can be effectively controlled and abnormal phenomena in the aspect of glucose tolerance can be eliminated by supplementing the trivalent chromium.

According to the technical scheme, compared with the prior art, the invention has the following beneficial effects:

(1) the components in the composition provided by the invention belong to homology of medicine and food, and the homology of medicine and food means that the components are both food and medicine and have both medicine and food functions. The long-term taking of the health-care food has no toxic side effect and strong safety;

(2) the composition provided by the invention can not only fundamentally treat diabetes and complications, but also has a health-care effect on non-healthy people with similar diabetes symptoms, and has double curative effects. The medicinal mechanism is to reduce the sensibility of islet hyposecretion and target cell to eliminate the adversity treatment, the composition is rich in islet activating factors, can promote the sensibility of insulin receptor in islet beta cells, promote glycometabolism and lipolysis to enter normal circulation, has strong effects of promoting blood circulation and removing blood stasis, can inhibit the agglutination of platelets, improve the viscous accumulation state of blood, enhance the elasticity of blood vessels, reduce the permeability of blood vessels, and has obvious effects of reducing blood sugar, reducing blood pressure, improving symptoms and self-regulating;

(3) the traditional Chinese medicine composition provided by the invention has a strong effect of promoting blood circulation to remove blood stasis, can improve the viscous accumulation of blood, can enhance the elasticity of blood vessels and reduce the permeability of blood vessels, and thus has a fundamental curative effect on complications of organs such as heart, brain, kidney, eyes and the like caused by diabetes or other unknown reasons.

Detailed Description

The technical solutions in the embodiments of the present invention are clearly and completely described below, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

Example 1

A traditional Chinese medicine composition for improving complications and regulating blood sugar comprises the following raw materials in parts by weight:

48g of astragalus membranaceus, 48g of Chinese yam, 30g of American ginseng, 30g of pumpkin powder, 30g of dark plum fruit, 24g of radix puerariae, 24g of gordon euryale seed, 24g of sea buckthorn, 24g of schisandra chinensis, 24g of spina date seed, 9g of liquorice and 0.06g of chromium gluconate.

Example 2

32g of astragalus membranaceus, 32g of Chinese yam, 20g of American ginseng, 20g of pumpkin powder, 20g of dark plum fruit, 16g of radix puerariae, 16g of gordon euryale seed, 16g of sea buckthorn, 16g of schisandra chinensis, 16g of spina date seed, 5g of liquorice and 0.04g of chromium gluconate.

Example 3

40g of astragalus, 40g of Chinese yam, 25g of American ginseng, 25g of pumpkin powder, 25g of dark plum, 20g of kudzu root, 20g of gordon euryale seed, 20g of sea-buckthorn, 20g of Chinese magnoliavine fruit, 20g of spina date seed, 7g of liquorice and 0.05g of chromium gluconate.

Example 4

The method for preparing a Chinese medicinal composition according to any one of embodiments 1 to 3, comprising the steps of:

(1) weighing the raw materials for later use;

(2) cleaning the raw materials, removing impurities, and drying at 70 deg.C;

(3) placing fructus Cucurbitae Moschatae powder, semen Ziziphi Spinosae, semen euryales, fructus Schisandrae chinensis and Glycyrrhrizae radix into a wall breaking machine, breaking wall at 45000r/min for 1min, and sieving with 100 mesh sieve to obtain fine powder A;

(4) placing radix Puerariae, radix astragali, rhizoma Dioscoreae, mume fructus, fructus Hippophae and radix Panacis Quinquefolii in a multifunctional extraction tank, adding 11 times of water, reflux-extracting for 3h, adding 9 times of water into the residue, reflux-extracting for 2h to obtain extractive solution, filtering the extractive solution with centrifuge, concentrating under reduced pressure to obtain soft extract with relative density of 1.34 at 70 deg.C, drying at 80 deg.C, pulverizing, and sieving with 100 mesh sieve to obtain fine powder B;

(5) mixing the fine powder A, the fine powder B and the chromium gluconate uniformly, and preparing the composition into tablets with the specification of 0.4 g/tablet.

Example 5

(1) weighing the raw materials for later use;

(2) cleaning the raw materials, removing impurities, and drying at 66 deg.C;

(3) placing fructus Cucurbitae Moschatae powder, semen Ziziphi Spinosae, semen euryales, fructus Schisandrae chinensis and Glycyrrhrizae radix into a wall breaking machine, breaking wall at 40000r/min for 2min, and sieving with 100 mesh sieve to obtain fine powder A;

(4) placing radix Puerariae, radix astragali, rhizoma Dioscoreae, mume fructus, fructus Hippophae and radix Panacis Quinquefolii in a multifunctional extraction tank, adding 11 times of water, reflux-extracting for 2.5 hr, adding 9 times of water to the residue, reflux-extracting for 1.5 hr to obtain extractive solution, filtering the extractive solution with centrifuge, concentrating under reduced pressure to obtain soft extract with relative density of 1.32 at 70 deg.C, drying at 85 deg.C, pulverizing, and sieving with 100 mesh sieve to obtain fine powder B;

(5) mixing the fine powder A, the fine powder B and the chromium gluconate uniformly, and preparing the composition into a capsule preparation with the specification of 0.4 g/granule.

Example 6

Effect experiment:

1. materials and methods

1.1 subject selection

The subjects were 60 patients with type II diabetes, 28 men and 32 women, with the age distribution of 30-49 years old and 24, 50-69 years old and 34, and 2 above 70 years old.

1.2 grouping of subjects

Dividing 60 experimental subjects into an experimental group and a control group randomly, and taking the capsule prepared in the embodiment 5 of the invention three times a day by a double-blind method, wherein 4-6 capsules are taken each time; the control group was administered with capsules containing no chromium gluconate ingredient, and the remaining ingredients were the same as those of the capsules prepared in example 5. Three times a day, 4-6 granules each time;

before the start of the experiment, all subjects were subjected to physical examination, while fasting blood glucose, 2 hours postprandial blood glucose, urine glucose, serum total cholesterol, triglycerides, blood picture examination and other biochemical index examinations were determined. The experimental time is 30 days, and the inspection instrument is a Hitachi 8810 full-automatic biochemical analyzer.

1.3 diagnostic criteria

The temporary standard proposed by WHO diabetes expert Committee in 1980 is taken as a diagnosis basis, namely the diabetes symptom exists, and the fasting blood sugar value is more than or equal to 7.8mmol/L, so that the diabetes is determined; fasting blood sugar is less than or equal to 5.7mmol/L, and diabetes is excluded; the fasting blood sugar is between 5.7mmol/L and 7.7mmol/L, and the symptoms are not obvious, namely abnormal glucose tolerance or abnormal blood sugar. The postprandial blood sugar is the blood sugar 2 hours after eating 100g of fine flour steamed bread, and the diagnosis standard in the invention is as follows: after 2 hours, the blood sugar is less than 7.8mmol/L and is normal; 7.8-11.1mmol/L is abnormal sugar tolerance, and more than 11.1mmol/L is diabetes.

2 efficacy determination

Blood sugar changes are used as main judgment indexes according to the clinical research guiding principle (1988) of endocrine medicaments of Ministry of health of the people's republic of China.

The method has the following advantages: at the end of the experimental period, symptoms basically disappear; the fasting blood glucose is reduced by more than or equal to 30 percent or more than 2mmol/L or less than 7.2mmol/L compared with the fasting blood glucose before the experiment, and the urine glucose is reduced to be "-" or one "+";

secondly, the method is effective: at the end of the experimental period, the symptoms are reduced, the fasting blood glucose is reduced by more than or equal to 10 percent or is reduced to less than 8.3mmol/L compared with the fasting blood glucose before the experiment, and the urine glucose is reduced by at least one plus';

③ invalid: any one that does not meet the "valid" criteria above is invalid.

3 results of the experiment

3.1 Observation of symptoms

Thirst, polydipsia, polyphagia, diuresis, emaciation, hypodynamia, lethargy, numbness and stabbing pain of limbs and the like are taken as main clinical symptoms, and according to the symptoms of chicken manure (3 parts of severe chicken manure, 2 parts of moderate chicken manure and 1 part of mild chicken manure), the symptom improvement rate (improvement 2 is marked as significant effect, 1 is marked as effective and 0 is marked as ineffective) is calculated according to the statistical integral value before and after the experiment, and the results are shown in Table 1

TABLE 1 clinical symptom improvement Rate

X compared to control group²＝15.42P＜0.01

The above results show that the experimental group has the effect of obviously improving clinical symptoms, and the improvement rate is 80%.

3.2 Observation of effects of assisting in regulating blood sugar

The results of the action on regulating blood sugar and urine sugar are shown in tables 2, 3 and 4.

TABLE 2 Effect on fasting plasma glucose

The difference from the previous experiment, t is 4.61, P < 0.01, is very significant.

The difference between the delta and the experimental end of the experimental group is significant, wherein t is 2.12, and P is less than 0.05.

TABLE 3 Effect on postprandial 2h blood glucose

The difference was very significant compared to the pre-experiment ratio, t 4.53, P < 0.01.

The difference between the delta and the experimental end of the experimental group is significant, wherein t is 1.68, and P is less than 0.05.

TABLE 4 Effect on urine glucose

Compared with the prior experiment, the difference is very significant, namely mu is 5.25, and P is less than 0.01.

The difference between the delta and the experimental end of the experimental group is significant, mu is 2.05, and P is less than 0.05.

3.3 Security Observation

The results of the tests on various biochemical indexes of human body are shown in Table 5 and Table 5

The results in Table 5 show that the invention has no any damage effect on liver and kidney functions.

4. Conclusion

Through observation experiments of 30 days, the average value (mmol/L) of fasting blood sugar of 30 people in the experimental group is reduced to 10.42 +/-3.96 from 15.69 +/-4.85 before the experiment, and the blood sugar of 2 hours after meal is reduced to 12.79 +/-5.50 from 18.56 +/-4.30, which is obviously lower than that of a control group; the urine sugar is reduced to 53 from 80 plus before the experiment, which shows that the invention has the health care efficacy of reducing blood sugar and urine sugar and relieving the clinical symptoms of diabetes, the significant efficiency is 30 percent, the effective rate is 53.3 percent, and the cumulative effective rate is 83.3 percent.

The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. The traditional Chinese medicine composition is characterized by comprising the following raw materials in parts by weight:

2. The traditional Chinese medicine composition according to claim 1, which is characterized by comprising the following raw materials in parts by weight:

3. The preparation method of the traditional Chinese medicine composition is characterized by comprising the following steps:

(1) weighing each raw material of any one of claims 1-2 for later use;

(2) cleaning the raw materials, removing impurities, and drying at 66-70 deg.C;

4. The preparation method of the traditional Chinese medicine composition according to claim 3, wherein the wall breaking treatment in the step (3) adopts a wall breaking machine, and the rotating speed is 40000-45000 r/min; the time is 1-2 min.

5. The method for preparing a Chinese medicinal composition according to claim 3, wherein the extracting in step (4) is carried out by putting radix Puerariae, radix astragali, rhizoma Dioscoreae, mume fructus, fructus Hippophae and radix Panacis Quinquefolii into a multifunctional extracting tank, adding 11 times of water, reflux-extracting for 2.5-3h, adding 9 times of water into the residue, reflux-extracting for 1.5-2h to obtain an extract.

6. The method for preparing a Chinese medicinal composition according to claim 5, wherein the step (4) of preparing the paste comprises filtering the extractive solution with a centrifuge, concentrating under reduced pressure to obtain a thick paste with a relative density of 1.32-1.34 measured at 70 deg.C, and drying at 80-85 deg.C.