CN117919305A

CN117919305A - Balsam pear hypoglycemic traditional Chinese medicine formula praised as plant insulin

Info

Publication number: CN117919305A
Application number: CN202310574500.5A
Authority: CN
Inventors: 杨智勇
Original assignee: Yuhuakang Beijing Biotechnology Co ltd
Current assignee: Yuhuakang Beijing Biotechnology Co ltd
Priority date: 2023-05-22
Filing date: 2023-05-22
Publication date: 2024-04-26

Abstract

The invention discloses a traditional Chinese medicine hypoglycemic formula prepared from astragalus, balsam pear, mulberry leaf, dogwood, kudzuvine root, ginseng and chromium-enriched yeast. The balsam pear known as plant insulin is used for cooling, quenching thirst, tonifying kidney and promoting urination, and the mulberry leaf known as the immortal grass is matched with the balsam pear for clearing lung, moistening dryness, suppressing hyperactive liver and improving eyesight, and the balsam pear and the immortal grass are used as monarch drugs. The ministerial drugs are ginseng and astragalus root, which are used for ascending clear yang, tonifying lung qi, regulating essence, assisting monarch drugs to strengthen primordial qi, and qi hyperactivity can promote the generation of yang fluid and the generation of body fluid can stop thirst. With the assistance of the radix puerariae, the five viscera deficiency can be compensated, and the body fluid is generated to quench thirst; the dogwood is used for tonifying liver and kidney, astringing and inducing diuresis, and has definite curative effects on thirst, dry throat, diuresis, eating and the like caused by diabetes. The chromium-enriched yeast is added to increase insulin sensitivity. The medicines are combined to play the roles of nourishing yin, promoting the secretion of saliva or body fluid, moistening dryness and quenching thirst. Clinical verification shows that the invention has the advantages of assisting in reducing blood sugar, reducing western medicine dosage, preventing the occurrence and development of diabetes complications, and being a preferred health care good product for diabetics or people with high blood sugar.

Description

Balsam pear hypoglycemic traditional Chinese medicine formula praised as plant insulin

Technical Field

The invention relates to the field of traditional Chinese medicines, in particular to a balsam pear hypoglycemic traditional Chinese medicine formula which is praised as plant insulin and a preparation process thereof.

Background

Diabetes is a common endocrine disorder disease, which is a group of endocrine and metabolic diseases characterized by persistent hyperglycemia, wherein the endocrine and metabolic diseases are caused by interaction of genetic and environmental factors, so that insulin secretion is absolute or relatively insufficient and insulin resistance is caused to different degrees, and in vivo sugar, fat and protein metabolism is disturbed.

In recent years, the global occurrence rate of diabetes has increased rapidly, and has become a chronic disease which is the third most serious threat to human health after tumor and cardiovascular lesions. Every 8 seconds worldwide, 1 person dies from diabetes, and every year about 400 ten thousand people die from diabetes. Diabetes is also one of the global 10 disability diseases, and about 1500 tens of thousands of people are estimated to be blinded by diabetes by WHO. The medical expenditure for diabetes is 3780 billion yuan worldwide in 2010, accounting for 12% of the global health expenditure. Diabetes belongs to the category of diabetes in traditional Chinese medicine, and the basic pathogenesis is yin deficiency and dryness-heat, the deficiency and the excess are the principal and secondary aspects of the disease, and yin deficiency and dryness-heat are the principal aspects of the disease. The lung dryness heat is over, the fluid consumption is impaired, the stomach heat is over, gu Yiji is eliminated, and the kidney deficiency is not enough to hold urine, so that the three symptoms of polydipsia, polyphagia and diuresis are presented. So it is indicated for heat-clearing and dryness-moistening, qi-tonifying and yin-nourishing, essence-securing and urination-reducing. Guided by the theory of traditional Chinese medicine, three-component theory treatment: jinliu the light and heavy degree of diabetes "three more and less" in its "three-theory of elimination" is divided into three different parts of upper, middle and lower, and diabetes is divided into upper, middle and lower three and cloud: the thirst and polydipsia are the upper elimination, the hunger and the hunger are the middle elimination, and the turbid urine is the lower elimination. The upper part pertains to the lung, the middle part pertains to the stomach, and the lower part pertains to the kidney, which respectively represent three different viscera and pathological changes. The pathogenesis is classified as three-eliminating, dryness-heat and one-heat. Different treatment principles, such as clearing heat and moistening lung, clearing stomach and purging fire, nourishing yin and tonifying kidney, nourishing yin and promoting the production of body fluid, and the like, are formulated according to different disease positions and pathogenesis, and have important guiding significance.

"Medical heart-wisdom" is: for treating the upper-jiao with the large recipe, it is advisable to moisten the lung and clear the stomach; for middle energizer and middle energizer, it should clear the stomach and nourish the kidneys; for lower energizer, it should nourish the kidneys and tonify the stomach; for the treatment of three kinds of diseases, it is not necessary to take the root cause and nourish its origin, but it is preferable to treat the disease. Because of the complexity and diversity of the etiology of diabetes, clinical symptoms vary widely and therapeutic methods vary. The method for nourishing yin and clearing heat by ① is mainly used as a heat-clearing medicine, namely coptis chinensis and gypsum. ② For kidney-tonifying method, it is usually combined with Liuwei Dihuang Wan, but also with Ba Wei Wan (warming and invigorating kidney yang). ③ The recipe of the recipe includes spleen invigorating, qi benefiting, yin nourishing decoction, spleen invigorating, scalding, bamboo leaf and astragalus root decoction, etc. Fructus Schisandrae chinensis and radix Ophiopogonis may be added in the decoction for invigorating middle warmer and replenishing qi. The traditional Chinese medicine is mainly used for clearing heat and promoting fluid production, nourishing yin and tonifying kidney, and the recipe is prepared from two kinds of Chinese medicinal herbs including radix Codonopsis, gypsum Fibrosum, herba Dendrobii, jiao Baique, coicis semen, radix Glycyrrhizae Preparata, radix Ophiopogonis meat, parched fructus Gardeniae, poria, and rhizoma Phragmitis. Many reports of treating diabetes by using traditional Chinese medicine preparations are also found in scientific and technical literature, but the known medicine components have complex components, different treatment methods, excessive cost, insufficient obvious curative effect and uncontrollable effective components, so the traditional Chinese medicine preparations are not suitable for popularization and are particularly suitable for industrial mass production.

Disclosure of Invention

The invention aims to adapt to the market demand, i.e. follow the traditional Chinese medicine diet therapy theory, combine the modern medical research results, stand on the principle of treating both principal and secondary aspects of the traditional Chinese medicine, strictly according to the compatibility of 'monarch, minister, assistant and guide' of the traditional Chinese medicine, screen dozens of traditional Chinese medicine prescriptions, repeatedly compare, select some medicine prescriptions from the prescriptions, and carry out pharmacodynamics, pharmacology and clinical research, and finally, the invention finally discloses a traditional Chinese medicine prescription with good curative effect, wide medicine sources, long-term edible safety, moderate price, reasonable process, stable quality and high safety. The prescription of the invention takes astragalus root, balsam pear, mulberry leaf, dogwood, kudzuvine root, ginseng and chromium-enriched yeast as main raw materials to prepare capsules, granules or tablets, and the marked components are puerarin, crude polysaccharide and chromium.

Taking a granular preparation as an example, the following raw materials are proportioned as follows:

every 1000 bags (3 g/bag) contain

The invention is prepared by following the traditional Chinese medicine diet therapy theory and combining the modern medical health care research results according to the principle of 'monarch, minister, assistant and guide' of the traditional Chinese medicine. The method mainly comprises the steps of balsam pear extract and mulberry leaf extract. The balsam pear is known as plant insulin, and the 'Yunnan herbal' records that the balsam pear is bitter and cold and enters the heart, spleen and stomach and three channels, can purge fire, clear summer heat, replenish qi and quench thirst, and the traditional Chinese medicine considers that the pathogenesis of early diabetes is internal heat due to yin deficiency, and clinical manifestations are common in thirst, polydipsia and other manifestations, so the balsam pear is a good food therapy product for diabetics from the aspect of traditional Chinese medicine. Modern research results show that: the balsam pear extract mainly contains plant insulin, is an effective blood sugar regulator, contains rich nutrition components necessary for synthesizing insulin by human body, has a large amount of active pancreatic factors with the functions of nourishing pancreas islet B cells and enhancing the blood sugar reducing activity of insulin, and is a purely natural blood sugar reducing nutrient. According to researches, the balsam pear saponin in the balsam pear can restore the normal secretion function of damaged islet beta cells, thereby playing a role in assisting in reducing blood sugar. Mulberry leaf, folium Mori, sweet and cold in nature, light in weight, capable of removing lung and liver meridian, nourishing yin and moistening dryness, promoting the production of body fluid to quench thirst, and its decoction can be used as tea for relieving thirst, carried in Ben Cao gang mu, sang Shenai in the medicine of hand-foot-yang. Modern pharmacological studies show that the mulberry leaf total flavone achieves remarkable hypoglycemic effect by inhibiting the activity of intestinal bifida. A plurality of experimental results show that the mulberry leaf extract has good effect of reducing fasting blood glucose and has no influence on blood glucose of normal animals. Is supplemented with radix Puerariae extract and Ginseng radix extract. The pueraria extract has sweet and cool taste, can tonify deficiency of five viscera, clear heat and relieve restlessness, tonify qi and nourish yin, promote the production of body fluid to quench thirst, reduce lipid and blood sugar, remove internal toxin, and effectively regulate and restore the functions of the viscera of the organism. Puerarin, the main ingredient of Puerarin, improves insulin sensitivity by acting on vasoconstriction by anti-epinephrine, and reducing whole blood viscosity and blocking beta receptors. Therefore, the radix puerariae extract has pharmacological effects of reducing blood viscosity and improving local blood circulation, and can be used for preventing and treating diabetes and chronic complications. The ginseng extract contains various active ingredients such as saponin, polysaccharide, alkaloid and the like, and the ginseng can be used for treating type 1 and type 2 diabetes, has remarkable effect on diabetic complications, namely diabetic nephropathy, and the hypoglycemic effect is mainly realized by the ways of increasing insulin secretion, improving the sensitivity of an organism to insulin, improving the ingestion of glucose by fat and muscle tissues, inhibiting the absorption of glucose by intestinal tracts, inhibiting the generation of glucose in liver cells and the like by the active ingredients such as ginsenoside and the like. With the addition of radix astragali extract and Corni fructus extract. Astragalus extract, astragalus polysaccharide as the active component for treating diabetes in Chinese medicine may be used in improving liver endoplasmic reticulum stress to reduce endoplasmic reticulum damage, increase glycogen synthase activity and increase insulin signal protein synthesis amount and activity and thus has antidiabetic effect. The dogwood extract has sour and astringent taste and slightly warm nature, enters liver and kidney channels, has the effects of tonifying kidney and stopping nocturnal emission, and is recorded for treating diabetes (Chinese medicine is called as diabetes) from ancient times. Research shows that dogwood has no obvious effect on normal blood sugar level, but has obvious effect of reducing blood sugar increase caused by diabetes. Modern pharmacological studies show that cornus officinalis mainly improves serum insulin levels by protecting islet beta cells or promoting repair of damaged beta cells, and increases liver glycogen content by promoting glycogen synthesis, thereby achieving the purpose of reducing blood sugar. And chromium-rich yeast is matched, and chromium is one of microelements necessary for human body, and plays a special role in sugar metabolism and lipid metabolism of the organism. Trivalent chromium is the main component of glucose tolerance factor GTF, and the GTF has the function of promoting the combination of insulin and receptor on target cell membrane, so that disulfide bond is formed between insulin and receptor sulfhydryl, and insulin is promoted to act. The chromium-enriched yeast can improve the absorption and utilization rate of chromium in the organism and better plays the role of assisting in reducing blood sugar. The above medicines are matched and synergistic to play the roles of nourishing yin, promoting the production of body fluid, moistening dryness and quenching thirst, and the symptoms can be relieved and healed, so that the purpose of healing is achieved.

The raw materials and the dosage are as follows:

Raw materials	Daily intake of raw materials	Daily dosage of raw materials	Prescribed amount
				Astragalus mongholicus extract	720mg	4.32g	9-30
Balsam pear extract	456mg	2.736g	-----
				Mulberry leaf extract	240mg	1.92g	5-10g
Extract of cornus officinalis	228mg	2.28g	6-12
				Radix Puerariae extract	204mg	3.06g	10-15
Ginseng extract	108mg	0.54g	3-9
				Chromium-enriched yeast	39.6mg	89.28μg	Chromium less than or equal to 250 mug

The dosage of each raw material in the formula is within the safe edible dosage range, and the raw materials have no incompatibility, so that the use is safe.

Compared with the prior art, the invention has the outstanding substantial characteristics and remarkable progress that:

1. The invention is proved by the traditional Chinese medicine theory and modern experiments that the traditional Chinese medicines are optimized, and are scientifically matched and manufactured, so that the medicines are matched with each other, the advantages of the medicines are compensated for, the synergistic effect is achieved, the medicines are combined, the curative effect is enhanced, and both the symptoms and root causes are treated.

2. Most of the raw materials used in the invention are food and medicine homologous, the toxicity is low, and the defect that other hypoglycemic drugs, particularly western medicines, have toxic and side effects, and particularly damage to liver and kidney after long-term use is overcome. Therefore, no toxic or side effect is found in long-term test use, and the product is safe to use according to daily doses and treatment courses.

3. The supercritical wall-breaking extraction technology is adopted to furthest reserve the bioactive substances of the traditional Chinese medicine, enrich the hypoglycemic active ingredients, synergistically increase the effect of regulating and controlling diabetes, effectively prevent and improve the occurrence and development of diabetic complications, and animal experiments and human body test feeding experiments prove that the invention can reduce the fasting blood sugar and postprandial blood sugar of type II diabetics for 2 hours, has longer maintenance time and simultaneously reduces the triglyceride and cholesterol of hyperlipidemia patients. Has the health care function of assisting in reducing blood sugar, and is suitable for long-term taking by people with high blood sugar.

4. The raw materials are easy to obtain, the formula is scientific, most of the raw materials are fruits, the production process is advanced, the operability is strong, the product price is moderate, and the method is suitable for industrial production.

5. In the production process, according to the properties of the active ingredients of each traditional Chinese medicine and the preparation requirements, water extraction, alcohol precipitation and sterilization methods are adopted, so that the product has high active ingredient content, stability, difficult deterioration and long storage life.

The preparation is subjected to safety toxicology evaluation test by Guangxi Zhuang autonomous region disease prevention control center, and the test conclusion is that:

1. Acute oral toxicity test: after the mice are subjected to gastric lavage by using a 20000mgkg BW dose sample, no toxic symptoms and no death of the animals are observed, the animals are dissected after the test, no abnormality is observed in general, and the acute oral toxicity MTD of the sample to the mice is more than 20000mg/kg BW, and the acute oral toxicity belongs to a non-toxic grade.

TABLE 1 acute toxicity test results on mice

2. Genotoxicity test: the results of all three genotoxicity tests (Ames test, mouse bone marrow cell micronucleus test and mouse sperm malformation test) are negative.

TABLE 2 results of first Ames test

3.30 Days feeding trial: the rats are continuously fed with 3 doses of sample of 2500, 5000 and 10000mg/kg BW (corresponding to 25, 50 and 100 times of the recommended dosage of human body respectively) mixed into the feed for 30 days, the growth and development of animals are good during the experiment, and the animal weight, weight increment, feeding rate, food utilization rate, blood routine index, blood biochemical index, organ weight and organ/weight ratio of each dose group are all not significantly different (P is more than 0.05) compared with the comparison group; no abnormal changes associated with the samples were seen from gross anatomic observations and histopathological examination. The sample has no toxic or side effect on various observation indexes of rats within the range of the received reagent amount. The health rat is subjected to a blood sugar reducing function test by the Guangxi Zhuang autonomous region disease prevention and control center, and the result is judged that: the mice with hyperglycemia model are continuously perfused with BW (equivalent to 5, 10 and 20 times of human recommended amount) doses of 500, 1000 and 2000mg/kg respectively for 30 days, so that the fasting blood glucose value of the mice can be reduced, the area under the blood glucose curve at each time point of the glucose tolerance test of the mice is reduced, and the weight of the mice is not obviously influenced; normal mice were continuously perfused with a 2000mg/kg BW dose of the sample for 30 days without significant impact on body weight gain and fasting blood glucose levels. In conclusion, the sample has an auxiliary blood sugar reducing function.

Fasting blood glucose results in hyperglycemia model mice

Note that: * P < 0.05 compared with the model control group is shown.

The Chinese people's free army 303 hospital performs a blood sugar reducing function-human body test food test, 109 hyperglycemia groups (56 groups and 53 groups) meeting the test selection standard of the test, wherein the test food group continuously takes the granules for 60 days (2 times a day, 1 bag each time).

After the test food, various clinical symptoms of the test food group population are improved to a certain extent, the total improvement rate is 80.1 percent, which is higher than 33.3 percent of that of the control group, and the difference is significant (P is less than 0.01).

Table 1 comparison of clinical symptom score for two groups of people before and after food trial

The clinical symptom integral of the population of the test food group is reduced by 1.82 and is greater than 0.41 of the control group, and the difference between the front and back comparison of the test food group and the comparison between the groups after test food has significance (P is less than 0.01).

Table 2 symptom improvement in the population before and after the experiment

The average blood sugar content of fasting blood sugar and postprandial blood sugar content of 2 hours are respectively reduced by 10.17 percent and 10.68 percent, which are higher than 1.73 percent and 1.27 percent of the control group, and the differences are significant (P is less than 0.01);

The difference between fasting blood glucose and postprandial blood glucose of the test group is significant (P < 0.01).

The fasting blood glucose effective rate of the test group is 56.6 percent, which is more than 0.0 percent of that of the control group, and the difference has significance (P is less than 0.01); the postprandial blood sugar effective rate of the test group is 62.3 percent, which is obviously greater than 1.8 percent (P is less than 0.01) of the control group.

The differences between the two groups of people are not significant (P is more than 0.05) because of the self comparison before and after the test food.

Serum TC and TG levels of the two groups of people before and after trial feeding are not changed obviously, and no significant difference (P is more than 0.05) exists in comparison among the groups.

The general symptoms, the blood routine, the urine and the stool routine, the blood biochemical indexes and other clinical examinations of the subject are not abnormal, the results of all indexes are within the normal range, and adverse reactions such as nausea, flatulence, diarrhea and allergy do not occur to the person taking the sample in the test process. Therefore, the sample has the auxiliary blood sugar reducing function, and has no harm to the health of the tested population.

Detailed Description

In order to meet different requirements, a capsule formulation is developed on the basis of a granular preparation, and the product takes astragalus extract, balsam pear extract, mulberry leaf extract, dogwood extract, kudzuvine root extract, ginseng extract and chromium-enriched yeast as main raw materials, and is solid powder, so that the product is suitable for preparing solid preparations such as granules, tablets, hard capsules and the like.

The invention is further described below with reference to the accompanying drawings:

FIG. 1 is a schematic flow chart of the preparation process and a process description of the capsule dosage form of the invention.

Figure 2 is a schematic flow chart of the process for preparing the granular dosage form of the present invention and its technological illustration.

Figure 3 is a schematic flow chart of the process for preparing the tableting dosage form of the present invention and its technological illustration.

Example 1: as shown in figure 1, the preparation is processed into a capsule preparation through the process steps of crushing, sieving, weighing, mixing, filling, polishing, selecting, packaging and the like according to the following raw material proportion.

Every 1000 (0.35 g/granule) contains

Description of the production Process

1. Taking astragalus extract, balsam pear extract, mulberry leaf extract, dogwood extract, kudzuvine root extract, ginseng extract, chromium-enriched yeast and starch which meet the enterprise standard and are qualified through inspection;

2. removing the outer package of each raw material and auxiliary material, and enabling the inner package to enter a clean area through a transmission window;

3. Crushing and sieving: pulverizing radix astragali extract, fructus Momordicae Charantiae extract, folium Mori extract, corni fructus extract, radix Puerariae extract, and Ginseng radix extract respectively, sieving with 80 mesh sieve to obtain fine powder, and sieving chromium-rich yeast and starch with 80 mesh sieve to obtain fine powder;

4. Weighing and mixing: weighing radix astragali extract fine powder, fructus Momordicae Charantiae extract fine powder, folium Mori extract fine powder, corni fructus extract fine powder, radix Puerariae extract fine powder, ginseng radix extract fine powder, chromium-rich yeast fine powder, and starch fine powder according to formula ratio; mixing chromium-rich yeast fine powder with Ginseng radix extract fine powder for 10min to obtain mixed powder 1; mixing radix astragali extract fine powder, fructus Momordicae Charantiae extract fine powder, folium Mori extract fine powder, corni fructus extract fine powder, radix Puerariae extract fine powder, and starch fine powder with mixed powder 1 for 30min to obtain total mixed powder;

5. preparing a soft material: adding 75% ethanol (food grade) into the total mixed powder to obtain soft material;

6. granulating: making the soft material into granule with 20 mesh to obtain wet granule;

7. drying and granulating: drying the wet particles at 50-70 ℃ until the moisture is less than or equal to 5%, and sieving the wet particles with a 20-mesh sieve to obtain dry particles;

8. Filling capsules: filling the dry particles into capsules to obtain hard capsules, wherein the weight of the hard capsules is 0.35 g/granule;

9. Polishing: removing powder on the surface of the capsule, improving the surface smoothness and enabling the capsule to be tidy and beautiful;

10. selecting: selecting and removing unqualified products;

11. and (3) inner packaging: bottling with packaging material conforming to YBB00122002 oral solid medicine high-density polyethylene bottle, and packaging specification: 60 grains/bottle;

12. And (3) outer packaging;

13. Quality inspection: inspecting the finished product by a quality inspector;

14. Warehousing;

15. Clean range of production factory: and removing the outer package from the raw and auxiliary materials, and entering a clean area to an inner packaging process, wherein the cleanliness of a production workshop is 10 ten thousand.

Example 2: as shown in fig. 2, the granule preparation is prepared by the following steps of crushing, sieving, weighing, mixing, granulating, drying, granulating, packaging and the like according to the following raw material proportion.

Every 1000 bags (3 g/bag) contain

Description of the production Process

1. Taking astragalus extract, balsam pear extract, mulberry leaf extract, dogwood extract, kudzuvine root extract, ginseng extract, chromium-enriched yeast, lactose, stevioside and maltodextrin which are qualified by the enterprise standard through inspection;

3. Crushing and sieving: pulverizing radix astragali extract, fructus Momordicae Charantiae extract, folium Mori extract, corni fructus extract, radix Puerariae extract, and Ginseng radix extract respectively, sieving with 80 mesh sieve to obtain fine powder; sieving chromium-enriched yeast, lactose, stevioside and maltodextrin with 80 mesh sieve to obtain fine powder;

4. Weighing and mixing: weighing folium Mori extract fine powder, corni fructus extract fine powder, radix Puerariae extract fine powder, ginseng radix extract fine powder and chromium-rich yeast fine powder according to formula proportion, mixing for 30min to obtain mixed powder 1, weighing radix astragali extract fine powder, fructus Momordicae Charantiae extract fine powder, lactose fine powder, stevioside fine powder, maltodextrin fine powder according to formula proportion, mixing with mixed powder 1 for 30min to obtain total mixed powder;

8. and (3) inner packaging: 3 g/bag, wherein the inner packaging material accords with the general rule of composite films and bags for GB/T21302 packaging;

9. and (3) external packing: boxing, namely 20 bags/boxes, wherein the external packing material accords with the regulations of single corrugated boxes and double corrugated boxes for GB/T6543 transportation packaging;

10. Quality inspection; inspecting the finished product by a quality inspector;

11. warehousing;

12. clean range of production factory: and removing the outer package from the raw and auxiliary materials, and entering a clean area to an inner packaging process, wherein the cleanliness of a production workshop is 10 ten thousand.

Example 3: as shown in fig. 3, the tablets are prepared by the following steps of crushing, sieving, weighing, mixing, preparing soft materials, granulating, mixing, tabletting, coating, selecting, packaging and the like according to the following raw material proportion.

Every 1000 tablets (0.6 g/tablet) contain

Description of the production Process

1. Taking astragalus extract, balsam pear extract, mulberry leaf extract, dogwood extract, kudzuvine root extract, ginseng extract, chromium-enriched yeast, microcrystalline cellulose, carboxymethyl starch sodium and magnesium stearate which are qualified by the enterprise standard through inspection, and coating the powder;

3. Crushing and sieving: pulverizing radix astragali extract, fructus Momordicae Charantiae extract, folium Mori extract, corni fructus extract, radix Puerariae extract, and Ginseng radix extract respectively, and sieving with 80 mesh sieve respectively to obtain fine powder;

4. Weighing and mixing: weighing chromium-rich yeast fine powder and carboxymethyl starch sodium fine powder according to the formula proportion, and mixing for 10min to obtain mixed powder 1; weighing the balsam pear extract fine powder, the mulberry leaf extract fine powder, the dogwood extract fine powder, the kudzuvine root extract fine powder and the ginseng extract fine powder according to the formula proportion, and mixing with the mixed powder 1 for 25min to obtain mixed powder 2; weighing radix astragali extract fine powder and microcrystalline cellulose fine powder according to the formula proportion, and mixing with the mixed powder 2 for 25min to obtain total mixed powder;

5. preparing a soft material: adding 70% ethanol (food grade) into the total mixed powder to obtain soft material;

7. and (3) drying: drying the wet particles at 50-70 ℃ until the moisture is less than or equal to 5% to obtain dry particles;

8. Finishing: sieving the dry particles with a 20-mesh sieve to obtain qualified particles;

9. Mixing: weighing magnesium stearate fine powder according to the formula proportion, and mixing with qualified particles for 5min to obtain a mixture;

10. tabletting: tabletting the mixture to obtain plain tablets (600 mg/tablet);

11. Coating: coating powder and 75% ethanol to prepare coating liquid, and coating the plain tablets to obtain film coated tablets;

12. selecting: rejecting unqualified products;

13. And (3) inner packaging: 60 sheets/bottle, wherein the inner packaging material meets the standard of YBB00122002 oral solid medicinal high-density polyethylene bottles;

14. and (3) external packing: packaging with single corrugated paper boxes and double corrugated paper boxes which accord with GB/T6543 transportation packaging;

15. Quality inspection; inspecting the finished product by a quality inspector;

16. warehousing;

17. clean range of production factory: and removing the outer package from the raw and auxiliary materials, and entering a clean area to an inner packaging process, wherein the cleanliness of a production workshop is 10 ten thousand.

The foregoing description is only illustrative of the invention and is not intended to limit the scope of the invention, and all changes and modifications made by those skilled in the art to which the invention pertains are deemed to lie within the spirit and scope of the invention.

Claims

1. A balsam pear hypoglycemic traditional Chinese medicine formula known as plant insulin is characterized by being prepared from astragalus mongholicus, balsam pear, mulberry leaf, dogwood, kudzuvine root, ginseng and chromium-enriched yeast, wherein the traditional Chinese medicine is calculated by the weight of an extract.

The dosage of the raw materials is as follows:

1) The capsule preparation contains 1000 capsules (0.35 g/capsule)

2) Every 1000 bags (3 g/bag) of the granule preparation

3) Every 1000 tablets (0.6 g/tablet) contain

2. The preparation process of the traditional Chinese medicine hypoglycemic prescription for treating diabetes and complications thereof as claimed in claim 1, which is characterized in that the specific process flow is characterized in that

1) Taking astragalus extract, balsam pear extract, mulberry leaf extract, dogwood extract, kudzuvine root extract, ginseng extract, chromium-enriched yeast and auxiliary materials which meet the enterprise standard and are qualified through inspection;

2) Removing the outer package of each raw material and auxiliary material, and enabling the inner package to enter a clean area through a transmission window;

3) Crushing and sieving: pulverizing radix astragali extract, fructus Momordicae Charantiae extract, folium Mori extract, corni fructus extract, radix Puerariae extract, and Ginseng radix extract respectively, sieving with 80 mesh sieve to obtain fine powder; sieving chromium-rich yeast and adjuvants with 80 mesh sieve to obtain fine powder;

4) Weighing and mixing: weighing folium Mori extract fine powder, corni fructus extract fine powder, radix Puerariae extract fine powder, ginseng radix extract fine powder and chromium-rich yeast fine powder according to formula proportion, mixing for 30min to obtain mixed powder 1, weighing radix astragali extract fine powder, fructus Momordicae Charantiae extract fine powder and adjuvants according to formula proportion, mixing with mixed powder 1 for 30min to obtain total mixed powder;

5) Preparing a soft material: adding 75% ethanol (food grade) into the total mixed powder to obtain soft material;

6) Granulating: making the soft material into granule with 20 mesh to obtain wet granule;

7) Drying and granulating: drying the wet granules at 50-70deg.C until the water content is less than or equal to 5%, and sieving with 20 mesh sieve to obtain dry granules.

3. The traditional Chinese medicine hypoglycemic formula according to claim 1, wherein the marker components are puerarin, crude polysaccharide and chromium.

4. Use of a composition according to claims 1-3 for the preparation of a medicament having a hypoglycemic function.

5. Use of the composition according to claims 1-3 for the preparation of a health food with an auxiliary hypoglycemic function.

6. The hypoglycemic formula according to claims 4-5, wherein the traditional Chinese medicine composition can be prepared into teabags, granules, capsules and tablets.

7. The traditional Chinese medicine hypoglycemic formula of claim 1, wherein the formula is characterized in that; the carrier is selected from auxiliary materials such as filler, disintegrating agent, adhesive, wetting agent and lubricant, wherein the filler is starch, dextrin, lactose, sucrose, powdered sugar, microcrystalline cellulose glucose, meglumine, glucosamine, mannitol, calcium sulfate or calcium bisulfate, and the disintegrating agent is hydroxypropyl cellulose, sodium carboxymethyl starch, crosslinked povidone, crosslinked sodium carboxymethyl cellulose or crosslinked hydroxypropyl methyl cellulose; the adhesive is hydroxypropyl methyl cellulose sodium or povidone; the wetting agent is water or ethanol; the lubricant is magnesium stearate or talcum powder.