Traditional Chinese medicine capsule for treating diabetes and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine capsule for treating diabetes and a preparation method thereof, and belongs to the technical field of medicine preparation. The capsule is composed of main materials and auxiliary materials. The main materials are composed of 23-27 g of radix astragali, 23-27 g of radix puerariae, 18-22 g of rhizoma polygonati, 18-22 g of Chinese yam, 13-17 g of radix scrophulariae, 13-17 g of radix rehmanniae praeparata, 13-17 g of radix salviae miltiorrhizae, 8-12 g of rhizoma coptidis, 8-12 g of silkworm excrement, 8-12 g of rhizoma polygoni cuspidati, 7-9 g of liquorice and 5-7 g of fructus momordicae. The auxiliary material consists of lactose, microcrystalline cellulose and superfine silica powder in a mass ratio of 10: 10: 1, and the total weight of the auxiliary material is 210g. Double-section countercurrent extraction and low-temperature belt type drying are adopted, the retention rate of effective components is increased, the content of berberine and the content of salvianolic acid B are increased by 18% and 22% respectively, in addition, particle size grading compatibility is adopted, quick release and gastrointestinal tolerance are both considered, artificial sweeteners or chemical hypoglycemic drugs are not additionally added to the finished product, and the finished product conforms to human body metabolic motility.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of medicine preparation, and particularly relates to a traditional Chinese medicine capsule for treating diabetes and a preparation method thereof. BACKGROUND

[0002] Diabetes is a global metabolic disease characterized by chronic hyperglycemia, mainly divided into type 1 diabetes (absolute lack of insulin) and type 2 diabetes (insulin resistance with relative lack). Long-term poor glycemic control can lead to complications in multiple systems such as heart, brain, kidney, eye and nerve, seriously endangering human health. At present, the treatment of western medicine mainly uses hypoglycemic drugs (such as metformin, insulin, SGLT-2 inhibitors, etc.), which can effectively control blood glucose, but some patients have side effects, secondary failure, need long-term injection or are difficult to consider overall regulation.

[0003] Traditional Chinese medicine compound capsules developed on the basis of the overall concept and syndrome differentiation and treatment theory of traditional Chinese medicine have become an important supplement and exploration direction in the field of comprehensive treatment of diabetes. Such capsules aim to achieve the comprehensive goal of regulating blood glucose, improving insulin resistance, protecting islet beta cell function, delaying the occurrence and development of complications, and improving the clinical symptoms (such as thirst, polydipsia, fatigue, limb numbness, etc.) of patients through the synergistic effect of multiple components, multiple targets and multiple pathways. Its application positioning is often used as an auxiliary treatment for mild type 2 diabetes, or used in combination with western medicine for moderate and severe patients to enhance efficacy, reduce the dosage and potential side effects of western medicine, reflecting the characteristics and advantages of traditional Chinese medicine in "preventing disease" and "preventing disease from changing" after the disease.

[0004] Although traditional Chinese medicine capsules show potential in the treatment of diabetes, their research and application still face some key problems and challenges, which are specifically manifested as follows: 1. Most compound capsules have complex components, and the exact targets of their hypoglycemic effect, signal pathways and interaction mechanisms between different components are still not clear enough, making it difficult to accurately explain their "multiple target" synergistic principle in modern medical language, which restricts the wide recognition of the international academic community. 2. Although some varieties have a certain clinical application basis, high-quality clinical research (RCT) of large scale, multi-center and randomized double-blind is relatively lacking, and the data of long-term drug effectiveness and safety, especially the evidence of the impact on hard endpoints (such as cardiovascular and cerebrovascular events, end-stage renal disease) are still insufficient. 3. Although the capsules of fixed composition are convenient for promotion, they have some contradictions with the essence of traditional Chinese medicine "syndrome differentiation and treatment". How to make the capsule products cover the core pathogenesis of diabetes (such as deficiency of both qi and yin, dryness-heat due to yin deficiency) and adapt to individual differences, or develop a series of products for different types of syndromes, is a strategic problem that needs to be solved. 4. When used as a combination drug, whether there is an interaction between the complex components of traditional Chinese medicine and western medicine in pharmacokinetics or pharmacodynamics, and the potential risks and synergistic mechanisms need to be systematically studied to ensure drug safety. SUMMARY

[0005] In view of this, the purpose of the present application is to provide a traditional Chinese medicine capsule for treating diabetes to solve the above problems.

[0006] To achieve the above purpose, the present application provides the following technical solutions: The present application provides a traditional Chinese medicine capsule for treating diabetes and a preparation method thereof, wherein the capsule is composed of main materials and auxiliary materials, and the main materials are composed of 23-27g of Radix Astragali, 23-27g of Radix Puerariae, 18-22g of Rhizoma Polygonati, 18-22g of Rhizoma Dioscoreae, 13-17g of Radix Scrophulariae, 13-17g of Radix Rehmanniae Preparata, 13-17g of Radix Salviae Miltiorrhizae, 8-12g of Rhizoma Coptidis, 8-12g of Bombyx Batryticatus, 8-12g of Giant Knotweed, 7-9g of Radix Glycyrrhizae, and 5-7g of Fructus Momordicae. The auxiliary materials are composed of lactose, microcrystalline cellulose, and micro-powder silica with a mass ratio of 10:10:1, and the total amount of the auxiliary materials is 210g.

[0007] Further, the main materials are composed of 25g of Radix Astragali, 25g of Radix Puerariae, 20g of Rhizoma Polygonati, 20g of Rhizoma Dioscoreae, 15g of Radix Scrophulariae, 15g of Radix Rehmanniae Preparata, 15g of Radix Salviae Miltiorrhizae, 10g of Rhizoma Coptidis, 10g of Bombyx Batryticatus, 10g of Giant Knotweed, 8g of Radix Glycyrrhizae, and 6g of Fructus Momordicae.

[0008] Further, a preparation method of a traditional Chinese medicine capsule for treating diabetes includes the following steps, S1, vacuum drying Bombyx Batryticatus, Radix Salviae Miltiorrhizae, and Giant Knotweed, and then grinding them into 20-mesh coarse powder to obtain medicinal material A; freeze-drying Rhizoma Dioscoreae, Rhizoma Polygonati, and Radix Rehmanniae Preparata to maintain porosity for disintegration, to obtain medicinal material B; S2, mixing medicinal material A with 70% ethanol, countercurrent extraction at 50-60°C, and then recovering ethanol to obtain extract A; S3, mixing the alcohol-extracted residue with medicinal material B, Radix Glycyrrhizae, Fructus Momordicae, Rhizoma Coptidis, Radix Astragali, and Radix Puerariae, adding water, countercurrent extraction at 85-95°C, and then filtering; adding water to the filtered residue for continuous extraction, combining the two filtrates, and reducing pressure to concentrate to extract B; S4, belt drying extract A and extract B, respectively, to obtain dry extract A and dry extract B; S5, airflow pulverizing dry extract A to D90 of 14-16µm to obtain dry extract powder A; and mechanically pulverizing dry extract B to D90 of 42-48µm to obtain dry extract powder B; S6, preliminarily mixing dry extract powder A, dry extract powder B, lactose, microcrystalline cellulose, and micro-powder silica, then adding magnesium stearate for uniform mixing, and then filling into gastric-soluble capsules, and performing internal packaging and sterilization treatment to obtain the traditional Chinese medicine capsule for treating diabetes.

[0009] Further, in step S1, the vacuum drying temperature of the silkworm excrement, salvia miltiorrhiza and giant knotweed is 38-42 DEG C, and the drying is performed until the moisture content is less than or equal to 8%; the freeze-drying conditions of the yam, polygonatum and prepared rehmannia are -50 DEG C and 0.05 mbar.

[0010] Further, in step S2, the volume ratio of the medicinal material A to 70% ethanol is 1:8, the countercurrent extraction time is 2 hours, the relative density of the extract A after recovery of ethanol is 1.18, and the temperature is 60 DEG C.

[0011] Further, in step S3, the material ratio of the medicinal material to water is 1:10, the countercurrent extraction time is 1 hour; the material ratio of the filtered residue to water is 1:8, and the extraction time is 40-50 minutes; the relative density of the concentrated extract B is 1.20, and the temperature is 60 DEG C.

[0012] Further, in step S4, the temperature of the extract A and the extract B during the belt drying is 65 DEG C, and the drying is performed under -0.09 MPa; the extract A is controlled to have an extract rate of 18%, the extract B is controlled to have an extract rate of 22%, and the moisture content of both is less than or equal to 5%.

[0013] Further, in step S6, the inner package adopts an HDPE high-density bottle, a molecular sieve drying agent is used for sterilization, 60Co-gamma irradiation and 6 kGy sterilization are adopted, and the microbial load is controlled to be less than or equal to 100 cfu / g.

[0014] Further, in step S6, in step S6, the magnesium stearate is 1.8 g of 0.5% magnesium stearate.

[0015] The present application has the following beneficial effects: 1. The present application uses silkworm excrement, giant knotweed and salvia miltiorrhiza in combination to achieve the effects of promoting blood circulation to remove blood stasis, clearing wind and removing dampness, clearing heat and removing dampness, promoting blood circulation and cooling blood, and the combination of the three drugs can improve insulin resistance and abnormal blood rheology, and has more advantages in reducing fat and reducing viscosity than the combination of atractylodes lancea and salvia miltiorrhiza.

[0016] 2. The mogroside in the present application acts as a natural flavoring agent, has antioxidant and alpha-glucosidase inhibitory activities, can slightly delay carbohydrate absorption, and has a synergistic effect with berberine in reducing blood sugar. The silkworm excrement is used to replace atractylodes lancea, which can reduce dryness and promote blood circulation; the mogroside is introduced for decoction, which can flavor and slightly inhibit alpha-glucosidase.

[0017] 3、The application adopts double-section countercurrent extraction and low-temperature belt drying, improves the retention rate of effective components, and makes the content of berberine and salvianolic acid B increase by 18% and 22% respectively.

[0018] Additional advantages, objects, and features of the application will be set forth in the descriptions to follow, and in part will become apparent to those skilled in the art from the drawings and the descriptions, and will be learned by practice of the application. The objects and other advantages of the application will be realized and attained by the methods particularly pointed out in the written description and claims hereof. BRIEF DESCRIPTION OF DRAWINGS

[0019] In order to make the objectives, technical solutions and beneficial effects of the application clearer, the application provides the following drawings for description: Figure 1 It is a preparation flowchart of the application. DETAILED DESCRIPTION

[0020] As shown in the drawings, Figure 1 The application provides a preparation method of a traditional Chinese medicine capsule for treating diabetes. Example 1

[0021] S1, classification pretreatment: 10g of silkworm sand, 15g of Danshen, 10g of giant knotweed containing volatile oil and heat-sensitive components are vacuum dried at 40 DEG C to moisture ≤8%, and then ground to 20 mesh for use, to obtain medicinal material A; 20g of Chinese yam, 20g of polygonatum, and 15g of prepared rehmannia containing high polysaccharide and starch are freeze-dried at-50 DEG C and 0.05 mbar, so as to maintain porosity, which is beneficial to subsequent disintegration.

[0022] S2, double-section countercurrent extraction is performed: first, medicinal material A is subjected to alcohol extraction with 70% ethanol at 1:8 (w / v), and countercurrent extraction is performed at 55 DEG C for 2 hours, and then 60 DEG C extract A with a relative density of 1.18 is obtained after recovering ethanol; the residue after alcohol extraction is mixed with medicinal material B, 8g of licorice, 6g of lo han guo, 10g of coptis, 25g of astragalus, and 25g of pueraria, and then water extraction is performed at 90 DEG C for 1 hour, and then filtration is performed, and 8 times the weight of water of the residue is continuously added for extraction for 45 minutes, and then the filtrates of the two times are combined, and then 60 DEG C extract B with a relative density of 1.20 is obtained after concentration under reduced pressure; S3, extract A and extract B are subjected to belt drying at 65 DEG C and-0.09 MPa respectively, and dry extract A and dry extract B are obtained, and the extract yield of dry extract A is controlled to be 18%, and the extract yield of dry extract B is controlled to be 22%, and the moisture content is ≤5%. S4, dry paste A airflow crushing to D90 is 15 μm; dry paste B mechanical crushing to D90 is 45 μm, coarse and fine powder can improve the capsule filling fluidity, while fine powder A is beneficial to the rapid dissolution of tanshinone and polygeline, and coarse powder B delays the burst of polysaccharide and reduces gastrointestinal irritation; S5, dry paste powder A and dry paste powder B are added to 105 g of lactose, 105 g of microcrystalline cellulose, 10.5 g of micronized silica gel and 1.8 g of magnesium stearate, and three-dimensional mixing is performed for 20 min, and 0 size gastric soluble capsules are filled, with a target loading of 0.35 g / capsule, and the difference is ≤ ± 3%; S6, HDPE high-density bottles and molecular sieve drying agents are used, 60Co-γ irradiation is performed at 6 kGy, sterilization is performed, the microbial load is ≤ 100 cfu / g, and the traditional Chinese medicine capsules for treating diabetes are obtained. Example 2

[0023] In this embodiment, silkworm sand 12 g, salvia miltiorrhiza 13 g, giant knotweed 8 g, yam 22 g, polygonatum 18 g, rehmannia 17 g, licorice 6 g, monk fruit 7 g, coptis 12 g, astragalus 27 g, and pueraria 23 g.

[0024] Example 2 and example 1 differ in that the components of each raw material are different, but are within the protection scope of the present application. Example 3

[0025] In this embodiment, silkworm sand 8 g, salvia miltiorrhiza 17 g, giant knotweed 12 g, yam 18 g, polygonatum 22 g, rehmannia 13 g, licorice 8 g, monk fruit 5 g, coptis 8 g, astragalus 23 g, and pueraria 27 g.

[0026] Example 3 and example 1 differ in that the components of each raw material are different, but are within the protection scope of the present application.

[0027] The traditional Chinese medicine capsules of examples 1-3 are used for streptozotocin (STZ) and high-fat diet type 2 diabetes rats, and continuous gavage is performed for 4 weeks: The test results are as follows: ① fasting blood glucose is reduced by 28% (vs model control P<0.01); ② serum TG is reduced by 35%, LDL-C is reduced by 30%, and HDL-C is increased by 20%; ③ insulin sensitivity index (ISI) is increased by 42%; ④ pancreatic section shows that the vacuolar degeneration of β cells is significantly reduced.

[0028] 20 type 2 diabetes patients are selected, 3 capsules of the traditional Chinese medicine capsules of the present application are added to the original metformin, tid, and 12 weeks are used: The test results are as follows: ① HbA1c is reduced by an average of 0.9%; 2. No gastrointestinal discomfort, abnormal liver and kidney function, and hypoglycemia events; 3. A decrease in patient's thirst and fatigue symptom score of > 50 %.

[0029] Finally, it should be noted that the above preferred embodiments are merely intended to illustrate the technical solutions of the present application but not to limit the present application. Although the present application has been described in detail through the above preferred embodiments, it should be understood by those skilled in the art that various changes in form and details can be made without departing from the scope defined by the claims of the present application.

Claims

1. A traditional Chinese medicine capsule for treating diabetes, characterized in that: The capsule main material and auxiliary material composition, the main material is composed of 23-27g Astragalus, 23-27g Pueraria, 18-22g Polygonatum, 18-22g Chinese yam, 13-17g Scrophularia, 13-17g Rehmannia glutinosa, 13-17g Salvia miltiorrhiza, 8-12g Coptis, 8-12g silkworm sand, 8-12g giant knotweed, 7-9g licorice, 5-7g Ficus hispida. ​ The auxiliary material is composed of lactose: microcrystalline cellulose: micro powder silica gel with a mass ratio of 10:10:1, and the total amount of auxiliary material is 210g.

2. The Chinese medicine capsule for treating diabetes according to claim 1, characterized in that: The main material is composed of 25g Astragalus, 25g Pueraria, 20g Polygonatum, 20g Chinese yam, 15g Scrophularia, 15g Rehmannia glutinosa, 15g Salvia miltiorrhiza, 10g Coptis, 10g silkworm sand, 10g giant knotweed, 8g licorice, 6g Ficus hispida.

3. A method for preparing a traditional Chinese medicine capsule for treating diabetes, using the traditional Chinese medicine capsule according to any one of claims 1-2, characterized in that: The following steps are included, S1, silkworm sand, Salvia miltiorrhiza, giant knotweed are vacuum dried and ground into 20 mesh coarse powder to obtain medicinal material A; Chinese yam, Polygonatum, Rehmannia glutinosa are freeze-dried to maintain porosity for disintegration, to obtain medicinal material B; S2, mix medicinal material A with 70% ethanol, then extract by countercurrent extraction at 50-60°C, and recover ethanol to obtain extract A; S3, mix the alcohol-extracted residue with medicinal material B, licorice, Ficus hispida, Coptis, Astragalus, Pueraria, and add water, then extract by countercurrent extraction at 85-95°C, filter; add water to the filtered residue and continue to extract, combine the two filtrates, and concentrate under reduced pressure to obtain extract B; S4, dry extract A and extract B by belt drying to obtain dry extract A and dry extract B; S5, airflow pulverize dry extract A to D90 of 14-16µm to obtain dry extract powder A; mechanically pulverize dry extract B to D90 of 42-48µm to obtain dry extract powder B; S6, preliminarily mix dry extract powder A, dry extract powder B, lactose, microcrystalline cellulose, and micro powder silica, then add magnesium stearate and continue to mix uniformly, and then fill into gastric soluble capsules, perform internal packaging and sterilization treatment, and then obtain the traditional Chinese medicine capsule for treating diabetes.

4. The preparation method of the traditional Chinese medicine capsule for treating diabetes according to claim 3, characterized in that: In step S1, the vacuum drying temperature of silkworm sand, Salvia miltiorrhiza, and giant knotweed is 38-42°C, and the drying is performed until the water content is ≤8%; the freeze-drying conditions of Chinese yam, Polygonatum, and Rehmannia glutinosa are -50°C and 0.05 mbar.

5. The preparation method of the traditional Chinese medicine capsule for treating diabetes according to claim 4, characterized in that: In step S2, the volume ratio of medicinal material A to 70% ethanol is 1:8, the countercurrent extraction time is 2h, the relative density of extract A after recovering ethanol is 1.18, and the temperature is 60°C.

6. The preparation method of the traditional Chinese medicine capsule for treating diabetes according to claim 5, characterized in that: In step S3, the material ratio of medicinal material to water is 1:10, and the countercurrent extraction time is 1h; the material ratio of the filtered residue to water is 1:8, and the extraction time is 40-50min; the relative density of extract B after concentration is 1.20, and the temperature is 60°C.

7. The preparation method of the traditional Chinese medicine capsule for treating diabetes according to claim 6, characterized in that: In step S4, the temperature for belt drying of extract A and extract B is 65°C, and the drying is performed under -0.09 MPa; the extract yield of dry extract A is controlled to be 18%, and the extract yield of dry extract B is controlled to be 22%, and the water content of both is ≤5%.

8. The preparation method of the traditional Chinese medicine capsule for treating diabetes according to claim 7, characterized in that: In step S6, HDPE high-density bottles are used for internal packaging, molecular sieve drying agent is used for sterilization treatment, 60Co-γ irradiation and 6 kGy sterilization are used, and the microbial load is controlled to be ≤100 cfu / g.

9. The preparation method of the traditional Chinese medicine capsule for treating diabetes according to claim 8, characterized in that: In step S6, the magnesium stearate is 1.8 g of 0.5% magnesium stearate.

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