PHARMACEUTICAL COMPOSITION FOR CONTROLLING BLOOD SUGAR

Abstract

A pharmaceutical composition or a health food composition for controlling blood sugar, raw materials of which include Dioscoreae rhizome, medlar, and coconut oil. A preparation method for the composition includes: mixing Dioscoreae rhizome and a decoction thereof with medlar for homogenization, pulverization and drying, and mixing the resultant product with coconut oil and water, followed by baking and drying. Further disclosed are a pharmaceutical preparation or a health food including the composition and an excipient, and a use of the composition in the preparation of a pharmaceutical preparation or a health food for reducing or eliminating diabetic conditions.

Claims

1. A drug mixture or health food mixture for controlling blood glucose, comprising dioscoreae rhizoma, lycii fructus and coconut oil.

2. The mixture of claim 1, wherein a weight ratio of dioscoreae rhizoma, lycii fructus and coconut oil is 3070:540:540.

3. A method for preparing the mixture of claim 1, comprising the following steps: (1) decoct or steam dioscoreae rhizoma with water to obtain dioscoreae rhizoma and its decocting liquid; (2) mixing dioscoreae rhizoma and its decoction liquid with lycii fructus to obtain pulverized product; (3) drying the pulverized product, and then mixing with water and coconut oil, and then baking and drying at a high temperature of 100200 C.

4. A method for preparing the mixture of claim 1, comprising the following steps: (1) decoct or steam dioscoreae rhizoma with water to obtain dioscoreae rhizoma and its decocting liquid; (2) mixing the dioscoreae rhizoma and its decoction liquid with lycii fructus to obtain pulverized product; (3) drying the pulverized product, and then mixing with water and coconut oil, and then baking and drying at a high temperature of 60200 C.

5. A pharmaceutical preparation or health food containing the mixture of claim 1 and medically acceptable auxiliary or food materials.

6. A method for preparing a pharmaceutical preparation or health food for alleviating diabetic disease, comprising applying the mixture of claim 1 to the preparation of pharmaceutical preparations or health food.

7. A method for alleviating the condition of diabetes, comprising administering the mixtures of claim 1 to a person in need.

8. The method of claim 7, wherein the person in need has type 2 diabetes.

9. The method of claim 7, wherein the condition includes increased fasting insulin level, increased free fatty acid level, increased glycosylated hemoglobin level, and/or conditions indicated by relevant inflammatory factors or other metabolic indicators.

10. The method of claim 7, wherein the administering step comprises administering the person in need with a combination of the mixture of claim 1 and a drug for the treatment of diabetes selected from metformin or Empagliflozin.

11. The mixture of claim 1, wherein the mixture consists of dioscoreae rhizoma, lycii fructus and coconut oil.

12. The mixture of claim 2, wherein the weight ratio is 4060:1030:1030.

13. The method of claim 3, wherein the high temperature is 120160 C.

Description

BRIEF DESCRIPTION OF THE DRAWING

[0066] FIG. 1 shows the blood glucose levels of HH003B (15%) group and the combined administration group (HH003B (15%)+MET) rats given 2 g/kg of glucose by gavage 12 hours after fasting without water, and then measured at each time.

DETAILED DESCRIPTION

[0067] The plant raw materials and chemical reagents in particular embodiments are conventional materials purchased from the market.

Example 1: Preparation of HH003

[0068] Weigh the cleaned dioscoreae rhizoma 180 g, add 540 ml (3 times the amount) water, heat to boil, keep boiling state for 30 min, put at room temperature, the container is not completely sealed, then get a total of about 350 ml dioscoreae rhizoma and decoction, refrigerate it for usage.

[0069] Take 60 g lycii fructus and dioscoreae rhizome and its decoction liquid mentioned above into VITAMIX0109 refiner (available from VITA-MIX Corp), grind at a low speed (1000 rpm) for 1 min, and then a high speed (20000 rpm) for 3 min, and then repeat a low-speed and high-speed again for 4 times.

[0070] HH003 dry powder will get after the crushing product mentioned above dried at 50 C., and then wet the dry powder with water, whose weight is 15% of the HH003 dry powder. Granulation with No. 1 sieve, and then dry 2 hours at 50 C., and consolidation with No. 1 sieve. Finally HH003 particles are prepared.

Example 2: Preparation of HH003B

[0071] Referring to the method of implementing case 1, the difference is: the dioscoreae rhizoma's weight is 210 g, the added water is 500 ml, and dioscoreae rhizome's weight is 70 g. Mix 60 g crushing product after dried at 50 C., with 30 ml (30 g) water and coconut oil 20 ml (16 g) well, and cut them into small pieces. Bake these small pieces for 10 minutes to dry at 130 C., and then put them at room temperature to get HH003B.

Example 3: Pharmacodynamic Experiment

[0072] Wistar rats were bred adaptively for 1 week. The subjects were randomly divided into the normal Control group (10) and the modeling group (60) according to their body weight from the second week. The normal Control group (Control) was fed with basic feed, and the model group was fed with high-fat and high-sugar feed. After 4 weeks, the model group received intraperitoneal injection of 30 mg/kg streptozotocin (STZ) and continued to eat a high-fat diet, while the control group received intraperitoneal injection of citric acid-sodium citrate buffer at the same volume and continued to eat a normal diet. On the 9th weekend, rats fasted overnight, measured FBG and insulin levels, and calculated the insulin index (ISI). The model would be successfully established if the fasting blood glucose (>) was 11.1 mmol/L and the ISI was decreased.

[0073] The successfully modeled rats were randomly divided into Model group, Metformin hydrochloride group, HH003 group, and HH003B group, with 10 rats in each group. The last three groups were given corresponding drugs, metformin hydrochloride group was given a gavage 200 mg/kg daily, HH003 and HH003B group was given drug by feeding, and 30% of the normal feed was replaced by HH003 and HH003B of the high-fat and high-sugar feed separately (about 13 g/d/kg), all the groups were administered for 4 weeks in a row. Fasting but gave water after the last dose, and then weighted the rats after 12 hours. Detected the content of fasting insulin (Insulin), separated the serum, detected the high-density lipoprotein (HDL), free fatty acid (FFA) and glycosylated hemoglobin (GHB).

[0074] As shown in table 1, after 4 weeks of administration of various drugs, fasting insulin level in Model rats was significantly increased compared with that in Control rats. HH003B could significantly reduce fasting insulin level in rats and reach a level not significantly different from that of normal rats, while none of the other drugs could do that. Compared with the Control group, FFA level in the serum of Model rats was significantly increased, and HH003B could significantly reduce FFA level of free fatty acids in the serum of rats and reach a level not significantly different from that of normal rats, while other drugs could not do that. The glycosylated hemoglobin GHB level of the Model group was significantly higher than that of the Control group. HH003B could significantly reduce the glycosylated hemoglobin GHB level of the rats and reach the level not significantly different from that of the normal rats. Metformin and HH003 could also significantly reduce the GHB level of the rats but still significantly higher than that of the normal rats. Thus, HH003B can eliminate the disease condition of type 2 diabetes, while metformin and HH003 can only improve the disease condition of type 2 diabetes to a certain extent. In addition, metformin can significantly increase HDL level, and HH003B can also increase HDL level but not significantly, suggesting that both of them have an improvement effect on lipid metabolism.

TABLE-US-00001 TABLE 1 influence of drugs on biochemical indexes of rat model Insulin HDL FFA GHB (uIU/ml) (mmol/L) (mmol/L) (mmol/L) Control 25.42 4.65 0.57 0.2 0.42 0.05 11.50 0.96 Model 33.28 6.00** 0.57 0.2 0.54 0.06*** 16.11 0.6*** Metformin 31.15 6.28 0.74 0.15*# 0.56 0.03*** 15.07 0.85***# HH003 29.64 5.49 0.58 0.25 0.5 0.09* 13.38 0.9***### HH003B 25.90 6.73# 0.72 0.22 0.44 0.06## 11.94 2.15### Compared with the normal control group, ***P < 0.001, **P < 0.01, *P < 0.05; Compared with the model group, #P < 0.05, ##P < 0.01, and ###P < 0.001.

Example 4: Combined Drug Use Experiment

[0075] HH003B alone in large amounts (30%, basically replacing one meal) has a significant effect on improving the disease condition of type 2 diabetes. Reducing the amount of HH003B also has an improvement, but it is not as good as the large amount of it. So a trial of combination with existing diabetes drugs was conducted. Empagliflozin group was given by gavage 1 mg/kg once a day. HH003B group (15%) was given drug by feeding, and 15% of the normal feed was replaced by HH003B of the high-fat and high-sugar feed separately (about 7 g/d/kg). Combined drug group (HH003B (15%)+Emp) was given Empagliflozin by gavage 1 mg/kg, plus high fat and sugar feed, whose 15% ordinary feed was instead of HH003B (about 7 g/kg/d), other are the same as the implementation example 3 experiments. HbA1c was determined at the end of the experiment.

[0076] As shown in table 2, Empagliflozin alone had no effect on glycosylated hemoglobin in patients with diabetes, but in combination with HH003B with reduced dose showed a significant effect on the control of glycosylated hemoglobin elevation.

TABLE-US-00002 TABLE 2 influence of drugs on glycosylated hemoglobin (HbA1c) in rat model Group HbA1c (mg/dl) Control 6.03 0.18 Model 7.32 0.12### Empagliflozin 7.01 0.17 HH003B (15%) 6.86 0.25* HH003B (15%) + Emp 6.21 0.15* Compared with the model group, ***P < 0.001, **P < 0.01, *P < 0.05; Compared with the normal control group, #P < 0.05, ##P < 0.01, and ###P < 0.001.

Example 5: Preliminary Study on Mechanism

[0077] 15% of the normal feed was replaced by HH003B of the high-fat and high-sugar feed (about 7 g/d/kg) in the HH003B (15%) group, while in the combined group (HH003B (15%)+MET), metformin hydrochloride was given by gavage 200 mg/kg daily, plus 15% of the normal feed was replaced by HH003B of the high-fat and high-sugar feed (about 7 g/d/kg), and the rest were the same as the experiment in case 3.

[0078] At the end of the experiment, glucose tolerance and serum triglyceride (TG), low-density lipoprotein (LDL), uric acid (UA) and IL-8 were measured.

[0079] As shown in table 3 and FIG. 1, HH003B combined with metformin can further reduce blood glucose, triglyceride (TG), low-density lipoprotein (LDL) IL-8, uric acid (UA) and other levels, which may also have an effect on the diabetic condition or its potential complications, indicating that HH003B and metformin have different mechanisms of action.

TABLE-US-00003 TABLE 3 influence of HH003B combined with metformin on serum biochemical indexes of rats TG LDL IL-8 UA Group (mmol/L) (mmol/L) (pg/mL) (mol .Math. L.sup.1) HH003B (15%) 1.60 0.40 0.28 0.02 46.38 2.93 293.752 HH003B 0.98 0.32 0.20 0.02 40.51 2.13 129.343 (15%) + MET