WO2010135858A1

WO2010135858A1 - Pharmaceutical composition and use for preparing medicament thereof

Info

Publication number: WO2010135858A1
Application number: PCT/CN2009/071956
Authority: WO
Inventors: 郭成辉; 吴聪; 梁灏; 王晓玲
Original assignee: 成都中汇制药有限公司
Priority date: 2009-05-25
Filing date: 2009-05-25
Publication date: 2010-12-02
Also published as: CN102271698A; CN102271698B

Abstract

A pharmaceutical composition comprising Radix Astragali and Radix Rehmanniae, optionally with Radix Salviae Miltiorrhizae, Radix Puerariae, Radix Paeoniae Rubra, Herba Epimedii, Radix Ophiopogonis and Rhizoma Coptidis is provided, the pharmaceutical composition may be useful for treatment of metabolic syndrome, diabetes mellitus and complications thereof, hyperlipemia and the like.

Description

Instruction manual

Pharmaceutical composition and application thereof in preparing medicament

[1] Technical field

[2] The present invention relates to a pharmaceutical composition and use thereof, and in particular to a traditional Chinese medicine preparation which is prepared by using a traditional Chinese medicine as a main raw material and which can be used for treating diabetes, metabolic syndrome and the like.

[3] Background Art

[4] Diabetes is a common endocrine and metabolic disease characterized by a relative or absolute deficiency of insulin in a patient that causes disorders in the metabolism of sugar, fat and protein, and thus with hypertension, hyperlipidemia, obesity, arteriosclerosis, crown Diseases such as heart disease are closely related. In 1999, WHO used the name "metabolic-Syndrome" for these diseases and defined its connotation as follows: Hyperglycemia (diabetes, impaired glucose tolerance and/or insulin resistance), accompanied by two Abnormalities in items or more, such as hypertension, hypertriglyceridemia and / or low-density lipoprotein (HDL) cholesterol, central obesity or microalbuminuria. The central link of metabolic syndrome is insulin resistance (IR). A large number of studies have shown that insulin resistance is one of the important pathogenesis of diabetes mellitus, and it runs through the whole process of diabetes development and development. The "power" of the disease.

[5] There is still no cure for diabetes and metabolic syndrome. Clinically, Western medicine has side effects such as hypoglycemia and gastrointestinal reactions. With the prolongation of treatment, the hypoglycemic effect is decreasing. The treatment of its composition is an important treatment method currently used, but there are few drugs with reliable curative effect and simple prescription; drugs for treating metabolic syndrome are also rare.

[6] Chinese patent ZL02128052.5 discloses an oral pharmaceutical composition for treating diabetes, from the proportion of weight of jaundice 19-30, habitat 20-31, red peony 20-31, salvia miltiorrhiza 19-30' achyranthes 11- 18 ' Maidong 1 1 - 18 , Pueraria 12-20, Mulberry 12-20, Coptis 3 _6 , Polygonatum 12-18, Epimedium 16-22, with diabetes, high blood lipids, improved blood rheology , enhance physical strength and other effects. However, the patent has a large amount of medicinal properties, and the solid granule preparation prepared is large in dosage, which is difficult for foreigners to receive, and is not advantageous for in-depth study of its mechanism of action and active ingredients.

[7] Summary of the invention

[8] A technical problem solved by the present invention is to provide a pharmaceutical composition containing astragalus and rehmannia as main components [9] Another technical problem to be solved by the present invention is to provide a preparation prepared from the pharmaceutical composition for treating diabetes, metabolic syndrome, and hyperlipemia and insulin resistance.

[10] The technical solution of the pharmaceutical composition of the present invention is:

[11] The pharmaceutical composition comprises at least two traditional Chinese medicines of astragalus and rehmannia, the weight fraction of the xanthine is at least 20% by weight of the total weight of the pharmaceutical composition, and the weight fraction of the rehmannia is at least the total weight of the pharmaceutical composition. 21%. That is to say, the proportion of the weight fraction of the astragalus can be 20% to 79%, and the proportion by weight of the rehmannia can be 21% to 80%. If there are other components, such as one or more of Salvia miltiorrhiza, Radix Puerariae, Radix Paeoniae Alba, Epimedium, Ophiopogon japonicus, and Rhizoma Coptidis, the proportion by weight may be 0% to 59%.

[12] A further technical solution is that the parts by weight of the xanthine account for at least 25% by weight of the total weight of the pharmaceutical composition, and the parts by weight of the rehmannia are at least 26% by weight of the total weight of the pharmaceutical composition. That is, the proportion by weight of the xanthine may be 25% to 74%, and the proportion by weight of the rehmannia may be 26% to 75%. If there are other components, the proportion by weight may be 0% to 49%.

[13] A further technical solution is: the weight fraction of the xanthine is at least 33% of the total weight of the pharmaceutical composition.

2%, the weight of the rehmannia is at least 26.5% of the total weight of the pharmaceutical composition. That is, the proportion by weight of the xanthine may be 33.2% to 73.5%, and the proportion by weight of the rehmannia may be 26.5% to 6.68. If there are other components, the proportion by weight may be 0% to 40.3%.

[14] A further technical solution is that the proportion by weight of the xanthine may be 33.2% to 66.8%, and the proportion by weight of the rehmannia may be 33.2% to 66.8%. If there are other components, the proportion by weight may be 0% to 33.6%.

[15] The pharmaceutical composition is prepared in a single-dose preparation containing a crude drug amount of 0.15 to 0.6 g (the average body weight of the human body is 50 to 60 kg per kilogram of body weight). A further technical solution is that the amount of the crude drug contained in the preparation for one-time use is 0.2 to 0.5 g, and a further technical solution is that the amount of the crude drug contained in the preparation for the primary dosage is 0.3 to 0.4 g. Apply 0.5 to 6 times a day, preferably 1 to 3 times.

[16] Rehmannia in the pharmaceutical composition is preferably rehmannia.

[17] A further technical solution of the above pharmaceutical composition is: the proportion by weight of the xanthine is 22% to 45%, the proportion by weight of the rehmannia is 23% to 50%, and the proportion by weight of the other components 5% to 55% [18] A further technical solution is: the proportion of the weight of the xanthine is 24% to 44%, the proportion by weight of the rehmannia is 24% to 46%, and the proportion by weight of the other components is 10%. ~52%.

[19] A further technical solution is: the proportion of the weight of the xanthine is 25% to 40%, the proportion by weight of the rehmannia is 26% to 45%, and the proportion by weight of the other components is 17%. ~49%.

[20] The remaining components are at least one of Salvia miltiorrhiza, Radix Puerariae, Radix Paeoniae Alba, Epimedium, Ophiopogon japonicus, and Rhizoma Coptidis. Wherein the ratio by weight of the salvia miltiorrhiza is 16% to 36%, the proportion by weight of the Pueraria lobata is 10% to 22%, and the proportion by weight of the red peony is 10% to 16%, The proportion by weight is 12% to 18%, the proportion by weight of the Ophiopogon japonicus is 12% to 18%, and the proportion by weight of the Coptidis Rhizoma is 5% to 45%.

[21] One technical solution of the above pharmaceutical composition is: the pharmaceutical composition contains 25% to 40% by weight of xanthine, and the proportion by weight is 26% to 43%, and the proportion by weight is 18%~ 34% of Salvia.

[22] A further technical solution is: the proportion of the weight of the xanthine is 39.7%~40%, the proportion of the weight of the rehmannia is 33.3%~33.6%, and the weight of the salvia is 26.7%~27%.

[23] Another technical solution of the above pharmaceutical composition is: the pharmaceutical composition contains 25% by weight

~35% of astragalus, the proportion of 26% to 32% by weight of rehmannia, the proportion of 18% to 25% by weight of Danshen, and the proportion of 12% to 21% by weight of Pueraria.

[24] A further technical solution is: the proportion of the weight of the xanthine is 33% ~ 33.3%, the proportion by weight of the rehmannia is 26.7% ~ 27%, the weight ratio of the salvia miltiorrhiza is 20% ~ 21% The ratio of the weight of the kudzu root is 19% to 20%.

[25] A further technical solution of the above pharmaceutical composition is: the pharmaceutical composition contains 26% by weight

~30% of Astragalus, weight ratio of 26% to 28% of Rehmannia, weight ratio of 19% to 21% of Salvia miltiorrhiza, weight ratio of 12% to 14% of Pueraria, weight ratio of 12%~14 % red oak.

[26] A further technical solution is: the proportion of the weight of the xanthine is 26.7%~27%, the proportion by weight of the rehmannia is 26.7%~27%, and the proportion by weight of the salvia miltiorrhiza is 19.5%~20%. The weight fraction of the radix radix is 13% to 13.3%, and the weight fraction of the radix is 13% to 13.3%.

[27] A further technical solution of the above pharmaceutical composition is: the pharmaceutical composition contains 25% by weight

~40% of Astragalus, the ratio of 28% to 45% by weight of Rehmannia, the proportion of 14% to 16% by weight of Epimedium, and the proportion by weight of 14% to 16% of Ophiopogon japonicus. [28] A further technical solution is: the proportion of the weight of the xanthine is 25% to 26%, the proportion by weight of the rehmannia is 44% to 45%, and the proportion of the weight of the epimedium is 15%~ 16%, the ratio of the weight of the Ophiopogon is 14% to 15%.

[29] A further technical solution of the above pharmaceutical composition is: the pharmaceutical composition contains 22% by weight

~45% of Astragalus, a proportion of 23% to 50% by weight of rehmannia, and a ratio of 5% to 45% by weight of Coptis.

[30] A further technical solution is: the proportion of the weight of the xanthine is 25% to 40%, the proportion by weight of the rehmannia is 26% to 45%, and the proportion by weight of the berberine is 20% to 35%. .

[31] A further technical solution of the above pharmaceutical composition is: the pharmaceutical composition contains 26% by weight

~33% of Astragalus, a proportion of 26% to 33% by weight of rehmannia, 10% to 25% by weight of Coptis, and a ratio of 19% to 24% by weight of Salvia miltiorrhiza.

[32] A further technical solution is: the proportion of the weight of the xanthine is 28%~32%, the proportion by weight of the rehmannia is 28%~30%, and the proportion by weight of the berberine is 18%~22% The weight ratio of the salvia miltiorrhiza is 19% to 21%.

[33] According to the theory of traditional Chinese medicine, among the various medicinal odors constituting the above-mentioned pharmaceutical composition of the present invention, the scutellaria is sweet and warm, and the qi is tempered, and the pathogenesis for the prolonged period of diabetes, heat and gas consumption, and other components in the composition The blood-activating and stasis-removing drugs are effective in relieving gasification and phlegm; the rehmannia glutinosa is sweet, the bitter cold is cold, the yin is clearing heat, and the main pathogenesis of yin deficiency and internal heat is the main medicinal taste in the pharmaceutical composition. Blood stasis syndrome is one of the main indications for the drug of the present invention, and the formation of diabetic blood stasis syndrome is mainly caused by yin deficiency and heat, stagnation of stagnation and stagnation, and yin deficiency can not be carried by blood, so it is clearing heat and cooling blood stasis. The compatibility of Danshen, playing the role of cooling blood and removing blood stasis; Pueraria is cool, sweet, and antipyretic, and can also add heat, cool and bloody red peony, which is effective in clearing away heat and nourishing yin. Or with the bitter cold, clearing the heat and diarrhea of the berberine, plus the heat and cool blood stasis of Salvia, can also achieve better results.

[34] Clinically, the syndrome of qi and yin deficiency and the syndrome of yin and yang deficiency can not be completely divided. The syndrome of deficiency of qi and yin often has a tendency to transform into yin and yang. Therefore, it is possible to use the spleen and warm, and the stagnation of kidney and impotence. In the same way, it not only tonifies kidney yang, but also nourishes kidney yin, yin and yang, and is a combination of kidney and kidney protection. It is accompanied by a slightly cold, sweet and bitter, nourishing Yin and clearing the heart, which can achieve better curative effect. .

[35] The results of modern scientific research show that the physiologically active ingredient in the above-mentioned raw material medicine of the present invention is an effective medicine. The main components are polysaccharides, flavonoids, saponins, phenols, amino acids, alkaloids, etc., which have good water solubility. Therefore, the pharmaceutical composition of the above-mentioned effective drug composition according to the present invention is prepared into a preparation, and each of the effective pharmaceutical ingredients used may be a particle or a particle obtained directly from each corresponding natural crude drug in accordance with the particle size required for the corresponding oral preparation. It may also be in the form of a water extract component or an alcohol extract component obtained by using a drug corresponding to the weight ratio relationship as a raw material.

[36] The medicament of the present invention can be added to various conventional excipients required for preparing different dosage forms, such as a disintegrating agent, a lubricant, a binder, a cosolvent, etc., and is prepared into any conventional one by a conventional traditional Chinese medicine preparation method. Dosage form. For example, the raw materials of the traditional Chinese medicines of each component can be directly pulverized to form a powder; the raw materials can also be extracted with medicinal water or ethanol, and the extracts can be combined, filtered, concentrated, and different auxiliary materials required for different solid preparations can be added and carried out. After the corresponding treatment, it can be prepared into different forms of solid preparations such as granules, capsules, tablets, pills, powders, pills, etc.; all of these raw materials can also be extracted with medicinal water or ethanol, filtered, concentrated, Refining, adding different auxiliary materials required for preparing different liquid preparations, and performing corresponding treatment, can be prepared into a liquid preparation of different forms such as a mixture, a syrup, an injection, an emulsion, etc.; Distilled wine is extracted and made into a wine.

[37] The invention greatly reduces the medicinal taste of the prior art, adopts astragalus and rehmannia as its main components, and greatly increases the weight ratio of jaundice and rehmannia (generally greater than the weight ratio of other individual components), and the same Larger doses (i.e., the amount of crude drug contained in the formulation per dose) resulted in unexpected benefits. The experimental results show that the pharmaceutical composition has a good effect on the treatment of diabetes and metabolic syndrome, can significantly reduce the blood sugar level after the starch load in mice and the blood lipid and blood sugar levels of the rats fed with high-fat food, and improve insulin resistance. The curative effect is superior to the prior art, and the composition of the prepared preparation is reduced, the impurity component is also correspondingly reduced, and the possibility of interaction of the pharmaceutical ingredients is also reduced, so that it is suitable for preparing a traditional Chinese medicine preparation for treating diabetes, metabolic syndrome and the like.

[38] Specific implementation

[39] The present invention is further illustrated by the following examples and experimental examples, but it should be understood that the scope of the present invention is limited to the following examples and experimental examples, and all the techniques based on the above-described contents of the present invention belong to the present invention. The scope of the claimed invention. Changes in the actual weight of each component within ±20% do not have a significant effect on the results of the implementation.

[40] Example 1: Preparation of prior art extract powder A [41] Take Astragalus 240g, 260g of raw land, 250g of red peony, 230g of Salvia miltiorrhiza, 145g of Radix Puerariae, 150g of Achyranthes, 15g of Ophiopogon japonicus, 145g of mulberry leaves, 145g of Rhizoma Coptidis, 145g of Radix Astragali, 100g of Epimedium, more than 11 flavors, add water Decoction three times, the temperature is controlled at 95±5°C, the first time adding 7 times the amount of water to cook for 1.5 hours, the second time adding 6 times the amount of water to cook for 1 hour, the third time adding 5 times the amount of water to cook After 1 hour, the decoctions were combined, filtered, and the filtrate was concentrated to a clear paste having a relative density of 1.20 to 1.25 (70 ° C heat), and dried under vacuum to obtain extract A.

[42] Example ² : Preparation of extract powder B

[43] Take 260kg of Astragalus, 440kg of raw land, 140kg of Ophiopogon japonicus, 160kg of Epimedium, above four flavors, boiled three times with water, the temperature is controlled at 95±5°C, the first time added 8 times the amount of water to cook for 2 hours The second time is added with a 6-fold amount of water for 1 hour, and the first time is added with a 5 times amount of water, and the mixture is decocted, and the filtrate is concentrated to a relative density of 1. 20~1.25 (60 ° C). Thermal test). Spray drying under conditions of an inlet air temperature of 155 to 165 ° C and an outlet air temperature of 75 to 85 ° C to obtain an extract powder ^

[44] Example 3: Preparation of extract powder C

[45] Take Astragalus 400g, Rehmannia 333g, Salvia 267g, the above three flavors, add water to cook twice, the first time add 7 times the amount of water for 30 minutes, then boil for 1.5 hours, the second time plus 5 times the amount of water to boil 1 small吋, combine the decoction, 100 mesh filtration, the filtrate is concentrated to a relative density of 1.20~1.25 (80 ° C thermal measurement), centrifuged and vacuum dried to obtain the extract powder. .

[46] Example 4: Preparation of extract powder D

[47] Take Astragalus 330g, 270g of raw land, 200g of Salvia miltiorrhiza, 200g of Radix Puerariae, the above four flavors, dip twice with ethanol, combine the impregnation solution, filter, and recover the ethanol from the filtrate, then concentrate it under reduced pressure in a three-effect concentrator to a relative density of 1.20 ~ 1.25 (80 ° C thermal test), after vacuuming, vacuum drying to obtain extract powder D.

[48] Example 5: Preparation of extract powder E

[49] Take jaundice 700g, raw ground 300 _g) Wash and cut, add water to cook twice, first add 7 times the amount of water for 30 minutes, then boil for 1.5 hours, and add 5 times the amount of water to boil 1 Osmium, two decoctions over 100 mesh, concentrated and concentrated to a relative density of 1.20-1.25 (80 ° C), centrifuged and dried in a vacuum oven to obtain extract powder E, sealed and stored.

[50] The extract or extract powder of each of the above embodiments may be granulated by adding appropriate auxiliary materials, or may be tableted or encapsulated by tableting, encapsulation, etc., and suitable solvents and auxiliary materials may also be added. Formulated into liquid preparations to meet clinical needs. Those skilled in the art can perform the corresponding work without creative labor. Example 5: Tablet preparation of the pharmaceutical composition of the present invention

[52] Take Astragalus 267g, 267g of raw land, 133g of red peony, 200g of Salvia miltiorrhiza, 133g of Radix Puerariae, boiled twice with water, the temperature is controlled at 95±5°C, the first time added 8 times the amount of water to cook for 2 hours, the second Add 6 times the amount of water to boil for 1 hour, combine the decoction, filter, and the temperature of the filtrate in the three-effect concentrator is 80~85. C, two-effect 70~75 °C, three-effect 60~65 °C, vacuum degree is one-effect -0.04Mpa, two-effect -0.06Mpa, three-effect -0.08Mpa under reduced pressure to a relative density of 1.15~ 1.20 (70.C thermal test), add ethanol to make the alcohol content 70%~80%, let stand for 24 hours, filter, filter the filtrate to reduce the ethanol and centrifuge, about 0.6 times the amount of micro-silica gel as the auxiliary material, Adding the extract, the granulation is carried out under the conditions of a spray pressure of 0.12 MPa, a material temperature of 70 to 80 ° C, an inlet air temperature of 105 to 1 15 ° C, and an outlet temperature of 75 to 85 ° C. % of magnesium stearate is evenly mixed, tableted, made into 250 tablets, coated, that is. Take 3 times a day, 4 tablets each time.

Example 7: Preparation of a mixture of the pharmaceutical composition of the present invention

[54] Take scutellaria 380g, 380g of raw land, 240g of berberine, extract the medicinal material with ethanol and reflux for 2~3 times, combine the filtrate, and set aside; the slag is boiled with water for 2~3 times, each time 0.5~1 吋, filtered. The above two filtrates were combined, centrifuged, and concentrated to a relative density of 1.15 to 1.20. The supernatant was added to 10 g of polysorbate 80, cyclamate 0.5 g, and sorbic acid 2 g, mixed, and water was added to 500 ml, filtered, and filled. Sterilize, that is. Take 2 times a day, 10 ml each time.

Example 8: Preparation of an injection of the pharmaceutical composition of the present invention

[56] Take Astragalus 320g, raw ground 320 _g) Coptis 100g, Salvia miltiorrhiza 260g, add 8, 6 times the amount of water for injection, 1.5, 1 small simmer, combine the decoction, filter, the filtrate is concentrated to a relative density of 1.20, Add ethanol to make the alcohol content up to 60%, let stand for 24 hours, filter it, recover the ethanol under reduced pressure, and then concentrate to a relative density of 1.15. Add ethanol to make the alcohol content 80%, let stand for 48 hours, filter, recycle Centrifugation after ethanol, take the supernatant, add the auxiliary materials required for the injection, mix, adjust the pH to 5.0~7.0, add water for injection to 500ml, filter, fill, sterilize, pass the identification test, the content is qualified. , that is. Infusion once a day, 15ml each time.

Example 9: Preparation of granules of the pharmaceutical composition of the present invention

[58] Take scutellaria 250g, 750 _{g of} raw ground ₎ Wash and cut, add water to cook three times, the temperature is controlled at 95±5. C, the first time add 8 times the amount of water to cook for 2 hours, the second time add 6 times the amount of water to cook 1.5 hours, the third time plus 5 times the amount of water to cook 1 small B inch, combined with decoction, filter After that, the filtrate is concentrated to a clear paste having a relative density of 1.20 to 1.25 (60 ° C thermal measurement), spray-dried at an inlet air temperature of 155 to 165 ° C, and an outlet air temperature of 75 to 85 ° C. Cream powder, About 0.5 times the amount of 4:3 by weight of silica gel and starch was added, wet granulation, and the granules were packed into 100 bags. Take 4 times a day, 2 bags each time.

[59] Experimental Example 1 : Mouse efficacy test

[60] The extract powders obtained in Examples 1 to 5 were used as experimental drugs (eight, B, C, D, and E, respectively), and their traits were yellow-brown to tan granules, slightly fragrant, slightly bitter, per gram. The dry extract powder is equivalent to 4.000 to 4.386g of the original medicine. Take healthy Kunming mice, weighing 18~22g, and fasting for 12 hours before the test. The test group will be administered once according to the drugs and doses listed in Table 1. After 1 hour of administration, the starch load will be given. After the starch load, blood was collected from the eyeball 1 hour, and the serum was separated by anticoagulation with heparin sodium. The blood glucose was measured. The blood glucose of each group was compared to analyze whether the drug had an effect on the blood glucose of the starch-loaded mice. See Table 1, Table 2.

[61]

[62] Table 1 mouse dosing regimen

Table 2 mouse test results Number of animals in the group (only) Blood glucose level (mmol/L) Blank control group 10 1.768 +0.34

Model group 10 3.801 +0.99

Glequinone group 10 1.821 +0.52

A high dose group 10 2.228 +0.67

A medium dose group 10 2.587 soil 0.58

A low dose group 10 2.801 +0.61

B high dose group 10 2.125 ±0.58

B medium dose group 10 2.444 ±0.30

B low dose group 10 2.455 +0.21

C high dose group 10 2.004 +0.12

C medium dose group 10 2.755 +0.38

C low dose group 10 2.592 +0.41

D high dose group 10 2.383 +0.52

D medium dose group 10 2.656 +0.54

D low dose group 10 2.515 +0.46

E髙 dose group 10 2.424 +0.48

E medium dose group 10 2.663 ±0.27

E low dose group 10 2.932 ± 0.60 The results show that the extract powder obtained in Examples 1 to 5 has a significant effect on the blood sugar of starch-loaded mice, wherein the extract powders C and D obtained in Examples 2 to 5 The effect of E is similar to that of the prior art composition A extract powder of Example 1, and the effect of some schemes or dose groups is even better than that of the corresponding dose group of the composition A extract powder, so the present invention can be The composition is formulated into various traditional Chinese medicine preparations for treating diabetes and its complications. [66] Experimental Example 2: Rat efficacy test

[67] Rats weighing 180~220g SD were given for 12h after fasting. Each rat was intraperitoneally injected with 100mg/k _{g of} alloxan according to body weight. Blood was collected from the tail vein 72h after injection. After the blood sugar is raised, the blood sugar levels are divided into 17 groups, 10 groups/group, male and female, fed with high-calorie feed (basic feed 92%, 2% sucrose, 3% lard, 2% cholesterol and 1% sodium cholate sodium is mixed). The extract powders obtained in Examples 1 to 5 were used as experimental drugs (eight, B, C, D, and E, respectively), and their traits were yellow-brown to brown granules, slightly fragrant, slightly bitter, and each gram of dry extract. The powder is equivalent to about 4 grams of the original medicine. According to the drugs and doses shown in Table 3, the rats were intragastrically administered with water once a day for 4 weeks. Ten SD rats (male and female) with similar body weight were taken as normal control group, and only administered as shown in Table 3, once a day for 4 weeks. Blood was taken from the tail vein every 1 week, and serum was centrifuged at 2500 rpm/min to measure blood glucose. The results are shown in Table 4.

[68] Table 3 Administration dose of rat experiment

[69]

[70] Table 4 Rat efficacy test results [71] Number of animals in the group (only) 1 week blood glucose administration 2 weeks blood glucose administration 3 weeks blood glucose value

(mmol/L) (mmol/L) (mmol/L) blank control group 10 4.208 ± 0.49 2.14 +0.39 3.903 ± 1.47 model group 10 9.997 ± 3.02 ^ΛΛΛ 5.09 ± 1.46 ^ΛΛΛ 11.659

士1·18 ^{ΛΛΛ格列列科}酮组10 5.920 ±1.53** 2.676 ±0.92** 5.975 ±1.90

A high dose group 10 5.146 ±0.95 3.530 +1.00* 7.935 +2.37**

A medium dose group 10 6.390 +1.16** 4.04 ±1.61 7.58 ±0.74***

A low dose group 10 7.015 ±1.43* 3.293 ±1.19** 9.258 ±4.58

B high dose group 10 6.073 +1.52** 3.334 ±0.61* 7.362 ±1.58***

B medium dose group 10 4.190 ±0.79*** 2.732 ±0.56** 9.538 ±1.92*

B low dose group 10 4.677 ±0.74*** 2.648 ±0.96** 5.98 ±3.00***

C high dose group 10 4.880 soil 1.27*** 3.65 ±1.01* 8.5 ±2.75*

C medium dose group 10 4.249 ±1.02*** 4.024 ±0.18 7.51 ±1.34

C low dose group 10 6.268 ±1.68** 4.322士 1.44 6.52 ±0.84***

D high dose group 10 6.121 ± 2.42 * 3.354 ± 0.94 * 5.282 ± 1.71 ***

D medium dose group 10 7.506 ± 1.96 4.316 ± 0.60 6.625 ± 1.46 ***

D low dose group 10 6.400 +1.03** 3.520 ±0.46* 8.303 +0.56***

E髙 dose group 10 4.856 ±1.82** 3.634 ±0.72* 5.362 ±1.52***

E medium dose group 10 5.190 +1.79** 3.232 +0.56** 8.538 ±2.02*

E low dose group 10 6.677 ±1.82** 3.448 ±0.96** 6.98 ±2.50**

[72] Note: 1 Model group compared with normal control group: ^ΛΛΛ Ρ<0.001

[73] 2 Each drug-administered group was compared with the model group: *Ρ<0.05 ** Ρ<0.01 *** Ρ<0.001

[74] Table 4 shows that the blood glucose index in the experimental diabetic model group is extremely significantly increased (Ρ<0.001), and The technical solution of the invention has a significant and significant reduction effect (Ρ<Ο.Ο ΠΡ<Ο.Ο5), and the effect of some schemes or dose groups is even better than that of the corresponding dose group of the composition, indicating that the present invention The invention has a good effect on treating diabetes. The indicators of blood lipids and insulin resistance in the same experiment were also significantly decreased, indicating that the present invention also has the effects of treating hyperlipidemia and insulin resistance.

Claims

Claim

[I] 1. A pharmaceutical composition comprising astragalus and rehmannia, characterized in that: the weight fraction of the xanthine accounts for at least 20% by weight of the total weight of the pharmaceutical composition, and the weight fraction of the rehmannia at least accounts for the drug 21% of the total weight of the composition.

[2] 2. The pharmaceutical composition according to claim 1, wherein: the weight fraction of the xanthine accounts for at least 25% by weight of the total weight of the pharmaceutical composition, and the weight fraction of the rehmannia at least accounts for the drug 26% of the total weight of the composition.

[3] The pharmaceutical composition according to claim 1, wherein: the weight fraction of the xanthine accounts for at least 33.2% of the total weight of the pharmaceutical composition, and the weight fraction of the rehmannia accounts for at least the drug. 26.5% of the total weight of the composition.

[4] 4. The pharmaceutical composition according to claim 3, wherein the weight of the rehmannia is at least 33.2% of the total weight of the pharmaceutical composition.

[5] The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition is prepared in a single-use preparation containing 0.15 to 0.6 g of a crude drug per kilogram of body weight.

[6] 6. The pharmaceutical composition according to claim 1, wherein the rehmannia is rehmannia.

[7] The pharmaceutical composition according to any one of claims 1 to 6, further comprising at least one of other components: Salvia miltiorrhiza, Radix Puerariae, Radix Paeoniae Alba, Epimedium, Ophiopogon japonicus, Rhizoma Coptidis .

[8] The pharmaceutical composition according to claim 7, wherein the ratio by weight of the salvia miltiorrhiza is 16% to 36%, and the ratio by weight of the Pueraria lobata is 10% to 22%, The proportion by weight of the red peony is 10% to 16%, the proportion by weight of the icariin is 12% to 18%, and the proportion by weight of the yam is 12% to 18%, and the weight of the coptis is The ratio is 5% to 45%.

[9] 9. The pharmaceutical composition according to claim 1, 5 or 6, wherein the proportion of the weight of the xanthine is 22% to 45%, and the proportion by weight of the rehmannia is 23% to 50%. % also contains other components in a proportion by weight of 5% to 55%.

[10] The pharmaceutical composition according to claim 1, 2, 5 or 6, wherein the proportion of the xanthine is 25% to 40%, and the proportion by weight of the rehmannia is 26%. ~45% also contains other components in a proportion by weight of 17% to 49%.

[II] 11, The pharmaceutical composition according to claim 9, wherein the weight ratio of the xanthine is 24% to 44%, and the weight ratio of the rehmannia is 24% to 46%, and the weight of the other components The proportion is 10%~52%.

[12] The pharmaceutical composition according to claim 9, wherein the pharmaceutical composition contains 25% to 40% by weight of xanthine, and the proportion of 26% to 43% by weight of rehmannia. The ratio of parts by weight is 18% to 34% of Salvia miltiorrhiza.

[13] The pharmaceutical composition according to claim 12, wherein: the weight ratio of the xanthine is 39.7% to 40%, and the proportion by weight of the rehmannia is 33.3% to 33.6%, The weight of Salvia miltiorrhiza is 26.7%~27%.

[14] The pharmaceutical composition according to claim 9, wherein the pharmaceutical composition contains 25% to 35% by weight of xanthine, and the proportion of 26% to 32% by weight of rehmannia. The ratio of parts by weight is 18% to 25% of Salvia miltiorrhiza, and the ratio of parts by weight is 12% to 21% of Pueraria.

[15] The pharmaceutical composition according to claim 14, wherein the ratio of the weight of the xanthine is 33% to 33.3%, and the proportion by weight of the rehmannia is 26.7% to 27%. The ratio by weight of Salvia miltiorrhiza is 20% to 21%, and the proportion by weight of Radix Puerariae is 19% to 20%.

[16] 16. The pharmaceutical composition according to claim 9, wherein the pharmaceutical composition contains xanthine in a proportion of 26% to 30% by weight, and a proportion of 26% to 28% by weight of rehmannia. The ratio of parts by weight of 19% to 21% of Salvia miltiorrhiza, the proportion of 12% to 14% by weight of Radix Puerariae, and the proportion by weight of 12% to 14% of red peony.

[17] The pharmaceutical composition according to claim 16, wherein: the weight ratio of the xanthine is 26.7% to 27%, and the proportion by weight of the rehmannia is 26.7% to 27%, The weight ratio of Salvia miltiorrhiza is 19.5% to 20%, the weight fraction of Radix Puerariae is 13% to 13.3%, and the weight fraction of Radix Paeoniae is 13% to 13.3%.

[18] The pharmaceutical composition according to claim 9, wherein the pharmaceutical composition contains 25% to 40% by weight of xanthine, and the proportion of 28% to 45% by weight of rehmannia. Epimedium in a proportion by weight of 14% to 16%, and a ratio of 14% to 16% by weight of Ophiopogon japonicus.

[19] 19. The pharmaceutical composition according to claim 18, wherein: the weight ratio of the xanthine is 25% to 26%, and the proportion by weight of the rehmannia is 44% to 45%, Epimedium The proportion by weight is 15% to 16%, and the proportion by weight of the Ophiopogon is 14% to 15%.

[20] 20. The pharmaceutical composition according to claim 9, wherein the pharmaceutical composition contains xanthophyll in a proportion by weight of 22% to 45%, and a proportion of 23% to 50% by weight of rehmannia. The ratio of parts by weight is 5% to 45% of berberine.

[21] 21. The pharmaceutical composition according to claim 20, wherein: the weight ratio of the xanthine is 25% to 40%, and the proportion by weight of the rehmannia is 26% to 45%, The proportion by weight of Coptis is 20% to 35%.

[22] 22. The pharmaceutical composition according to claim 9, wherein the pharmaceutical composition contains xanthine in a proportion of 26% to 33% by weight, and a proportion of 26% to 33% by weight of rehmannia. The ratio of 10% to 25% by weight of Rhizoma Coptidis, and the proportion by weight of 19% to 24% of Salvia miltiorrhiza.

[23] 23. The pharmaceutical composition according to claim 22, wherein: the weight ratio of the xanthine is 28% to 32%, and the proportion by weight of the rehmannia is 28% to 30%, The weight ratio of Coptidis Rhizoma is 18% to 22%, and the weight ratio of Salvia miltiorrhiza is 19% to 21%.

[24] 24. Use of the pharmaceutical composition according to any one of claims 1 to 23 for the preparation of a preparation for treating metabolic syndrome.

[25] 25. The use of the pharmaceutical composition according to any one of claims 1 to 23 for the preparation of a medicament for treating diabetes

[26] 26. Use of the pharmaceutical composition according to any of claims 1 to 23 in the preparation of a preparation for lowering postprandial blood glucose.

[27] 27. Use of the pharmaceutical composition according to any one of claims 1 to 23 for the preparation of a blood lipid lowering preparation.

[28] 28. Use of the pharmaceutical composition according to any one of claims 1 to 23 for the preparation of a preparation for improving insulin resistance.