CN112915150A - Pharmaceutical composition for preventing and/or treating diabetes - Google Patents
Pharmaceutical composition for preventing and/or treating diabetes Download PDFInfo
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- CN112915150A CN112915150A CN202110443071.9A CN202110443071A CN112915150A CN 112915150 A CN112915150 A CN 112915150A CN 202110443071 A CN202110443071 A CN 202110443071A CN 112915150 A CN112915150 A CN 112915150A
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Abstract
The invention discloses a pharmaceutical composition for preventing and/or treating diabetes, which is prepared from the following raw material medicines in parts by weight: 6-12 parts of cape jasmine, 10-20 parts of radix rehmanniae recen, 8-16 parts of radix puerariae, 10-20 parts of Chinese yam, 6-12 parts of antrodia camphorata, 6-12 parts of astragalus membranaceus, 4-8 parts of angelica sinensis and 1-5 parts of liquorice. The composition can obviously reduce the concentrations of blood sugar, low-density lipoprotein (LDL), Total Cholesterol (TC) and Triglyceride (TG) in the blood of a diabetic patient, increase the concentrations of insulin and high-density lipoprotein (HDL), obviously reduce the content of MDA in liver tissues, obviously improve the activities of SOD and CAT, have obvious functions of reducing blood sugar and blood fat and oxidation resistance, have a certain function of repairing islet cells, and is easy to popularize and use clinically.
Description
Technical Field
The invention particularly relates to a pharmaceutical composition for preventing and/or treating diabetes.
Background
Diabetes mellitus is a chronic disease caused by a defect in insulin secretion or action. Diabetes and its complications are one of the major diseases threatening human health, and the incidence of diabetes is on the rising trend year by year as the living standard of people is improved and the global aging trend is increased. It is expected that the Worldwide Health Organization (WHO) will reach 3.8 billion of people with diabetes mellitus worldwide in 2025, about 90% of which are type ii diabetes mellitus. The etiology is not clear, but is closely related to factors such as obesity, improper diet, lack of exercise, family history of diabetes, and the like. In the treatment of diabetes, in addition to diet control in daily life, diabetic patients currently rely mainly on drugs for blood sugar control.
Diabetes belongs to the category of ' diabetes ' in traditional Chinese medicine, the name of the disease is first found in Huangdi's inner meridian, and the theoretical system of the disease is formed and developed in Tang and Song dynasties and matured in Ming Qing. Traditional Chinese medicine considers that insufficient innate endowment, overeating fatness and sweetness, five-emotion imbalance, excessive desire, fever and fire dryness and the like are the causes of diabetes. The traditional Chinese medicine of the past generation has rich experience in preventing and treating diabetes, and provides a beneficial reference for the treatment of diabetes by modern Chinese medicine. At present, a lot of traditional Chinese medicine compositions for treating diabetes are reported, and patent CN106853229 discloses a traditional Chinese medicine composition for treating diabetes and complications thereof, but the traditional Chinese medicine composition has more than 33 medicinal herbs, and meanwhile, the curative effect is not clear, so that the medication cost of a patient is high, high benefit matched with the medication cost cannot be obtained, the popularization and the application are not facilitated,
disclosure of Invention
In order to solve the problems, the invention provides a pharmaceutical composition for preventing and/or treating diabetes, which is prepared from the following raw material medicines in parts by weight:
6-12 parts of cape jasmine, 10-20 parts of radix rehmanniae recen, 8-16 parts of radix puerariae, 10-20 parts of Chinese yam, 6-12 parts of antrodia camphorata, 6-12 parts of astragalus membranaceus, 4-8 parts of angelica sinensis and 1-5 parts of liquorice.
Further, the traditional Chinese medicine is prepared from the following raw material medicines in parts by weight:
9 parts of cape jasmine, 15 parts of radix rehmanniae recen, 12 parts of radix puerariae, 15 parts of Chinese yam, 9 parts of antrodia camphorata, 9 parts of astragalus membranaceus, 6 parts of angelica sinensis and 3 parts of liquorice.
Furthermore, the traditional Chinese medicine composition is a preparation prepared by taking medicinal powder of raw material medicines, or water or organic solvent extracts of the raw material medicines as active ingredients and adding pharmaceutically acceptable auxiliary materials.
Still further, the formulation is an oral formulation.
Further, the oral preparation is a granule, powder, pill or solution, preferably a granule.
The invention also provides a preparation method of the pharmaceutical composition, which comprises the following steps:
(1) weighing the raw materials according to the proportion;
(2) grinding the raw materials into powder, or extracting with water or organic solvent, and adding pharmaceutically-acceptable adjuvants or auxiliary components.
Further, the raw material medicines of gardenia, radix rehmanniae, radix puerariae, Chinese yam, astragalus membranaceus, angelica sinensis and liquorice in the step 2) are added with 10-15 times of w/w of water, g/g of water is extracted for 2-3 times at 100 ℃, each time lasts for 2 hours, the filtering is carried out, the mixture is concentrated into thick paste with the specific gravity of 1.1-1.2, antrodia camphorata and dextrin are added to prepare soft materials, and the soft materials are sieved, dried and granulated to obtain the traditional Chinese medicine; or:
step 2), adding 10-15 times of w/w of raw material medicines of cape jasmine, radix rehmanniae recen, radix puerariae, Chinese yam, astragalus membranaceus, angelica sinensis and liquorice, extracting for 2-3 times at 100 ℃ with g/g of water for 2 hours each time, filtering, concentrating into thick paste with the specific gravity of 1.1-1.2, adding antrodia camphorata and dextrin after spray drying to prepare soft materials, sieving, drying and finishing the particles to obtain the traditional Chinese medicine composition; or:
and 2) mixing the granules of the raw material medicines, adding dextrin to prepare a soft material, sieving, drying and finishing the granules to obtain the traditional Chinese medicine.
Further, the antrodia camphorata is crushed and sieved by a 100-mesh sieve; the addition amount of the dextrin is 1.5-2 times of the weight of the thick paste in terms of w/w and g/g; the sieving is 40-mesh sieving.
The invention also provides application of the pharmaceutical composition in preparing a medicament for preventing and/or treating diabetes and complications thereof.
The invention finally provides application of the pharmaceutical composition in preparing a medicament for clearing stomach heat and tonifying kidney water.
The medicine composition of the invention uses gardenia which is bitter and cold and enters stomach meridian, and has the function of clearing stomach and discharging fire, which is recorded in the book of the Ming dynasty: "dominating pathogenic qi in five interior and heat qi in stomach", Sheng Di Huang is sweet and cold and enters kidney meridian, nourishing kidney yin, cooling blood and clearing heat ", Ben Cao Yan Yi: blood cooling and enriching, kidney water tonifying and yin deficiency tonifying are monarch drugs together; the assistant drugs include Kudzuvine root, pungent, sweet and cool in flavor, entering stomach meridian, Ben Jing: "the principal diabetes", this treatise on the materia Medica: the Chinese medicine also can help gardenia clear stomach heat and promote the production of body fluid to quench thirst in the formula; the Chinese yam is sweet and neutral in entering kidney channel, helps the radix rehmanniae to nourish kidney yin, the antrodia camphorata is capable of activating blood and dissolving stasis, has good effect of reducing blood sugar, is used as ministerial medicine, is compatible with monarch medicine and ministerial medicine, combines the effects of clearing and nourishing, gives consideration to both principal and subordinate medicine, and has the effect of nourishing in the clear and nourishing the middle; the astragalus root is used for supplementing qi and strengthening the spleen, the modern research is particularly remarkable for reducing blood sugar, and the nature and the temperature can be prevented from being harmed by cold and cool in the whole formula; dang Gui is used for nourishing blood and promoting the circulation of blood, and is combined with Sheng Di Huang and shan Yao to nourish yin and blood; it is combined with Huang Qi to tonify qi and blood; the composition is compatible with antrodia camphorata, can promote blood circulation to remove blood stasis without damaging healthy qi, and is used as an adjuvant drug together; the liquorice is used as a guiding drug for coordinating the effects of the other drugs in the recipe; the prescription is compatible, the heat clearing and the yin nourishing are combined, the deficiency and the excess are treated simultaneously, the stomach heat is cleared, the kidney water is supplemented, and all the symptoms can be cured.
The test proves that: the composition can obviously reduce the concentrations of blood sugar, low-density lipoprotein (LDL), Total Cholesterol (TC) and Triglyceride (TG) in the blood of a diabetic patient, increase the concentrations of insulin and high-density lipoprotein (HDL), obviously reduce the content of MDA in liver tissues, obviously improve the activities of SOD and CAT, have obvious functions of reducing blood sugar and blood fat and oxidation resistance, have a certain function of repairing islet cells, and is easy to popularize and use clinically.
Obviously, many modifications, substitutions, and variations are possible in light of the above teachings of the invention, without departing from the basic technical spirit of the invention, as defined by the following claims.
The present invention will be described in further detail with reference to the following examples. This should not be understood as limiting the scope of the above-described subject matter of the present invention to the following examples. All the technologies realized based on the above contents of the present invention belong to the scope of the present invention.
Detailed Description
Example 1 preparation of the drug-granule (Compound Antrodia camphorate hypoglycemic granule for short) of the invention
The formula is as follows: 9 g of gardenia, 15 g of radix rehmanniae recen, 12 g of kudzu root, 15 g of Chinese yam, 9 g of antrodia camphorata, 9 g of astragalus, 6 g of angelica and 3g of liquorice.
The preparation method comprises the following steps:
1) extracting fructus Gardeniae, radix rehmanniae, radix Puerariae, rhizoma Dioscoreae, radix astragali, radix Angelicae sinensis, and Glycyrrhrizae radix with 12 times of water for 2 times (extraction at 100 deg.C for 2 hr each time), filtering, and concentrating the filtrate to specific gravity of 1.15 to obtain soft extract;
2) crushing antrodia camphorata, sieving with a 100-mesh sieve, adding the crushed antrodia camphorata and dextrin which is 1.5-2 times of the amount of the thick paste in the amount of g/g into the thick paste in the step 1) to prepare a soft material, sieving with a 40-mesh sieve, drying and finishing. The compound antrodia camphorate hypoglycemic granules are obtained.
Example 2 preparation of the drug-granule (Compound Antrodia camphorate hypoglycemic granule for short) of the invention
The formula is as follows: 9 g of gardenia, 15 g of radix rehmanniae recen, 12 g of kudzu root, 15 g of Chinese yam, 9 g of antrodia camphorata, 9 g of astragalus, 6 g of angelica and 3g of liquorice.
The preparation method comprises the following steps:
1) extracting fructus Gardeniae, radix rehmanniae, radix Puerariae, rhizoma Dioscoreae, radix astragali, radix Angelicae sinensis, and Glycyrrhrizae radix with 12 times of water for 3 times (2 hr per time) and filtering, and concentrating the filtrate to specific gravity of 1.12 to obtain soft extract;
2) taking the thick paste obtained in the step 1), adding crushed antrodia camphorata which is sieved by a 100-mesh sieve and dextrin which is 1.5-2 times the amount of the thick paste in terms of w/w and g/g to prepare a soft material, sieving the soft material by a 40-mesh sieve, drying and grading to obtain the compound antrodia camphorata blood sugar reducing particles.
Example 3 preparation of the drug-granule (Compound Antrodia camphorate hypoglycemic granule for short) of the invention
The formula is as follows: 9 g of gardenia, 15 g of radix rehmanniae recen, 12 g of kudzu root, 15 g of Chinese yam, 9 g of antrodia camphorata, 9 g of astragalus, 6 g of angelica and 3g of liquorice.
The preparation method comprises the following steps:
1) extracting fructus Gardeniae, radix rehmanniae, radix Puerariae, rhizoma Dioscoreae, radix astragali, radix Angelicae sinensis, and Glycyrrhrizae radix with 12 times of water for 3 times (2 hr per time) and filtering, and concentrating the filtrate to specific gravity of 1.12 to obtain soft extract;
2) taking the thick paste obtained in the step 1), spray drying, adding crushed antrodia camphorata which is sieved by a 100-mesh sieve and 1.5-2 times of the amount of the thick paste in terms of w/w and g/g to prepare a soft material, sieving by a 40-mesh sieve, drying and finishing. The compound antrodia camphorate hypoglycemic granules are obtained.
Example 4 preparation of the drug-granule (Compound Antrodia camphorate hypoglycemic granule for short) of the invention
The formula is as follows: 9 g of gardenia, 15 g of radix rehmanniae recen, 12 g of kudzu root, 15 g of Chinese yam, 9 g of antrodia camphorata, 9 g of astragalus, 6 g of angelica and 3g of liquorice.
The preparation method comprises the following steps: mixing the traditional Chinese medicine granules, adding 1.5-2 times of the weight of the thick paste in terms of w/w and g/g to prepare soft materials, sieving, drying and finishing granules. The compound antrodia camphorate hypoglycemic granules are obtained.
The advantageous effects of the present invention are described below by way of test examples.
Test example 1 evaluation of drug efficacy of the present invention on streptozotocin-induced mouse diabetes model
1 materials of the experiment
SPF-grade KM mice, male, purchased from shanghai slaike laboratory animals llc, laboratory animal license number: SCXK (Shanghai) 2012-2002. And selecting individuals with strong physique, complete and undamaged body and uniform size for carrying out group culture. Mice (25. + -.5) g were selected for the experiment. The raising environment temperature is 20-25 ℃, the sunshine is 12 hours every day, the water is freely taken for feeding, and the relative humidity is as follows: 45% -55%, mice acclimated for 1 week.
A Chinese herbal medicine grinder (Tester instruments Co., Ltd., Tianjin); RE-52AA rotary evaporator (Shanghai Yangrong Biochemical Instrument factory); f6-10 superfine homogenizer (Ongsewa Co., Ltd.); AL104 electronic balance [ Mettler-Toledo instruments (shanghai) ltd ]; FreeStyle (lisu) glucometer; FreeStyle blood glucose test paper; alcohol meter (Hongli instrument factory in river city, Hebei province).
Streptozotocin (STZ, Sigma); metformin hydrochloride (new pharmaceutical factory approved by Tianjin New pharmaceutical group GmbH, No. 12020587); rutin (Sigma Co.); p-nitrophenyl-alpha-D glucopyranoside (pNPG, Shanghai-derived leaf Biotech Co., Ltd.); 3, 5-dinitrosalicylic acid (DNS, shanghai-derived leaf biotechnology limited); cholesterol (TC), Triglyceride (TG), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), Catalase (CAT), superoxide dismutase (SOD) and Malondialdehyde (MDA) determination kit (Nanjing institute of bioengineering); citric acid, sodium citrate, absolute ethyl alcohol, normal saline and the like are analytically pure.
2 method of experiment
2.1 in vivo hypoglycemic experiments
Selecting 100 KM mice, fasting for 12h, and then according to 150 mg/kg-1Dose injection of STZ with fasting plasma glucose value after 72h>11.1mmol·L-1Is an experimental diabetic mouse which is successfully modeled. Taking 11 normal mice as a normal group, selecting 55 diabetic mice successfully molded by STZ, randomly grouping into a model group, a metformin group and a compound antrodia camphorata blood sugar reducing granule low, medium and high dose group, and feeding in cages without food restriction and free drinking water. The compound antrodia camphorate hypoglycemic particles prepared in the embodiment 1 of the invention have low, medium and high dosage components which are separately gavaged for 15 days, and the metformin is 100 mg.kg-1The stomach was gavaged for 15d, and the normal control group and the model group were given equal volumes of physiological saline, respectively. The body mass of the experimental mice is weighed at the time of gavage for 0, 3, 6, 9, 12 and 15 days, and fasting for 12 hours is followed by tail-cutting blood sampling to measure the fasting blood glucose value. Mice in each experimental group were fasted for 6h at day 16 at a rate of 3 g.kg-1The glucose dose is perfused into stomach for glucose tolerance test, and the blood glucose values at 0, 0.5, 1.0 and 2.0h are measured respectively by tail breaking. Finally, the mice are anesthetized by ether, the eyeballs are picked up and blood is taken, and 2500 r/min-1Centrifuging at low temperature for 10min, separating serum, and preserving at low temperature.
The mice were killed the last day, a small piece of liver tissue with approximately the same liver part of the same lobe of each mouse was taken, the residual blood was washed away, and the filter paper was wiped dry and weighed. Preparing tissue homogenate according to the mass-to-volume ratio (1g tissue: 9mL physiological saline) and 2000 r.min-1Centrifugation
And (5) storing the supernatant in a refrigerator for later use.
The biochemical indexes in serum and liver homogenate are measured by a kit method, and in addition, part of pancreatic tissues are taken for pathological section observation.
2.2 processing of the Experimental data
The experimental data were analyzed for variance using the SPSS17.0 software package, and plotted for Excel to
Showing that the difference between groups is compared by t test, P<0.05 is the significant difference criterion.
3 results
3.1 Effect of Compound Antrodia camphorata hypoglycemic granule on STZ diabetic mouse body quality
The results of the measurements of the physical quality of the diabetic mice on days 0, 3, 6, 9, 12 and 15 according to the experimental procedures are shown in Table 1. The normal group mice increased their body mass continuously, the average body mass increased 8.21% after day 15, while the average body mass of the model group mice decreased all the time, finally decreased by 13.85%. The body mass of the other mice in each group is remarkably increased after 12 days of gastric lavage compared with that of the model group, the average body mass of the metformin mice is finally reduced by 0.44%, the average body mass of the mice in the low and high dose groups of compound antrodia camphorata blood sugar reducing particles is respectively reduced by 7.33% and 1.17%, and the average body mass of the mice in the medium dose group of compound antrodia camphorata blood sugar reducing particles is increased by 0.89%.
Table 1. influence of compound antrodia camphorata hypoglycemic granules on change of mouse body mass, n is 12,
note: compared to the normal group, # P < 0.05; p <0.05 in comparison with model group
3.2 Effect of Compound Antrodia camphorata hypoglycemic granule on blood sugar level and sugar tolerance of STZ diabetic mice
Blood glucose values were measured on days 0, 3, 6, 9, 12, and 15 for the mice in each experimental group. Except for the normal group, the mice in each group were hyperglycemic. The blood sugar concentration of the model group mouse is basically unchanged and is reduced by 0.47 percent; after the metformin is perfused for 15 days, the blood sugar of the mouse is reduced by 23.44 percent; after the compound antrodia camphorate hypoglycemic particles are used for intragastrically infusing low, medium and high doses, the blood sugar concentration of a mouse is respectively reduced by 16.35%, 21.05% and 22.12%, wherein the hypoglycemic effect of the high dose group is equivalent to that of the metformin group.
And (5) carrying out a sugar tolerance test after the intragastric administration for 16d, and measuring the test result. Except for normal group of mice, the blood sugar concentration of other experimental mice is higher than 11.1 mmol.L-1And judging that the mice are diabetic from the successful molding to the end of the gavage. After the intragastric administration of the glucose solution is carried out for 120min, the blood sugar of the model group is still kept at the highest level, the blood sugar of mice in the metformin group and the compound antrodia camphorata blood sugar reducing particles recovers or approaches to the level before the intragastric administration, the capability of stabilizing the blood sugar concentration of the mice is improved compared with that of the model group, the blood sugar values of the mice in the compound antrodia camphorata blood sugar reducing particles and the compound antrodia camphorata blood sugar reducing particles are lower than that of the metformin group, and the blood sugar reducing effect is better.
Table 2 mouse blood glucose and AUC (n ═ 12, x ± s)
Note: indicates comparison to blank group; # denotes comparison with model set; and # indicates P <0.05, and or # # indicates P <0.01
3.3 Effect of Compound Antrodia camphorata hypoglycemic granules on serum insulin of STZ diabetic mice
The insulin level of the mice in the model group is obviously reduced compared with that in the normal group (P <0.0 l); compared with the model group, the middle and high dose groups of the compound antrodia camphorata hypoglycemic granules can obviously increase the serum insulin (P <0.01) of diabetic mice, and the action effect of the high dose group is equivalent to that of metformin (Table 3).
TABLE 3 influence of FUFANGZHANGZHIJIANGTANG granule on serum insulin level of diabetic mice (n ═ 12, x + -s)
Note: compared to the normal group, # P < 0.01; p <0.01 in comparison to model groups
3.4 Effect of Compound Antrodia camphorata hypoglycemic granule on the concentration of TC, TG, LDL and HDL in blood serum of STZ diabetic mice
The results of measuring the contents of TC, TG, LDL and HDL in the serum of mice of each experimental group are shown in Table 4. As can be seen from Table 4, the serum contents of TC, TG and LDL in the model group mice are all significantly higher than those in the normal group, and the HDL content is lower than that in the normal group, so that the difference is very significant (P < 0.01). After the metformin and the compound antrodia camphorate blood-sugar-reducing particles are infused into the stomach, the contents of TC, TG and LDL in the blood of a mouse are obviously reduced (P is less than 0.01), and the capabilities of the compound antrodia camphorate blood-sugar-reducing particle high-dose group for reducing TC, TG and LDL are almost equivalent to that of the metformin. The metformin and the extract of the compound antrodia camphorata hypoglycemic particles can obviously improve the content of HDL (P <0.01) in serum of mice, wherein the effect of the compound antrodia camphorata hypoglycemic particles in a high-dose group is equivalent to that of the metformin. The compound antrodia camphorata blood sugar reducing particles have obvious effect of maintaining normal physiological concentration of lipoprotein, and the effect proves that the compound antrodia camphorata blood sugar reducing particles can effectively reduce the content of blood fat and cholesterol in blood of diabetic mice.
Table 4 influence of compound antrodia camphorata hypoglycemic granules on the concentration of TC, TG, LDL and HDL in the serum of mice, n ═ ll,
note that # p <0.01 compared to the normal group; comparing with the model group; p <0.01
3.5 Effect of Compound Antrodia camphorata hypoglycemic granule on MDA content and SOD and CAT activities in liver tissue of STZ diabetic mouse
The MDA content of the model group mice is obviously increased compared with that of the normal group; the MDA content of the metformin group mice was significantly reduced compared to the model group (P < 0.01); the compound antrodia camphorate hypoglycemic particle has a general MDA reducing effect (P <0.05), the medium and high dose groups can obviously reduce the MDA content and reach an extremely obvious level (P <0.01), and the effect of the high dose group is similar to that of metformin. SOD and CAT activities in liver tissues of mice in a model group are obviously reduced, and the difference with a normal group is extremely obvious; the SOD and CAT activities of other groups of mice are obviously improved, the difference with the model group is extremely obvious, and the effect of the compound antrodia camphorata blood sugar reducing particle high-dose group is equivalent to that of metformin. The results show that the compound antrodia camphorata hypoglycemic particles can obviously improve the activity of SOD and CAT in mice (P is less than 0.01). The results are shown in Table 4.
Table 5 influence of compound antrodia camphorata hypoglycemic granules on the concentration of TC, TG, LDL and HDL in the serum of mice, n ═ l2,
| group of | MDA/nmol·mg(prot)-1 | CAT/u·g(prot)-1 | SOD/u·mg(prot)-1 |
| Normal group | 7.73±1.32 | 258.74±63.24 | 226.35±32.01 |
| Model set | 12.67±2.441) | 191.56±65.251) | 80.59±26.141) |
| Metformin hydrochloride | 1007.19±1.643) | 366.85±43.423) | 206.24±39.343) |
| Low dose group | 10.93±3.342) | 295.15±62.393) | 163.24±49.523) |
| Middle dose group | 9.41±2.873) | 320.15±69.533 | 184.29±37.153) |
| High dose group | 7.67±1.513) | 374.69±64.243) | 202.18±48.353) |
Note:1)P<0.01; in comparison with the set of models,2)P<0.05，3)P<0.01
3.6 Effect of Compound Antrodia camphorata hypoglycemic granules on pathological morphology of pancreas of STZ diabetic mice
HE staining results show that the islet cells of the mice in the normal control group are full and large in number, and are clearly separated from peripheral acinus; the islet cells of the model group mice shrink, are fuzzy with the surrounding boundary, are irregular in shape, have small islet quantity and obviously reduce in volume; compared with the model group, the islet cells of the mice in the metformin group are plump, the boundary is clear, and the number of islets is increased; the compound antrodia camphorata blood sugar reducing particles improve the phenomenon of islet cell atrophy of mice in low, medium and high dose groups, increase the diameter of islet cells and have slightly clear boundaries.
The main antioxidant enzymes in the cells include SOD, CAT and the like, and the activity reflects the strong and weak ability of the organism to eliminate free radicals. MDA is one of main products of lipid peroxidation caused by free radicals, and the content of MDA can indirectly reflect the capabilities of organisms in resisting oxidation and eliminating oxidation products. The experimental result shows that the MDA level in the liver tissue of the STZ-modeled diabetic mouse is obviously higher than that of a normal mouse, and the SOD and CAT activities are obviously reduced, which indicates that the liver of the diabetic mouse is seriously damaged. The compound antrodia camphorate hypoglycemic particles with high dose can obviously improve the activity of SOD and CAT in liver tissues of mice and reduce the content of MDA, has obvious difference (p is less than 0.01) compared with a model group, and has equivalent antioxidant effect with metformin hydrochloride. Therefore, the compound antrodia camphorata blood sugar reducing particles enhance the oxidation resistance of the body of a diabetic mouse and play a certain role in protecting the liver of the diabetic mouse from oxidative damage.
By inducing a diabetic mouse through STZ, taking metformin hydrochloride as a positive control, finding that the compound antrodia camphorate hypoglycemic particles have obvious influences on blood sugar, body mass, sugar tolerance and TC, TG, LDL and HDL in serum of the diabetic mouse after being perfused into the diabetic mouse for 15 days, wherein the body mass of the diabetic mouse shows a rising trend, the fasting blood sugar value is obviously reduced, the sugar tolerance level is raised, and the increase of the concentration of TC, TG and LDL in the serum of the mouse can be inhibited, and the decrease of the concentration of HDL is inhibited. The compound antrodia camphorate blood sugar reducing particles can repair islet beta cells, promote the secretion of insulin and accelerate the oxidative decomposition of glucose by inhibiting the damage of free radicals to the islet beta cells, thereby achieving the purposes of reducing blood sugar and improving the symptoms of diabetes.
Type II diabetes is characterized by an absolute or relative deficiency of insulin secretion and/or insulin, leading to metabolic disorders. By measuring the content of insulin in the serum of the STZ diabetic mouse, the low, medium and high dose groups of the compound antrodia camphorata hypoglycemic particles can increase the serum insulin of the STZ-induced diabetic mouse (p is less than 0.05). The results of pancreas section and HE staining show that the compound antrodia camphorata hypoglycemic particles with low, medium and high doses can improve the damage degree of islet cells of STZ diabetic mice. Therefore, the compound antrodia camphorate blood sugar reducing particles have better treatment effect on diabetes.
In conclusion, the invention provides a pharmaceutical composition prepared by combining gardenia, radix rehmanniae recen, radix puerariae, Chinese yam, astragalus membranaceus, angelica sinensis and liquorice in a specific proportion, and in vivo experiments show that the pharmaceutical composition can remarkably reduce the concentrations of blood sugar, low-density lipoprotein (LDL), Total Cholesterol (TC) and Triglyceride (TG) of diabetic mice and increase the concentrations of insulin and high-density lipoprotein (HDL); HE staining experiments show that the composition has a certain repairing effect on islet cells of diabetic mice; physiological and biochemical experiments show that the composition can obviously reduce the content of MDA in liver tissues, and obviously increase the activities of SOD and CAT. The compound has obvious hypoglycemic effect and antioxidant capacity, can repair islet cells, and has excellent application prospect in preparing medicine for preventing and/or treating diabetes.
Claims (10)
1. A pharmaceutical composition for preventing and/or treating diabetes mellitus, characterized in that: the traditional Chinese medicine is prepared from the following raw materials in parts by weight:
6-12 parts of cape jasmine, 10-20 parts of radix rehmanniae recen, 8-16 parts of radix puerariae, 10-20 parts of Chinese yam, 6-12 parts of antrodia camphorata, 6-12 parts of astragalus membranaceus, 4-8 parts of angelica sinensis and 1-5 parts of liquorice.
2. The pharmaceutical composition of claim 1, wherein: the traditional Chinese medicine is prepared from the following raw materials in parts by weight:
9 parts of cape jasmine, 15 parts of radix rehmanniae recen, 12 parts of radix puerariae, 15 parts of Chinese yam, 9 parts of antrodia camphorata, 9 parts of astragalus membranaceus, 6 parts of angelica sinensis and 3 parts of liquorice.
3. The pharmaceutical composition according to claim 1 or 2, characterized in that: the preparation is prepared by taking medicinal powder of raw material medicines, or water or organic solvent extracts of the raw material medicines as active ingredients and adding pharmaceutically acceptable auxiliary materials.
4. The pharmaceutical composition according to any one of claims 1 to 3, wherein: the preparation is an oral preparation.
5. The pharmaceutical composition of claim 4, wherein: the oral preparation is granule, powder, pill or solution, preferably granule.
6. A process for preparing a pharmaceutical composition according to any one of claims 1 to 5, characterized in that: it comprises the following steps:
(1) weighing the raw material medicines according to the proportion of claim 1;
(2) grinding the raw materials into powder, or extracting with water or organic solvent, and adding pharmaceutically-acceptable adjuvants or auxiliary components.
7. The pharmaceutical composition of claim 6, wherein: step 2), adding 10-15 times of w/w of raw material medicines of cape jasmine, radix rehmanniae recen, radix puerariae, Chinese yam, astragalus membranaceus, angelica sinensis and liquorice into water per gram, extracting for 2-3 times at 100 ℃ for 2 hours each time, filtering, concentrating into thick paste with the specific gravity of 1.1-1.2, adding antrodia camphorata and dextrin to prepare soft materials, sieving, drying and finishing the soft materials to obtain the traditional Chinese medicine composition; or:
step 2), adding 10-15 times of w/w of raw material medicines of cape jasmine, radix rehmanniae recen, radix puerariae, Chinese yam, astragalus membranaceus, angelica sinensis and liquorice, extracting for 2-3 times at 100 ℃ with g/g of water for 2 hours each time, filtering, concentrating into thick paste with the specific gravity of 1.1-1.2, adding antrodia camphorata and dextrin after spray drying to prepare soft materials, sieving, drying and finishing the particles to obtain the traditional Chinese medicine composition; or:
and 2) mixing the granules of the raw material medicines, adding dextrin to prepare a soft material, sieving, drying and finishing the granules to obtain the traditional Chinese medicine.
8. The pharmaceutical composition of claim 7, wherein: crushing antrodia camphorata and sieving the crushed antrodia camphorata with a 100-mesh sieve; the addition amount of the dextrin is 1.5-2 times of the weight of the thick paste in terms of w/w and g/g; the sieving is 40-mesh sieving.
9. Use of the pharmaceutical composition of any one of claims 1 to 5 in the preparation of a medicament for the prevention and/or treatment of diabetes and its complications.
10. Use of the pharmaceutical composition of any one of claims 1 to 5 in the preparation of a medicament for clearing stomach heat and tonifying kidney water.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110443071.9A CN112915150A (en) | 2021-04-23 | 2021-04-23 | Pharmaceutical composition for preventing and/or treating diabetes |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110443071.9A CN112915150A (en) | 2021-04-23 | 2021-04-23 | Pharmaceutical composition for preventing and/or treating diabetes |
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| Publication Number | Publication Date |
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| CN112915150A true CN112915150A (en) | 2021-06-08 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202110443071.9A Withdrawn CN112915150A (en) | 2021-04-23 | 2021-04-23 | Pharmaceutical composition for preventing and/or treating diabetes |
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| Country | Link |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114748567A (en) * | 2022-03-29 | 2022-07-15 | 福州和杏健康管理服务有限公司 | Blood sugar reducing composition containing antrodia camphorata and preparation method and application thereof |
-
2021
- 2021-04-23 CN CN202110443071.9A patent/CN112915150A/en not_active Withdrawn
Non-Patent Citations (1)
| Title |
|---|
| 漆姣媚等: ""显齿蛇葡萄黄酮降血糖作用研究"", 《中国药学杂志》 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114748567A (en) * | 2022-03-29 | 2022-07-15 | 福州和杏健康管理服务有限公司 | Blood sugar reducing composition containing antrodia camphorata and preparation method and application thereof |
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Application publication date: 20210608 |