CN117982601A - Application of traditional Chinese medicine composition in preparation of hypoglycemic drugs - Google Patents
Application of traditional Chinese medicine composition in preparation of hypoglycemic drugs Download PDFInfo
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- CN117982601A CN117982601A CN202410218025.2A CN202410218025A CN117982601A CN 117982601 A CN117982601 A CN 117982601A CN 202410218025 A CN202410218025 A CN 202410218025A CN 117982601 A CN117982601 A CN 117982601A
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- chinese medicine
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- Medicines Containing Plant Substances (AREA)
Abstract
The invention relates to application of a traditional Chinese medicine composition in preparation of hypoglycemic drugs, which comprises the following raw material medicines in parts by weight: 165 parts of phellodendron, 165 parts of red paeony root, 165 parts of angelica, 165 parts of szechuan lovage rhizome, 165 parts of glabrous greenbrier rhizome, 99 parts of common burreed rhizome, 132 parts of oriental waterplantain rhizome, 132 parts of purslane, 132 parts of verbena, 132 parts of saxifrage, 99 parts of bupleurum, 99 parts of medicinal cyathula root and 33 parts of liquorice.
Description
Technical Field
The invention relates to an application of a traditional Chinese medicine composition in preparing a hypoglycemic drug, belonging to the field of new clinical application of drugs.
Background
The traditional Chinese medicine composition disclosed by the application is a Qianlieshutong capsule, is a traditional Chinese medicine for treating male prostate diseases, and is produced by Baoding Tianhao pharmaceutical Co., ltd, and the approval document number of the traditional Chinese medicine is as follows: the Chinese medicinal preparation Z20027671 is prepared from 165g of phellodendron bark, 165g of red peony root, 165g of Chinese angelica, 165g of szechuan lovage rhizome, 165g of glabrous greenbrier rhizome, 99g of common burreed rhizome, 132g of oriental waterplantain rhizome, 132g of purslane, 132g of vervain, 132g of saxifrage, 99g of bupleurum root, 99g of medicinal cyathula root and 33g of liquorice. The composition has effects in clearing heat, promoting diuresis, removing blood stasis, and resolving hard mass. Can be used for treating chronic prostatitis, and prostatic hyperplasia with syndrome of damp-heat stagnation, wherein the symptoms are as follows: frequent urination, urgent urination, dribbling urine, distention or pain of the perineum, lower abdomen or lumbosacral region, damp scrotum, etc. The inventor lays out 3 patent applications in the earlier stage of the traditional Chinese medicine composition, namely: 02153461.6 (formulation and dosage), 200410022067.1 (preparation process method), 202210023784.4 (traditional Chinese medicine fingerprint detection method).
The study carries out systematic combing on the prior art documents of the Qianlieshutong traditional Chinese medicine composition, and finds that the clinical study has most of therapeutic application in treating chronic prostatitis, benign prostatic hyperplasia, chronic pelvic inflammatory disease, seminal vesiculitis, chronic nonbacterial prostatitis, semen nonliquefaction sterility, chronic epididymitis, chronic prostate with varicose veins, benign prostatic hyperplasia and the like. In combination, for example: feng Jingmin, yang Er, etc., and the primary observation of the treatment of chronic prostatitis complicated with erectile dysfunction premature ejaculation by the combination of tadalafil and Qianlieshutong capsules, chinese medicine and clinic 2020, 20 (11). Li Yue, observation of the efficacy of quinolone antibacterial agents in combination with Qianlieshutong capsules for the treatment of chronic bacterial prostatitis, journal of clinical medicine literature electronics 2020,7 (04). The article describes: the application of the quinolone antibacterial combined Qianlieshutong capsules in chronic prostatitis has obvious treatment effect, can improve the symptoms of patients, improves the quality of life, and is worthy of clinical popularization and application. Lin Meng, han Sheng, yang Dakun, etc., and the prostatauxe capsule is combined with tamsulosin hydrochloride sustained release capsules for treating prostatitis after transurethral prostatectomy, chinese and foreign medicine research. 2019,17 (32). The article discloses that the medicine can improve clinical symptoms of patients, improve inflammatory factor level, can not increase adverse reaction, and has higher clinical application value. Li Fudong, kong Feiyan, zhang et al, the clinical efficacy observation of the combination of the Qianliuotong capsules and tamsulosin for treating chronic prostatitis with premature ejaculation. North-west national defense journal of medicine 2019,40 (01). From the above-disclosed scientific literature, most of the therapeutic diseases of the medicine are concentrated on the aspect of prostate, and the medicine belongs to the field of kidney diseases, and report researches on the application of other indications of the medicine are very few.
Disclosure of Invention
The invention aims to provide an application of a traditional Chinese medicine composition in preparing hypoglycemic drugs, and in particular relates to a new clinical application of the traditional Chinese medicine composition. The Chinese medicinal composition has the advantages of improving clinical symptoms of patients with diabetes mellitus and obvious treatment effect in the long-term medication feedback process of a large number of patients. Therefore, the invention develops hypoglycemic pharmacological experiments, and the experiments show that the invention obviously reduces the blood sugar in the serum of the fasting abdominal aorta of the rat. The results show that the traditional Chinese medicine composition can provide a new medicine selection for diabetics.
The technical scheme of the invention is as follows:
The application of a traditional Chinese medicine composition in preparing a medicament for treating blood glucose reduction is characterized in that the traditional Chinese medicine composition is a Qianlieshutong capsule, and the raw material composition and the weight ratio thereof are as follows: 165 parts of phellodendron, 165 parts of red paeony root, 165 parts of angelica, 165 parts of szechuan lovage rhizome, 165 parts of glabrous greenbrier rhizome, 99 parts of common burreed rhizome, 132 parts of oriental waterplantain rhizome, 132 parts of purslane, 132 parts of vervain, 132 parts of saxifrage, 99 parts of Chinese thorowax root, 99 parts of medicinal cyathula root, 33 parts of liquorice and 123 parts of starch.
The disease treated by the traditional Chinese medicine composition is type II diabetes.
The dosage of the usage for treating diseases is as follows: oral administration was performed 3 times daily, 3 granules each time.
The preparation method of the Qianlieshutong capsules comprises the following steps: reflux-extracting cortex Phellodendri, alismatis rhizoma, radix Angelicae sinensis, and rhizoma Ligustici Chuanxiong with 60% ethanol twice for 1.5 hr each time, filtering, and recovering ethanol under reduced pressure to obtain fluid extract; decocting the other nine medicinal materials with water twice for 1.5 hr for the first time and 1 hr for the second time, filtering, mixing the filtrates, concentrating under reduced pressure to obtain fluid extract with relative density of 1.08, mixing with the above fluid extract, concentrating to obtain soft extract with relative density of 1.32-1.35, drying under reduced pressure, pulverizing the dry extract, adding starch, mixing, granulating, drying, and making into capsule.
The traditional Chinese medicine composition has the beneficial effects that:
the invention provides a new application of a traditional Chinese medicine composition, and pharmacological experiments show that the fasting tail blood sugar of a rat is obviously reduced, and the blood sugar in the fasting abdominal aortic serum of the rat is obviously reduced. The results show that the traditional Chinese medicine composition can effectively treat diabetes. In the clinical application process, no toxic or side effect is found.
The invention provides a new therapeutic application of Qianlieshutong capsules for treating diabetes, aims to expand the application range of the Qianlieshutong capsules in clinical medication, has no toxic or side effect, and provides a new choice for clinical medication of diabetics.
Drawings
The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and together with the description serve to explain the invention and do not constitute a limitation on the invention.
FIG. 1-diabetic rats were dosed for 8 days, wherein the effect on fasting tail tip peripheral blood glucose in the normal control group, model control group, low-dose group of the drug of the present invention, medium-dose group of the drug of the present invention, high-dose group of the drug of the present invention, positive control group;
FIG. 2-effect of 21 days on fasting tail tip peripheral blood glucose in rats treated with normal control, model control, low-dose, medium-dose, high-dose, positive control;
FIG. 3-effect of 30 days on fasting tail tip peripheral blood glucose in rats treated with normal control, model control, low dose of the drug of the invention, medium dose of the drug of the invention, high dose of the drug of the invention, positive control;
FIG. 4-effect of 36 days of diabetic rats on fasting tail-tip peripheral blood glucose in normal control, model control, low-dose of the drug of the invention, medium-dose of the drug of the invention, high-dose of the drug of the invention, positive control;
FIG. 5-effect of 44 days on fasting tail tip peripheral blood glucose in diabetic rats, in normal control, model control, low-dose of the drug of the invention, medium-dose of the drug of the invention, high-dose of the drug of the invention, positive control;
FIG. 6-effect of 51 days on fasting tail tip peripheral blood glucose in diabetic rats, in normal control, model control, low-dose of the drug of the invention, medium-dose of the drug of the invention, high-dose of the drug of the invention, positive control;
FIG. 7-effect of 58 days on fasting tail tip peripheral blood glucose in diabetic rats, in normal control, model control, low-dose of the drug of the invention, medium-dose of the drug of the invention, high-dose of the drug of the invention, positive control;
FIG. 8-effect of 61 days on fasting tail peripheral blood glucose in diabetic rats in normal control, model control, low-dose of the drug of the invention, medium-dose of the drug of the invention, high-dose of the drug of the invention, positive control.
The invention will be further described by way of exemplary embodiments in order to provide a more thorough understanding of the practice of the invention. The beneficial therapeutic effects of the drug are demonstrated below and by pharmacodynamics.
Detailed Description
In order to better understand the present invention, several examples are listed below, which are all simple alternatives equivalent to the conventional technology, and all fall within the scope of the present invention, which further illustrates its new use in the field of diabetes through pharmacological or clinical experiments. The following experiments are intended to illustrate the invention and not to limit it.
EXAMPLE 1 preparation method of Qianlieshutong Capsule of the present invention
The formula comprises the following components: 165g of phellodendron, 165g of red peony root, 165g of angelica, 165g of ligusticum wallichii, 165g of rhizoma smilacis glabrae, 132g of rhizoma sparganii, 132g of herba portulacae, 132g of herba verbenae, 132g of saxifrage, 99g of radix bupleuri, 99g of radix cyathulae, 33g of liquorice and 123g of starch;
The thirteen medicinal materials are taken, four medicines of phellodendron, alisma orientale, angelica and ligusticum wallichii are added with 60% ethanol, reflux extraction is carried out twice for 1.5 hours each time, filtration is carried out, the ethanol is recovered from the filtrate under reduced pressure, and the obtained clear paste is reserved; decocting the other nine medicinal materials with water twice for 1.5 hr for the first time and 1 hr for the second time, filtering, mixing the filtrates, concentrating under reduced pressure to obtain fluid extract with relative density of 1.08 (60 deg.C), mixing with the above fluid extract, concentrating to obtain soft extract with relative density of 1.32-1.35 (60 deg.C), drying under reduced pressure, pulverizing the dry extract, adding starch, mixing, granulating, drying, and encapsulating.
EXAMPLE 2 Effect of the Chinese medicinal composition of the invention on diabetic rats
1. Experimental materials
1.1 Test drug
The medicine name of the invention is: qianlieshutong capsule, lot number: 20210705, manufacturer, baoding, pharmaceutical limited.
1.2 Positive control
A capsule for quenching thirst and lowering blood sugar is administered orally. 5 granules at a time, 3 times a day, and 8 weeks as a treatment course. Lot number 20200902, shaanxi step size pharmaceutical Co.
1.3 Test reagents
Glucose, lot number: 2020901, national pharmaceutical group chemical company, inc; 0.1M sodium citrate buffer, pH4.5, beijing Soy Corp; streptozotocin (STZ), sigma; glucose (GLU), glucose oxidase method, lot number 01101D11.
1.4 Animals
SD rats, SPF grade, 80-100g, male 135, license number: SCXK (Beijing) 2020-0011, beijing Vitolihua laboratory animal technologies Co., ltd.
1.5 Feed
The rats maintained feed, SPF grade, product lot number 21043213, 21053213, 21063213, 21073213, beijing australia synergetic feed limited. 35% fat ratio diabetic rats custom feed formula: 65% rat maintenance feed +10% lard +20% sucrose +2.5% cholesterol +1% sodium cholate +1% mineral mixture +0.5% cellulose mixture, date of manufacture 20210318, 20210410, supplied by beijing borborg biotechnology limited.
1.6 Raising, management of laboratory animals and environmental conditions thereof
Feeding conditions: raising in laboratory of Chinese medical institute of Chinese medicine, and shielding environment, and experimental facility license SYXK (Beijing) 2020-0003.
1.7 Instruments
Blood glucose meter: sanuo biosensing Co., ltd; blood glucose test system: blood glucose test strip: lot number 1I0324,1I0121,1I0127,1I0513,1I0512,1I0324,1I0601, sanuo biosensing Co., ltd.
2. Experimental method
2.1 Modeling of high sugar high fat modeling
After the rats were fed with normal diet for 3d, the normal control group was fed with normal feed, the modeling group was fed with customized feed for rats and mice with 35% fat ratio, continuously fed for 60d, and modeling was performed.
2.2STZ (diabetes animal model) modeling
STZ streptozotocin is dissolved in 0.1M sodium citrate to prepare buffer solution with pH of 4.5, STZ streptozotocin is injected intraperitoneally, the concentration of STZ (streptozotocin) is 1%, the dosage of administration is 35mg/kg, the light is prevented, the preparation is carried out within 30min after the preparation, and the injection is completed.
2.3 Trial grouping and handling
SD male rats were fed with high-sugar and high-fat feed for 59d, fasted, injected with STZ intraperitoneally at a dose of 35mg/kg, and the fasting blood glucose of the tail tip was measured at 7d, 9d and 11d of the model, and rats with unsuccessful model formation (blood glucose value lower than 16.7 mmol/L) were removed, and a normal control group was additionally provided. The animals were regrouped according to blood sugar and body weight, respectively, as model control groups, low, medium and high dose groups (5.04 g, 10.08g, 20.16g crude drug/kg), and diabetes hypoglycemic drug control group (0.46 g/kg), all animals were fed with normal diet, were given by stomach infusion, the administration volume was 1mL/100g, were given 1 time per day, and the normal control group was given pure water, and the administration was continued for 60 days.
2.4 Detection of fasting blood glucose and oral glucose tolerance in rats fed with high-sugar and high-fat feeds
At 43d, animals were fasted, not deprived of water for 16h, collected from the tail, assayed for fasting blood glucose, recorded as 0min blood glucose, and then each group of rats was orally administered 2g/kg glucose solution (50%), tested for 30min,60min,120min blood glucose, and area under the curve (AUC) was calculated. At 58d, animals were fasted without water withdrawal for 18h, blood was collected from the tail, fasting blood glucose was measured and recorded as 0min blood glucose, then each group of rats was orally administered and administered 2g/kg glucose solution (50%), 30, 90, 120min blood glucose was measured, and the area under the recorded curve was calculated.
2.5 Detection of fasting blood glucose values in the caudal tip
Fasting blood glucose was measured by feeding high-sugar and high-fat feeds 30d,43d, and 58d, and after injection of STZ (streptozotocin), fasting blood glucose was measured in rats 7d, 9d, and 11d, and fasting blood glucose was measured in rats 8d, 21, 36d, 51d, and 58 d.
2.6 Detection of serum Biochemical index
Serum was taken for serum glucose metabolism index at dosing 23d, 30d, 44d, 61 d: glucose (GLU). At 61d, glucose (GLU) was detected in serum.
2.7 Hypoglycemic effects on diabetic rats
2.7.1 Effect on fasting blood glucose in the caudal tip
TABLE 1 influence on the peripheral blood glucose of the fasting tail tip of diabetic rats
TABLE 2 influence on the peripheral blood sugar of the fasting tail tip of diabetic rats
As can be seen from the data in tables 1 and 2 above, the fasting tail blood glucose of rats was significantly higher in the model control group than in the normal control group (p < 0.01) at 8, 21, 36, 51, 58 d; with 5.04g crude drug/kg of Qianlington administered for 8d, the blood sugar of the fasting tail tip is obviously reduced (p <0.01 compared with a model control group), the blood sugar of the fasting tail tip of a diabetic rat is obviously reduced (p <0.01 compared with a model control group) at the time of 51d administration, the high dose group of the medicament of the invention is administered with the Qianlington medicament, the blood sugar of the fasting tail tip is obviously reduced (p <0.05 compared with a model control group) at the time of 51d and 58d administration with 20.16g crude drug/kg, the blood sugar of the fasting tail tip is obviously reduced (p <0.01 compared with a model control group) at the time of 8d, 21d and 58d administration with the model control group, and the test shows that the blood sugar of the fasting tail tip is obviously reduced (p <0.01 compared with the model control group) at the time of 8d, 21d, 36d, 51d and 58d administration of the control medicament of the invention.
2.7.2 Effect on fasting blood glucose in serum of diabetic rats
TABLE 3 influence of Qianlieshutong on glucose in serum of diabetic rats
As can be seen from table 3, the model control group had significantly higher fasting blood glucose in the abdominal aorta at 30d, 44d, 61d than the normal control group (p < 0.01); the low dose group of the medicine of the invention is given with 5.04g crude drug/kg, blood sugar in abdominal aortic serum is obviously reduced (p <0.01 compared with a model control group) when 44d is given, the high dose group of the medicine of the invention is given with the prostasulon medicine, and when 61d is given with 20.16g crude drug/kg in dosage unit, glucose in fasting rat serum of rats is reduced, but no statistical difference exists (p >0.05 compared with the model control group); the positive control group was given diabetes hypoglycemic drugs, and at 61d, the rats had reduced fasting abdominal aortic blood glucose, but no statistical difference (p >0.05 compared to model control group); the positive control group was given diabetes hypoglycemic drugs, and when 30d, 44d and 61d were given, glucose in serum of diabetic rats was detected, and as a result, blood glucose in serum of fasting abdominal aorta of rats was significantly reduced (p <0.01 compared with the model control group).
In conclusion, the results of the pharmacological experiments show that the Qianlieshutong capsule has the efficacy of reducing blood sugar and can improve clinical effects.
3. Adverse reaction conditions
The traditional Chinese medicine composition does not find any toxic or side effect and adverse reaction symptoms on the medicine in the clinical administration process, and also shows the safety.
Claims (3)
1. The application of the traditional Chinese medicine composition in preparing the hypoglycemic medicine is characterized in that the traditional Chinese medicine composition comprises the following raw material medicines in parts by weight: 165 parts of phellodendron, 165 parts of red paeony root, 165 parts of angelica, 165 parts of szechuan lovage rhizome, 165 parts of glabrous greenbrier rhizome, 99 parts of common burreed rhizome, 132 parts of oriental waterplantain rhizome, 132 parts of purslane, 132 parts of vervain, 132 parts of saxifrage, 99 parts of Chinese thorowax root, 99 parts of medicinal cyathula root, 33 parts of liquorice and 123 parts of starch.
2. The use according to claim 1, wherein the disease treated by the Chinese medicinal composition is type ii diabetes.
3. The use according to claim 1, wherein the preparation method of the traditional Chinese medicine composition comprises the following steps: reflux-extracting cortex Phellodendri, alismatis rhizoma, radix Angelicae sinensis, and rhizoma Ligustici Chuanxiong with 60% ethanol twice for 1.5 hr each time, filtering, and recovering ethanol under reduced pressure to obtain fluid extract; decocting the other nine medicinal materials with water twice for 1.5 hr for the first time and 1 hr for the second time, filtering, mixing the filtrates, concentrating under reduced pressure to obtain fluid extract with relative density of 1.08, mixing with the above fluid extract, concentrating to obtain soft extract with relative density of 1.32-1.35, drying under reduced pressure, pulverizing the dry extract, adding starch, mixing, granulating, drying, and making into capsule.
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