Study On Pharmacy And Main Pharmacodynamics Of Dongbai Tonglin Granules

Objective:Dongbai Tonglin granule is a hospital preparation developed according to the experience of Professor Ye Jinghua of the Seventh People’s Hospital Affiliated to Shanghai University of traditional Chinese medicine.The prescription consists of Huangbo,Rendongteng,Bianxu,Qumai,Wuyao and other traditional Chinese medicine.It has the effect of clearing heat,promoting dampness,dredging lymph and detoxification.It is suitable for urinary system infection.Clinical application for more than 40 years,the curative effect is accurate.In order to meet the needs of clinical patients,granules were prepared on the basis of the original traditional Chinese medicine decoction.The preparation process,quality standard,preliminary stability and main pharmacodynamics were studied.Method:1.In the study of preparation process,L₉（3⁴）orthogonal test was used to investigate the amount of extraction solvent,extraction time and extraction times of dongbaitonglin granules.Taking the yield of dry extract,the content of berberine,chlorogenic acid and loganin as the indexes,the comprehensive weighted scoring method and analysis of variance were used to determine the best extraction process.2.In the study of quality standard,the quality of this product is comprehensively controlled from the aspects of identification,inspection and content determination.The identification is to identify Cortex Phellodendri,honeysuckle vine and flat storage in the preparation by TLC;Check the properties,moisture,particle size and solubility of dongbaitonglin granules according to the general principles of preparations in part I of Chinese Pharmacopoeia,2015 edition;The contents of berberine and chlorogenic acid were determined by HPLC.3.In the preliminary stability test,the influencing factors of light（4500lx）,high temperature（60℃）and high humidity（RH 92.5%）were tested on three batches of samples,and samples were taken on 5 and 10 days respectively;For accelerated test,the relative humidity is 75%,samples are kept in a constant temperature drying oven at 40℃,and samples are taken in January,February,March and June respectively;In the long-term experimental study,samples were kept at room temperature（25℃,60%）and sampled at 0,1,2,3,6,12 and 18 months respectively.The properties,identification,solubility and content of the samples were investigated.4.Pharmacodynamics experiment,according to the function and main treatment of Dongbai Tonglin granule,carry out the research on anti urinary tract infection,anti-inflammatory and analgesic effects.The rat model of urinary tract infection induced by Escherichia coli was established,and its anti urinary tract infection effect was evaluated by urine bacterial culture,urine routine examination and he staining pathological examination;The anti-inflammatory test was mouse ear swelling test induced by xylene and rat foot swelling test induced by carrageenan.The analgesic test was mouse hot plate test and mouse writhing test induced by glacial acetic acid.Result:1.The preparation process of dongbaitonglin granules was formed.The raw materials of traditional Chinese medicine were added with 8 times of water,extracted for 3 times,1 hour each time,filtered,combined with the filtrate,concentrated to the thick paste,vacuum dried and crushed to obtain dry powder;Add appropriate auxiliary materials,mix well,granulate,dry and make granules.2.The identification results showed that the characteristic spots of thin layer were clear,the resolution was good and the specificity was strong;General inspection of the preparation:the properties,moisture,particle size and solubility are in conformity with the regulations.Berberine content>3.0%,chlorogenic acid content>0.10%..3.Among the influencing factors,high heat and light have no obvious effect on the stability of the product,but the sample has serious moisture absorption under high humidity conditions,so the product should be sealed and dried for storage;All indexes in the accelerated test meet the drug quality standards;In the long-term test,the sample was kept at room temperature for 12 months,and all indexes met the drug quality standard.The results showed that the product was stable.4.Dongbaitonglin granule 1,2 and 4g/kg can significantly increase the p H value of urine in rats with urinary tract infection,reduce the number of leukocytes and bacteria in urine,and reduce the pathological changes of kidney.In the anti-inflammatory test,dongbaitonglin granule at doses of 2,4 and 8g/kg could reduce the degree of auricle swelling induced by xylene in mice,and 1,2 and 4g/kg could inhibit the toe swelling induced by carrageenan in rats;In the analgesic test,the doses of 2,4 and 8g/kg of dongbaitonglin granule could reduce the body twisting latency of mice induced by glacial acetic acid and delay the foot licking time of mice induced by thermal stimulation.It shows that Dongbai Tonglin granule has anti-inflammatory and analgesic effects.Conclusion:The optimized preparation process of Dongbai Tonglin granules is reasonable,stable and feasible.The established preparation quality control method is simple and specific,and can effectively control the preparation quality.The main pharmacodynamic test results show that dongbaitonglin formula can improve the symptoms of urinary tract infection,has anti-inflammatory and analgesic effects,and has a good therapeutic effect on urinary tract infection.