The Study Of Quality And Preliminary Pharmacodynamics Of Huayutongmai Granule

Huayu Tongmai Granule(HYTM)is produced by Sichuan people's provincial hospital,it has the effect of promoting blood circulation and removing blood stasis.It is often used in the treatment of cutaneous vasculitis.Huayu Tongmai Granules mainly includes Salvia miltiorrhiza,Ilex pubescens,peony root,Ligusticum chuanxiong and peach seed.Salvia Miltiorrhiza and Ilex pubescens are the monarch drugs that can activate blood circulation and dredge collaterals,clear heat and detoxify toxins.As most hospital preparation,it also lacks of pharmaceutical research.Therefore,in order to improve the quality standards of the preparation,this thesis has studied the quality of Huayu Tongmai Granule.We have also studied the preliminary pharmacodynamics to evaluate the pharmacological effect of Huayu Tongmai Granule.All these work has made contribution to the rational clinical use of HYTM.Methods:(1)To establish a method for detecting the content of Ilexsaponin A and Ilexgenin A in Ilex pubescens by high performance liquid chromatography(HPLC),and to detect the contents of them in 9 batches Ilex pubescens,HYTM and the intermediate product of HYTM.The contents of salvianolic acid B(SAB)and paeoniflorin in Huayu Tongmai Granules were simultaneously detected by HPLC,and detected the contents of effective components in three batches of HYTM.This thesis has researched the fingerprint of HYTM to overall evaluate the quality of the preparation.(2)Acute toxicity test of maximum dosage was carried out to evaluate the safety of HYTM according to the test results.Anti-inflammatory effect of the preparation was investigated by the model of ear-swelling in mice.The anticoagulant effect of HYTM was evaluated by the bleeding time and coagulation time in mice.Results: In this experiment,the content of Ilexsaponin A and Ilexgenin A in Ilex pubescens can be detected accurately and stably by HPLC.The contents of triterpenoid saponins in 9 batches of Ilex pubescens were quite different,and the contents in the HYTM and intermediate products of it were low.So as to the results of the detection of contents of the preparation,a method for simultaneous detection of SAB and paeoniflorin in HYTM was established and it has good linear relationship,and RSD of stability,repeatability and the precision is less than 2%.By studying the fingerprint of HYTM,it was found that the quality of each batch preparation was slightly different.Acute toxicity test showed that Huayu Tongmai Granule was safe and had no obviously adverse reactions.Pharmacological test found that high dosage of HYTM could reduce ear-swelling rates in mice,and low,medium and high dosage could all prolong bleeding time and coagulation time.Conclusion: The methods for the detection of the active ingredients in Ilex pubescens and Huayu Tongmai Granules were successfully established,and the fingerprint of the preparation was established,which can comprehensively reflect and evaluate the quality level of Huayu Tongmai Granules,so as to promote the quality control of HYTM and improve the quality standards of the preparation.Animal experiments have shown that Huayu Tongmai Granule has high level of safety,anti-inflammatory and anticoagulant effects,which can provide reference as clinical use.