Pharmaceutical Reasearch On Bu Shen Huo Xue Granules Polycystic Ovary Syndrome

Polycystic ovary syndrome is a heterogeneous endocrine disorder disease,characterized by androgen excess and loose hair ovulation.Western medicine therapy have more side effects,stimulating,Postoperative adhesion easily,Acupuncture effect is not obvious.Is safe and effective traditional Chinese medicine treatment side effects and the characteristics of multi-channel,multiple targets,has been get more and more the attention and approval of the medical profession.Bushen Huoxue Granules is a kind of compound preparations which treats of polycystic ovary syndrome,It consists of Traditional Chinese Medicine.Specifically,Astragalus,Salvia,Herb,Poria cocos,Epimedium,Coptischinensis and Hawthorn.After many years of clinical application shows that it has the effect of Huatanhuoxue kidney,Spleen dampness,Endometriosis Menstruation progesterone.It has good effect to treat Phlegm,Phlegm polycystic ovary syndrome,Irregular menstruation,Obesity,Infertility.The traditional dosage form pills quality difficult to control,medicinai broth is not easy to save,finally established for stable quality portable taste better granules.Objective:The issue from the preparation process,quality standard and stability of three aspects of BuShen HuoXue Granules,expanded pharmaceutical.Using the modern science and technology and method to develop an efficient,safe and convenient TCM compound preparations for the treatment of PCOS.Methods:1.Preparation:Through accessing relevant literature about the physical and chemical properties,Most of the active ingredient for water-soluble and have better leaching amount,Finally process path with water as solvent.Though single factor test、L9(34)orthogonal test and accessing relevant literature,soak time、extraction times、extraction time、amount of water and concentration of alcohol precipitation are investigated.The extract rate and content of Astragaloside as evaluation index,comprehensive evaluation determined extraction process,Evaluation criterion concludes ratio of briquetting,granularity,ratio of moisture absorption,fluidity,colliquation and ratio of diffluence.Type amount of materials and process conditions were investigated evaluated,Established Bushen Huoxue Granules prescription preparation process.2.Study on the quality standard of:In order to control the quality,adopt TLC analysis for the qualitative identification of Astragalus,Herb,Poria cocos,Epimedium and Coptischinensis.Take HPLC method to determine the content of Astragaloside.Moisture,granularity,According to "Chinese pharmacopoeia" granules of granules under relevant indicators for testing,Make Bushen Huoxue Granules established a quality control system.3.Stability studies:Bushen Huoxue Granules preliminary stability test.Respectively in 12months and speed up 6months of preparation,the appearance of TLC identification examination and determination of content.Results:1.raw materials extraction technology of Ganshu particle identified as:12 times amount of water for 60 minute,were decocted 3 times with 1hours every time,decoction fluid was concentrated on stress to the relative proportion of 1.1 to 1.2,75%alcohol,drying pieces,for aside.The optimize granulating process was:Dextrin and sucrose as auxiliary materials,Power、Dextrin and sucrose according to 1:0.5:1,through 100 mesh,add 85%ethanol,granulat,dry,granulation.The preparation methods of kidney invigorate the circulation of granules is established.2.in Quality control:the TLC method was established to identify the Astragalus,Herb,Poria cocos,Epimedium and Coptischinensis.in high performance liquid chromatography(HPLC)measuring astragalus glycosides,linear regression equation was Y=1.4434X+10.558(R2=0.999),the linear range was 11.2595 μg-22.5190μg,with the minimum Astragalus content in granules of each bag was not less than 2.7mg.Test of the granules of related indicators meet to the "Chinese pharmacopoeia" under regulation,Establish a kidney invigorate the circulation of granules quality control standards.3.Bushen Huoxue Granules preliminary stability test though 12 months and speed up 6 months,the results show that preparation,the appearance of TLC,identification examination and determination of content did not change significantly.Conformed to the standard and relevant provisions of decoction agent of 2015 version "Chinese Pharmacopoeia",good stability.Conclusions:Pilot scale test show that preparation process of BuShen HuoXueGranules is stable,feasible and can meet the production requirements.This study is determined the quality of the control scheme to be a quick,accurate,real control BuShen HuoXueGranules quality,it meets the requirements of quality control of this preparation,to ensure that the drug is safe and effective.This study provide practical reference for traditional Chinese medicine clinical treatment of polycystic ovary syndrome.