Studys On The Preparation And Quality Standards Of Qingjinhuatantang Granules

Qingjin Huatan Decoction is a traditional classic name for the treatment of sputum and cough caused by lung heat.The earliest from the Ming Dynasty general medical "YixueTongzhi" Volume 6.The side consists of Scutellaria baicalensis,gardenia,Bellflower,Ophiopogon,Morus alba,Zhejiang Fritillaria,Anemarrhena,Trichosanthes,Citrus,Poria,Licorice.It has the effect of clearing away heat,resolving phlegm,and relieving cough.Indications cough,cough,expectoration,sputum thick yellow stench,or with bloodshot eyes,dry throat swelling,yellow and greasy moss,pulse or urine slip.It is now used to treat coughs,pneumonia,and chronic bronchitis that caused by heat and sputum.The original prescription and its addition and subtraction prescriptions are still widely used in modern clinics,and are included in the multi-edition prescription textbooks.This topic is guided by the theory of traditional Chinese medicine.After consulting a large amount of literature and materials,combined with the practical application of the drug,and applying the research technology of traditional Chinese medicine and new drugs,this party is developed into a modern dosage form granule,and its preparation process,quality standards,stability,etc.Research.Study on preparation technology:according to the physicochemical properties,pharmacological action and clinical application of each medicinal herb in the prescription,the result of the extraction of the original Decoction and reflux extraction method was compared,and a reasonable process route was worked out.Through the single factor test,absorption of medicinal materials were investigated,the optimum soaking time;through L9(34)orthogonal test,the extraction solvent dosage,extraction times,extraction time were investigated,the optimum extraction conditions;by concentrating test of concentration,temperature,pressure and the relative density were investigated,to determine the appropriate conditions and the degree of concentration;molding process research on different correctant after discussion and study,and selecting the appropriate amount of accessories.The whole process is smooth,scientific,reasonable and stable.Quality standard:to ensure the granules is stable and controllable in quality,the use of modern methods and precision instruments,the quality standard of Qingjinhuatan granules were studied by thin layer chromatography(TLC)of three medicinal materials in the preparation of Scutellaria baicalensis,gardenia,Citrus,Morus alba,Licorice established TLC identification;HPLC(HPLC)drug in Rheum Baicalin in determination of each other,and made the methodological study,established the quality control system of Qingjinhuatan granules.Preliminary study on stability of the preparation:according to the requirements of "drug registration management measures" in technology,the stability of the initial 6 month trial of ointment,respectively,in the 0 month,1 months,2 months,3 months and 6 months regularly "Chinese Pharmacopoeia" 2015 edition four granules(rules 0104)under examination are examined,results showed that there was no significant difference in the indexes are in line with the provisions of.