Study On Improving Thequality Standard Of Qingkailing (Freeze Dried) For Injection

Objective: To improved the quality control standard of Qingkailing Injection(Freeze dried)on GuizhouYibai Pharmaceuticalguaranteed maximumly drug quality to provide reference for the revision of quality standards in the future.Methods:(1)To established Qingkailing injection fingerprint analysis method by HPLC from the raw medicinal materials extract liquor to the final product.To determine the common peak by the "Chinese medicinal chromatographic fingerprint similarity evaluation system"(2012 Edition)of the national pharmacopoeia Committee.Principal component analysis was performed through the PCA function in the R language mixOmics tool kit to find out the differences among the batches of medicinal materials and the correlation between the original medicinal extract liquor and the product.The efficiency and controllability of the product were improved,finally.(2)To establishedmethods of measuring Qingkailing injection(Freeze dried)by HPLC-DAD and HPLC-CAD,which contain Adenosine,Chlorogenic acid,Gardenoside and Baicalin,Cholic acid,Hyodeoxycholic acid six indicators content and carry out methodological verification.(3)Using full automatic graphite furnace digestion instrument to process samples such as Qingkailing injection(Freeze dried),Gardenia,Honeysuckle and Radix isatidis.Using graphite furnace atomic absorption spectrometry to measure Plumbum and Cadmium content in samples.Using flame atomic absorption spectrometry to measure cuprum content in samples.Using fluorescence spectrophotometer to measure arsenic and mercury content in samples.Using automatic mercury measuring instrument to measure cuprum content in samples.The determination results of Pb,Cd,As,Hg and Cu in Qingkailing injection(Freeze dried)were compared by inductively coupled plasma mass spectrometry(ICP-MS).(4)According to “Chinese Pharmacopoeia” 2015 edition of four injection requirements(0102)detection,including visible foreign bodies,Chinese medicine injection related substances,nitrogen content.Results:(1)To established a HPLC-DAD fingerprint of gardenoside as the reference peak,the calibration of total of 27 fingerprint peaks,of which 13 peaks attributable to Honeysuckle,2 peaks attributable to Gardenia and 5 peaks attributable to Radix Isatidis.Identify baicalin(peak 25)and other 10 components.(2)The content of adenosine,chlorogenic acid,gardenoside and baicalin,cholic acid and hyodeoxycholic acid in Qingkailing(Freeze dried)were determined by HPLC.The method established in this paper has stable results,linearity,precision,repeatability,recovery and specificity.(3)The contents of Pb,Cd,As,Hg and Cu inQingkailing Injection(Freeze dried)were all in accordance with the four "injection" requirements of the 2015 edition of the Chinese Pharmacopoeia.(4)According to “Chinese Pharmacopoeia”2015 edition of four injection requirements(0102)detection,the results are all in accordance with rules such as visible particles,related substances of traditional Chinese medicine injection and nitrogen content.Conclusion: A new draft quality standard for the injection of Qingkailing(Freeze dried),which can be used to control the quality of Qingkailing injectionmore comprehensively and effectively.