Study On The Extraction Process And Quality Control Standard Of The Qi Guan Yan Ke Li

Objective: Qiguanyan Ke Li has a good clinical application as a hospital preparation. But it does not have a clear quality stardard, that does not conforn to the new requirement of hospital preparation and limits its application for hospital preparation, Studying the the extraction process and quality Control standard of the Qiguanyan KeLi, establishing a draft of quality standard to effectively control the quality of preparation and make it conform to the relevant standards.To lay the foundation for the follow-up study and the industrial development of the Qiguanyan Ke Li. Method:(1) We use orthogonal experimental method to a paste rate and the effective components of ephedrine, laetrile and Imperialine in the index to determine the optimum extraction process.(2)By the method of TLC to identification the Citrus grandis, Condonopsis pilosula, Ephedrasinica, Fritillaria Cirrhosa and bitter almond in the Qiguanyan Ke Li; The content of ephedrine hydrochloride, amygdalin, naringin, lobetyolin, schisandrin, senegenin and tussilagone in the Qiguanyan KeLi were determined by HPLC Results:(1) The optimum preparation process is confirmed as follows: Extract Qiguanyan KeLi for 2 times under extract with 18 times water for 2.5 hour., the first time to join 10 times of water and extract for 90 min; The second time to join 8 times of water and extract for 60 min, To merge two extraction solution and filter out impurities, To concentrate solution evaporation to the specific gravity of 1.08 and add the same volume of precipitator(ethanol), To stand for 24 hours and concentrate into the specific gravity of 1.41,To join mixed materials and stir well,Put mixed materials powder in it, mix thoroughly, pelleting and drying at 60°C.(2)Study on effective components: The HPLC gradient elution method was used to simultaneous determination the Qiguanyan Ke Li content of ephedrine hydrochloride about 0.410mg·g-1,amygdalin about 0.418mg·g-1,naringin about 0.203mg·g-1,lobetyolin about 0.029mg·g-1,schisandrin about 0.020mg·g-1,senegenin about 0.041mg·g-1 and tussilagone about 0.044 mg·g-1.(3)Study on the TLC Identification Method:The TLC maps of Citrus grandis, Condonopsis pilosula, Ephedrasinica, Fritillaria Cirrhosa and bitter almond were clear. they had a clear relationship and good reproducibility.(4) Study on the project of granule: Refer Pharmacopoeia 2010 edition, Effects the quality inspection on the granule. Include load difference, granularity, determination of Water, dissolution, microbiological and arsenic salt check. The test results are all compliance. Conclusion:In this paper, we study and select the best manufacturing technology of QiGuanYan KeLi,The TLC maps of Citrus grandis, Condonopsis pilosula, Fritillaria Cirrhosa and bitter almond were incorporated into the quality control standard. The HPLC gradient elution method of effective components is rapid and accurate, the test results on the project of granule are all compliance. The draft can be used as quality standard of QiGuanYan KeLi, It conforms to the new requirement of hospital preparations.