Study On Preparation Technology And Quality Standard Of Qingfei Pingchuan Capsule

Bronchial asthma is a main chronic lung disease threatening the health of human beings. With the further development of modern medicine research, the treatment of asthma has been made great progress, especially the traditional Chinese medicine that is used on treating asthma disease has gradually accumulated abundant experience reply on the clinical practices.Qingfei Pingchuan Capsules originate from a cipher prescription (Qingfei Dingchuan Decoction) of Xi'an Zao Lu Tang Hospital of traditional Chinese medicine, it's composed of Radix Scutellariae, Tinglizi, Balloon flower root, dried tangerine peel, semen pharbitidis, American ginseng, all these herbs were combined together to focus on clearing lung, purging heat, eliminating phlegm and relieving asthma that belongs to retention of phlegm heat in the lung to control disease and curative effect was found through clinical use. This article studied the preparation process and quality standard of Qingfei Pingchuan Capsules, then made preliminary stability testing, all finding as below:1.Findings on preparation process:to optimize the extraction process for different kinds of herbs by using the orthogonal test. Coarse powder of Radix Scutellariae with 8 times amount of water,3 times decoction,30minutes every time, to adjust the pH to be 2 by adding hydrochloric acid when heating to 40 degrees and keep warm 30 minutes when heating to 80 degrees. Dregs of decoction from Tinglizi, semen pharbitidis, American ginseng, dried tangerine peel with 8times amount of 60% ethanol to make 3 times reflux extraction,1 hour every time. Balloon flower root with water for 3 times decoction,11 times amount of water for the first time in 1 hour,8times amount of water for 2nd and 3rd time in 1 hour respectively. The combined filtrate under vacuum condition will be concentrated and will add ethanol to achieve the 70% alcohol in the liquid, then filtrate and vacuum concentrated again to achieve relative density 1.10-1.15 (at 60 degrees) after 12 hours stewing. The granulation of Qingfei Pingchuan Capsules was defined to use starch as ingredients by observing the preparation process and particle mobility in accordance with related regulations. Also 3 times of middle test enlargement testing proved the stability and feasibility of the preparation process.2.Findings on quality standard:the TLC identification for Radix Scutellariae, dried tangerine peel, semen pharbitidis, American ginseng in the medicine was set up. The HPLC for the content of Radix Scutellariae and ginseng was set up. The limitation of Scutellaria baicalin (C21H18O11) in each capsule was settled down to be no less than 30mg. And the limitation of American ginseng, means ginsenoside Re, Rg1,Rb13 in total in each capsule was stipulated no less than 2.0mg.3.Findings on Preliminary stability:The accelerated stability test was made by simulating to take 3 batches of commercially available medicine and keep in 6 months under 40+/-2? and humidity 75+/-5%, both the qualitative and quantitative criteria meet the requirements according to the draft standard test method.This article finished the main preclinical pharmaceutical information for Qingfei Pingchuan Capsules through above studies and testing, and build up a foundation for later pharmacology, toxicology and clinical research.