Majie Asthma Cough Oral Liquid Pharmaceutical Research

Majie Cough and Asthma Liquid is created ording to the clinical practice by experts of the Affiliated Hospital of the Chengdu University of TCM.It is a compound preparation consisting of Ephedrae, Semen Armeniacae Amarum and so on, which. It has the efficacy of relief of reducing phlegm and stopping coughing, and in clinic it is purposed to treat pulmonary heart disease. Under the guidance of Traditional Chinese Medicine theories and with the help of the modern pharmaceutical technology, this study is on its preparation and quality stangards.A、Preparation TechnologyIn extraction study, we examined the aromatic water-extraction process and the rest of medicine mixed water-extraction process.About the aromatic water-extraction process,we took the content of volatile oil as the index and the single factor test to optimize grinding particle sizes,water addition,macerating time,decoction time; In mixed water extraction study, taking the rate of dry paste, the yield of ephedrine hydrochloride and pseudoephedrine hydrochloride and amygalin as indicator, an orthogonal experiment design was used to inspect the three factors of water addition,macerating time and decoction time.The optimal preparation technology process of this does type is as follow:First, take Allium macrostemon Bunge and distill with10times water for3hours to collect aromatic water.Second, the dregs of a decoction and the others were added9times water and extracted3times and1.5hour each time.In the part of the concentration and purification process,using the single factor test and taking the rate of dry paste, the yield of ephedrine hydrochloride and pseudoephedrine hydrochloride and amygalin as indicator,we examined the concentration way and the purification way. Finally,the condense thchnology got the relative density1.10～1.20(50℃)) extractum;The alcohol sinking method was elected to the ethanol concentration75%.In the formalizing process, selected the solution PH range and the type and the dosage of preservative agent.The formalizing process is to choose the2%o sorbic acid and use10%NaOH solution to get pH4.0-6.0, mix well, put standing, filter,split charging, then get the mixture.B、Quality standard and stability testAt the study of quality standard, a series of quality studies about Majie Cough and Asthma Liquid performed as character,distinguish,the content determination. Set up the TLC methods for the identification of Ephedra, Semen Armeniacae Amarum, Latycodon grandiflorum, Pericarpium Trichosanthis and the HPLC method for the content measure of ephedrine hydrochloride and pseudoephedrine hydrochloride.The detection was performed with the mobile phase of acetonitrile-0.1%phosphoric(6:94),the detection wavelength of210nm,flow velocity of1ml.min-1, column temperature of30℃By6months’ accelerated stability test, every index accords with the regulation.These results suggested that the sample were basicly stable during6months.In summry,the preparation process of Majie Cough and Asthma Liquid can remain most active copmponents like ephedrine hydrochloride and pseudoephedrine hydrochloride,and the process has advantage of high handle. he quality standard by formulated has the properties of high specificity and reproducibility,and is suit for the development of Majie Cough and Asthma Liquid.