The Pharmaceutical Research Of "Xiaoer Qingfei Zhike Cataplasm"

The prescription of "Xiaoer Qingfei Zhike Cataplasm" comes from clinical experience and is mainly used for phlegm heat closed lung pneumonia in traditional Chinese medicine.The development of "Xiaoer Qingfei Zhike Cataplasm" take the requirements for the development of 6 types of new drugs are required According to SFDA as a standard.Currently,the main medicines used for children with pneumonia are chemical drugs,proprietary Chinese medicine.However,the chemical drugs has toxic side effects,Chinese medicine injection is prone to serious adverse reactions such as allergic reactions and oral proprietary Chinese medicine and Chinese medicine decoction have some issues including large does,poor taste and low dependence for children.While external preparations-Catapasm has the characteristics such as novelty,safety,less skin irritation and high adaptation.The paper through six parts of the study solves the problems that the low permeation rate,low transmissivity,molding difficulty of cataplasm,lack of viscosity,residue on skin and so on.The study of"Xiaoer Qingfei Zhike Cataplasm" has not only scientific research value,but also social and economic value.1.Literature studyStudying the literature,mastering the research progress of the medicinal ingredients in this prescription at home and abroad in recent years and taking a more in-depth understanding of research ideas and methods about cataplasm which is a solid theoretical basis of the development of pharmacy-related research work in"Xiaoer Qingfei Zhike Cataplasm".2.Extraction and purification technology research(1)Study on the alcohol extraction technology of herba ephedrae and salviae miltiorrhizaeIt is beneficial to transfer the active ingredient from the herba ephedrae and salviae miltiorrhizae by the alcoholic extraction with the transfer rate of ephedrine and cryptotanshinone as the evaluation indexes.And then with the transfer rate of ephedrine and cryptotanshinone and leaching content as the evaluation indexes,based on the best alcohol concentration which is inferred from single factor study,optimizing the best process of alcohol extraction site by the orthogonal experimen.The result is as follows:weighing herba ephedrae and salviae miltiorrhizae,for the first time,add 70%ethanol 8 times,soak 0.5h,and heating reflux for 2 hours.For the second time,add 70%ethanol 7 times and heating reflux for 1 hour.(2)Study on the water extraction technology of licorice peach kernel,bittter almonds and so onWith the transfer rate of amygdalin and glycyrrhizin and leaching content as the evaluation indexes,optimizing the best process of water extraction site by the orthogonal experiment.The result is as follows:weighing licorice,peach kernel,bitter almonds,gypsum and agrimony to water extraction 3 times,12 times water and 1.5 hours for each time.(3)Study on the extraction of volatile oil from herba houttuyniae and nepetaOptimizing the best process of volatile oil by the orthogonal experiment with the relative extraction as the evaluation index.The result is as follows:weighing herba houttuyniae and nepeta and extract with 15 times water for 5 hours.(4)Study on the concentration and precipitation technology of water extractionWith the retention and removal rate of amygdalin and glycyrrhizin as evaluation indexes,optimizing the best process of water extraction and alcohol precipitation by the orthogonal experiment.The result is as follows:combine the water extraction,decompression concentrate to 1g/mL and add alcohol to make the alcohol concentration to 60%with 12 hours stayed in room temperature.3.Filter of penetration enhancers in "Xiaoer Qingfei Zhike Cataplasm"With the vitro skin from rat abdomen as the material and ephedrine and amygdalin as evaluation indexes,the combination of 5%azone and 5%propylene glycol is finally choosed as the transdermal penetration enhancers by the vitro transdermal experiments.The equations of cumulative percutaneous amount of ephedrine is Y=3.3558X-16.266,and the cumulative permeation within 48h is about 117.89μg;the equations of cumulative percutaneous amount of amygdalin is Y=15.088X-176.33,and the cumulative permeation within 48h is about 696.18μg.At the same time,it is found in the vitro transdermal experiment that the volatile oil extracted from "Xiaoer Qingfei Zhike Cataplasm" has no promoting effect on ephedrae and amygdalin.4.Study on formulation technologyWith the appearance and initial viscidity as the evaluation indexes,optimizing the amount of excipients which have a great influence on the forming of the preparation.Also,the transdermal behavior of ephedrine and amygdalin is well.5.Determination of physical and chemical propertiesThe equilibrium solubility of ephedrine and amygdalin from the extractive is determined in series solutions with different polarities and different pH.By the way.the apparent oil-water partition coefficient of ephedrine and amygdalin in water and other solutions with different pH is determined by the shaking bottle method.The equilibrium solubility and the apparent oil-water partition coefficient of ephedrine and amygdalin in "Xiaoer Qingfei Zhike Cataplasm" are mastered by testing pH of "Xiaoer Qingfei Zhike Cataplasm".6.Study on quality standardThe preliminary research on the quality standard of "Xiaoer Qingfei Zhike Cataplasm" is completed,some herbs in the prescription are identified by TLC,the methods of extracting and testing the content of the ephedrine and amygdalin by HPLC are established,"Xiaoer Qingfei Zhike Cataplasm" is tested according to the general principles of the preparation.Finally,the draft on " Xiaoer Qingfei Zhike Cataplasm " is worked out.