Study On The Preparation Technology And Quality Control Of Jiezi Kechuan Paste

Objective:Bronchitis in children is one of pediatric clinical common diseases,the main symptoms are cough,sputum,wheezing and so on.Bronchitis in children Serious impact on the daily lives of children and their parents,if the children is not treated as well,It will lead to the recurrent or persistent disease,which affects the growth and development of children and their mental health.Therefore,finding a safe and effective clinical treatment has become one of the tasks of medical workers.Patching therapy of Traditional Chinese Medicine is a transdermal thrapeutic systems by Acupuncture point,it not only play topical effect by penetrating into skin,but also systemic effect by penetrating into blood through skin capillary,which avoid first pass effect and decreases side effects.TCM Plaster therapies has unique advantages in treating children with bronchitis,Children with oral medication and intravenous injection problems can be solved by TCM Paster therapies,children easily to accept it,so they are willing to cooperate the treatment better.Effective prescription "Jiezi Kechuangao",Which contained of Semen Sinapis albae,Rhizoma Corydalis,Rhizoma Zingiber officinale et.al,was clinically used to opening the inhibited lung energy and relieving cough and asthma.This study aims to develop a safe efficient,convenient and stable patch preparation based on this prescription.Method:① Manufacture procedure:Optimization of Water extracting and alcohol precipitating procedure for Semen Sinapis albae combined with Radix et Rhizoma Glycyrrhiza,the ethanol-extracting procedure for Rhizoma Corydalis and Radix Arnebia,essential oil from Rhizoma Zingiber officinale combined Radix et Rhizoma Asari,and patch-forming procedure by orthogonal test.② Quality standard:the concentration of Sinapine thiocyanate and tetrahydropalmatine in patch was qualitatively analyzed by HPLC,and the medical component in patch was qualitatively identified by TLC.The stability of the patch was investigated by sample-keeping ovservation method.③A LC-LTQ-Orbitrap MS/MS method was developed for the study of Jiezi Kechuan patch and Semen Sinapis albae、Rhizoma Corydalis、Radix et Rhizoma Glycyrrhiza,t and Radix Arnebia.Result:①The optimal water extracting and alcohol precipitating procedure for Semen Sinapis albae combined with Radix et Rhizoma was 12-times volume,extracting for 2 times and 1 hour for each,then concentrate it until the relative density goes to 1.1,add ethanol until the Volume fraction of ethanol goes to 70%,standing for 12 hours.ethanol The optimal ethanol-extracting procedure for Rhizoma Corydalis and Radix Arnebia was 60%ethanol of 9-times volume,extracting for 3times and 1.5 hour for each.The optimal procedure for essential oil from Rhizoma Zingiber officinale combined Radix et Rhizoma Asari was water of 12-times volume,soaking 2 hours and extracting for 6 hours by wet distillation.The optimal baser formulation was NP700 6,dihydroxyaluminium amnoacetate 0.4,tartaric acid 0.4,carboxymethylcellulose sodium 1.5,glycerol 35,physic liquor 56.②The primary quality standard was set and it was proved that this method was convenient,sensitive and reproducible,and the patch could maintain stable in room temperature for 3 months.③25 compounds were identified or tentatively characterized from 71 compounds in Jiezi Kechuan Patch by HPLC-MS,including 51 compounds from Semen Sinapis albae、Rhizoma Corydalis、Radix et Rhizoma Glycyrrhiza,t and Radix Arnebia.Conclusion:The manufacture procedure of Jiezi Kechuan Patch was reasonable,feasible,stable,controllable and be safe to skin.