Preparation And In Vitro Drug Release Of The Kuh-seng Prescription LTSG For The Vaginal Delivery

The domestic and foreign data display, vaginitis is the frequently occurring and commonly-seen diseases among women,Women of all ages will suffer,affect women’s health and daily life. Vaginitis of traditional Chinese medicine is " vaginal itching" and " leucorrhoea to fall" category.In ancient times there are Kushen Recipe consists of Schizonepeta and Sophora flavescens, the first seen in"taiping huimin Prescription of peaceful benevolent, is an effective prescription in treating eczema and pruritus caused by dampness diseases and vaginitis, Sophora flavescens is the good medicine for clearing heat and expelling dampness, Its active ingredients have anti-inflammatory and anti-inflammatory effects,and the effective parts of sophora alkaloid in sophora also has the same effect. Our research selected drugs for Oxymatrine,and the schizonepetae naphtha as promoting Oxymatrine mucosal permeation agent are added, Play the role of promote infiltration and treatment.The conventional vaginal delivery in patients with there is foreign body sensation, poor compliance, short residence time. This study will combine liposomes and temperature-sensitive gel, by compare the retention time, drug release time, oxymatrine mucosal permeation time and retention advantage with ordinary gel, and to study its stability and safety,in order to provide the theory basis for the vaginal delivery.This study first Set up the analytical method of OMT,investigate the oil/water partition coefficient of OMT,the solubility of OMT in the different organic solvents and aqueous solution have different PH.THe results showed that OMT has strong hydrophilicity, logP was-0.66, it’s easily soluble in water, insoluble in ethyl acetate, petroleum ether. According to the preliminary experimental results,OMT liposomes was prepared by reverse evaporation method,and we Select the best craft and prescription by the central composite design and response surface method and act encapsulation efficiency、drug-polymer interactions, OD value as index. Then test the conditions and inspected the stability of OMT liposomes.With the same method to determine the prescription of temperature-sensitive gel,preparation of OMT liposome temperature-sensitive gel,examines the different concentration of Schizonepeta nepeta transdermal properties influence on it,,the results showed that 2% Schizonepeta nepeta is the best.We also compare it’s mucous membrane performance with other preparation, the results of Q24 and Qs of this preparation were higher than ordinary gel (P< 0.05).Study the Quality standard, stability, security, retention time of this preparation,its stability is good, the stimulus in the acceptable range.The average residence time of 8.02 min, is 1.16 times that of ordinary gel.For this study,it can prolong the residence time with in the vagina, delay the OMT release, and for fluid flow in low temperature, into semi-solid preparations after the treatment, is conducive to patient autonomy, improve the compliance and bioavailability, at the same time, the preparation has good stability, and for vaginal mucosa, so this study provides a theoretical and clinical application for vaginal drug delivery basis.