The Basic Pharmaceutical Research Of Huaaizhentong Cataplasm

Cataplasm is a new transdermal formulation, which has unique advantages such asgood percutaneous permeability, comfortable pasting, convenient using and so on.HuaaiZhentong cataplasm, which we have studied in this project, consisting of Panaxnotoginseng, Radix Aconitum Kusnezoffii, Arisaema erubescens Schott and SalviaMiltiorrhiza Root, had proved to be very effective with the form of black plaster in clinicalapplication for many years,which had notable effect in the respect of the detoxification andanalgesic of cancer pain. However, the form of black plaster had a lot of shortcomings suchas containing lead, easy to stick to clothes,inconvenient and so on. So it had been planned totransfer the form of black plaster to cataplasm. This project was based on thepharmaceutical research of HuaaiZhentong cataplasm,and the main contents were asfollows:1. The study of extraction processThe orthogonal design was carried out with the total extractum and the content ofginsenoside Rg₁ as indicators, and the optimum extract condition for Panaxnotoginseng, Radix Aconitum Kusnezoffii and Arisaema erubescens Schott wasselected: extracted with 8 times amount of 70% alcohol for three times,1 hour every time.With the content of total ketone of salviae miltiorrhizae and salvianolic acids asindicators, the optimum extract process for Salvia Miltiorrhiza Root was screened:extractedwith 10 times amount of alcohol for 1.5 hour, with the residue extracted with 10 timesamount of 50% alcohol for 1.5 hour, then the residue further extracted with 10 timesamount of water for 2 hour, mixing the extracting solution.2. The preparation reseach of HuaaiZhentong cataplasmThe subjective evaluation and sticky force were used as indicators to select theoptimum ratio of matrix as adhesion agent①: adhesion agent②: adhesion agent③:Moisture-preserving agent: filling material=9: 14: 7: 40: 4; Franze diffusion cell wasapplied and the cumulative percutaneous amount of notoginsenoside was used as indicatorto select penetration enhancers. The results showed that the combination of Azone andpropylene glycol had the best effect; with the subjective evaluation,tackness and thecumulative percutaneous amount of notoginsenoside used as comprehensive indicators, the best ratio of matrix and extract was 10: 1, and the concentration of Azone and propyleneglycol were 3% and 7% respectively.3. The study of quality control standardPrimary study of quality control standard for HuaaiZhentong cataplasm wasestablished. Panax notoginseng and Salvia Miltiorrhiza Root were identified qualitatively byTLC.The examination of Aconitine limitation was carried out by TLC,and shaping propertyand extractrum-bearing quantity of HuaaiZhentong cataplasm were examined.The contentof ginsenoside Rgl was determined by HPLC.4. The study on skin irritation and allergy of HuaaiZhentong cataplasmTo apply hair-cut guinea pigs with HuaaiZhentong cataplasm,matrix and2,4-dinitrochlorobenzene once or several times, to study the skin irritation and allergy. Itwas concluded that HuaaiZhentong cataplasm had no irritation and allergy to complete skinbut should be avoided on injured skin.