The Study On Preparation And Quality Standards Of Relieving Asthma Cream

Objective: To research the prescription and the technology of preparation, investigate the in vitro transdermal features and to establish the quality standards of Re lieving asthma Cream. Methods:(1) Use the sigle factor combined with orthogonal experiment, determine the amount of extraction of astragaloside, ephedrine hydroc hloride and pseudoephedrine hydrochloride, total polysaccharide, an the colligationsc ore was obtained as the index, to select the top Astragalus and Ephedra deficiency et. medical materials to sure the water extraction technology parameter;(2) Use t he method of uniform design, determine the contents of stability、uniformity、irritat ion、heat&cold-resistance and wash off resistance as the index, to select the best moulding technology of Relieving asthma Cream.(3) Taking the isolated rat skins as transdermal barrier and using the improved Franz diffusion cells to carry on the in vitro transdermal trial. And to investigate the influence of the cumulativeperme ation percentage of ephedrine hydrochloride to the different transdermal enhancers b y HPLC.(4) Qualitative test with thin-layer chromatography was performed on Rel ieving asthma Cream, with all species of medical materials, use the method of HP LC to measure the contents of astragalo-side, ephedrine hydrochloride and pseudoep hedrine hydrochloride and chlorgenic acid, and make out the quality standard. Resu-lts:(1) The optimum water extraction procedure was adding 10 times amount of water extracted three times, each time 1.5h;(2) The optimum moulding technology was that: the appropriate matrix composition is: stearic acid、glyc-eryl monostearat e、albolene、lanolin、octadecyl alcohol、glycerol and wa-ter, and the emulsifieris S DS, the transdermal enhancers is 2% azone, the preservative is 0.1% ethyl phydro xybenzoate. Mix medicine extract with water phase, and add the oil phase to the water phase slowly under the temperature of 85℃, then make the Relieving asthma Cream;(3) The influence of in vitro release of 7 different transdermal enhancer to Relieving asthma Cream is that: 2% azone > 2% azone + 2% propylene glycol> 1% azone > 2% borneol > 3% aznoe > 2% propylene glycol > 2% aznoe+2%borneol.(4) Established the qualitative differentiation with the method of TLC of Astragalus、Ephedra deficiency and radix sileris, and the contents of astragaloside,ephedrine hydrochloride and ps-eudoephedrine hydrochloride and chlorgenic acid we re detected by HPL-C, the mobile phases: acetonitrile-water(32:68), acetonitrile-0.6%H3PO4(3:97), acetonitrile-0.4%H3PO4(10:90); and the detective wavelength was at 208 nm and 327nm; column temperature:30℃, flow rate: 1.0m L/min. Conclusions: Th e extraction technology was stable, feasible. The quality standards were convenient,fast and accurate, and can effectively control the quality of the preparations.