Study On The Pharmacy Of Nuanqi Cataplasm

Objective To make cataplasm as the form of the hospital pharmaceutical preparation "Supplemented Nuanqi Powder" instead of the form of powder.Methods 1.The perfect extracting process was chosen by L9(34) orthogonal test according to the physical and chemical properties of active ingredient in prescription.2.Agglutinants and addition sequence was screened by single factor experiments, the optimal matrix proportion in the blank cataplasm had been obtained with uniform design, the optimal quantity of penetration enhancers and portion of matrix and drug were selected by skin permeation test in vitro with diffusion cell.3.Made Quality Control according to Chinese Pharmacopoeia(Ver 2005), used TLC to identify herbs in prescription with control medicinal materials and chemical control article, choose the amount of rutaecarpine as the index, used HPLC to determine the amount and found out the best method.4.The skin irratation test was studied by the influence of nuanqi Cataplasm single dose and continuous dose on entire skin of mice.5.The preliminary stability test was researched on nuanqi Cataplasm according to Chinese Pharmacopoeia.Results The optimum process was that immersing 1h with 70% alcohol which were 2 times amount of wuzhuyu, adding totally 24 times of 70% alcohol, backflowing extracting 2 times, each time 1 hour, filtrating and merging the filtration, enriching them into dense cream which relative density was 1.05(T=50℃, P=0.01pa); adding water which were 8 times of another 4 herbs which were dingxiang,rougui,xiaohuixiang,aiye and dregs of wuzhuyu, unimmersing, extracting 7 hours, collecting volatile oil, filtrating the extracted liquid, enriching them into dense cream which relative density was 1.30(60℃).Single factor experiments defined agglutinants was carbomer,PANa and CMC-Na, mixedⅡandⅢfirstly, then addedⅠ.The perfect matrix proportion was chosen by uniform design which was as follow:Carbomer:PANa:CMC-Na:PVA:Glycerin:Propylene Glycol=1:2: 1.6:1.5:6:4.The permeation tests through rat skin in vitro demonstrated that add 3% Azone and the portion of matrix and drug was 5:1 were the optimal way.After identification by TLC, the separation of the stains was apparent and the negative contrast was not disturbed.HPLC fits to control the amount of rutaecarpine in nuanqi cataplasm, accordong to three batch preparations, temporarily defined the amount of wuzhuyu calculated with rutaecarpine(C18H13N3O) in each nuanqi cataplasm should not lower than 0.8mg.The study on the skin irritation showed that nuanqi cataplasm have no obvious irritation on skin.The results of the preliminary stability test showed that the preparing technology fit nuanqi cataplasm, the product is stability.Conclusion This topic has been studied on the prescription, which could lay a good foundation of further preparation and drug development.