Asthma Apply Spirit The Cataplasm Pharmaceutical Research

"Chuanfuling Cataplasm" is developed on basis of the experimental prescription of Hubei hospital of Tradional Chinese Medicine, which is composed of several Chinese herbs, including Baijiezi, Yanhusuo, Xixin etc. It is used in clinic to treat the relievement period of children asthma. This medicine was researched in Preparing Technology, Quality Standard and Tentative Stability according to the rules for national new medicine.In the aspect of Preparing Technology, the alcohol extracting technology of Baijiezi, Yanhusuo and Zaojia was researched at first. Chose the rate of dry extract and the quality of sinapine thiocyanate in Baijiezi as monitoring indexes, alcohol consistency, smashing level, alcohol volume and backflow extract times were important factors for extract, the perfect extracting process was chosen by L₉(3⁴) orthogonal test which was as follow: smashed into coarse powder, adding 60% alcohol which were 8 times amount of herbs, backflowing extracting 3 times, each time 2 hour; merged the extracted liquids, recycled alcohol, enriched them into dense cream which relative density was 1.29 (60℃)。Then chose the proper technology for the herbs which contain volatile oil: Xixin and Shengjiang. Chose the rate of volatile oil as monitoring index, smashing level, the volume of water, immersing time and extracting time were important factors for extract, the perfect extracting process was chosen by L₉(3⁴) orthogonal test which was as follow: smashed into coarse powder, adding water which were 8 times amount of herbs, extracting 6 hours after immersing 0.5 hour. Added absolute Sodium Sulfate into the received volatile oil in order to dehydrate. Filtrated the extracted liquid, added likely water into the gruffs and then decocted, merged the filtration, enriched them into dense cream which relative density was 1.13 (60℃)。Studied on the proportion of matrix for cataplasm: chose stick power as monitoring index, the amount of Polyvinyl alcohol (PVA), Gelatin, Sodium Carboxymethylcellulose (CMC-Na), Glacerin, Polyethylene glycol (PEG)400 were important factors, the perfect matrix proportion was chosen by L₉(3⁴) orthogonal test which was as follow: PVA: Gelatin: CMC-Na: Glacerin: PEG 400=6∶5∶2∶12∶6. Then chose the portion of matrix and herbs in cataplasm, the kind and amount of appended materials, defined the portion of matrix and herbs in cataplasm was 1∶1, Tween 80 as emulsifying agent with 2%, Sorbio acid as preservative with 0.2%, A-zone for infiltrate accelerate with 1%. In the last, we defined the ultimate preparing technology as follow: PVA, Gelatin, CMC-Na added proper water in order to let them absorb enough water and expand, heating in 60℃by water in order to dissolve fully, added Glacerin and PEG 400 after well-mixed. Volatile oil, Tween 80, Sorbio acid and A-zone mixed completely, then mixed into matrix with herbs' extracts together, and decreased air bubble, painted on glass, put Adhesive-bonded cloth on it, and over night, cut out and sealed up, then we got product.Made Quality Standard according to China Pharmacopoeia, including character, distinguishment, examination, content determination and limit examination. Used TLC to identify Yanhusuo and Xixin, the separation of the stains was apparent and the negative contrast was not disturbed. All of these proved that the method we used was specific. The examination items included the amount of cream in cataplasm, bestows on the shape, and microorganism limit examination. Choose the amount of sinapine thiocyanate as the index, used HPLC to determine the amount and found out the best method which was the basis to explore the tentative stability of Chuanfuling Cataplasm. The column employed was Aichrom Bond-AQ C₁₈(250×4.6mm,5um); the mobile phase was acetonitrile-0.1 mol·L^-1 KH₂PO4 (18∶82); the flow rate was 1.0 mL·min^-1 and detection was effected at 326nm, the column temperature was 25℃, and the retain time was 8.426min. The results showed that: this method was not only simple and reliable, but also high pricision, which fit to control the amount of sinapine thiocyanate in Chuanfuling Cataplasm. Temporarily defined the amount of sinapine thiocyanate calculated with (C₁₆H₂₄NO₅·SCN) in each Chuanfuling Cataplasm should not lower than 3.1mg. Examined the limit of aristolochic acid by HPLC, and defined this product should not have aristolochic acid according to three batch preparations.In the aspect of Tentative Stability, the affecting factors in door temperature were studied, the results showed that the Preparing Technology fit Chuanfuling Cataplas, the product was stability. Define temporarily the period of validity was 1 year.The prescription was reformed by modern preparation technology to exploit a kind of lower dosage and good application new dosage form, which could lay the foundations of creation more social benefit and economical benefit.