| According to the traditional Chinese medical theory and the modern preparing process,the northeast agriculture university pharmaco-laboratory developed the traditional Chinese medicine percutaneous oinment,which was composed of Scutellaria,Dandelion and Weeping Forsythia Capsule, its functions were heat-clearing and detoxicating,bacteriostasis and dephlogisticate,detumescence and odynolysis,promoting blood flow and lactogenesis.It was mainly used to treat mastitis which had clinical symptom and the mastitis caused by all kinds of reasons. According to the new veterinary drugs management regulation,the experiment studied quality control methods of the traditional Chinese medicine percutaneous oinment,established quality criteria protocol,the results provided the assurance for the report to a higher authority of the new veterinary drugs and the normalization production.About its characters,we mainly described its color and appearance,it was yellow brown,uniform and exquisite oinment,its characters did not change in store.Using the thin-layer chromatography(TLC) to identified three medicinal materials in the prescription.Baicalin:a polyamide film was adopted with developing solvent 36% acetic acid, alcohol solution of chloride ferric(2%) was used as colouring agent,inspected under the sunlight.Caffeic acid:a silica ged G plate was adopted with developing solvent consist of the upper layer of the mixture acetidin, formic acid and water(7﹕2.5﹕2.5),inspected at 365nm. Forsythin:a silica gel G plate which contain 0.5%CMC-Na was adopted with developing solvent consisted of chloroform and methanol(5﹕1),alcohol solution of sulfuric acid(10%)was used as colouring agent,baked it until coloration clearly at 105℃.The study indicated that the sample displayed the same spots or fluorescence spots as the control article and the control medical material did in the Chromatography,while the negative sample did not,the separation of the spots was apparent,all of these proved that the method had a higher specificity.About its assaying,the high performance liquid chromatogrophy (HPLC)method was established to determine baicalin and forsythin in the preparation.Chinese Acadamy of Science dalian Chemical research institute C18 column(250×4.6mm , 10μm)was used,the mobile phase:acetonitrile(A)-0.002% orthophosphoric acid solution (B)(A+B=100%) gradient elution, wavelength:280nm,velocity of flow:1.0ml·min-1,temperature 25℃.The results suggested that the linear ranges of baicalin and forsythin was 10μg·mL-1～80μg·mL-1,regression equations were Y=38561x﹣7630.3,Y=7843.7x﹣2177.1 respectively, coefficient correlations were r2=0.9994,r2=0.9995 respectively, average recovery were 98.36%,97.60%. In addition,we also detected azone, Chinese Acadamy of Science dalian Chemical research institute C18 column(250×4.6mm,10μm)was used,the mobile phase: methanol-water(85﹕ 15), wavelength:225nm,velocity of flow:1.0ml·min-1,temperature 25℃.The linear ranges of azone was 1mg·mL-1～5mg·mL-1,regression equations was Y=747896x+28788, coefficient correlations was r2=0.9991 average recovery were 98.16%.The methods were used to determin 5 groups of samples ,we established the main component's content limit,baicalin and forsythin no less that 700μg and 150μg per g, azone no less than 3.6%.According to"Chinese Veterinary Pharmacopoeia"(2005) preparation general information,we also needed to work out other inspection items according to its characteristics,technology,the results of stability.we examined three group of samples,including accumulative permeation quantity,emulsive stability,content uniformity and microbial limit,and inspected the heavy metal and arsenic salt.The results suggested that the three groups of samples conform to the regulation.According to the"Stability test requests for the new Chinese traditional medicine",oinment stability examination items.Accelerated test and long test run were carried out.The results suggested that its stability is well,and the storage life can tentatively set on two years.
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