Research And Development On Eliminate Cuo New Paste Paste

Objective:At present, in the treatment of acne skin diseases such as lack of curative effect, little side effect from natural medicines, traditional Chinese medicine in the treatment of acne and other skin diseases with unique curative effect. In order to further explore the traditional heritage of traditional Chinese medicine in China, we are in the clinical curative effect, the application has a long history of traditional black plaster formulations for the treatment of acne reform, process and quality standard study, developed a kind of advanced formulations, the clinical efficacy of the new Chinese medicine compound preparation for external use only. Clinical observation research for new products at the same time, the results show that the new developed product has a further development of the research and the value of clinical application, in line with the current national demand for the development of new drugs of traditional Chinese medicine, to eliminate Cuo new cream paste development laid a solid foundation.Methods:1. The ethanol extraction process study to the gentleman medicine radix scutellariae,official medicine salvia miltiorrhiza effective component in the extraction of baicalin and Dan phenolic acid B quantity, extract as examining index, high performance liquid chromatography(HPLC) method is used to determine the content of baicalin and Dan phenolic acid B, choose extraction times, extraction time(h),dosage of ethanol(ml/g) and ethanol concentration as influence factors, by L9(34) orthogonal test optimization prescription medicine ethanol reflux extraction process.2. Preparations molding process research: on the basis of preliminary experiments, to paste paste melt, evenness, hardness, adhesive rate, choose glycerin, stearic acid,triethanolamine, emulsifier, single gan grease, lanolin, paraffin wax as the substrate, such as with L18(37) orthogonal experiment optimization Cuo elimination matrix formula of the new paste paste.3. The quality analysis and research: cancellation Cuo new cream paste and angelica radix bupleuri Chinese herbs medicine thin layer identification study of medicinal liquor by high performance liquid chromatography(HPLC) method for king active ingredients baicalin in scutellaria baicalensis georgi and study on the content determination of official medicine salvia miltiorrhiza.4. Preparation stability influence factors test: will disappear Cuo new cream paste placed in 40 ℃ condition, and 25 ℃, RH 93.7 % condition, the investigation on the cream of hygroscopicity, the influence of the content determination.5. The preparation for the release and experimental study of rats in vitro transdermal,with preparation of jun wine as an index, content of baicalin in scutellaria baicalensisgeorgi on the expedition.6. Preparation: clinical observation research will disappear Cuo new paste paste combined doxycycline has carried on the preliminary clinical observation, western medicine diagnosis and treatment of clinical observation of outpatient service of 146 patients with liver blood heat syndromes after female adolescent acne.Results:1. Optimization of ethanol extraction process: prescription medicine + 8 times 80%ethanol extract 2 times, each time 1 hour. Baicalin and Dan phenolic acid B transfer rate is57.90% and 52.74%, respectively, showed that the extraction process of optimization.2. Optimizing the preparation of molding process: 1 g dry paste, adding glycerol 0.45 g, emulsifier, 0.06 g and 0.15 g, triethanolamine stearate 0.90 g, single fat 0.90 g, 0.30 g lanolin, paraffin 0.90 g, 0.01 g p-hydroxy benzoic acid ethyl ester.3. Preparation of radix bupleuri medicinal materials and thin layer identification features of angelica herbs spots were clear, negative control without interference;Determination of baicalin content in the linear range of Y = 111857 X- 50279,(r =0.9998). Precision test: RSD = 0.96%; Repeatability test: RSD = 1.25%; Stability test:RSD = 1.41%; Recovery test: the average sample recovery rate was 100.43%, RSD =1.50%. Dan phenolic acid B content in 3 batches of preparations were 22.11 mg/g, 22.94mg/g, 22.56 mg/g. Dan phenolic acids content determination of linear range for B Y =14789 X- 12873,(r = 0.9996). Precision test: RSD = 0.74%; Repeatability test: RSD =2.05%; Stability test: RSD = 1.39%; Recovery test: the average sample recovery rate was100.87%, RSD = 1.50%. Dan phenolic acid B content in 3 batches of preparations were21.10 mg/g, 22.17 mg/g, 22.50 mg/g.4. Factors affecting the results: Elimination Cuo new cream paste sample, test under the condition of 40 degrees in continuous inspection within 10 days, the test results compared with before the test, no obvious change. Can be seen from the results of baicalin in cream paste and Dan phenolic acids content under the condition of high temperature stability of B. Due to the elimination Cuo new cream paste samples under the condition of high humidity easily absorb moisture, increase water content of samples, it is recommended that products to seal, guarantee the quality of stability.5. Determination of baicalin in Cuo elimination new paste paste release within 120 min degree is 70.16%, paste paste of baicalin in the transdermal rate of 29.66% within 24 h.Result table people away Cuo new cream with good release and transdermal effects.6. By collecting of 146 cases of liver blood heat female adolescent acne patients after clinical observation, the results show that the treatment of 6 weeks, 8 weeks of efficient were 61.5%, 89.5% respectively. Eliminate Cuo new cream combined western medicine curative effect is distinct, provide the basis for clinical use.Conclusion:Cuo elimination of the new type of paste paste appearance is good, with the help of plaster cloth can apply to stick on the skin to achieve good results. Preparations moldingprocess, extraction technology, quality and clinical research, for its development to provide the basis.