Studies On The Production Technology And Quality Standard Of Kaile Effervescent Tablet

The development of Kaile Effervescent Tablet was based on the clinical experience of human papillomavirus infection, as well as the principle of treatment and compatibility of Chinese traditional medicine.Kaile Effervescent Tablet contains several Chinese medicines or Chinese medicine extracts, such as Berberine Hydrochloride, Rhubarb Extract, Galla Chinensis Extract, Brucea Javanica Seed Oil, Borneolum syntheticum, and Arsenic Trioxide. This proved prescription originated from the clinical experience of human papillomavirus infection, and has very good prevention and treatment effect on HPV infection caused genital tract diseases. It can be used to prevent the recurrence of local lesion area of vulval, vagina or cervical cancer postoperative, and has certain application value on HPV infection of genital tract, and was worthy to be spreaded.In order to develop a safer and more effective medicine for the human papillomavirus infection patient, the production technology of Kaile Effervescent Tablet and quality standard were studied. Drawing lessons from modern preparative technique of Chinese medicine, we optimized medicinal material, adopted orthogonal experiment with poly-factors, to inspect the preparation technology and parameter, and searched for the best technology condition. Besides, the quality and clinical effect can be guaranteed by building reasonable, feasible quality specification to inspect the stability of preparation. The result is showed as follows:Quality verification of medicinal materials. Check the quality of medicinal materials based on<Chinese Pharmacopoeia>2010. Vol. I&II, and set up quality standard of medicinal materials used in the prescription, including Berberine Hydrochloride, Rhubarb Extract, Galla Chinensis Extract, Brucea Javanica Seed Oil and Arsenic Trioxide.Prep-technological research of Kaile Effervescent Tablet. According to the pre-research results, the main factors which affected the performance of effervescent tablet were tested by single-factor experiments, and the range of main factors were confirmed. We also design the orthogonal experiment to optimize the prescription, with the disintegrating time, foaming result and pH value as the inspection indexs. The optimum prescription obtained has good repeatability.The research of the quality standard.To establish the TLC methods of active components of Rhubarb Extract, Galla Chinensis Extract, Brucea Javanica Seed Oil and Borneolum syntheticum, and establish a method for the determination of Arsenic Trioxide by UV spectrophotometry.The HPLC fingerprint of Kaile Effervescent Tablet was also studied. Based on the established of HPLC fingerprint, using gallic acid, aloe emodin, rhein, emodin, chrysophanol and physcion as quality component indexs. After establishing the mesureing method, full-quantified fingerprint was studied on the specificity, linear, degree of precision, stability, reproducibility and recovery percent. It turned out that the calibration curve of gallic acid was linear from0.12～2.4μg with r=0.9999, the average recovery was100.97%; The calibration curve of aloe emodin was linear from0.015～0.30μg, with r=0.9998, the average recovery was99.01%; The calibration curve of rhein was linear from0.02～0.40μg with r=0.9998, the average recovery was99.76%; The calibration curve of emodin was linear from0.008～0.16u g with r=0.9999, the average recovery was101.10%; The calibration curve of chrysophanol was linear from0.013～0.26μg with r=0.9998, the average recovery was101.97%; The calibration curve of physcion was linear from0.006～-0.12μg with r=0.9999, the average recovery was101.56%. The established full-quantified fingerprint can be used to control the quality of Kaile Effervescent Tablet.