The Study On The Quality Standard Of Xiaochuanning Tablet

Xiaochuanning tablet is a compound preparation, which is composed of Ephedra Herba, Pseudostellariae Radix, Schisandra chinensis Fructus, Polygalae Radix, Arisaema Cum Bile, Gypsum Fibrosum, Daturae Flos and Glycyrrhizae Radix et Rhizoma. Xiaochuanning tablet has antitussive, antiasthmatic, anti-inflammatory and expectorant effects, used primarily in the treatment of bronchial asthma, chronic cough, and shortness of breath. It is recorded in the "Drug Standards of the Ministry of Health of the People's Republic of China, the fourth volume of Chinese patent medicine preparations". As the standards level is low, the further research on it was carried out. The literature was summaried about the chemical composition and assaying and pharmacology of each herb of Xiaochuanning tablet. After much experiment study, a method was developed, using thin layer chromatography (TLC) and high-performance liquid chromatography (HPLC), for the qualitative identification of Ephedra Herba, Schisandra chinensis Fructus and Polygalae Radix in Xiaochuanning tablet, and for the quality evaluation of the preparatum through determination of active component in Ephedra Herba, namely ephedrine hydrochloridum. Ephedra Herba, Schisandra chinensis Fructus and Polygalae Radix can be identified in different TLC conditions. In addition, the HPLC method for determination of ephedrine hydrochloridum in Ephedra Herba was validated for good linearity accuracy and precision. We carried out the studies as follows:1. ReviewIn this part, a detailed review included the summaries of the outline of respiratory diseases about bronchial asthma in the field of Traditional Chinese Medicine; the introductions of the chemometrics application in quality evaluation of Traditional Chinese Medicines (TCMs), and research advances in chemical components and pharmacological effects of eight Traditional Chinese Medicines(herb medicines) in the formula of Xiaochuanning tablet, named Ephedra Herba, Pseudostellariae Radix, Schisandra chinensis Fructus, Polygalae Radix, Arisaema Cum Bile, Gypsum Fibrosum, Daturae Flos and Glycyrrhizae Radix et Rhizoma.2. Research on thin-layer chromatography of Ephedrae Sinicae HerbaThere was no item of thin-layer chromatography of Ephedrae Sinicae Herba in previous standard of Xiaochuanning tablet, and the method of thin-layer chromatography of Ephedrae Sinicae Herba was developed firstly for qualitative evaluation of Xiaochuanning tablet in this study. To outspread in developed chromatographic condition using ephedrine hydrochloride as reference substance, the chromatograph of sample show the identical colour spot with reference substance in homologus position. The experiment indicated the established TLC identification method has a good reproducibility, and the TLC stain is distinctly, with a non-interferential control stain.3. Research on thin-layer chromatography of Schisandrae Chinensis FructusThere was no item of thin-layer chromatography of Schisandrae Chinensis Fructus in previous standard of Xiaochuanning tablet, and the method of thin-layer chromatography of Schisandrae Chinensis Fructus was developed firstly for qualitative evaluation of Xiaochuanning tablet in this study. To outspread in developed chromatographic condition using deoxyschizandrin as reference substance, the chromatograph of sample show the identical colour spot with reference substance in homologus position. The experiment indicated the established TLC identification method has a good reproducibility, and the TLC stain is distinctly, with a non-interferential control stain.4. Research on thin-layer chromatography of Palygalae RadixThere was no item of thin-layer chromatography of Palygalae Radix in previous standard of Xiaochuanning tablet, and the method of thin-layer chromatography of Palygalae Radix was developed firstly for qualitative evaluation of Xiaochuanning tablet in this study. To outspread in developed chromatographic condition using Palygalae Radix as reference herb medicine, the chromatograph of sample show the identical colour spot with reference herb medicine in homologus position. The experiment indicated the established TLC identification method has a good reproducibility, and the TLC stain is distinctly, with a non-interferential control stain.5. Research on the assay of ephedrine hydrochlorideThere was no item of the assay of ephedrine hydrochloride in Ephedra Herba in previous standard of Xiaochuanning tablet, and the method, using high performance liquid chromatography, was developed for the quality evaluation of Xiaochuanning tablet through determination the content of ephedrine hydrochloride in Ephedra Herba in the formula of Xiaochuanning tablet. Validation studies of this method proved that this assay had good reproducibility and stability, and the developed analytical method had good linear relationship at a range of 4.7～75.5μg/ml, the average recovery are 100.05%, and the RSD of repetitiveness test result is 2.21%(n= 6) for the analyte concerned. All of these indicate that this HPLC method is precise, accurate and sensitive enough for the quantitative evaluation of ephedrine hydrochloride in Xiaochuanning tablet.