Study On Pharmaceutical Part Of Shi Hu Qing Yan Buccal Tablet

Shihu qingyan buccal tablet,prepared from the drugs of Dendrobiu,ophiopogon root, Platycodonis radix,licorice root.lt has the functions of nourishing yin and clearing heat,and qutan liyan,and is indicated for the treatment of chronic nasopharyngitis.dendrobium aurantiacum Kchb.f.yar.denneanum (Kerr)Z.H.Tsi is the most widely distributed Herba Dendrobii in Sichuan.To investigate preparation process of Shi Hu Qing Yan buccal tablets,taking Dendrobium aurantiacum Kchb.f.var.denneanum (Kerr) Z.H.Tsi as the study subject. In order to ensure the accuracy of clinical use as drugs, expand the range of applications and increase industry value of Herba Dendrobii.Objective:To study Shi Hu Qing Yan buccal tablets extraction and the preparation technology,and the establishment of its quality specification.Method: ① According to the physico-chemical properties of the active ingredients in each herb used in this prescription,inspection gigantol content level and extract yield,and used a three-factor and three-level Box-Behnken experimental design was employed,with extraction time, solvent ratio,soaking time and extraction times,and optimized the extraction process. In order to select the prescription of Shi Hu Qing Yan buccal tablets, angle of repose and rigidity was used as index,single factor method and mixture design were used.② To establish the quality standards for Shi Hu Qing Yan buccal tablets.including identification, inspection.tablet weight difference,microorganisms and content determination were carried out on Shi Hu Qing Yan buccal tablets. Some of the constituents,including Herba Dendrobii, Radix Ophiopogonis, Radix Platycodonis, and Radix Et Rhizoma Glycyrrhizae in the formulation,were identified by TLC;the main effective ingredient of Dendrobiu in the formulation,was determined by HPLC. ResuIt:③ The optimum extraction process of Shi Hu Qing Yan buccal tablets was as follow:The crude drugs were refluxed with 11 times amount of water as the extraction solvent for three times, 1h per time; and then the extract powder, Lactose, mannitol and menthol were mixed evenly in proportion of 1000g,794g,206g,8g; then prepared granules with 90% ethanol as wetting agent.②The study on quality standard of Shi Hu Qing Yan buccal tablets showed that:the tablet had brown color,the identification results showed that the spots of the sample and the control were quite clear;Tablet weight difference was in accordance with the general rule of Chinese Pharmacopoeia;gigantol were determined by HPLC,good linear indications has been shown as a result of the injection for HPLC being controlled within 0.0512-0.5140 μg;with the average recovery of 97.52% and RSD of 4.9%. Conclusion:These results showed that the formulation and the preparation process were feasible; the established standards can be used for the quality control of Shi Hu Qing Yan buccal tablets.