Study On Technology And Quality Standard Of Lianhua Qingwen Capsule

Influenza is one of infectious diseases in the key prevention list of the national state, the characteristics of influenza were short incubation period, high speed of propagation, high rate of incidence. The typical symptoms were sudden fever, sore throat, dry cough, fatigue, conjunctival redness, muscle ache.Traditional Chinese medicine(TCM) has been used for thousands of years in China. It has an unique advantage in the prevention and treatment of disease. Lianhua Qingwen Capsule(LHQW) was an effective preparation of traditional Chinese medicine(TCM) formula, including 13 herbs such as forsythia fructus, honeysuckle, Chinese ephedra, etc. The formula was conducted according to the collateral disease of traditional Chinese medicine combined with modern medicine and many years of clinical practice summaries. LHQW has showed excellent anti-cold efficacy in the prevention and treatment of SARS, avian flu, foot and mouth disease, H1N1 influenza in serious public health event recently. It was widely used to treat the flu patients and was list in the national health insurance B varieties. However, many factors, including the traditional process, the low degree of automation, the low production efficiency, the undeveloped impurity process and the problem of moisture absorption and caking for the traditional Chinese medicine preparation technology, influenced the stability of the drug. TCM has the characteristic of complex compositions, and one or two components could not evaluate the quality of medicine. In order to enhance the level of automation, improve production efficiency, reduce production cost, and achieve energy saving and environmental protection, the process technology of LHQW was optimized using modern production equipment in the present study. Moreover, according to “good manufacturing practice”(GMP, 2010 Revision) and “drug registration regulation”, the quality standards of LHQW were developed, which was suitable for the quality control of LHQW.Studies on process technology: To solve the ethanol consumption and high production cost problem, traditional reflux extraction technology was changed into ultrasonic reflux extraction extraction technology. The granularity of materials, ultrasonic temperature and ultrasonic time were investigated by using single factor design and the ultrasonic countercurrent extraction process was eventually determined as follows: the materials were crushed into 40 meshes, the extraction temperature was set at 40-60℃ and the extraction time was kept for 60 min. To study the purification process and the retention of main active ingredients, the ceramic membrane filtration technology was used to purify water extraction part of Lianhua Qingwen capsule. The different pore size inorganic ceramic membrane, the solution temperature and liquid film pressure on membrane flux were investigated by determining the factor the membrane flux and the retention rates of main active ingredients. the ceramic membrane filtration technology was eventually determined as follows: under the membrane flux pressure of 0.15~0.2MPa and the extraction temperature of 60~70℃, the pore size of 0.2 μm ceramic membrane was selected to apply to purification process of Lianhua Qingwen Capsule water extraction. To solve the agglomeration of traditional Chinese medicine and the losing of active constituents in two drying process, dry granulation technology was used to prepare the granules of Lianhua Qingwen capsule. The parameters of dry granulation technique, including roll pressure, rotation speed and feed speed, were optimized using the amount of granules as the evaluation index. The optimum technique is roll pressure of 12 MPa, rotation speed of 5 rpm and feed speed of 10 rpm. The amount of particle prepared by dry granulation process was significantly more than wet granulation technology and the granulation process of Lianhua Qingwen capsule and was suitable for granulating process of Lianhua Qingwen capsule.Studies on quality standard: To established an UPLC method for determination of five active compounds in Lianhua Qingwen Capsules, including chlorogenic acid, cryptochlorogenic acid, forsythoside A, 3,4-dicaffeoylquinic acid, 4,5-dicaffeoylquinic acid. The results indicated that the analytical method was simple, accurate and credible, which is useful for quality control of Lianhua Qingwen Capsules.