Research And Development Of Yuanhuzhitong Controlled-release Tablet And Qingre Gel

Yuanhuzhitong tablet is an effective prescription commonly used in clinic. It is made up with Rhizaoma Corydalis and Radix Angelica Dahuricae and has the effect of regulating qi, promoting blood circulation and relieving pain, the prescription is usually used in stomachalgia, hypohondriac pain, headache and menstruation pain due to qi stagnation and blood stasis. In this dissertation, we try to reform it to be controlled-release preparation, which can promptly and permanently take analgesia effect. The R&D of Yuanhuzhitong controlled-release tablet(CRT)is performed as follows. Firstly, we confirm the optimizing extract process of Rhizaoma Corydalis and Radix Angelica Dahuricae by applying orthogonal design and test, in order to extract and purify the effective constituent groups of Yuanhuzhitong tablet. Secondly, we design the Yuanhuzhitong CRT as double layers tablets by applying double layers tablet manufacture procedure, one is the quickly releasing lamella, the other is sustained releasing lamella. Thirdly, we confirm the optimizing ratio of active constituents and excipients in the different lamella. Fourthly, taking tetrahydropalmatine and imperatorin as index, we establish the content examination by HPLC, enhance the quality standard. Fifthly, we conduct dissolution test of Yuanhuzhitong CRT to discuss the drug releasing model.Gel is a new preparation emerging in recent years, which can easily be manufactured and used. The child gel is a new Chinese medicine preparation, which can resolve the children's difficulty when taking medicine. Qingre gel is a prescription derived from an old proved recipe, which has the effect of dispelling wind and clearing away heat, nourishing yin and activate blood, and smoothing throat and reliving pain. And this preparation can treat child fever, sore throat, and so on. The R&D of Qingre gel includes in six aspects as below. The first, taking carrageenin and konjaku flour as main fundamental material, we confirm the optimizing ratio by applying orthogonal design and test. The second, as to Flos Lonicerae Japonicae, Fructus Forsythiae, Herba Menthae, which active constituent is essential oil, we use steam distillation to extract the essential oil; as to Radix Paeoniae Rubra, Radix Isatidis, Radix Rehmanniae, Rhizoma Imperatae, which active constituent is saponins, flavone, terpene, we confirm the optimizing process of water extract and alcohol sediment by applying orthogonal design and test; as to Radix et Rhizoma Rhei , Bulbus Fritillariae Cirrhosae, Radix scrophulariae, which active constituent is anthraquinones , alkaloid, we confirm the optimizing process of alcohol extract by applying orthogonal design and test. The third, according to the result of above tests, we try to manufacture the Qingre gel, in order to verify the rationality and feasibility of process. The fourth, establishing the qualitative analysis method of Flos Lonicerae, Radix scrophulariae, Radix Paeoniae Rubra, Radix Isatidis by TLC, and establishing quantitative analysis method to examine the content of emodin and chrysophanol by HPLC. The fifth, conducting experiments in vivo and in vitro to illustrate the therapeutical mechanism from the different aspects, such as antiflammatiom, antipyretic analgesic, antivirus, antisepsis. The sixth, conducting the acute toxicity and chronical toxicity to evaluate the safety of the Qingre gel.