Gaoreqing Injection which come from the old Chinese medicine doctor' s experience prescription is cured for multiple high body temperature.The effective ingredient is selected by the systemic impregnant means and the index of relieving hot effect .The valid part of Radix Puerariaet is Isoflavone,the one of Radix Bupleuri Chinensis is Volatile oil and the one of Radix Angelicae Dahuricae is Volatile oil and Coumarin..The qualified semi-processed product is acquired through distilling and seperating the effective ingredient and the medium test,then the freeze-dry powder injection moulding technic research is based the semi-processed product,including the solidification of Volatile oil (Volatile oil wrapped by Liposome or HP-3-CD),the selection excipient of the bracket,the technic of the contacting liquid,the technic of the freeze-dry and so on .Finally,the qualified Gaoreqing freeze-dry powder injection is acquired after medium test.The evaluation quality system is researched .which include the general examination item,the measurement of the content(Puerarin .total Isoflavone and total Coumarin),thr chromatographic fingerprint research (the Radix Puerariaei Isoflavone fingerprint,the Radix Bupleuri Chinensis Volatile oil fingerprint,the Radix Angelicae Dahuricae Volatile oil fingerprint,the Radix Angelicae Dahuricae Coumarin. fingerprint,the Gaoreqing injection Isoflavone fingerprint,the Gaoreqing injection Volatile oil fingerprint,the Gaoreqing injection Coumarin fingerprint),the stability experiment,the pharmacodynamics experiment(the relieving hot experiment,the anti-bacteria experiment,the anti-virus experiment,the anti-inflammation experiment and the abirritation experiment),the acute toxic reaction experiment of the small rat,the chronic toxic reaction experiment of the big rat,the security experiment(the initiative hypersensitivity experiment of the cavy,the passive skin hypersensitivity experiment of the,cavy,the stimulating rabit' s muscle experiment,the stimulating Beagle' s vein experiment). |