Study Of Xiao'er Yindakang Granule

Xiao'er Yindakang Granule is a clinical experience formula of traditional Chinese medicine (TCM). Under the guidance of the theories of TCM, it is changed from decoction to granule with modern methods. It keeps decoction's characteristics of rapid effect and has new ones, such as small volume, conveniences for administration, storing and transportation.To select its optimum preparation technology, establish content detecting methods of geniposide and baicalin with HPLC and do pharmacodynamics and acute toxicity test were main contents.1) The conditions of extraction and preparation technology were determined, which included volatile oil extraction, extraction by boiling, concentration, and alcohol sedimentation to eliminate impurity, dryness and preparation. The technology was proved reasonable and the nature satisfactory by test. It took 3h to extract volatile oil completely by using the optimum extraction technology we selected. The inclusion compounds ofβ-CD was used for from Bohe, Lianqiao, Jingjie and Chaihu. The orthogonal test showed that the ratio of volatile oil andβ-CD was 1∶10, 60% alcohol could resolve volatile oil as much as 8 times,β-CD was resolved with water as much as 6 times, and the time for inclusion was 6h. The technology parameters for extraction were water as much as 14 times, extracting twice, the time for extraction 2.5 h, optimum assist material lactose (as much as 1.5 times dry powder) with starch, improvement for taste with 2.5% stevioside and 1.5% citric acid, and preparation with 85% alcohol of 10% dry powder. The nature of the granule was satisfactory.2) The content detecting methods of geniposide and baicalin with HPLC were established. Geniposide and baicalin showed a satisfactory relation in 0.1032—0.5160μg(r=0.9999)and 0.07682—0.3841μg(r=0.9997)respectively. The average recovery rates of geniposide and baicalin were 98.94% and 100.36% respectively. The methods had satisfactory precision, stability and repetition.3) Xiao'er Yindakang Granule given orally had obvious anti-inflammatory and antipyretic effects with the dosages of 50, 25 and 12.5 g crude drugs/kg. The test in vivo showed its obvious bacteriostasis. Furthermore it also could remove stagnation and relieve pain with oral administration. Its max doses tolerance for mice was 130 g crude drugs/kg. That's to say its toxicity for mouse was low. Xiao'er Yindakang Granule has satisfactory effects with simple and stable technology and controllable quality standard, and lays a good foundation for clinical application.