ABSTRACT
Objective To select the optimum process of granule spray for Tangwang Mingmu Granules, To improve the yield and finished product quality. Methods The effects of the relative density, the type of excipients, the ratio of the extract and the excipient, the inlet temperature-the material temperature, the spray rate and the atomization pressure were selected by single factor and orthogonal test respectively to determine the optimum preparation process. Validation for three batch sample, particle flow, hygroscopicity and other related content of the preparation were studied. Results The optimum spray granulation process of Tangwang Mingmu Granules: the relative density of extract (60 ℃ determination) was 1.15–1.20; the excipient was selected as dextrin; the ratio of dry extract and excipient was 58:42; inlet temperature - material temperature was 90-75 ℃; atomization pressure was 0.12 mPa;spray rate was 10 Hz.Conclusion The preparation technology of Tangwang Mingmu Granules optimized in this study is with high preparation rate, good fluidity and hygroscopicity, which can be used for the preparation of Tangwang Mingmu Granules.
ABSTRACT
Objective To observe toxic symptoms and signs , toxic damage extents and reversibility in rats after oral administration of Tangwang Mingmu granules .Methods Four dose groups with 40 rats in each group were designed in this study, including control group fed with distilled water and three groups at different dosages of the test drug .Tangwang Mingmu granules were orally administered to SD rats at the dosage of 8.4, 4.2 and 2.1 g/kg for 3 weeks and 14.0, 8.4 and 4.2 g/kg for 23 weeks, for 26 consecutive weeks .The general state of the rats was observed every day , while body mass and food consumption were calculated once a week .Halfway through and at the end of the administration (13 and 26 weeks) and after four weeks of recovery, parameters of body mass, hematology, hematological biochemistry, organ/body mass ratio and histopathology were measured .Results Compared with the control group at the same time-point, body mass of male rats in the other three groups was slightly reduced .Food consumption in high and medium dose groups was reduced (P<0.05), MCHC, ALT, TBIL and Na +in high dose group were decreased (P<0.05), TP, ALB and D-BIL were increased (P<0.05), the mean body mass and relative organ weight of thymus in medium dose male rats were decreased (P<0.05), relative organ weight of the liver and kidney in high dose male rats was increased (P<0.05), and focal chronic inflammation to different extent was observed in the liver , kidney and prostate gland .No dose-effect relationship was found in these perturbations that were all within the normal range of animals .No significant drug-related pathological changes were found.Conclusion The NOAEL of Tangwang Mingmu granules is considered to be 14.0 g/kg body mass/day (equal to 50 times the proposed clinical adult dosage ) for the 26-week repeated dose oral toxicity study in male andfemale rats.