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Preparation and in Vivo Evaluation of Andrographolide Tablets for Colon-trageting Delivery

Author: DanChunYan
Tutor: XuJianGuo；ChenWen
School: Xinjiang Medical University
Course: Pharmacy
Keywords: Andrographolide Colon targeting Preparation Process In vitro evaluation of
CLC: R283
Type: Master's thesis
Year: 2009
Downloads: 63
Quote: 0
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Abstract


Abstract: Objective: ① andrographolide-based medicine, Eudragit S100 coating materials prepared by the pH-dependent colon targeted tablets. The ② andrographolide quality inspection system, drug dissolution in artificial colonic fluid and colon targeted tablets drug content was determined by high performance liquid chromatography. ③ Research andrographolide colon-targeted tablets in vitro release performance conditions and release determination of drug release. ④ establish andrographolide colon targeting film qualitative identification method, to examine its stability in the impact factor experiments. Methods: ① Lactose 80 and the MCC (102) for tablet cores fillers, tablet core was prepared using the direct powder tabletting. Screening chip core prescription and coating process by univariate analysis, single factor experiments based on orthogonal experimental design to optimize the coating liquid prescription. Press optimize the best preparation conditions trial andrographolide colon targeted-coated tablets. ② establish andrographolide the HPLC detection standard curve in the dissolution medium and preparations, and verify its methodology. ③ by the similarity of the elution curves of f2 factor method different release profile similarity, to determine the release rate measurement conditions. ④ application of physics and chemistry and thin-layer chromatography were identified according to the andrographolide visits andrographolide colon targeted tablets under the conditions of high temperature, high humidity, and bright light changes in appearance, content and release. Results: ① Preparation of Lactose 80 and MCC (102) acts as a filler, a powder of silica gel (3%) in a 2:1 glidants, direct powder tabletting Preparation of tablet hardness 8-9, tablet weight 200mg of the tablet core. Fixed coating pan speed 25R / min, coating pan, tilt angle 45 °, inlet air temperature 40-50 ° C, the liquid discharge rate was 2.5ml / min, sprayed with Eudragit S100 as coating materials, diethyl phthalate plasticizer, the plasticizer accounts for the coating solution of the polymer 30%, so that the tablet cores were coated by weighing 6%. ② HPLC with the dissolution medium andrographolide release equation: y = 62340x 46026 in the range of 2.06 ~ 51.50μg/mL a good linear relationship (r = 0.9995) precision RSD = 0.89%, and the average recovery was 98.3% ; HPLC with preparations andrographolide content equation: y = 64104x 36335 in 4-80μg/mL range a good linear relationship (r = 0.9995) precision RSD = 0.59%, the average recovery rate was 98.92%. ③ release test conditions were as follows: a slurry method, 75R / min, coated tablets without heat treatment. Conclusion: ① Eudragit S100 colon-targeted tablets of the coating material on the strong dependence of PH to maintain drug release in the stomach and small intestine, and release in the colon area in line with the requirements of the experimental design, and its release. ② high performance liquid detection method is accurate, reproducible, colon-targeted tablets as andrographolide process selection and quality control methods. ③ for andrographolide qualitative identification of simple physical and chemical methods, thin-layer chromatography separation, specificity; stable colon targeted tablet influencing factors experiments.

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CLC: > Medicine, health > Chinese Medicine > Of Pharmacy > Chinese medicine processing,preparation
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