Pharmaceutical Research Of Jianghuang Qingzhi Dispersible Tablets

Objective:This paper choose Jianghuang Qingzhi dispersible tablets as the research object, research the entire preparation process, take preparation process related physical properties of raw and auxiliary materials as key point,to explore the collapse mechanism of TCM dispersible tablet. Bring surface modifier technology into the preparation process of Chinese medicine, and try Trying to make qualified Jianghuang Qingzhi dispersible tablets in materials under the condition of limited amount. To breakthrough the existing research pattern that increase dosage of disintegrating agent for solving the problem of disintegrating delayed, and provides a new research idea for dispersible tablets of TCM.Methods:1. The study before preparation:Check the quality of curcumin according to the pharmacopoeial requirements. Select qualified medicinal material as the research object, examine the factors that ethanol extract of turmeric by the single factor method combined with vacuum reflux extraction.The research was to optimize the extraction conditions by the central composite design and response surface method. The purification methods will refer to Capsule.2. Preparation research:Based on the physical properties of raw and auxiliary materials and exploration of the relationship between these properties and tablets' disintegrative, choose disintegrating agent and design tablet conventional formula; Study the water absorption of Jianghuang Qingzhi dispersible tablet formula, to make sure that what are the factors influence tablets'disintegrative; Prepare qualified Jianghuang Qingzhi dispersible tablet by adjustment formula in a certain range and surface modification of extracts; Inspect pellet methods,and select the best method.3. Preparation Quality Check:According to the pharmacopoeia requirements of dispersible s, check of the tablet quality, including process quality, main composition, in vitro dissolution test and so on. Results:1.Select turmeric herbs (Origin:Yibin) as the research object. The extraction temperature on the extraction process did not affect the stability of substances, ethanol refluxing extraction have higher efficiency. Extraction method of curcumin is:75% ethanol concentration, extracting 2 times, each time 2 hours, and ethanol for the first time 12 times the weight of the herbs and the second time 10 times.The method used for the extraction of turmeric curcumin extract rate is 78%.The purification methods is:vacuum extraction recovery of ethanol, added lmol/L NaoH solution 2 times the volume of medicinal weight, standing more than 8 hours, collect the water bed, plus 3 times the amount of water, adjust the pH with hydrochloric acid to 1～2, filtration, precipitate vacuumg freeze-drying 36 hours, which was powdered turmeric extract.2.wettability, water absorption rate and swelling ability of Excipients powder the tablet have a reference value for the choice of disintegrating agents, the tablet condition water absorption of raw and auxiliary materials have direct guidance for Tablet disintegrating;Turmeric powder can absorpt water in powder state, but can not in tablet condition;Add turmeric extracts in 5% of silica powder by grinding, can significantly improve water absorption and shorten the disintegration time of Jianghuang Qingzhi dispersible.The final tablet formula is:60% modified turmeric extract,10% of the disintegrating agent (CMS-Na:PVPP=1:2),30% MCC, tablet weight 0.35g; Choose powder tablet direct compression method, not only simple process, but also save time and energy.3.The quality of preparation of Jianghuang Qingzhi dispersible tablet was qualified. Curcumin content was not less than 20mg per tablet, but the in vitro dissolution was ineffective.Conclusion:The study show that, Combined with tablet formulation, to study the relationship between the physical properties of raw and auxiliary materials and tablet disintegration was more meaningful. The study also Confirm that it can improve the TCM dispersible tablets disintegrating performance through the powder surface modification technology. In the control preparations specifications, materials usage, dispersible tablets can be prepared by qualified. In brief, the study broke the existing research mode of dispersible tablet preparations research, and provided a new idea for the TCM dispersible tablets.