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目的筛选小儿清降掩味粉末干混悬剂处方系统,并对其进行评价。方法针对掩味后小儿清降复方粉体的特殊性问题,寻找适合的处方系统,并以混悬液中药物含量均一性(RSD)为客观评价指标,使处方系统中助悬剂、润湿剂二者的用量达到最佳组合状态。通过粉体流动性、液体流变性、电位、口感对其最终确定处方系统进行干混悬剂的相关质量评价。结果以CEOLUS RC-A591NF与黄原胶联用为助悬剂,泊洛沙姆为润湿剂时为适合的处方系统,二者的最佳组合为当小儿清降掩味粉末为1g时,CEOLUS RC-A591 NF:0.15g,黄原胶:0.08g,poloxamer188:0.05g,且各项评价指标均符合干混悬剂的相关质量评价要求。结论针对掩味小儿清降干混悬剂处方系统开发的新型助悬剂,对改善中药混悬剂的稳定性具有重要的意义。
Objective To screen the prescription system of children’s dry-clearing and taste-masking powder dry suspension and evaluate it. Methods Aiming at the peculiarities of taste-clearing compound powder after taste-masking, the author aimed to find a suitable prescription system, and take the RSD as an objective evaluation index to make the prescription system suspending and wetting The amount of both agents to achieve the best combination of state. Through the powder fluidity, fluid rheology, potential, taste on its final determination of the prescription system for dry suspension related quality evaluation. Results With CEOLUS RC-A591NF and xanthan gum as suspending agent and poloxamer as wetting agent, the suitable prescription system was the best combination of the two. When the children cleared and masked powder was 1g, CEOLUS RC-A591 NF: 0.15g, Xanthan gum: 0.08g, poloxamer188: 0.05g, and the evaluation indicators are in line with the relevant quality evaluation requirements of dry suspensions. Conclusions A new type of suspending agent developed for the prescription system of the taste-masking pediatric desiccation-dried suspension is of great significance to improve the stability of the traditional Chinese medicine suspension.