四味清口含片处方的优化及制备工艺研究

Study on optimization and preparation technique for the prescription ofSiweiqing buccal tablets

目的对四味清口含片处方中的配比及辅料进行优化,研究其制备工艺。方法以三味药材[桂心(肉桂)、细辛、广陈皮]提取物挥发油的β-环糊精包合物粉与四味药材[桂心(肉桂)、细辛、广陈皮、甘草]提取物浸膏粉的混合物为主药,用外观、口感、硬度和崩解时限为考察指标,在单因素试验的基础上,采用L9(34)正交实验设计,固定清凉剂及润滑剂量,试验原料药粉用量、填充剂用量、润湿剂浓度、矫味剂用量对口含片质量的影响,筛选四味清口含片处方中的最佳配比及辅料;探讨了浸膏的干燥条件。采用湿法制粒压片,以单因素试验法筛选制粒及干燥条件;研制了四味清口含片,并对其质量进行了评价。结果四味清口含片最优处方为:固定清凉剂薄荷脑用量1.0%及润滑剂硬脂酸镁用量1.0%,原料药粉用量45%、填充剂用量45%、矫味剂用量8%、φ=90%乙醇适量;浸膏的干燥条件为60℃,减压干燥7h;最佳工艺条件为:20目筛制粒,60℃干燥90min,20目筛整粒。按最佳配比的原料药粉、辅料用量,加入φ=90%药用乙醇适量制软料,制粒(20目筛),于60℃干燥90min,20目筛整粒,等量递加法加入硬脂酸镁、薄荷脑,混匀压片。结论按优化处方和工艺制备的四味清口含片外观完整光洁,色泽均匀,崩解时限、硬度、片重量差异限度、脆碎度、微生物等指标均符合药典要求。口感苦甜适中,有清凉感;优化出的处方合理及制备工艺稳定可行。

Objective To study the optimization for the ingredient and adjuvant material of prescription of Siweiqing buccal tablets and it＇s preparation technique. Methods Using the mixture of extract volatile oil 13 -cyclodextrin（ 13 - CD） clusion compounds powder from three species（Citrus Chachiensis Hortorum, Cortex Cinnamomi and Asarum heterotropoides Fr. Schmidt var. mandshuricum（Maxim.） Kitag and powdered extract from four species（Citrus Chachiensis Hortorum, Cortex Cinnamomi, Asarum heterotropoides Fr.Schmidt var. mandshuricum（Maxim.） Kitag and licorice） as the primary drugs, using the appearance characteristics,texture, hardness and disintegrating time as the evaluation indexes,based on the single factor test,using L9（34） orthogonal experimental design,fixing the dosage of freshener and moistening agent,the influence of the factors such as primary drugs powder dosage,fillers dosage,concentration of moistening agent and correctant dosage on the quality of buccal tablets were discussed, and the optimum ingredient and adjuvant material of Siwelqing buccel tablets were optimized,and the dry conditions of extractum was investigated. The granulation and dry conditions were optimized through using the wet granulation tabletting method and the single factor test, then the Sl＂weiqing buccal tablets were prepared and their quality assessments were carried out. Results The optimum prescription of SiWel＂qlng buccal tablets were the fixed amount of 1.0% freshener menthol and 1.0% lubricant magnesium stearate,45% primary drugs powder dosage,45% fillers dosage,8% correctant dosage, and tb =90% alcohol appropriate amount;The extractum was vacuuming dried 7h at 60~C and the optimum preparation process parameters were as follows：granulated with 20 mesh sieve, dried at 60~C for 90min,and unified with 20 mesh screen, respectively.According to the optimum ingredient primary drugs powder and adjuvant material dosage,the adequate amounts of qb =90% alcohol were added into the prescription, the soft granules were prepared.Then the granules were granulated with 20 mesh sieve,and dried at 60~C for 90rain,and unified with 20 mesh screen,and added magnesium stearate and menthol by using equivalent increment, the above products was completed through tabletting after homogeneous mixing. Conclusion Siwelqing baccal tablets prepared according to the optimum prescription and technique has the indexes including the uniform color and smooth appearance, disintegrating time,hardness,tablet weight Variation limit, friability and stability and microbe, which meet the requirements of State Pharmacopoeia,and a moderate bitter and sweet and cool texture. The optimum prescription is reasonable, and the optimal preparation technique is stable and feasible.