中国医药科学
中國醫藥科學
중국의약과학
CHINA MEDICINE AND PHARMACY
2013年
21期
51-56
,共6页
张丽珍%詹晓如%胡奕勤%郑小吉%周之荣
張麗珍%詹曉如%鬍奕勤%鄭小吉%週之榮
장려진%첨효여%호혁근%정소길%주지영
四味清口含片%配比及辅料%优选处方%制备工艺%正交实验设计%质量评价
四味清口含片%配比及輔料%優選處方%製備工藝%正交實驗設計%質量評價
사미청구함편%배비급보료%우선처방%제비공예%정교실험설계%질량평개
Siweiqing buccal tablets%Ingredients and adjuvant material%Optimum prescription%Preparation technique%Orthogonal experimental design%Quality assessment
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。
目的：對四味清口含片處方中的配比及輔料進行優化，研究其製備工藝。方法以三味藥材[桂心(肉桂)、細辛、廣陳皮]提取物揮髮油的β-環糊精包閤物粉與四味藥材[桂心(肉桂)、細辛、廣陳皮、甘草]提取物浸膏粉的混閤物為主藥，用外觀、口感、硬度和崩解時限為攷察指標，在單因素試驗的基礎上，採用L9（34）正交實驗設計，固定清涼劑及潤滑劑量，試驗原料藥粉用量、填充劑用量、潤濕劑濃度、矯味劑用量對口含片質量的影響，篩選四味清口含片處方中的最佳配比及輔料；探討瞭浸膏的榦燥條件。採用濕法製粒壓片，以單因素試驗法篩選製粒及榦燥條件；研製瞭四味清口含片，併對其質量進行瞭評價。結果四味清口含片最優處方為：固定清涼劑薄荷腦用量1.0%及潤滑劑硬脂痠鎂用量1.0%，原料藥粉用量45%、填充劑用量45%、矯味劑用量8%、φ=90%乙醇適量；浸膏的榦燥條件為60℃，減壓榦燥7h；最佳工藝條件為：20目篩製粒，60℃榦燥90min，20目篩整粒。按最佳配比的原料藥粉、輔料用量，加入φ=90%藥用乙醇適量製軟料，製粒(20目篩)，于60℃榦燥90min，20目篩整粒，等量遞加法加入硬脂痠鎂、薄荷腦，混勻壓片。結論按優化處方和工藝製備的四味清口含片外觀完整光潔，色澤均勻，崩解時限、硬度、片重量差異限度、脆碎度、微生物等指標均符閤藥典要求。口感苦甜適中，有清涼感；優化齣的處方閤理及製備工藝穩定可行。
목적：대사미청구함편처방중적배비급보료진행우화，연구기제비공예。방법이삼미약재[계심(육계)、세신、엄진피]제취물휘발유적β-배호정포합물분여사미약재[계심(육계)、세신、엄진피、감초]제취물침고분적혼합물위주약，용외관、구감、경도화붕해시한위고찰지표，재단인소시험적기출상，채용L9（34）정교실험설계，고정청량제급윤활제량，시험원료약분용량、전충제용량、윤습제농도、교미제용량대구함편질량적영향，사선사미청구함편처방중적최가배비급보료；탐토료침고적간조조건。채용습법제립압편，이단인소시험법사선제립급간조조건；연제료사미청구함편，병대기질량진행료평개。결과사미청구함편최우처방위：고정청량제박하뇌용량1.0%급윤활제경지산미용량1.0%，원료약분용량45%、전충제용량45%、교미제용량8%、φ=90%을순괄량；침고적간조조건위60℃，감압간조7h；최가공예조건위：20목사제립，60℃간조90min，20목사정립。안최가배비적원료약분、보료용량，가입φ=90%약용을순괄량제연료，제립(20목사)，우60℃간조90min，20목사정립，등량체가법가입경지산미、박하뇌，혼균압편。결론안우화처방화공예제비적사미청구함편외관완정광길，색택균균，붕해시한、경도、편중량차이한도、취쇄도、미생물등지표균부합약전요구。구감고첨괄중，유청량감；우화출적처방합리급제비공예은정가행。
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 oilβ-cyclodextrin(β-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 Siweiqing buccelltablets 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 Siweiqing buccal tablets were prepared and their quality assessments were carried out. Results The optimum prescription of Siweiqing 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, andφ=90%alcohol appropriate amount;The extractum was vacuuming dried 7h at 60℃and the optimum preparation process parameters were as follows:granulated with 20 mesh sieve, dried at 60℃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 φ=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℃for 90min,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 Siweiqing 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.
