桂梔助眠膠囊成型工藝研究

杜正彩　齊彪　張明哲　韋燕霞　李麗潔　郝二偉　侯小濤　胡小勤　鄧家剛

摘要：目的 ?篩選桂梔助眠膠囊的最佳成型工藝。方法 ?以吸濕率和休止角為評(píng)價(jià)指標(biāo)，篩選出適當(dāng)?shù)妮o料，并對(duì)主藥與輔料的比例進(jìn)行優(yōu)化;以制粒情況、顆粒收得率和成型率為指標(biāo)，篩選出最佳乙醇濃度;考察顆粒的吸濕率、休止角、堆密度、臨界相對(duì)濕度。結(jié)果 ?最佳成型工藝為：主藥與微晶纖維素、可溶性淀粉按6∶3∶1比例混勻，加入75%乙醇制軟材，過24目篩制粒，真空干燥（0.08～0.1 MPa，60 ℃）4 h，整粒。所得顆粒休止角為29.30°，吸濕率為8.95%，堆密度為0.444 8 g/mL，臨界相對(duì)濕度為74.27%。結(jié)論 ?本研究所得成型工藝合理、可行，可為桂梔助眠膠囊大生產(chǎn)提供依據(jù)。

關(guān)鍵詞：桂梔助眠膠囊;成型工藝;吸濕率;休止角;堆密度;臨界相對(duì)濕度

中圖分類號(hào)：R285.5????文獻(xiàn)標(biāo)識(shí)碼：A ???文章編號(hào)：1005-5304（2019）09-0080-05

Study on Forming Process of Guizhi?Sleeping Capsules

DU Zhengcai¹， QI Biao²， ZAHNG Mingzhe¹， WEI Yanxia²， LI Lijie²， HAO Erwei³，?HOU Xiaotao²， HU Xiaoqin²， DENG Jiagang³

1. Science Experimental Center of Guangxi University of Chinese Medicine， Nanning 530001， China; 2. School of Pharmacy， Guangxi University of Chinese Medicine， Nanning 530001， China; 3. Guangxi Key Laboratory of Efficacy Study on Chinese Materia Medica， Nanning 530001， China

Abstract：?Objective To optimize?the forming process of Guizhi?Sleeping Capsules. Methods With hygroscopicity and the angle of repose as the evaluation indexes， the appropriate excipients were screened out， and the proportion of main medicine and excipients were optimized. With granulation condition， particle yield and molding rate as indicators， the optimal ethanol concentration was screened out; and the moisture absorption rate， repose angle， bulk density and critical relative humidity of particles were investigated. Results The optimal?molding process was that the powder was mixed with microcrystalline cellulose-soluble starch （6：3：1）; 75% ethanol was added to make soft material， granulated in 24 meshes， dried in vacuum （0.08–0.1 MPa， 60 ℃） for 4 hours; the whole granule was obtained. The repose angle of the granule was 29.30°; the moisture absorption rate was 8.95%; the bulk density was 0.444 8 g/mL; and the critical relative humidity was 74.27%. Conclusion?The forming process is reasonable and feasible， and can provide basis for the production of Guizhi?Sleeping Capsules.