保健食品褪黑素维生素B6片的成型工艺研究  

Preparation on Health Food of Melatonin Vitamin B6 Tablets

作　　者：韩亚明 苏恩谊 黎宇盛 刘春芳 王小妹 Han Yaming;Su Enyi;Li Yusheng;Liu Chunfang;Wang Xiaomei(Guangzhou Hanfang Pharmaceutical Co.,Ltd.,National Engineering Research Center of Pharmaceutical Processing Technology of Traditional Chinese Medicine and Drug Innovation,Guangdong Provincial Key Laboratory of Medicinal Lipid,Guangzhou 510240,China)

机构地区：[1]广州白云山汉方现代药业有限公司,中药制药过程技术与新药创制国家工程研究中心,广东省药用脂质重点实验室,广东广州510240

出　　处：《广东化工》2022年第22期71-73,20,共4页Guangdong Chemical Industry

摘　　要：研究保健食品褪黑素维生素B6片的成型工艺。采用原辅料总混压片法,探究单因素硬脂酸镁添加量、羧甲基淀粉钠添加量、微晶纤维素与麦芽糊精用量比例、混合方式、混合时间、包衣剂对片剂成型的影响,结合脆碎度、硬度、片重差异、片剂外观等指标选出符合片剂成型质量要求的成型工艺。实验结果表明最佳成型工艺为微晶纤维素:麦芽糊精比例为3∶1,硬脂酸镁添加量为0.1%,羧甲基淀粉钠添加量为5.0%,包衣液固含量为12%,混合时间为40 min,褪黑素与维生素B6先分别稀释再混合,所得片剂外观性状良好,硬度、脆碎度、崩解时间等指标均符合要求,工艺稳定可靠,适合大规模产业化生产。To optimize the preparation process on health food of Melatonin Vitamin B6 Tablets.Adopt total mixed of raw and auxiliary materials pressing tablet method.To explore the effects of single factor magnesium stearate addition,sodium carboxymethyl starch addition,microcrystalline cellulose and maltodextrin dosage ratio,mixing method,mixing time,coating agent on tablet molding,combined with brittleness,hardness,tablet weight difference,tablet appearance and other indicators select the best formulation.The experimental results show that the best molding process is:microcrystalline cellulose:maltodextrin is 3∶1,magnesium stearate addition amount was 0.1%,sodium carboxymethyl starch content was 5.0%,the coating liquid solid content is 12%,the mixing time of 40 min,melatonin and vitamin B6 dilution respectively first and then mix,the appearance of tablet,degree of hardness,brittle broken,disintegration time and other indexes meet the requirements.The process is stable and reliable,suitable for large-scale industrial production.

关 键 词：褪黑素维生素B6片 片剂 成型工艺 硬度 脆碎度 崩解时间 

分 类 号：TQ[化学工程]