养血生乳口服液制备及其对产后乳汁分泌影响.docVIP

养血生乳口服液制备及其对产后乳汁分泌影响【摘要】 目的 研制防治产后乳汁分泌不足的中药复方制剂。方法 采用当归、黑芝麻、党参等中药，经水提醇沉工艺制备成养血生乳口服液，应用显色反应、薄层确认和高效液相色谱法控制其内在质量，并对80例正常产妇进行了临床观察。结果 阿魏酸的进样量在0.1~0.5μg范围内与峰面积积分值呈良好线性关系，平均加样回收率为98.6%(RSD=1.04%，n=6)；正常产妇产后服用该制剂能促进产后迅速升乳，显著提高其日泌乳量，预防产后乳汁分泌不足的发生。结论 养血生乳口服液的质量稳定，是防治产妇分娩后乳汁分泌不足的理想制剂。? 【关键词】 养血生乳口服液；制备；质量标准；乳汁分泌 ?? Preparation of Yangxue shengru oral liquid and its effects on postpartum breast milk secretion FU Jin-yu, LI Yan, WU Xiu-qin. Family Planning Service Stations of Yiling District in Yichang City, Yichang 443100,China? 【Abstract】 Objective To prepare a compound Chinese drugs for treating and preventing prerperal hypogalactia. Methods With the color reaction,TLC and HPLC could effectively control the intrinsic quality of the oral liquid.Using single blind random control method,we studied the recovery process of 80 normal women during general puerperium. Results The linear range of ferulic acid was 0.1~0.5μg and the average recovery was 98.6%(RSD=1.04%，n=6).The results revealed that it could improve breast milk secretion significantly and increase daily lactation amount of parturient. Conclusion Yangxueshengru oral liquid was a satisfactory preparation for treating and preventing puerperal hypogalactia.? 【Key words】 Yangxueshengru oral lipuid;Preparation;Quality standards;Breast milk secretion 产后乳汁分泌不足是造成母乳喂养率低下的主要原因。养血生乳口服液由黑芝麻、当归、党参、大枣、益母草等12味中药组成，具有催乳、补虚、化瘀之功效，临床用于防治产后乳汁分泌不足和促进产褥复旧等。现将该制剂的制备方法、质量标准和临床观察结果报告如下。? 1 材料与仪器? 养血生乳口服液(宜昌市夷陵医院制剂室制备，批20091114；阿魏酸(中国药品生物制品检定所，批号0773-9910，供含量测定用)；当归药材(宜昌众生药业有限公司，经宜昌市药品检验所鉴定为伞形科植物当归Angelica sinensis(Oliv.)Diels的干燥根)；硅胶G板(青岛海洋化工厂)；Waters高效液相色谱仪，包括490紫外检测器、510输液泵、745数据处理机。所用试剂均为分析纯。? 2 制备及质量控制? 2.1 制备工艺 将当归碎成粗粒，加10倍量水蒸馏提取挥发油约2 h，收集馏出液200 ml，备用。另取处方中其他11味中药加5倍量水，煎煮1.5 h，过滤；药渣加入蒸馏后的当归药渣，加5倍量水煎煮2次，每次1 h，过滤。合并3次滤液，浓缩至1000 ml，冷却。向浓缩液中加入95%乙醇，使含醇量达70%，静置48 h，吸取上清液，过滤。滤液减压回收乙醇至无醇味，并继续浓缩至400 ml，加蒸馏水稀释至600 ml，冷藏24 h。吸取上清液，过滤。向馏出液中加适量吐温-80，使挥发油全部溶解，合并提取液，加蒸馏水定容至1000 ml，冷藏24 h，过