CN109350630A - 一种注射用银杏叶冻干粉针剂及其制备方法 - Google Patents

一种注射用银杏叶冻干粉针剂及其制备方法 Download PDF

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CN109350630A
CN109350630A CN201811289620.6A CN201811289620A CN109350630A CN 109350630 A CN109350630 A CN 109350630A CN 201811289620 A CN201811289620 A CN 201811289620A CN 109350630 A CN109350630 A CN 109350630A
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宋育刚
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Abstract

本发明公开了一种注射用银杏叶冻干粉针剂，其方法是取干燥银杏叶，粉碎成提取液备用，残渣加入残渣质量5倍体积量的60％乙醇回流提取2次提取液合并，滤过，浓缩至70℃时相对密度1.20‑1.30的溶液，上清液调节pH值4；取上述上清液洗脱至无色，洗脱液弃去，洗脱液回收乙醇至尽，加入水饱和乙酸乙酯萃取备用；水液层调节pH值至8，用水饱和正丁醇萃取两次，调节pH值至10上清液调节pH值至5，继续浓缩，加入乙醇使乙醇达到10％，加入0.4％活性炭，煮沸，滤过，得到银杏叶提取提取物；取上述银杏叶提取物60重量份，加入冻干赋形60重量份，调节PH值，过滤，冷冻干燥，得到银杏叶冻干粉针剂。

Description

一种注射用银杏叶冻干粉针剂及其制备方法
技术领域
本发明属于中药制药技术领域，具体涉及一种注射用银杏叶冻干粉针剂及其制备方法
背景技术
临床及药理研究发现银杏叶提取物具有增强心功能、改善微循环、降低血液粘稠性、拮抗血小板活化因子(PAF)，清除体内自由基及明显的纤维蛋白原溶解，抑制血流再灌注后的损伤，增强心脏细胞对缺血的耐受能力等。在国外尤其是德国、法国已有一定量银杏叶提取物应用于临床并证明了其效果，目前已发展到欧、亚、美等几十个国家。目前国内外利用银杏叶提取物开发出了许多能有效治疗与预防心脑血管、周边血管、神经系统、泌尿系统疾病的药物与保健食品，银杏叶提取物及其制剂已在临床与人们的生活中有了一定的应用，但应用程度不高，银杏制剂主要作为辅助药物用于临床，主要原因是银杏叶提取物质量标准中有效成分量偏低，影响了疗效。如国际上通用的EGB761银杏叶提取物质量标准中以银杏黄酮苷24％、萜内酯6％为质量指标，用银杏黄酮苷24％、萜内酯6％作为银杏叶提取物的有效成分限度是偏低的，不能满足临床的疗效要求。造成银杏叶提取物有效成分含量偏低的原因同银杏叶提取物的生产工艺有很大关系。已报道的银杏叶提取物现有工艺技术有：树脂吸附纯化法、热浸法、微波提取法、二氧化碳超临界提取法等。现有技术存在的主要问题：提取的有效成分总量不高、工艺路线不够合理或工业化条件不具备等。
发明内容
本发明的目的是一种注射用银杏叶冻干粉针剂，具有增强心功能、改善微循环的作用。
为了达到上述目的，本发明是通过以下技术方案实现的：(1)取干燥银杏叶，粉碎成2mm，加入银杏叶质量10倍体积量的60％乙醇，浸泡2小时，回流提取2小时，提取液备用，残渣加入残渣质量5倍体积量的60％乙醇回流提取2次，每次1.5小时，提取液合并，滤过，回收乙醇至尽，浓缩至70℃时相对密度1.20-1.30的溶液，搅拌加入浓缩液2倍体积的10％乙醇，静置30分钟，离心，上清液搅拌加入1％壳聚糖溶液，加入体积为上清液体积的1/20，静置60分钟，离心，上清液调节pH值4；
(2)取上述上清液上D101大孔树脂，10％乙醇洗脱，流速2倍柱体积/小时，至无色，洗脱液弃去，用70％乙醇继续洗脱，流速2倍柱体积/小时，洗脱液回收乙醇至尽，加入水饱和乙酸乙酯萃取2次，乙酸乙酯液层回收溶剂，备用；水液层调节pH值至8，用水饱和正丁醇萃取两次，正丁醇液层回收溶剂弃去，水层继续浓缩，用85％乙醇溶解，调节pH值至10，静置30分钟，离心，上清液调节pH值至5，回收乙醇至尽，与乙酸乙酯萃取有机相浓缩液合并，继续浓缩，加入乙醇使乙醇达到10％，加入0.4％活性炭，煮沸，滤过，滤液浓缩至相对密度1.25，减压干燥，得到银杏叶提取提取物；
(3)取上述银杏叶提取物60重量份，加注射用水溶解完全，加入冻干赋形60重量份，调节PH值，0.22微米滤芯过滤，冷冻干燥，得到银杏叶冻干粉针剂。
通过上述药理实验表明，本申请银杏叶冻干粉针剂比市售银杏叶注射制剂具有更好的药理作用。
制备实施例
下面结合实施例对本发明作进一步说明。
实施例1：
(1)取干燥银杏叶，粉碎成2mm，加入银杏叶质量10倍体积量的60％乙醇，浸泡2小时，回流提取2小时，提取液备用，残渣加入残渣质量5倍体积量的60％乙醇回流提取2次，每次1.5小时，提取液合并，滤过，回收乙醇至尽，浓缩至70℃时相对密度1.20-1.30的溶液，搅拌加入浓缩液2倍体积的10％乙醇，静置30分钟，离心，上清液搅拌加入1％壳聚糖溶液，加入体积为上清液体积的1/20，静置60分钟，离心，上清液调节pH值4；
(2)取上述上清液上D101大孔树脂，10％乙醇洗脱，流速2倍柱体积/小时，至无色，洗脱液弃去，用70％乙醇继续洗脱，流速2倍柱体积/小时，洗脱液回收乙醇至尽，加入水饱和乙酸乙酯萃取2次，乙酸乙酯液层回收溶剂，备用；水液层调节pH值至8，用水饱和正丁醇萃取两次，正丁醇液层回收溶剂弃去，水层继续浓缩，用85％乙醇溶解，调节pH值至10，静置30分钟，离心，上清液调节pH值至5，回收乙醇至尽，与乙酸乙酯萃取有机相浓缩液合并，继续浓缩，加入乙醇使乙醇达到10％，加入0.4％活性炭，煮沸，滤过，滤液浓缩至相对密度1.25，减压干燥，得到银杏叶提取提取物；
(3)取上述银杏叶提取物60重量份，加注射用水溶解完全，加入冻干赋形60重量份，调节PH值，0.22微米滤芯过滤，冷冻干燥，得到银杏叶冻干粉针剂。

Claims (1)

1.一种注射用银杏叶冻干粉针剂，其特征在于它是由下述方法制备而成：
(1)取干燥银杏叶，粉碎成2mm，加入银杏叶质量10倍体积量的60％乙醇，浸泡2小时，回流提取2小时，提取液备用，残渣加入残渣质量5倍体积量的60％乙醇回流提取2次，每次1.5小时，提取液合并，滤过，回收乙醇至尽，浓缩至70℃时相对密度1.20-1.30的溶液，搅拌加入浓缩液2倍体积的10％乙醇，静置30分钟，离心，上清液搅拌加入1％壳聚糖溶液，加入体积为上清液体积的1/20，静置60分钟，离心，上清液调节pH值4；
(2)取上述上清液上D101大孔树脂，10％乙醇洗脱，流速2倍柱体积/小时，至无色，洗脱液弃去，用70％乙醇继续洗脱，流速2倍柱体积/小时，洗脱液回收乙醇至尽，加入水饱和乙酸乙酯萃取2次，乙酸乙酯液层回收溶剂，备用；水液层调节pH值至8，用水饱和正丁醇萃取两次，正丁醇液层回收溶剂弃去，水层继续浓缩，用85％乙醇溶解，调节pH值至10，静置30分钟，离心，上清液调节pH值至5，回收乙醇至尽，与乙酸乙酯萃取有机相浓缩液合并，继续浓缩，加入乙醇使乙醇达到10％，加入0.4％活性炭，煮沸，滤过，滤液浓缩至相对密度1.25，减压干燥，得到银杏叶提取提取物；
(3)取上述银杏叶提取物60重量份，加注射用水溶解完全，加入冻干赋形60重量份，调节PH值，0.22微米滤芯过滤，冷冻干燥，得到银杏叶冻干粉针剂。
CN201811289620.6A 2018-10-31 2018-10-31 一种注射用银杏叶冻干粉针剂及其制备方法 Withdrawn CN109350630A (zh)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117419990A (zh) * 2023-10-27 2024-01-19 安徽合森医学检验有限公司 一种环保型无醛组织固定液

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117419990A (zh) * 2023-10-27 2024-01-19 安徽合森医学检验有限公司 一种环保型无醛组织固定液

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