CN1064258C - 三七提取物软胶囊及其制备工艺 - Google Patents
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Abstract
本发明为软胶囊剂口服保健食品及制备工艺。每粒产品中含三七提取物10-400毫克，并含有卵磷脂和食用辅料。囊壳中含有明胶10份，甘油3.25-3.35份(重量比)，制备工艺：明胶加适量水完全溶解后加入甘油，搅拌均匀，抽真空脱气后保温静置待用；三七提取物与溶剂相混合后再加入抗氧剂等，搅拌均匀，室温静置；用模具压软胶囊。本发明提供了以三七提取物为主要有效成分的软胶囊保健(功能)食品，食用和携带便利，保健功能强。
Description
本发明涉及含有三七提取物有效剂量的软胶囊剂口服保健(功能)食品及其制备工艺。
三七提取物为黄色粉末，可溶于甲醇、乙醇、水，不溶于乙醚等。具有较明显的调节血脂和免疫调节作用。试验证明：对免疫功能失调及血脂失调的人群有较好的辅助治疗作用。也无毒副作用。
目前，市场上尚未有以三七提取物为主要有效成分的保健(功能)食品，更无相应的软胶囊的食品。
本发明的目的是提供一种三七提取物软胶囊及其制备工艺，产品为保健(功能)食品，其质量稳定，使用方便、有效。
-本发明产品由保健液和囊壳两大部分构成，保健液含有效剂量的三七提取物作为有效成分，并含有食用辅料，其特征是食用辅料包括稀释剂、抗氧剂、助悬剂，囊壳中含有明胶10份，甘油3．25-3．35份(重量比)，保健液按重量每粒含有三七提取物10-400毫克，并还含有卵磷脂。
稀释剂可以是花生油、玉米油、豆油、茶油、色拉油中的一种或几种。
抗氧剂可以是乙二胺四乙酸、乙二胺四乙酸二钠盐、二丁基羟基甲苯、D-木糖、木糖醇、甘氨酸、α-生育酚、α-醋酸生育酚、肌醇、抗坏血酸、抗坏血酸钠、卵磷脂、苹果酸、氢醌、枸橼酸、琥珀酸、植酸、焦亚硫酸钠、焦亚硫酸钾中的一种或几种。
助悬剂可以是乙基羟乙基纤维素、甲壳素、卵磷脂、甲壳糖、甲基纤维素、乙基纤维素、琼脂、黄原胶、羟乙基甲基纤维素、羟乙基纤维素、羟丙基甲基纤维素、羟丙基纤维素、蜂蜡等中的一种或几种。
在研究三七提取物软胶囊的过程中，解决了以下主要难题：
1、囊壳配方(适用于油溶性保健液)
囊壳的配方中明胶、甘油配比难以掌握。甘油的量太多，囊壳较软，比较容易受挤压变形；甘油的量太少，囊壳较硬、脆，影响软胶囊的质量稳定性及崩解时间。我们对囊壳的明胶、甘油的配比进行了详细的试验研究，最后获得了一个较好的配比。
将适量明胶加入不锈钢溶胶罐中，再加入适量水，密闭，70℃保温3小时，再分别加入试验用量的甘油、防腐剂，搅拌，抽真空脱气2小时，放入明胶保温桶中70℃保温静置过夜，第二天，压胶丸，室温干燥，留样考察三个月，考查囊壳外观和物理性能，结果如下：
| 指标／试验内容 | 明胶10kg甘油3.0kg | 明胶10kg甘油3.2kg | 明胶10kg甘油3.25-3.35kg | 明胶10kg甘油3.4kg | 明胶10kg甘油3.6kg |
| 囊壳外观及物理性能 | 太硬、易脆 | 太硬、易脆 | 合适 | 较软、易潮 | 较软、易吸潮 |
说明：所筛选出的囊壳配方适用于温暖潮湿的地方。
通过以上试验，可以得出结论，囊壳的配方中应含有：明胶10份，甘油3．25-3．35份(重量比)。
2、保健液配方
软胶囊的囊壳决定了保健液所用的稀释剂不能是水、乙醇及一些毒性较大的有机溶剂，最为理想的是油脂类物质。但由于三七提取物难以溶于植物油，因此，我们通过大量的试验，选用了一种毒性较小、能够溶解于植物油中、能很好地将三七提取物悬浮于植物油中，并且能够长时间稳定的物质-卵磷脂。
将适量的卵磷脂溶解于适量的植物油中，再将三七提取物加入其中，之后加入合适的抗氧剂以防止软胶囊中的保健液在贮存过程中发生变质(氧化)，胶丸每粒含主药-三七提取物的量是确定的；考虑经济因素及制备方便选定每丸的大小，最终可确定实施例的保健液配方。
本发明产品的最佳配方中应含有：组 份 量(克／粒)三七提取物 0．01-0．5稀释剂 0．06-1．2明胶 0．04-0．5甘油 (明胶量的32．5-33．5％)卵磷脂 0．002-0．022助悬剂 0．005-0．009抗氧剂 0．0007-0．005
注：最佳配方仅为了对本发明作进一步的说明，而本发明产品的范围不受该最佳配方的局限。
三七提取物软胶囊的制备工艺包括以下步骤：
明胶在搅拌状态下加入适量水，待明胶完全溶解后，加入甘油，搅拌均匀，抽真空脱气后保温静置待用：称取三七提取物与配方量的溶剂相混合，待完全混合后再加入抗氧剂等，搅拌均匀，室温静置：
将配好的药液倒入药液斗中，用模具压软胶囊。
本发明的积极效果是提供了以三七提取物为主要有效成分的软胶囊保健(功能)食品，食用和携带便利，保健功能强。
本发明按上述方法制备，其详细组份由下列实施例给出，但本发明的保护范围不局限于此。实施例1组 份 量(克／粒)三七提取物 0．05花生油 0．22明胶 0．11甘油 0．04卵磷脂 0．007α-生育酚 0．0008实施例2组 份 量(克／粒)三七提取物 0．1豆油 0．07明胶 0．05甘油 0．015乙基羟乙基纤维素 0．005卵磷脂 0．005实施例3组 份 量(克／粒)三七提取物 0．02玉米油 0．1明胶 0．05甘油 0．017羟乙基纤维素 0．006α-醋酸生育酚 0．0008卵磷脂 0．003实施例4组 份 量(克／粒)三七提取物 0．1豆油 0．2玉米油 0．1明胶 0．12甘油 0．04卵磷脂 0．006抗坏血酸 0．0008实施例5组 份 量(克／粒)三七提取物 0．2花生油 0．4豆油 0．15明胶 0．17甘油 0．06羟丙基纤维素 0．007α-生育酚 0．0008卵磷脂 0．015实施例6组 份 量(克／粒)三七提取物 0．4色拉油 0．8茶油 0．3明胶 0．4甘油 0．14甲基纤维素 0．009α-醋酸生育酚 0．0008卵磷脂 0．020
以上实施例产品的制备工艺为：
称取明胶加入100L明胶反应罐，在搅拌状态下加入适量水，密闭，待明胶完全溶解后，再加入甘油，搅拌均匀，抽真空脱气2小时，放入明胶保温桶中，保温静置过夜，待用。
于室温下将助悬剂加入植物油中，称取三七提取物，粉碎，过筛，与植物油混合，待完全混匀后再加入抗氧剂等，搅拌均匀，室温静置。
将明胶保温桶悬挂至一定高度，配好的药液倒入漏斗中，换上模具开始压软胶囊，调整软胶囊装量至设计范围，室温干燥二天，剔除外观质量差的胶丸，将胶丸洗涤(去除压丸过程中的润滑油)，再于24℃干燥二天，得灯盏花素软胶囊半成品，质量检测合格后分装、贴签、包装，即得三七提取物软胶囊成品。
Claims (4)
1、一种三七提取物软胶囊，由保健液和囊壳两大部分构成，保健液由作为有效成分的有效剂量的三七提取物和食用辅料组成，其特征是食用辅料包括稀释剂、抗氧剂、助悬剂，囊壳由明胶10份、甘油3．25-3．35份、卵磷脂组成，所述有效剂量是10-400毫克三七提取物／粒软胶囊。
2、如权利要求1所说的三七提取物软胶囊，其特征是：
稀释剂是花生油、玉米油、豆油、茶油、色拉油中的一种或几种，
抗氧剂是乙二胺四乙酸、乙二胺四乙酸二钠盐、二丁基羟基甲苯、D-木糖、木糖醇、甘氨酸、α-生育酚、α-醋酸生育酚、肌醇、抗坏血酸、抗坏血酸钠、卵磷脂、苹果酸、氢醌、枸橼酸、琥珀酸、植酸、焦亚硫酸钠、焦亚硫酸钾中的一种或几种，
助悬剂是乙基羟乙基纤维素、甲壳素、卵磷脂、甲壳糖、甲基纤维素、乙基纤维素、琼脂、黄原胶、羟乙基甲基纤维素、羟乙基纤维素、羟丙基甲基纤维素、羟丙基纤维素、蜂蜡等中的一种或几种。
3、如权利要求2所说的三七提取物软胶囊，其特征是各组分及重量为：组 份 克／粒三七提取物 0．01-0．5稀释剂 0．06-1．2明胶 0．04-0．5甘油 明胶量的32．5-33．5％卵磷脂 0．002-0．022助悬剂 0．005-0．009抗氧剂 0．0007-0．005
4、权利要求1、2或3的三七提取物软胶囊制备工艺，其特征是包括以下步骤：
明胶在搅拌状态下加入适量水，待明胶完全溶解后，加入甘油，搅拌均匀，抽真空脱气后保温静置待用，
称取三七提取物按比例与溶剂混合，待完全混合后再加入抗氧剂等，搅拌均匀，室温静置，
将配好的药液倒入药液斗中，用模具压软胶囊。
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| CN1326518C (zh) * | 2004-03-26 | 2007-07-18 | 石药集团中奇制药技术（石家庄）有限公司 | 逍遥软胶囊及其制备工艺 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1129118A (zh) * | 1995-02-15 | 1996-08-21 | 昆明制药股份有限公司 | 复方三七制剂 |
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| CN1129118A (zh) * | 1995-02-15 | 1996-08-21 | 昆明制药股份有限公司 | 复方三七制剂 |
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| Title |
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| 《中药药剂学》第1版 1986.1.1 曹春霖，上海科技版 * |
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