CN104547008B - 一种鸡血藤镇痛剂的制备方法 - Google Patents
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Abstract
本发明公开了一种鸡血藤镇痛剂的制备方法，包括以下步骤：将鸡血藤药材粉碎，用水煎煮2次，每次1‑2小时，浓缩，静置；过滤，弃沉淀；将鸡血藤滤液，加蒸馏水稀释，进行膜分离；收取得到UF‑100，UF‑50、UF‑10、UF‑5共4段膜分离液，真空冷冻干燥，得冻干粉；将UF‑100、UF‑50、UF‑10、UF‑5的冻干粉及混合比例为UF‑100:UF‑50:UF‑10:UF‑5=5:3:1:1的混合冻干粉分别加入常规辅料，按常规技术制成各种制剂。本发明所提供的鸡血藤镇痛剂的制备方法具有安全、环保无毒、工艺简单的特点。
Description
技术领域
本发明属于生物医药技术领域,具体涉及一种鸡血藤镇痛剂的制备方法。
背景技术
鸡血藤药典收录为密花豆（Spatholobus suberectus Dunn）的干燥藤茎，生于林中或灌林中，分布广西、广东、云南、贵州等地。因其藤汁殷红，似鸡血而得名。其药用已有上千年历史,是传统中药中一味典型的活血化瘀药，中医认为其是强壮性补血药，有去淤血，生新血，流利筋脉的功效，可用于治疗腰膝酸痛、麻木瘫痪、血虚萎黄、闭经、月经不调等症（中药大辞典，1986）。
膜分离技术制备中药制剂是应用不对称结构的高分子膜（Marcel Muider.膜技术基本原理第二版[M].北京:清华大学出版社,1999.），将中药浸出液中有效部位或有效成分与杂质加以分离的技术将其应用于中药的分离浓缩。据此原理可选择不同孔径和截留不同分子量的膜对中药复方提取物进行分子量分段分离，达到成分分离的目的。
膜分离技术的应用可以改善中药生产落后的现状，在中药生产中常用于滤除中药水提液中的大分子量杂质、保留并浓缩部分中药中的有效成分、精制小分子量中药制剂等。而目前将膜分离技术及冷冻干燥技术，联合用于鸡血藤水提液的分离、浓缩的研究尚未见报道。
发明内容
本发明的目的在于提供一种安全、环保无毒、工艺简单的鸡血藤镇痛剂的制备方法。
本发明的一种鸡血藤镇痛剂的制备方法，包括以下步骤：
（1）将鸡血藤药材1kg粉碎，用5-10倍水煎煮2次，每次1-2小时，浓缩至密度为0.8-1.0，静置24小时；
（2）过滤，弃沉淀；
（3）将鸡血藤滤液，加蒸馏水5-10倍稀释，进行膜分离，膜分离参数为：温度：30-35℃；压力：超滤膜0.1-0.2Mpa，纳滤膜0.2-0.3Mpa；
（4）收取得到UF-100，UF-50、UF-10、UF-5共 4段膜分离液，真空冷冻干燥，得冻干粉；
（5）将UF-100、UF-50、UF-10、UF-5的冻干粉及混合比例为UF-100:UF-50:UF-10:UF-5=5:3:1:1的混合冻干粉分别加入常规辅料，按常规技术制成各种制剂。
本发明与现有技术相比，具有明显有益效果，从以上技术方案可知：本发明所提供的鸡血藤镇痛剂的制备方法，采用微滤、超滤和纳滤三级分离，替代传统的水溶醇沉工艺，改善传统工艺中的活性成分损失大、周期长、能耗高等缺点；通过不同的膜截留不同的分子量部分，富集不同分子量物质；再利用冷冻干燥技术，干燥截留液，所得的冻干粉色泽好，形态疏松，容易成型，简化了制剂工艺，可工业化生产。
具体实施方式
下面通过实验例和实施例进一步说明本发明的有益效果。
实验例
分别将UF-100，UF-50，UF-10，UF-5冻干粉制剂及混合比例为UF-100:UF-50:UF-10:UF-5=5:3:1:1的混合冻干粉制剂进行小鼠醋酸扭体镇痛实验，具体实验如下：
将小鼠随机分成7组，每组雌雄各半，为UF-100、UF-50、UF-10、UF-5、混合比例为UF-100:UF-50:UF-10:UF-5=5:3:1:1的混合冻干粉制剂共5个给药组、阿司匹林组及生理盐水组，每组12只小鼠。阿司匹林（0.2g/ml）组、5个给药组分别用0.2g/ml相应的膜截留液冻干粉溶液灌胃，每组均按0.2ml/10g体重的体积灌胃给药，连续3d。于末次给药60min后，各组动物均腹腔注射0.6%的醋酸溶液0.2ml。观察并记录注射醋酸后15min内出现的扭体反应的次数及小鼠扭体潜伏期，即从注射醋酸到第1次出现扭体的时间，若15min未见扭体，其潜伏期按15min,记录实验结果。
实验数据用表示，各给药组与生理盐水组之间的比值采用t检验，各浓度间用SPSS 12.0分析软件进行数据分析。实验结果见表1。
抑制率%=（对照组扭体次数-给药组扭体次数）/对照组扭体次数×100%
试验结果显示：阿司匹林、UF-100制剂、UF-50制剂、UF-10制剂、UF-5制剂对小鼠有镇痛作用，与对照组比较均有极显著差异（P<0.01）；UF-100制剂、UF-50制剂、UF-10制剂、UF-5制剂的镇痛效果略小于阿司匹林，而4种冻干粉混合物的镇痛效果则优于阿司匹林；从分子量段分析，可初步断定鸡血藤中的镇痛成分是分子量大于5000的大分子化合物。
计量取决于所要达到的效果，治疗时间及给药方式；以人用鸡血藤生药材的计量及有效计量为参考，这些计量一般是成人每天口服含UF-100，UF-50，UF-10，UF-5及4段混合冻干粉的活性成分60mg。
实施例1：
一种鸡血藤镇痛颗粒剂的制备方法，包括以下步骤：
（1）将鸡血藤药材1kg粉碎，用5倍水煎煮2次，每次2小时，浓缩至密度为1.0，静置24小时；
（2）过滤，弃沉淀；
（3）将鸡血藤滤液，加蒸馏水10倍稀释，进行膜分离，膜分离参数为：温度：30℃；压力：超滤膜0.2Mpa，纳滤膜0.2Mpa；
（4）收取得到UF-100，UF-50、UF-10、UF-5共 4段膜分离液，真空冷冻干燥，得冻干粉；
（5）以含活性化合物60mg的颗粒剂计，UF-100，UF-50、UF-10、UF-5及UF-100:UF-50:UF-10:UF-5=5:3:1:1的混合冻干粉各60mg，分别加入糊精1540mg、蔗糖8400mg，按常规技术分别制成颗粒剂。
实施例2：
一种鸡血藤镇痛胶囊剂的制备方法，包括以下步骤：
（1）将鸡血藤药材1kg粉碎，用10倍水煎煮2次，每次1小时，浓缩至密度为0.8，静置24小时；
（2）过滤，弃沉淀；
（3）将鸡血藤滤液，加蒸馏水5倍稀释，进行膜分离，膜分离参数为：温度：35℃；压力：超滤膜0.1Mpa，纳滤膜0.3Mpa；
（4）收取得到UF-100，UF-50、UF-10、UF-5共 4段膜分离液，真空冷冻干燥，得冻干粉；
（5）以含活性化合物60mg的胶囊剂计，UF-100，UF-50、UF-10、UF-5及混合比例为UF-100:UF-50:UF-10:UF-5=5:3:1:1的混合冻干粉各60mg，分别加入淀粉135mg、滑石粉35mg、羧甲淀粉钠30mg、磷酸氢钠、25mg、硬脂酸镁15mg，按常规技术分别制成胶囊剂。
实施例3：
一种鸡血藤镇痛片剂的制备方法，包括以下步骤：
（1）将鸡血藤药材1kg粉碎，用7.5倍水煎煮2次，每次1.5小时，浓缩至密度为0.9，静置24小时；
（2）过滤，弃沉淀；
（3）将鸡血藤滤液，加蒸馏水7.5倍稀释，进行膜分离，膜分离参数为：温度：32.5℃；压力：超滤膜0.15Mpa，纳滤膜0.25Mpa；
（4）收取得到UF-100，UF-50、UF-10、UF-5共 4段膜分离液，真空冷冻干燥，得冻干粉；
（5）以活性化合物60mg的片剂计，UF-100，UF-50、UF-10、UF-5及混合比例为UF-100:UF-50:UF-10:UF-5=5:3:1:1的混合冻干粉各60mg，分别加入淀粉33mg、糊精15mg、羧甲淀粉钠6mg、硬脂酸镁45mg、羧甲基纤维素钠45mg、淀粉浆18% 100mg，按常规技术分别制成片剂。
以上所述，仅是本发明的较佳实施例而已，并非对本发明作任何形式上的限制，任何未脱离本发明技术方案内容，依据本发明的技术实质对以上实施例所作的任何简单修改、等同变化与修饰，均仍属于本发明技术方案的范围内。
Claims (1)
1.一种鸡血藤镇痛剂的制备方法，包括以下步骤：
（1）将鸡血藤药材1kg粉碎，用5-10倍水煎煮2次，每次1-2小时，浓缩至密度为0.8-1.0，静置24小时；
（2）过滤，弃沉淀；
（3）将鸡血藤滤液，加蒸馏水5-10倍稀释，进行膜分离，膜分离参数为：温度：30-35℃；压力：超滤膜0.1-0.2Mpa，纳滤膜0.2-0.3Mpa；
（4）收取得到UF-100，UF-50、UF-10、UF-5共 4段膜分离液，真空冷冻干燥，得冻干粉；
（5）将UF-100、UF-50、UF-10、UF-5的冻干粉及混合比例为UF-100:UF-50:UF-10:UF-5=5:3:1:1的混合冻干粉分别加入常规辅料，按常规技术制成各种制剂。
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