CN115120563A - 一种姜黄素与青蒿素组合纳米粒及其制备方法 - Google Patents
一种姜黄素与青蒿素组合纳米粒及其制备方法 Download PDFInfo
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Abstract
本发明涉及姜黄素与青蒿素组合纳米粒及其制备方法。本发明制剂处方中重量百分比计含有40‑60％的姜黄素、40‑60％的青蒿素、1‑20％的稳定剂，所制得的姜黄素与青蒿素组合为共无定形纳米粒。本发明采用溶剂蒸发结合高压均质制备姜黄素与青蒿素组合纳米粒，提高其溶出，且制备过程药物含量高，易于放大。
Description
技术领域
本发明涉及医药技术领域，具体涉及一种姜黄素与青蒿素组合纳米粒及其制备方法。
背景技术
姜黄素是一种从姜黄根茎中提取的低分子量疏水性多酚，可用作香料和着色剂。科学研究已经证实，姜黄素具有多种药理活性，如具有一定的抗癌活性，可以诱导细胞凋亡，防止癌细胞转移、侵袭血管等。青蒿素是一种具有内过氧化物桥的倍半萜三氧烷内酯，两千多来一直用于治疗间歇性发烧和疟疾。目前青蒿素也被证实具有抗肿瘤活性。研究表明两药联合运用对抗肿瘤细胞具有效叠加作用。
姜黄素和青蒿素均属于难溶性药物，水溶性极低，难以给药，同时口服生物利用度极低，这些限制了其疗效的发挥。
纳米技术作为一种新兴技术，通过采用湿法球磨或高压均质等方法可使药物活性成分粒径减小到1～1000nm，纳米药物具有比表面积大，饱和溶解度高及溶出速度快等优点，因此可以将难溶性药物制成纳米药物以增加药效。
共无定形药物通常是指药物与另一种药物等以一定的摩尔比形成无定形混合相，且该混合相具有单一的玻璃化转变温度。共无定形药物的形成不需要添加如聚合物等载体，与常规无定形固体分散体相比，其稳定性更强，减少载体所带来副作用。
制备纳米级姜黄素与青蒿素共无定形，通过降低结晶度和减小药物粒径双重作用，预期可提高其溶出速率、改善其生物利用度，为药品的开发提供了更广阔的前景。
发明内容
本发明的目的是提供一种提高溶出速率的姜黄素与青蒿素组合纳米粒及其制备方法。
本发明的姜黄素与青蒿素组合纳米粒，其特征在于：按重量百分比计，其含有40-60％的姜黄素、40-60％的青蒿素、1-20％的稳定剂，所制得的纳米粒为非晶态。
本发明的姜黄素与青蒿素组合纳米粒，其平均粒径约为100～900nm。
本发明的姜黄素与青蒿素组合纳米粒制备方法，包括以下制备步骤：
(1)在搅拌下将姜黄素和青蒿素溶于乙醇中，然后超声形成澄清溶液；
(2)将超声后的溶液加入到旋转蒸发瓶中，调节温度，减压蒸干瓶内的有机溶剂，使制成姜黄素与青蒿素共无定形固体分散体；
(3)将共无定形固体分散体加入含有稳定剂的水中后转移至0～5℃预冷的高压均质机中均质，在1000～1300bar下循环10-20次，制得纳米混悬液；
(4)将制得的纳米混悬液置于冷冻干燥机中干燥后可得姜黄素与青蒿素组合纳米粒。
本发明所述的稳定剂为聚乙烯吡咯烷酮、羟丙甲基纤维素、泊洛沙姆、十二烷基硫酸钠、吐温80、胆酸钠中的一种或多种。
本发明的优点在于：
(1)姜黄素与青蒿素难溶于水，制成共无定形纳米粒后，具有无定形及小粒径双重作用，能够迅速溶解利于其生物利用度提高。
(2)本发明的姜黄素与青蒿素纳米粒制备方法采用溶剂蒸发结合高压均质。制备过程药物含量高，具有工作效率高，易于放大，生产周期短及工艺重现性好等优点。
(3)本发明的纳米粒处方中，经过大量的处方筛选，得到的姜黄素与青蒿素组合纳米粒可以稳定地存在1个月以上，有利于进一步加工。
下面实施例仅对本发明作进一步的详细说明，但应注意本发明的保护范围不应受这些实例的任何限制。
实施例1
将0.046g姜黄素与0.035g青蒿素在搅拌下加入到含有50ml乙醇溶液中，超声至澄清。取旋转蒸发瓶，将超声后的溶液加入到旋转蒸发瓶中，调节温度至50℃，蒸干瓶内的有机溶剂。取旋转蒸发瓶内的固体分散在含有吐温80的水中后转移至0～5℃预冷的高压均质机中均质，在1300bar下循环20次，即得纳米混悬液。将制得的纳米混悬液置于冷冻干燥机中可得姜黄素与青蒿素组合纳米粒。测得纳米粒为无定形态且其平均粒径为373nm。X射线衍射表明其为无定形(非晶态)。
实施例2
将0.050g姜黄素与0.050g青蒿素在搅拌下加入到含有50ml乙醇溶液中，超声至澄清。取旋转蒸发瓶，将超声后的溶液加入到旋转蒸发瓶中，调节温度至50℃，蒸干瓶内的有机溶剂。取旋转蒸发瓶内的固体分散在含有聚乙烯吡咯烷酮的水中后转移至0～5℃预冷的高压均质机中均质，在1200bar下循环20次，即得纳米混悬液。将制得的纳米混悬液置于冷冻干燥机中可得姜黄素与青蒿素组合纳米粒。测得纳米粒为无定形态且其平均粒径为385nm。
实施例3
将0.046g姜黄素与0.035g青蒿素在搅拌下加入到含有50ml乙醇溶液中，超声至澄清。取旋转蒸发瓶，将超声后的溶液加入到旋转蒸发瓶中，调节温度至50℃，蒸干瓶内的有机溶剂。取旋转蒸发瓶内的固体分散在含有胆酸钠的水中后转移至0～5℃预冷的高压均质机中均质，在1300bar下循环20次，即得纳米混悬液。将制得的纳米混悬液置于冷冻干燥机中可得姜黄素与青蒿素组合纳米粒。测得纳米粒为无定形态且其平均粒径为393nm。
Claims (3)
1.一种姜黄素与青蒿素组合纳米粒，其特征在于：按重量百分比计，其含有40-60％的姜黄素、40-60％的青蒿素、1-20％的稳定剂，所制得的纳米粒为非晶态。
2.根据权利要求1所述的姜黄素与青蒿素组合纳米粒，其特征在于包括以下制备步骤：
(1)在搅拌下将姜黄素和青蒿素溶于乙醇中，然后超声形成澄清溶液；
(2)将超声后的溶液加入到旋转蒸发瓶中，调节温度，减压蒸干瓶内的有机溶剂，使制成姜黄素与青蒿素共无定形固体分散体；
(3)将共无定形固体分散体加入含有稳定剂的水中后转移至0～5℃预冷的高压均质机中均质，在1000～1300bar下循环10-20次，制得纳米混悬液；
(4)将制得的纳米混悬液置于冷冻干燥机中干燥后可得姜黄素与青蒿素组合纳米粒。
3.根据权利要求1或2所述的姜黄素与青蒿素组合纳米粒，其特征在于所述稳定剂为聚乙烯吡咯烷酮、羟丙甲基纤维素、泊洛沙姆、十二烷基硫酸钠、吐温80、胆酸钠中的一种或多种。
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| CN111686078A (zh) * | 2020-07-31 | 2020-09-22 | 青岛科技大学 | 槲皮素纳米粒及其制备方法 |
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