CN115337265B - 一种兽用药品—枇杷叶提取物注射液的研制 - Google Patents
一种兽用药品—枇杷叶提取物注射液的研制 Download PDFInfo
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Abstract
本发明属于兽药技术领域，具体涉及一种兽用的枇杷叶提取物注射液及其制备方法。该枇杷叶提取物注射液是由以下重量份原料组成：枇杷叶提取物1‑3份、良性溶媒5‑15份，油性助溶剂5‑15份，表面活性剂2.0‑5.0，止痛剂0.5‑1份，水溶性分散剂60‑92份，所制备的枇杷叶提取物注射液为棕褐色澄明液体，无可见异物。本发明研制了一种由良性溶媒，油性助溶剂与水溶性分散溶媒形成的三元两亲性体系，对复杂的中药提取物中各成分，因其不同极性对溶解度的不同的要求，提供了充分保障，该注射液经长期留样，稳定性良好，主成分含量均一且无明显改变，为临床治疗提供了技术保障。本研究开发的处方溶媒体系，同样为其他中药提取物注射液的研究，提供了一条全新的思路。
Description
技术领域
本发明属于兽药技术领域，具体涉及一种兽用药品枇杷叶提取物注射液及其制备方法。
背景技术
枇杷叶为蔷薇科植物枇杷的叶子，性微寒，味苦，具有清肺止咳，和胃降逆，止渴之功效。国内外对枇杷叶的化学成分和药理作用进行了较多研究,已成功分离了挥发油、三萜类、倍半萜类、黄酮类及多酚等多种活性成分，其中，三萜酸类化合物如齐墩果酸、熊果酸，山楂酸、科罗索酸等，作为枇杷叶主要药理活性成分因具有广泛的药理活性而被广泛研究并成功应用于抗感染等临床实践中中华人民共和国药典2020版一部枇杷叶项下，熊果酸和齐墩果酸为枇杷叶的双质控指标，含量占比较大，二者性质稳定，具有良好的定量线性关系。然而，三萜酸类化合物水溶性差，口服生物利用度低，不具有体内靶向性的特殊官能团，开发成注射液，无疑是最理想的给药形式。本发明采用一种混合溶媒系统，并利用提取物自身成分间相互促溶的理化性质成功研制了枇杷叶提取物注射液，本产品不仅大大增加了枇杷叶提取物的溶解性，且三萜酸类化合物含量高，稳定性好，药物体内生物利用度增强，根据稳定性检测结果，本发明所开发的注射液，有效期至少为24个月，可长期贮存，具有十分广阔的市场开发前景，并为中药提取物注射液的研制，奠定了一定的制剂工艺基础。
发明内容
针对现有技术存在的问题，本发明提供了一种兽用药品枇杷叶提取物注射液的制备方法。该注射液以中药枇杷叶提取物与适宜的辅料配制而成。
本发明为了实现上述目的所采用的技术方案为：
本发明提供了一种兽用药品枇杷叶提取物注射液，其每100ml注射液中，含有枇杷叶提取物2份，良性溶媒transcutolp10份，油性分散液中链甘油酸酯30份，，30g，聚山梨酯801份，苯甲醇1份，聚乙烯醇400 60份g。
本发明提供了枇杷叶提取物注射液的制备方法，具体步骤为：采用溶解法，加入枇杷叶提取物于transcutolp中，40℃20HZ持续搅拌至充分溶解，依次加入中链甘油酸酯，苯甲醇溶液，PEG400定容至处方全量，最终形成均一溶液体系，搅拌混匀，室温，放冷，滤过，灭菌，分装，即得。
本发明所使用良性溶媒为transcutolp。
本发明所使用良性溶媒，油性助溶剂，水溶性分散液质量比为1:3:6.5。
本发明的有益效果为：
(1) 本发明制备工艺所得的枇杷叶提取物注射液，为两亲性混合溶媒体系制备的枇杷叶提取物注射液，可明显提高枇杷叶提取物溶解性，有效成分含量稳定，安全绿色，能够提高动物的免疫力且未检出药物残留量。
（2）本发明制备的产品使用两亲性混合溶媒体系，可充分保证中药提取物中复杂成分不同溶解度要求，能够提升药物的贮存稳定性，减缓药物的局部组织的代谢速度，使药效长效持久。经药效学验证，采用的中链甘油酸酯可有效增加药物在体内的吸收，提高疗效。
具体实施方式
具体实施方式下面通过具体的实施例对本发明的技术方案作进一步比较、解释和说明。显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。
实施例1
枇杷叶提取物2g，transcutolp10g，中链甘油酸酯30g，苯甲醇1g，聚山梨酯80 1g，PEG400加至100g，过滤，灭菌，灌装，即得。其中枇杷叶提取物中主成分齐墩果酸的含量为89.2mg/ml。
实施例2
枇杷叶提取物2g，transcutolp5g，中链甘油酸酯30g，苯甲醇1g，聚山梨酯80 1g，PEG400加至100g，过滤，灭菌，灌装，即得。其中枇杷叶提取物中主成分齐墩果酸的含量为81.4mg/ml。
实施例3
枇杷叶提取物2g，transcutolp15g，中链甘油酸酯30g，苯甲醇1g，聚山梨酯80 1g，PEG400加至100g，过滤，灭菌，灌装，即得。其中枇杷叶提取物中主成分齐墩果酸的含量为88.7mg/ml
实施例4
枇杷叶提取物2g，transcutolp10g，中链甘油酸酯20g，苯甲醇1g，聚山梨酯80 1g，PEG400加至100g，过滤，灭菌，灌装，即得。其中枇杷叶提取物中主成分齐墩果酸的含量为83.6mg/ml
实施例5
枇杷提取物2g，transcutolp10g，中链甘油酸酯40g，苯甲醇1g，聚山梨酯80 1g，PEG400加至100g，过滤，灭菌，灌装，即得。其中枇杷叶提取物中主成分齐墩果酸的含量为75.3mg/ml
实施例6
枇杷提取物4g，transcutolp10g，中链甘油酸酯30g，苯甲醇1g，聚山梨酯80 1g，PEG400加至100g，过滤，灭菌，灌装，即得。其中枇杷叶提取物中主成分齐墩果酸的含量为86.7mg/ml
实施例7
枇杷提取物2g，transcutolp10g，中链甘油酸酯30g，苯甲醇1g，聚山梨酯80 0.5g，PEG400加至100g，过滤，灭菌，灌装，即得。其中枇杷叶提取物中主成分齐墩果酸的含量为84.7mg/ml
实施例8
枇杷提取物2g，transcutolp10g，中链甘油酸酯40g，苯甲醇1g，聚山梨酯80 5g，PEG400加至100g，过滤，灭菌，灌装，即得。其中枇杷叶提取物中主成分齐墩果酸的含量为83.1mg/ml
试验例l
枇杷提取物2g，transcutolp10g，，苯甲醇1g，聚山梨酯80 1g，中链甘油酸酯加至100g，过滤，灭菌，灌装，即得，其中枇杷叶提取物中主成分齐墩果酸的含量为74.3mg/ml。
试验例2
枇杷提取物2g，transcutolp10g，苯甲醇1g，聚山梨酯80 1g，PEG400加至100g，最终制得的枇杷叶提取物注射液未完全溶解。
表1 两亲性溶媒体系中枇杷叶提取物质量监测
结论：枇杷叶提取物中皂苷化合物的存在，经试验考察，对三萜类化合物具有一定的增溶作用，本研究中，良性溶媒，油性助溶剂与水溶性分散溶媒形成三元两亲性体系，且表面活性剂为此三元体系的构建起到了关键的支撑，为保证中药提取物中复杂成分的不同极性及溶解度的需要，提供了充分保障，经实施例考察，三元体系缺一不可，且任何混合体系均有固定的承载范围及溶解限度，过高过低，主成分含量都会受到明显影响，更重要的是三元体系缺一不可，表面活性剂的加入量也同样十分关键，否则含量下降明显，甚至枇杷叶提取物无法溶解综合上述结果，本发明研制了一种三元两亲性溶媒体系，可高效的溶解枇杷叶提取物，突显了混合溶媒体系对提取物独特的承载优势，此溶媒体系具有超强的溶解性能，使得注射液在长期留样中主成分含量均一和稳定，为临床治疗提供了技术保障。为其他中药提取物注射液的研究提供了一条新的研制思路。
以上所述，仅为本发明较佳的具体实施方式，但本发明的保护范围并不局限于此，任何熟悉本技术领域的技术人员在本发明揭露的技术范围内，根据本发明的技术方案及其发明构思加以等同替换或改变，都应涵盖在本发明的保护范围之内。
Claims (4)
1.一种兽用药品枇杷叶提取物注射液，其特征在于，该枇杷叶提取物注射液是由以下重量份原料组成：枇杷叶提取物1-3份，transcutolp 5-15份，中链甘油酸酯5-15份，聚山梨酯80 2.0-5.0份，苯甲醇0.5-1份，PEG-400 60-92份。
2.根据权利要求1所述的枇杷叶提取物注射液，其特征在于，所述枇杷叶提取物注射液中枇杷叶提取物为香花枇杷叶提取物，三萜类化合物总含量不低于2％，皂苷含量不低于0.5％。
3.根据权利要求1所述的枇杷叶提取物注射液，其特征在于，所述枇杷叶与transcutolp，中链甘油酸酯和PEG-400的比例为0.1:0.5:1:3-0.2:2:6:12。
4.根据权利要求1所述的一种兽用药品枇杷叶提取物注射液的制备方法，其中制备温度为35～45℃，搅拌速度为15-50HZ；所制备的枇杷叶提取物注射液为棕褐色澄明液体，无可见异物，室温，避光，有效期24个月。
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| CN1640885A (zh) * | 2004-01-08 | 2005-07-20 | 中国科学院上海药物研究所 | 一种枇杷叶总三萜酸及其制备方法和用途 |
| CN1939443A (zh) * | 2006-09-21 | 2007-04-04 | 福州大学 | 一种枇杷叶提取物的制备方法与用途 |
| CN101991532A (zh) * | 2009-08-14 | 2011-03-30 | 上海开拓者医药发展有限公司 | 一种自微乳组合物、一种微乳，及它们的制备方法 |
| CN107137437A (zh) * | 2017-05-17 | 2017-09-08 | 福建中医药大学 | 一种细梗香草总皂苷自微乳液及其制备方法 |
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| CN1939443A (zh) * | 2006-09-21 | 2007-04-04 | 福州大学 | 一种枇杷叶提取物的制备方法与用途 |
| CN101991532A (zh) * | 2009-08-14 | 2011-03-30 | 上海开拓者医药发展有限公司 | 一种自微乳组合物、一种微乳，及它们的制备方法 |
| CN107137437A (zh) * | 2017-05-17 | 2017-09-08 | 福建中医药大学 | 一种细梗香草总皂苷自微乳液及其制备方法 |
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