WO2021223397A1 - 治疗新型冠状病毒肺炎的中药组合物、制备方法、检测方法及其用途 - Google Patents
治疗新型冠状病毒肺炎的中药组合物、制备方法、检测方法及其用途 Download PDFInfo
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Abstract
Description
原料药材中橙皮苷实测含量 | 橙皮苷转移率 |
(mg/g) | (%) | |
实施例7 | 46.95 | 48.77% |
对比例2 | 46.95 | 40.34% |
Claims (10)
- 一种治疗新型冠状病毒肺炎的中药组合物,其特征在于,按重量份计,所述中药组合物主要由以下重量份配比的原料制成:陈皮250-400份、苍术100-200份、厚朴100-200份、甘草200-300份、藿香200-300份、石菖蒲200-300份、大枣250-330份和生姜100-200份;优选的,所述中药组合物主要由以下重量份配比的原料制成:陈皮270-350份、苍术130-175份、厚朴130-175份、甘草200-260份、藿香200-260份、石菖蒲200-260份、大枣280-330份和生姜150-180份;更优选的,所述中药组合物主要由以下重量份配比的原料制成:陈皮340.9份、苍术170.5份、厚朴170.5份、甘草255.7份、藿香255.7份、石菖蒲255.7份、大枣318.2份和生姜163.6份。
- 根据权利要求1所述的中药组合物,其特征在于,还包含500-700重量份的辅料;优选的,所述辅料为填充剂;更优选的,所述填充剂为糊精、可溶性淀粉或乳糖。
- 根据权利要求1或2所述的中药组合物,其特征在于,所述中药组合物为口服液、颗粒剂、散剂、滴丸剂、胶囊剂、泡腾剂或片剂。
- 权利要求1或2所述中药组合物的制备方法,其特征在于,包括以下步骤:将所述重量份配比的原料加水浸润后,煎煮提取,过滤获得提取液,减压浓缩,喷雾干燥,获得喷干粉;加粘合剂混合,湿法制粒;优选的,所述中药组合物的制备方法,包括以下步骤:(1)按重量份比例称取各原料组分;(2)加入15倍重量份的水,浸润0.5小时后,煎煮提取2次,每次0.5小时,合并煎液,过滤获得提取液备用;(3)将步骤(2)中的提取液在70℃减压浓缩至50℃测相对密度为1.10-1.20g/mL的浓缩液;(4)取步骤(3)中的浓缩液,喷雾干燥,获得喷干粉;(5)取步骤(4)中的喷干粉加糊精混合,湿法制粒。
- 权利要求1或2所述中药组合物的制备方法,其特征在于,包括以下步骤:将所述重量份配比的原料用水蒸气蒸馏法提取,同时收集挥发油;煎液过滤残渣后获得提取液;提取液减压浓缩后经喷雾干燥,得到喷干粉;挥发油加无水乙醇溶液,用β-环糊精水溶液包合制备环糊精包合物;将喷干粉和挥发油包合物加粘合剂混合,湿法制粒。
- 根据权利要求5所述的中药组合物的制备方法,其特征在于,所述水蒸气蒸馏法中加入8-15倍量的水提取挥发油,提取2-3次,将每次获得的提取液合并后,用于下一步骤;优选的,在所述β-环糊精水溶液中,β-环糊精的重量为挥发油重量的8-12倍,水的重量为β-环糊精的重量的10-20倍;优选地,β-环糊精的重量为挥发油重量的10倍,水的重量为β-环糊精的重量的15倍。
- 权利要求1或2所述的中药组合物的质量检测方法,其特征在于,包括橙皮苷薄层色谱定性鉴别和橙皮苷的含量测定,优选的,还包括6-姜辣素、甘草和厚朴酚的薄层色谱定性鉴别。
- 根据权利要求7所述的中药组合物的质量检测方法,其特征在于,薄层色谱定性鉴别包括:(1)取所述中药组合物制成的颗粒粉末2g,加水25ml溶解,用乙酸乙酯振摇提取2 次,每次20ml,合并提取液,挥干,残渣加甲醇1ml溶解,作为供试品溶液;另取橙皮苷对照品,加甲醇制成饱和溶液,作为对照品溶液;照薄层色谱法试验,吸取供试品溶液2-5μl,吸取对照品溶液5μl,分别点于同一硅胶G薄层板上,以体积比20:3:2的乙酸乙酯-甲醇-水为展开剂,展开,取出,晾干,喷5%三氯化铝乙醇溶液,在105℃加热5~10min,置紫外灯365nm下检视;供试品色谱中,在与对照药材色谱相应的位置上,显相同颜色的斑点;(2)取(1)中的供试品溶液作为供试品,另取6-姜辣素对照品,加乙酸乙酯制成每1ml含1mg的溶液,作为对照品溶液;照薄层色谱法试验,吸取供试品溶液3-10μl,吸取对照品溶液1μl,分别点于同一硅胶G薄层板上;以体积比2:1:1的石油醚(60~90℃)-三氯甲烷-乙酸乙酯为展开剂,展开,取出,晾干,喷2%香草醛硫酸溶液,在105℃加热至斑点显色清晰;供试品色谱中,在与对照品色谱相应的位置上,显相同颜色的斑点;(3)取所述中药组合物制成的颗粒3g,加水40ml溶解,用正丁醇振摇提取3次,每次20ml,合并正丁醇液,每次20ml,正丁醇液蒸干,残渣加甲醇1ml溶解,作为供试品溶液;另取甘草对照药材1g,加水40ml回流1h,放凉,过滤,用正丁醇振摇提取3次,每次20ml,合并正丁醇液,每次20ml,正丁醇液蒸干,残渣加甲醇1ml使溶解,作为对照品溶液;照薄层色谱法试验,吸取上供试品溶液2-5μl,对照药材溶液5μl,分别点于硅胶G薄层板上,以体积比为15:1:1:2的乙酸乙酯-甲酸-冰醋酸-水为展开剂,展开,取出,晾干,喷10%硫酸乙醇溶液,105℃加热至斑点显色清晰,置紫外光灯365nm下检视;供试品色谱中,在与对照药材色谱相应的位置上,显相同颜色的荧光主斑点;(4)取所述中药组合物制成的颗粒6g,研细,加乙酸乙酯40ml,超声处理30分钟,滤过,滤液蒸干,残渣加甲醇lml使溶解,作为供试品溶液;另取厚朴酚,加甲醇制成每1ml各含1mg的混合溶液,作为对照品溶液;照薄层色谱法试验,吸取供试品溶液10-15μl和对照品溶液5μl,分别点于同一硅胶G薄层板上,以体积比18:3:1的甲苯-乙酸乙酯-甲醇为展开剂,展开,取出,晾干,喷1%香草醛硫酸溶液,在105℃加热至斑点显色清晰;供试品色谱中,在与对照品色谱相应的位置上,显相同颜色的斑点。
- 根据权利要求7或8所述的中药组合物的质量检测方法,其特征在于,采用高效液相色谱法进行橙皮苷的含量测定:以十八烷基硅烷键合硅胶为填充剂;以体积比乙腈:0.1%磷酸溶液=19:81为流动相;检测波长为283nm,流速为1.0ml/min;理论板数按橙皮苷峰计算应不低于2000;对照品溶液的制备:取橙皮苷对照品适量,精密称定,加甲醇制成每1ml含15μg的溶液,即得;供试品溶液的制备:取所述中药组合物,研细,过五号筛,取0.3g,精密称定,置具塞锥形瓶中,精密加入10%甲醇50ml,称定重量,超声处理30分钟,放冷,再称定重量,用甲醇补足减失的重量,摇匀,滤过,取续滤液,即得;测定法:分别精密吸取对照品溶液与供试品溶液各10μl,注入液相色谱仪,测定,即得;本组合物颗粒每1g含陈皮以橙皮苷(C 28H 34O 15)计,不得少于2.325mg。
- 权利要求1至3中任一项所述的中药组合物在制备治疗寒湿症,特别是病毒性肺炎的药物中的用途;优选地,所述的中药组合物在制备治疗新型冠状病毒肺炎的药物中的用途。
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CN114588134A (zh) * | 2022-03-04 | 2022-06-07 | 湖南润农生态茶油有限公司 | 一种用于预防和辅助治疗呼吸道疾病的中药组合物雾化液和应用 |
CN115097058A (zh) * | 2022-06-24 | 2022-09-23 | 广西新桂环保科技集团有限公司 | 南酸枣的薄层色谱鉴别方法 |
CN115792041A (zh) * | 2022-12-28 | 2023-03-14 | 中山市中智药业集团有限公司 | 一种同时测定陈皮挥发性成分含量的方法及其应用 |
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CN112043804A (zh) * | 2020-08-19 | 2020-12-08 | 广东一方制药有限公司 | 化湿败毒颗粒及其制备方法和抗病毒药物 |
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CN115097058A (zh) * | 2022-06-24 | 2022-09-23 | 广西新桂环保科技集团有限公司 | 南酸枣的薄层色谱鉴别方法 |
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CN115792041A (zh) * | 2022-12-28 | 2023-03-14 | 中山市中智药业集团有限公司 | 一种同时测定陈皮挥发性成分含量的方法及其应用 |
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