CN110946831B - 一种中药组合物的制备新工艺 - Google Patents

一种中药组合物的制备新工艺 Download PDF

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CN110946831B
CN110946831B CN201911316244.XA CN201911316244A CN110946831B CN 110946831 B CN110946831 B CN 110946831B CN 201911316244 A CN201911316244 A CN 201911316244A CN 110946831 B CN110946831 B CN 110946831B
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schizonepeta
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许润
周红燕
谢俊
黄春玉
张庆晓
徐向阳
李剑
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Jinling Pharmaceutical Co ltd
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Abstract

本发明公开了一种中药组合物的制备新工艺，包括：按配方取蝉蜕、黄芩、地龙、紫菀、百部、诃子、荆芥、僵蚕；荆芥提取挥发油，以β‑环糊精包合制成挥发油包合物，药渣及残液备用；蝉蜕、黄芩、地龙、紫菀、百部、诃子加60～80％乙醇回流提取2～4次，每次1～3小时，滤过，滤液浓缩；醇提药渣与荆芥药渣、残液，僵蚕合并，加水煎煮2～4次，每次2～3小时，滤过，滤液减压浓缩；将醇提浸膏和水提浸膏混合，加入糊精，真空干燥，粉碎，补足糊精，加入含粘合剂的乙醇溶液，制粒，干燥；将挥发油包合物加入颗粒中，混匀。本发明提高了荆芥挥发油的包合率，缩短了浸膏干燥时间，避免了黄芩苷遇热分解；成品率由原工艺的68％上升到93％。

Description

一种中药组合物的制备新工艺
技术领域
本发明属于中药制药领域，涉及一种中药组合物的制备新工艺，尤其是涉及一种以蝉蜕、黄芩、地龙、紫菀、百部、诃子、荆芥、僵蚕为原料药材的中药组合物的制备新工艺。
背景技术
呼吸道疾病是临床常见的疾病类型，通常伴有咳嗽、咳痰、气喘、炎症、气道反应性增高等症状。病因比较复杂，病毒感染、细菌感染、非特异性炎症、过敏等均可发生，治疗措施需要标本兼治。常见病有支气管炎、肺炎、支气管哮喘、病毒性感冒等，特别是急性支气管炎，其发病率为其它各种呼吸道疾病之首位，气道炎症导致的咳嗽是其主要症状，同时可因炎症导致的气道反应性增高，而使呼吸症状持续不解，造成临床治疗比较棘手。目前，市场上存在多种中药和西药，均在不同方面有所侧重，部分药品价格较高，造成临床应用难以普及。
发明人根据中医学的基础理论“风为百病之长”，“风为阳邪，风火相搏则咳嗽”的观点，打破延用清热解毒的习惯，建立疏风邪、清肺络、宣肃止咳为大法的途径，精选药物，合理配伍，达到宣中有肃、散中有收、动静相合、升降相因的效果。以此为基础，研制出蝉蜕止咳颗粒(CN101181561A)，开发了一种安全、高效、方便、简捷的中药新药。但是其制备工艺存在的诸多不足：1.荆芥挥发油成分在包合物干燥过程中时间较长，挥发油损失较多；2.原工艺中浸膏多糖、大分子成分较多，粘性极大，减压干燥时间约50小时，能耗高，时耗长；3.原工艺因浸膏粉遇水即黏，制粒困难且收率较低；4.浸膏、颗粒剂干燥时间长、黄芩苷遇热易分解，导致原颗粒剂中指标成分黄芩苷损失较多，转移率较低，生产中存在不确定性。
发明内容
发明人针对原工艺进行了改进，提供了一种更加节能增效、简单易控、稳定合理的新工艺，在保持蝉蜕止咳颗粒功效的基础上，提高其制备工艺水平，克服原工艺存在的诸多不足。且新工艺下生产的蝉蜕止咳颗粒的功能主治，给药途径及服用剂量均与原工艺下的颗粒剂一致。
本发明的目的是通过以下技术方案实现的：
一种中药组合物的制备新工艺，包括以下步骤：
步骤(1)、按配方取原料药材：蝉蜕400～450重量份、黄芩200～250重量份、地龙250～300重量份、紫菀400～450重量份、百部400～450重量份、诃子200～250重量份、荆芥200～250重量份、僵蚕200～250重量份；
步骤(2)、荆芥提取挥发油，以β-环糊精包合制成挥发油包合物，药渣及残液另置备用；
步骤(3)、蝉蜕、黄芩、地龙、紫菀、百部、诃子加60～80％乙醇回流提取2～4次，每次1～3小时，滤过，滤液浓缩至70℃相对密度1.25～1.30；醇提药渣与荆芥药渣、残液，僵蚕合并，加水煎煮2～4次，每次2～3小时，滤过，滤液减压浓缩至70℃相对密度1.25～1.30；
步骤(4)、将醇提浸膏和水提浸膏混合，得稠浸膏，加入适量糊精，真空干燥至干脆，粉碎，补足糊精，加入适量粘合剂乙醇溶液，制粒，干燥；将挥发油包合物加入颗粒中，混匀。
步骤(2)中，挥发油的提取方法为：荆芥加6～10倍量水，浸泡1～3小时后加热至沸并保温2～4小时，收集荆芥挥发油。优选为：荆芥加8倍量水，浸泡2小时后加热至沸并保温3小时，收集荆芥挥发油。
所述的挥发油包合物的制备方法为：荆芥挥发油加3～5倍量80％～100％乙醇、4～8倍量β-环糊精，以胶体磨研磨10～30分钟包合，滤过，包合物40～60℃烘干3～5小时，过80目筛。
步骤(3)中，蝉蜕、黄芩、地龙、紫菀、百部、诃子加70％乙醇回流提取3次，每次2小时，滤过，滤液浓缩至70℃相对密度1.25～1.30；上述药渣与荆芥药渣、残液，僵蚕合并，加水煎煮3次，每次2.5小时，滤过，滤液减压浓缩至70℃相对密度1.25～1.30。
步骤(4)中，将醇提浸膏和水提浸膏混合，加入适量糊精，真空干燥至干脆，粉碎，补足糊精，置于高效湿法制粒机中，10rpm～20rpm搅拌约2分钟，加入适量粘合剂乙醇溶液，500rpm～800rpm切削约3分钟，16目筛制粒，干燥至水分≤3～5％，14～60目筛整粒。
按照糊精和稠浸膏质量比1:3～1:6，往稠浸膏中加入糊精进行真空干燥；糊精总量与干浸膏(稠浸膏干燥后的浸膏量)的比例为1:1～1:1.5。
所述的真空干燥的温度为50～70℃。
所述的粘合剂的用量为干浸膏与糊精总重量的1％～3％。
所述的粘合剂乙醇溶液以60％～100％乙醇为溶剂配制而成，粘合剂的浓度为5％～10％。
所述的粘合剂为聚乙烯吡络烷酮、纤维素衍生物如羟丙基纤维素。
和现有技术相比，本发明的有益效果：
本发明以80％～100％乙醇为介质对荆芥挥发油进行包合，且乙醇相对于水挥发速度更快，采用乙醇进行包合，既增加了包合率，又减少了包合物干燥的时间。
本发明在稠浸膏中加入糊精，一方面，糊精吸收了稠浸膏中的水分，增加了干燥面积；另一方面，浸膏在抽真空过程中因糊精形成了骨架，浸膏不易坍塌，也提高了干燥面积，因此干燥速度更快。由于浸膏干燥时间缩短，避免了黄芩苷遇热分解。
针对原工艺浸膏粉遇水即黏，制粒困难且收率较低的技术问题，本发明采用高浓度乙醇和粘合剂如羟丙甲基纤维素进行制粒，改善了制粒过黏的缺点，同时由于粘合剂的存在，颗粒不至于过于松散、无法成型，有效提升了成品率，由原工艺的68％上升到93％，降低损耗，大大提高了经济效益。
具体实施方式
下面通过具体实施方式对本发明的技术方案作进一步说明。
实施例1
步骤(1)、称取蝉蜕414g、黄芩230g、地龙276g、僵蚕230g、荆芥230g、紫菀276g、百部414g、诃子230g。
步骤(2)、荆芥230g加10倍量水，浸泡2小时后加热至沸并保温3小时，收集荆芥挥发油，量取、记录；药渣和残液备用；取荆芥挥发油，加4倍量β-环糊精、4倍量无水乙醇，以胶体磨研磨10分钟包合，抽滤，干燥(温度50℃)，过80目筛，备用；
步骤(3)、将配方量蝉蜕、黄芩、地龙、紫菀、百部、诃子依次加入提取罐内，加8倍量70％乙醇回流提取提取3次，每次提取2小时，过滤，过滤减压浓缩至相对密度1.25～1.30(70℃)的醇提浸膏；醇提浸膏、药渣备用；
将配方量僵蚕、荆芥药渣及残液加入到蝉蜕、黄芩、地龙、紫菀、百部、诃子的醇提药渣中，加8倍量水煎煮3次，每次煎煮2.5小时，，煎煮液过滤，减压浓缩至相对密度1.25～1.30(70℃)的水提浸膏，备用；
步骤(4)、将醇提浸膏和水提浸膏混合成稠浸膏，按比例(糊精:稠浸膏质量比＝1:5)加入糊精，60℃真空干燥至干脆，粉碎，过100目筛；补足糊精，置于高效湿法制粒机中，10rpm～20rpm低速搅拌约2分钟，加入7.5％羟丙基纤维素无水乙醇溶液适量，500rpm～800rpm高速切削约3分钟，16目筛制粒，干燥(60℃)至水分≤3-5％，14～60目筛整粒，备用；
步骤(5)、将步骤(4)颗粒与步骤(2)的挥发油包合物混匀，共制成1000g，分装，10g/袋，即得蝉蜕止咳颗粒。
本实施例蝉蜕止咳颗粒与原工艺(CN101181561A实施例1)颗粒剂在关键工艺参数以及检验结果方面进行比较，如表1、2所示：
表1：新旧工艺关键参数汇总结果(100袋)
Figure BDA0002325911190000041
表2：新旧工艺检测结果(100袋)
Figure BDA0002325911190000042
由表1、2可以看出：(1)、本发明工艺挥发油包合率为83％，较原工艺的64％有明显的提高；(2)、浸膏烘干时间由52小时缩短为20小时，节省了大量的能耗及时间；(3)、成品率由原工艺的68％上升到93％，降低了损耗率，大大提高了经济效益；(4)、指标成分黄芩苷由157mg/袋，上升至175mg/袋，提高了产品质量的可控性及可靠性；(5)、新工艺下生产的蝉蜕止咳颗粒的性状、鉴别、粒度、可溶性等方面均符合要求，也证明了新工艺在节能增效、简单易控、稳定合理的基础上，完全保证了药品的质量。

Claims (4)

1.一种中药组合物的制备新工艺，其特征在于包括以下步骤：
步骤(1)、按配方取原料药材：蝉蜕400～450重量份、黄芩200～250重量份、地龙250～300重量份、紫菀400～450重量份、百部400～450重量份、诃子200～250重量份、荆芥200～250重量份、僵蚕200～250重量份；
步骤(2)、荆芥提取挥发油，以β-环糊精包合制成挥发油包合物：荆芥挥发油加3～5倍量无水乙醇、4～8倍量β-环糊精，以胶体磨研磨包合，滤过，包合物40～60℃烘干，过筛；药渣及残液另置备用；
步骤(3)、蝉蜕、黄芩、地龙、紫菀、百部、诃子加60～80%乙醇回流提取2～4次，每次1～3小时，滤过，滤液浓缩至70℃相对密度1.25～1.30；醇提药渣与荆芥药渣、残液，僵蚕合并，加水煎煮2～4次，每次2～3小时，滤过，滤液减压浓缩至70℃相对密度1.25～1.30；
步骤(4)、将醇提浸膏和水提浸膏混合，得稠浸膏，按照糊精和稠浸膏质量比1:5，加入糊精，60℃真空干燥，粉碎，按照糊精总量与干浸膏的质量比为1:1～1:1.5，补足糊精，加入适量7.5%羟丙基纤维素无水乙醇溶液，制粒，干燥；将挥发油包合物加入颗粒中，混匀。
2.根据权利要求1所述的中药组合物的制备新工艺，其特征在于步骤(2)中，挥发油的提取方法为：荆芥加6～8倍量水，浸泡1～3小时后加热至沸并保温2～4小时，收集荆芥挥发油。
3.根据权利要求1所述的中药组合物的制备新工艺，其特征在于步骤(4)中，真空干燥的温度为50～70℃。
4.根据权利要求1所述的中药组合物的制备新工艺，其特征在于步骤(4)中，所述的粘合剂的用量为干浸膏与糊精总重量的1%～3%。
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