CN106138464A - 一种肺气肿胶囊的制备方法 - Google Patents
一种肺气肿胶囊的制备方法 Download PDFInfo
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- CN106138464A CN106138464A CN201610582091.3A CN201610582091A CN106138464A CN 106138464 A CN106138464 A CN 106138464A CN 201610582091 A CN201610582091 A CN 201610582091A CN 106138464 A CN106138464 A CN 106138464A
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- capsule
- emphysema
- preparation
- clear paste
- standby
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Abstract
本发明涉及一种肺气肿胶囊的制备方法。该制备方法将野马用水煎煮两次后过滤后，滤渣备用，滤液沉淀24小时，取上清液浓缩，再加乙醇静置沉降，离心，倾出上清液，回收乙醇，得清膏Ⅰ，将补骨脂提取挥发油，先用无水乙醇溶解后用β‑环糊精包合，冷藏后过滤，滤渣备用，包合物干燥后备用；将野马和补骨脂的滤渣与红花、淫羊藿、黄芪、丹参混合后，乙醇回流提取过滤提取液后浓缩得清膏Ⅱ；将清膏Ⅰ和清膏Ⅱ混合后，浓缩成浸膏，喷雾干燥成细粉后，与包合物、牡荆油、盐酸克仑特罗混均，装入胶囊即得产品。本发明制得的肺气肿胶囊质量稳定，生物利用度高、药物含量准确，疗效明显，适用于慢性气管炎和肺气肿患者。
Description
技术领域
本发明属于中医药技术领域，具体涉及一种肺气肿胶囊的制备方法。
背景技术
肺气肿片由野马追、红花、桃仁、淫羊藿、补骨脂、黄芪、丹参、牡荆油、盐酸克仑罗组成，具有补肾益气，活血化瘀，止咳祛痰功效，用于肺肾不足，痰浊阻肺，胸闷憋气，动辄喘乏，咳嗽痰多，腰膝酸痛，慢性气管炎阻塞性肺气肿属上述证候者。是临床上治疗虚证型慢性气管炎和肺气肿的常用药品，其中，野马追清热解毒，祛痰，定喘，降血压。治慢性气管炎，支气管炎，高血压病。全草含黄酮类、生物碱类、挥发油及香豆精等。野马追水煎液对金黄色葡萄球菌、痢疾杆菌、甲型链球菌有抑制作用，临床上，能使白细胞增加、血压下降，并抑制腺体分泌。因此，野马追水提后再进行醇提，更能发挥清热解毒、降血压的疗效。
补骨脂果实含挥发油约20％、有机酸、一种甲基糖甙、碱溶性树脂、不挥发性萜类油、皂甙。种子含香豆精类补骨脂素和异补骨脂素共约1.1％、黄酮类补骨脂黄酮、甲基补骨脂黄酮、异补骨脂黄酮和查耳酮类补骨脂查耳酮、异补骨脂查耳酮、单萜烯酚衍生物补骨脂酚。补骨脂挥发油具有①增强免疫和升白抗癌作用，能提高小鼠腹腔巨噬细胞的吞噬功能。能促进粒系祖细胞的生长，并能对抗注射环磷酰胺引起的白细胞下降，其机制可能是补骨脂香豆素激发了肾上腺皮质而使白细胞升高。②抗癌作用，可以治疗放疗，化疗导致的白细胞减少。可见，补骨脂挥发油对肺气肿片的功效有重要作用。
现有技术中，肺气肿片质地坚硬，崩解时间长，服用量大(一次服用6片，一日三次)，并且，肺气肿片中野马追水煎液有清热解毒、降血压的作用，补骨脂所含的挥发油对其功效有重要作用，因此，通过野马追水提后再进行醇提和尽可能提取出补骨脂所含的挥发油并使其在制剂中保持稳定，将会提高肺气肿片的作用强度，缩短起效时间，使这个方剂在速效、高效方面取得较大的进步。
发明内容
针对现有技术的不足，本发明的目的在于提供一种肺气肿胶囊的制备方法，提高了药物中药效成分的含量，缩短崩解时间和起效时间，提高了药物的作用强度，有效治疗慢性气管炎和肺气肿。
为解决现有技术问题，本发明采取的技术方案为：
一种肺气肿胶囊的制备方法，包括以下步骤：
步骤1，将野马用水煎煮两次，均为2-4小时，过滤后，滤渣备用，滤液沉淀24小时，取上清液浓缩至婆美度为6°Be，再加乙醇至含醇量为35-50％，静置沉降，离心，倾出上清液，回收乙醇，得清膏Ⅰ；
步骤2，将补骨脂用双提法提取挥发油，向挥发油中加无水乙醇溶解，再用β-环糊精加水制成饱和溶液包合，冷藏，过滤，滤渣备用，所得包合物在60℃以下干燥后备用；
步骤3，将步骤1和步骤2中的滤渣与红花、淫羊藿、黄芪、丹参混合后，用体积比为60％-90％乙醇回流提取1-3次，合并滤液，回收乙醇，提取液过滤后浓缩至4°Be得清膏Ⅱ；
步骤4，将清膏Ⅰ和清膏Ⅱ混合后，浓缩成15-20°Be浸膏，喷雾干燥成细粉后，与步骤2中的包合物、牡荆油、盐酸克仑特罗混均，装入胶囊即得产品。
作为改进的是，步骤1中两次用水煎煮的水量分别为野马量的5-8倍和4-6倍；浓缩温度为80℃；乙醇添加至含醇量为40％。
作为改进的是，步骤2中β-环糊精量为挥发油的3-9倍。
作为改进的是，步骤2中β-环糊精量为挥发油的7倍。
作为改进的是，步骤3中提取3次，3次提取时间分别为2-3小时，1-2小时和1-2小时。
有益效果
通过对肺气肿片的制备工艺改进，肺气肿胶囊提高了药物中药效成份的含量，缩短崩解时间和起效时间，提高作用强度，提高了治疗慢性气管炎和肺气肿的疗效。
附图说明
图1为肺气肿胶囊对小鼠氨水引咳的镇咳作用的影响；
图2为肺气肿胶囊对小鼠酚红排泄作用的影响；
图3为肺气肿胶囊对小鼠引喘潜伏期的影响；
图4为肺气肿胶囊对小鼠喘息发生率的影响；
图5为肺气肿胶囊对小鼠廓清指数的影响；
图6为肺气肿胶囊对小鼠胸腺指数的影响；
图7为肺气肿胶囊对小鼠脾脏指数的影响；
图8为肺气肿胶囊对小鼠血清溶血素的影响。
具体实施方式
以下通过试验例来进一步阐述本发明的有益效果。
实施例1
本发明方法中所用到原料的含量参照肺气肿片配制。
一种肺气肿胶囊的制备方法，包括以下步骤：
步骤1，将野马用水煎煮两次，均为2-4小时，过滤后，滤渣备用，滤液沉淀24小时，取上清液在80℃下浓缩至婆美度为6°Be，再加乙醇至含醇量为40％，静置沉降，离心，倾出上清液，回收乙醇，得清膏Ⅰ，其中，两次加水量分别为野马量的5-8倍和4-6倍；
步骤2，将补骨脂用双提法提取挥发油，向挥发油中加无水乙醇溶解，再用β-环糊精加水制成饱和溶液包合，冷藏，过滤，滤渣备用，所得包合物在60℃以下干燥后备用，其中β-环糊精量为挥发油的7倍；
步骤3，将步骤1和步骤2中的滤渣与红花、淫羊藿、黄芪、丹参混合后，用体积比为60％～90％乙醇回流提取3次，每次提取时间为2-3小时，1-2小时和1-2小时，再合并滤液，回收乙醇，提取液过滤后浓缩至4°Be得清膏Ⅱ；
步骤4，将清膏Ⅰ和清膏Ⅱ混合后，浓缩成15-20°Be浸膏，喷雾干燥成细粉后，与步骤2中的包合物、牡荆油、盐酸克仑特罗混均，装入胶囊即得产品。
本胶囊每粒内容物0.32g，服用量每天3粒，2次/天。而肺气肿片每次服用量为6片/次，3次/天，0.31g/片，可见，肺气肿胶囊经过工艺改进后，且不含赋型剂，大大减少了药物的服用量。
对肺气肿胶囊和肺气肿片的各项指标进行了比较测定，结果见表1和表2。
表1各种剂型的比较
肺气肿胶囊在挥发油含量、崩解时间、金丝桃苷含量等方面均优于肺气肿片。
表2肺气肿胶囊和肺气肿片的比较
实施例2
对本发明制备的肺气肿胶囊进行临床试验
1.肺气肿胶囊对小鼠氨水引咳的镇咳作用观察
取小鼠30只,随机分为3组，肺气肿片组：每日用药剂量5.38g生药/kg，每日一次灌胃；肺气肿胶囊组：每日用药剂量1.79g生药/kg，每日一次灌胃；连续7d；模型对照组(只进行烟熏，不给予药物治疗):灌服等容量生理盐水，每日一次。末次给药后1h进行氨水引咳实验,即用28％的氨水喷入特制的透明玻璃箱内,喷雾时间为10s。然后各组取1只小鼠同时放入箱内,过1min后,开始记录2min内各鼠的咳嗽次数。结果图1所示.
2.肺气肿胶囊对小鼠酚红排泄作用的影响
小鼠分组及给药方法同1，于末次给药后30min腹腔注射0.5％酚红液0.5ml只。30min后颈椎脱臼处死,暴露气管,在环状软骨下3～4环节处剪一小口,向心方向插入针头,深0.5cm，结扎固定,用5％NaHCO3冲洗呼吸道3次(每0.5ml),将冲洗液集中于试管中,静置5h于紫外-可见分光光度计546nm处测定吸收度。结果如图2所示。
3.肺气肿胶囊对豚鼠实验性哮喘的影响
取经预选合格的豚鼠(引喘潜伏期<120s)30只，豚鼠分组及给药方法同试验一，末次给药后1h,进行喷雾引喘,喷雾时间为10s。观察记录2min内各组动物的引喘潜伏期(以出现窒息翻倒为指标)和喘息发生率。结果如图3和图4所示。
4.肺气肿胶囊对免疫低下小鼠碳粒廊清指数的影响
NIH小鼠40只，体重18～22g，雌雄各半，随机分为4组，每组10只，即正常对照组、模型对照组、肺气肿片组(5.38g生药/kg)、肺气肿胶囊组(1.79g生药/kg)，灌胃给药，每天1次，连续14d。第8天开始每只小鼠腹腔注射环磷酰胺100mg/kg,连续3d。第14天每鼠尾静脉注射中华墨汁(以生理盐水1∶5稀释)，0.01mL/g体重。2min(t1)和10min(t2)后分别眼眶静脉丛取血20μL，并立即将其加入2mL质量分数为0.1％碳酸钠溶液中，混匀，以碳酸钠溶液为空白对照，用分光光度计于640nm波长处测吸光度(A1，A2)。同时称取小鼠的体重和胸腺、脾脏质量，计算胸腺指数和脾脏指数。各组数据如图5-7所示。
廓清指数＝(lgA1-lgA2)/(t2-t1)
胸腺指数＝胸腺重量÷体重
脾脏指数＝脾脏重量÷体重
5.肺气肿胶囊对免疫低下小鼠血清溶血素的影响
制备补体(实验当天进行)：豚鼠心脏取血，装入5mL离心管中，4℃放置30min，2000r/min，离心10min，取上清，待用；取抗凝的绵羊红细胞(SRBC)个3mL，2000r/min，离心10min，弃上清，沉淀为压积SRBC，体积约为1mL，然后按压积SRBC与豚鼠血清1∶5的比例往压积SRBC试管中加入豚鼠血清,吹打混合,4℃放置30min。取出,2000r/min，离心15min，轻轻吸取上清(注意不要溶血)，用生理盐水稀释8倍即为制备好的补体，4℃保存，备用。
半数溶血值的测定：健康NIH小鼠91只，18～22g，雌雄各半，分组给药同4。第8天开始每只小鼠腹腔注射环磷酰胺100mg/kg，连续3d。第11天每鼠腹腔注射10％SRBC(用生理盐水稀释)0.2mL致敏，第15天(即致敏后第4天)，每只小鼠摘眼球取血约0.3mL，4000r/mi，离心18mi，吸取10μL血清加入含1mL生理盐水的离心管中，然后每管加入10％SRBC0.5mL，冰浴。在冰浴中加入上述补体1mL，立刻37℃孵育30min，冰浴中止反应；2 000r/min，离心10min，取上清1m，加入装有3mL都氏试剂的试管中，室温放置10min，540nm波长处以蒸馏水调零，测定各管吸光值。往装有4mL都氏试剂的3支试管中,分别加入10％SRBC 0.25mL充分摇匀，放置10min，2000r/min，离心15min，吸取上清，540nm波长处以蒸馏水调零，测得绵羊红细胞半数溶血时的吸光值。按以下公式计算每只小鼠的半数溶血值(HC50)，比较结果如图8所示：
HC50＝样品吸光值×样品稀释倍数/绵羊红血球半数溶血时吸光值。
结论：综上各项试验，肺气肿胶囊在所选剂量范围内对小鼠氨水引咳的镇咳作用、对小鼠酚红排泄作用、对免疫低下小鼠的免疫调节作用均显著优于肺气肿片，对豚鼠实验性哮喘的作用与原剂型相当。
Claims (5)
1.一种肺气肿胶囊的制备方法，其特征在于，包括以下步骤：
步骤1，将野马用水煎煮两次，均为2-4小时，过滤后，滤渣备用，滤液沉淀24小时，取上清液浓缩至婆美度为6°Be，再加乙醇至含醇量为35-50%，静置沉降，离心，倾出上清液，回收乙醇，得清膏Ⅰ；
步骤2，将补骨脂用双提法提取挥发油，向挥发油中加无水乙醇溶解，再用β-环糊精加水制成饱和溶液包合，冷藏，过滤，滤渣备用，所得包合物在60℃以下干燥后备用；
步骤3，将步骤1和步骤2中的滤渣与红花、淫羊藿、黄芪、丹参混合后，用体积比为60%-90%乙醇回流提取1-3次，合并滤液，回收乙醇，提取液过滤后浓缩至4°Be得清膏Ⅱ；
步骤4，将清膏Ⅰ和清膏Ⅱ混合后，浓缩成15～20°Be浸膏，喷雾干燥成细粉后，与步骤2中的包合物、牡荆油、盐酸克仑特罗混均，装入胶囊即得产品。
2.根据权利要求1所述的肺气肿胶囊的制备方法，其特征在于，步骤1中两次用水煎煮的水量分别为野马量的5-8倍和4-6倍；浓缩温度为80℃；乙醇添加至含醇量为40%。
3.根据权利要求1所述的消肺气肿胶囊的制备方法，其特征在于，步骤2中β-环糊精量为挥发油的3-9倍。
4.根据权利要求3所述的肺气肿胶囊的制备方法，其特征在于，步骤2中β-环糊精量为挥发油的7倍。
5.根据权利要求1所述的肺气肿胶囊的制备方法，其特征在于，步骤3中提取3次，3次提取时间分别为2-3小时，1-2小时和1-2小时。
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| CN112402520A (zh) * | 2020-11-06 | 2021-02-26 | 江苏七○七天然制药有限公司 | 一种肺气肿片及其制备方法 |
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