CN104873565A - 一种药物的制备方法 - Google Patents
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Abstract
本发明涉及药物制备技术领域,尤其是药物的制备方法,包括步骤:分别取100份的刺柏、烈香杜鹃、大籽蒿混合后粉碎成药粉;将100份麻黄、100份水柏枝粉碎后加水煎煮、过滤获得浓缩液;将所述浓缩液与所述药粉搅拌均匀,灭菌后获得成品药物。本发明工艺简单、制作方便,成本低廉。制备获得的药物具有发汗,消炎,止痛,平黄水,活血通络的作用。用于治疗痹病即风湿性关节炎、类风湿性关节炎、痛风等症具有优异效果。
Description
技术领域
本发明涉及一种药物的组分及其制备技术。
背景技术
患有风湿性关节炎、类风湿性关节炎、痛风等病症的人们日夜遭受病痛煎熬,人们期待开发一种快速有效治疗该病症、且方便易用的药物。
发明内容
为减轻患病人们的痛苦,本发明提供一种药物的制备方法,分别取100份的刺柏、烈香杜鹃、大籽蒿混合后粉碎成药粉;将100份麻黄、100份水柏枝粉碎后加水煎煮1~2小时后过滤,获得浓缩液;将所述浓缩液与所述药粉搅拌均匀,灭菌后获得成品药物。
进一步地,所述药粉还通过孔径不大于100目筛子进行筛选。
进一步地,所述麻黄、水柏枝的质量和与水的质量比为1:6~8。
有益效果:
本发明工艺简单、制作方便,成本低廉。制备获得的药物具有发汗,消炎,止痛,平黄水,活血通络的作用。用于治疗痹病即风湿性关节炎、类风湿性关节炎、痛风等症具有优异效果。
附图说明
图1为本发明实施例的制作流程图。
具体实施方式
下面将结合附图对本发明实施例作详细说明。
藏药“五味甘露贴”由刺柏、烈香杜鹃、大籽蒿、麻黄、水柏枝五味单药组成,其中刺柏作用为补肾;烈香杜鹃作用为清热消肿,补肾;藏大籽蒿作用为清热解毒,散肿止血,利肾;麻黄作用为发汗解表,宣肺平喘,利水;水柏枝作用为清热解毒,发散透疹。
因此,五味甘露贴具有发汗,消炎,止痛,平黄水,活血通络的作用。用于治疗痹病即风湿性关节炎、类风湿性关节炎、痛风等症,并具有显著的疗效。本发明通过反复实验对其生产工艺及质量标准进行了研究,进一步加强了生产过程中的中间体及产品的质量控制,提高了制剂的质量。
本发明药物的制备方法,包括如下步骤,如图1所示:
净选处方五味药材刺柏、烈香杜鹃、大籽蒿、麻黄、水柏枝在不高于50℃的温度进行干燥,然后分别取100份的刺柏、烈香杜鹃、大籽蒿混合后粉碎成药粉,所述药粉通过孔径不大于100目筛子进行筛选,备用。
另行将100份麻黄、100份水柏枝粉碎,加入水煎煮获得浓缩液。其中,麻黄和水柏枝总质量与水的质量比为1:6~8。例如,第一次煎煮加入8倍分量的水煎煮2小时;第二次煎煮加入6倍分量的水煎煮1小时,最后合并两次煎煮后过滤获得的药液,获得所述浓缩液。将所述浓缩液与所述药粉搅拌均匀,在灭菌室辐射灭菌后获得成品药物。
最后,抽中间品进行质量检验,检验合格后进行制贴,包装,取成品检验合格,入库。
本实施例还对制得的药物成品的性状、含膏量、赋形性、微生物限量等质量控制的试验资料分析如下:
性状:本品为褐棕色的片状膏;气清香。
鉴别:(1)取本品置显微镜下观察:纤维状下皮细胞易见,木质化或硅质化,多成束,长480~960μm,直径10~16μm;叶表皮细胞多角形或类长圆形,胞壁微弯或平直,直径15~20μm;不定式气孔类圆形或长圆形,直径17~20μm,长约20~29μm,副卫细胞3~5个;木纤维淡黄色,细胞长条形,微木化。
(2)称取本品约5g,捣碎,加乙醚20ml,与浓氨试液2ml,密塞、放置2小时,时时振摇,滤过,残渣用15ml乙醚分3次洗涤,滤过、合并滤液,加稀盐酸试液2滴,摇匀、蒸干、残渣加乙醇2ml使溶解,滤过,滤液作为供试品溶液。另取盐酸麻黄碱对照品,加甲醇制成每1ml含1mg的溶液,作为对照品溶液。照薄层色谱法(附录57页)试验,吸取上述两种溶疲各5μl,分别点于同一硅胶G薄层板上,以氯仿-甲醇-浓氨试液(20:5:0.5)为展开剂,展开,取出,晾干,喷以茚三酮试液,在105℃烘约10分钟。供试品色谱中,在与对照品色谱相应的位置上,显相同的颜色斑点。
含膏量:按《中华人民共和国卫生部药品标准》检测,取供试品10片,精密称定,撕开内衬除去膏体,再精密称定盖衬和背衬,将得出的重量在之前测定的重量中减去,剩下的重量记为含膏量,标示含膏量范围在1.5g以上至6g的含膏量差异限度为±7%,结果:符合规定。
赋形性:按照《中国药典》2010年版一部(附录II)贴膏项下的赋形性方法检查,取供试品1片,置37℃,相对湿度64%的恒湿恒温箱中30分钟,取出,用夹子将供试品固定在一平整钢板上,钢板与水平面的倾斜角为60°,放置24小时,膏面应无流淌现象。结果:符合规定。
微生物限度:按《中国药典》2010年版一部(附录XIIIC)微生物限度检查法,因含药材原料,微生物限度标准,细菌数每1克不得超过l0000cfu,霉菌和酵母菌每克不得超过l00cfu,大肠埃希菌不得检出,大肠菌群每克小于100个。金黄色葡萄球菌、铜绿假单胞菌每1g不得检出,供样品检验结果:低于限度指数,符合规定。
将制得的药物样品用成品包装后,在室温下,相对温度75%±5%条件下放置18个月,分别在0月、3月、6月、9月、12月、18月,月末取样检测。在试验期间取样6次,结论:通过对样品进行稳定性研究,结果表明样品在稳定性考察过程中各项结果均符合要求,说明该药品质量稳定,药品包装材料的颜色等外观均没有发生变化。说明本发明制得的药物在18个月内保持稳定。
Claims (3)
1.一种药物的制备方法,其特征在于,分别取100份的刺柏、烈香杜鹃、大籽蒿混合后粉碎成药粉;将100份麻黄、100份水柏枝粉碎后加水煎煮1~2小时后过滤,获得浓缩液;将所述浓缩液与所述药粉搅拌均匀,灭菌后获得成品药物。
2.根据权利要求1所述的药物制备方法,其特征在于,所述药粉还通过孔径不大于100目筛子进行筛选。
3.根据权利要求1所述的药物制备方法,其特征在于,所述麻黄、水柏枝的质量和与水的质量比为1:6~8。
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Cited By (4)
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WO2016206575A1 (zh) * | 2015-06-25 | 2016-12-29 | 朱伯秦 | 一种药物的制备方法 |
CN107569533A (zh) * | 2017-09-18 | 2018-01-12 | 次旺 | 具有增强骨密度功效的组合物及其应用、制备方法 |
CN110251630A (zh) * | 2019-07-11 | 2019-09-20 | 金诃藏药股份有限公司 | 一种藏药巴桑浓缩片剂及其制备方法 |
CN113577125A (zh) * | 2021-08-27 | 2021-11-02 | 西藏藏医药大学 | 一种具有抗炎作用的五味甘露软膏剂及其制备方法 |
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CN114306698A (zh) * | 2022-01-27 | 2022-04-12 | 云南养尊堂生物科技有限公司 | 一种应用乙醇对中药进行渗透性控制微生物的方法 |
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CN1238944A (zh) * | 1998-06-11 | 1999-12-22 | 西藏宇妥藏药研究所 | 将天然植物药浴液加工成粉状药的方法 |
CN1660051A (zh) * | 2005-01-21 | 2005-08-31 | 西藏宇妥藏药研究有限公司 | 一种藏药浴散剂的制备方法及其质量控制方法 |
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CN1813861A (zh) * | 2005-11-29 | 2006-08-09 | 久美彭措 | 五味药浴颗粒 |
CN104873565A (zh) * | 2015-06-25 | 2015-09-02 | 青海藏浴生物科技有限公司 | 一种药物的制备方法 |
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CN1238944A (zh) * | 1998-06-11 | 1999-12-22 | 西藏宇妥藏药研究所 | 将天然植物药浴液加工成粉状药的方法 |
CN1660051A (zh) * | 2005-01-21 | 2005-08-31 | 西藏宇妥藏药研究有限公司 | 一种藏药浴散剂的制备方法及其质量控制方法 |
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
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WO2016206575A1 (zh) * | 2015-06-25 | 2016-12-29 | 朱伯秦 | 一种药物的制备方法 |
CN107569533A (zh) * | 2017-09-18 | 2018-01-12 | 次旺 | 具有增强骨密度功效的组合物及其应用、制备方法 |
CN110251630A (zh) * | 2019-07-11 | 2019-09-20 | 金诃藏药股份有限公司 | 一种藏药巴桑浓缩片剂及其制备方法 |
CN113577125A (zh) * | 2021-08-27 | 2021-11-02 | 西藏藏医药大学 | 一种具有抗炎作用的五味甘露软膏剂及其制备方法 |
CN113577125B (zh) * | 2021-08-27 | 2022-03-15 | 西藏藏医药大学 | 一种具有抗炎作用的五味甘露软膏剂及其制备方法 |
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