CN102335204B - 一种中药制剂金水宝丸及其制备方法 - Google Patents
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Abstract
本发明属于药学领域，具体涉及一种金水宝水蜜丸制剂，其特征在于，所述制剂是用以下配比的中药原料药加工制成：发酵虫草菌粉650-720重量份、蜂蜜680-870重量份。
Description
技术领域
本发明涉及一种丸剂，特别是涉及一种金水宝蜜丸及其制备方法。
背景技术
金水宝胶囊是由发酵虫草菌粉CS-4直接填充的胶囊，收载于《中国药典》2005年版一部，其有效成份为腺苷、腺嘌呤、尿苷、甘露醇、麦角甾醇、氨基酸组、多种微量元素等，发酵虫草菌粉CS-4经中国医学科学院药物研究所、北京医科大学、贵阳医学院、江西医学院、江西省药物研究所等单位药理实验证实具有抗炎、止咳被祛痰、镇静、抗流、促进腺作用，降低血清胆固醇、甘油三脂、低密度脂蛋白、极低密度脂蛋白及过氧化脂质值，提高高密度脂蛋白值和超氧化物歧化酶活性，增加心肌与脑的供血，对心脑组织有保护作用。能增加淋巴细胞，单核细胞DNA损伤后的修复能力。具有轻度降血压，抑制血小板聚集，抗心律失常，降低过氧化脂质及延长缺氧动物生存时间等作用；经大量临床试验证实具补益肺肾，秘精益气功能。主要用于肺肾两虚精气不足，久咳虚喘，神疲乏力，不寐健忘，腰膝酸软，月经不调，阳痿早泄；慢性支气管炎、慢性肾功能不全、高脂血症、肝硬化见上述证候者。用法用量为口服，一次3粒，一日3次；用于慢性肾功能不全者，一次6粒，一日3次。但金水宝胶囊为普通的硬胶囊剂，制成胶囊，不易患者吞服。
蜜丸为一种中药常用的制剂形式，但不同的中药，其配方和制备方法会有所不同，主要是根据中药本身的特性决定，本发明经过筛选，找到一种适合本发明药物的配方和制备方法，取得了意想不到的效果。
发明内容
本发明目的在于提供一种金水宝蜜丸，本发明的目的还在于提供一种金水宝蜜丸的制备方法。
本发明金水宝蜜丸是我国传统剂型之一，丸剂品种在中药成方制剂中比例最大，《中国药典》2000版一部丸剂占45％，《中国药典》2005版一部丸剂占40％，《中国药典》2010版一部丸剂占36％。
本发明的金水宝蜜丸经过特殊配方和特殊加工得到的一种纯中药制剂，服用后在胃肠道中溶散缓慢，逐渐释放药物，作用持久，能综合发挥发酵虫草菌粉中的有效作用，保证制剂的综合疗效。
本发明原料为发酵虫草菌粉CS-4。
本发明目的是通过如下技术方案实现的。
本发明金水宝蜜丸制剂是由如下重量份的原料制成的：
发酵虫草菌粉650-720重量份、蜂蜜680-870重量份
优选的配比为：发酵虫草菌粉700重量份、炼蜜750重量份
所述制剂根据需要可以加入一些药物可接受的载体。
所述可接受的载体选自：甘露醇、山梨醇、山梨酸或钾盐、焦亚硫酸钠、亚硫酸氢钠、硫代硫酸钠、盐酸半胱氨酸、巯基乙酸、蛋氨酸、维生素A、维生素C、维生素E、维生素D、氮酮、EDTA二钠、EDTA钙钠，一价碱金属的碳酸盐、醋酸盐、磷酸盐或其水溶液、盐酸、醋酸、硫酸、磷酸、氨基酸、氯化钠、氯化钾、乳酸钠、木糖醇、麦芽糖、葡萄糖、果糖、右旋糖苷、甘氨酸、淀粉、蔗糖、乳糖、甘露糖醇、硅衍生物、纤维素及其衍生物、藻酸盐、明胶、聚乙烯吡咯烷酮、甘油、丙二醇、乙醇、土温60-80、司班-80、蜂蜡、羊毛脂、液体石蜡、十六醇、没食子酸酯类、琼脂、三乙醇胺、碱性氨基酸、尿素、尿囊素、碳酸钙、碳酸氢钙、表面活性剂、聚乙二醇、环糊精、β-环糊精、磷脂类材料、高岭土、滑石粉、硬脂酸钙、硬脂酸镁。
优选的药物可接受的载体是淀粉。
优选的本发明所述金水宝蜜丸制剂，由以下成分加工制成：
本发明还包括本发明所述金水宝蜜丸制剂的制备方法，该方法的步骤如下：发酵虫草菌粉过300目筛，按本发明上述重量配比称取发酵虫草菌粉，加适量辅料混匀，每100g粉末加入85～100g炼蜜与适量的乙醇制成小蜜丸，用沸腾干燥床80℃以下干燥，即得。
上述制备方法发酵虫草菌粉过筛，过300目筛为最优选。
上述制备方法所述沸腾干燥床内干燥时其控制出风温度可以为80℃以下，优选温度可以50-80℃。
表1处方筛选
表2筛选结果
由以上实验结果可知，发酵虫草菌粉700g、炼蜜750g、淀粉150g，95％乙醇160g，(即处方III)，制丸，所得蜜丸适宜，表面光滑、溶散性好，口感较好，故选择该处方。
按上述方法制备金水宝蜜丸含量测定结果
| 批号 | 含量(mg/g) | 批号 | 含量(mg/g) |
| 20110401 | 1.2 | 20110501 | 1.0 |
| 20110402 | 1.5 | 20110502 | 1.2 |
| 20110403 | 1.4 | 20110503 | 1.3 |
| 20110404 | 1.0 | 20110504 | 1.0 |
| 20110405 | 1.1 | 20110505 | 1.2 |
本发明的金水宝蜜丸，其用法与用量为：口服，一次1.6g，一日3次。
采用本发明所述的原料制成的金水宝蜜丸，与胶囊剂相比，金水宝蜜丸作为一种纯中药制剂，丸剂服用后在胃肠道中溶散缓慢，逐渐释放药物，作用持久，能综合发挥发酵虫草菌粉中的有效作用，保证制剂的综合疗效。而胶囊剂，崩解时限规定为30分钟内崩解，一般都需要15-20分钟。再因本发明丸剂既可口服，对于吞咽较困难的老人尤为方便，而且加入蜂蜜，味甜芳香口感好，容易被服用的人群接受。
具体实施方式
下面结合实施例对本发明做进一步的说明，下述各实施例仅用于说明本发明，但对本发明并没有限制。
实施例1：金水宝蜜丸
上述原料按如下方法配制成1000g
将本发明上述发酵虫草菌粉过300目筛，按本发明上述重量配比称取发酵虫草菌粉、淀粉、混匀，每100g粉末加入88g炼蜜与适量的乙醇制成小蜜丸，于沸腾干燥床内60℃干燥，即得，每丸重0.04g。
本实施例生产的金水宝蜜丸，每克含腺苷(C10H13N5O4)应为0.90-1.60mg。
实施例2：金水宝蜜丸
上述原料按如下方法配制成1000g
将本发明上述发酵虫草菌粉过300目筛，按本发明上述重量配比称取发酵虫草菌粉、淀粉、混匀，每100g粉末加入100g炼蜜与适量的乙醇制成小蜜丸，于沸腾干燥床内60℃干燥，即得。
实施例3：金水宝蜜丸
上述原料按如下方法配制成1000g
将本发明上述发酵虫草菌粉过300目筛，按本发明上述重量配比称取发酵虫草菌粉、淀粉、混匀，每100g粉末加入85g炼蜜与适量的乙醇制成小蜜丸，于沸腾干燥床内60℃干燥，即得。
Claims (2)
1.一种中药蜜丸制剂，其特征在于，所述制剂由以下成分加工制成：
2.一种中药蜜丸制剂的制备方法，其特征在于，步骤如下：
上述原料按如下方法配制成1000g
制备方法，步骤如下：
将上述发酵虫草菌粉过300目筛，按重量配比称取发酵虫草菌粉、淀粉、混匀，每100g粉末加入88g蜂蜜与适量的乙醇制成小蜜丸，于沸腾干燥床内60℃干燥，即得。
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