CN105477364B - 一种治疗胃炎的中药组合物制备方法及制剂 - Google Patents

一种治疗胃炎的中药组合物制备方法及制剂 Download PDF

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CN105477364B
CN105477364B CN201510940130.8A CN201510940130A CN105477364B CN 105477364 B CN105477364 B CN 105477364B CN 201510940130 A CN201510940130 A CN 201510940130A CN 105477364 B CN105477364 B CN 105477364B
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陈致慜
马靖喧
李春雷
霍志金
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Handan pharmaceutical Limited by Share Ltd trade union committee
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Abstract

本发明涉及一种中药组合物的制备方法，特别涉及用于治疗胃炎的中药组合物的制备方法以及用该方法制备的药物制剂。通过本发明的方法制备的产品具有稳定性好、治疗效果显著等特点。本发明所述中药组合物由以下方法制备得到：百合、三七、鸡内金、蒲黄、延胡索、九节菖蒲、白芍(20‑100％)七味药粉碎成80‑200目粉末；剩余药味加水煎煮2‑4次，每次0.5‑3小时，合并药液滤过浓缩至相对密度1.10‑1.20的稀膏，加入乙醇使含醇量达50‑80％，静置1‑5天；乙醇液回收乙醇、浓缩至相对密度至1.10‑1.50的浸膏；粉末与浸膏混合、得到药物活性物质，经过制剂方法，制备成药物制剂组合物。

Description

一种治疗胃炎的中药组合物制备方法及制剂
发明领域
本发明涉及一种中药组合物的制备方法，特别涉及用于治疗胃炎的中药组合物的制备方法以及用该方法制备的药物制剂。
背景技术
摩罗丹是一种和胃降逆，健脾消胀，通络定痛的药物。用于慢性萎缩性胃炎及胃疼，胀满，痞闷，纳呆，嗳气，烧心等症。用法用量，口服，蜜丸一次9～18g，一日3次，饭前用米汤或温开水送下，或遵医嘱。其由百合、麦冬、石斛、茯苓、白术(麸炒)、乌药、白芍、三七、延胡索(醋炙)、鸡内金(炒香)、玄参、当归等18味中药制备而成，药理作用如下
1作用：当归对痢疾杆菌、霍乱弧菌、变形杆菌、大肠杆菌均有抑制作用，三七总皂甙对某些真菌有较强抑制作用。
2胃粘膜：本方对胃粘膜损伤有修复作用。
3理研究乌药对胃肠道平滑肌有兴奋和抑制的双向调节作用，促进消化液分泌；鸡内金提高胃液分泌量，酸度和消化能力。
4免疫功能：据药理性实验茯苓、白术除健脾外，有效提高体液免疫功能。
5药理发现本方中三七、当归、茯苓等皆有护肝、解除酒精肝中毒，促进肝中血清转化的功能。
中国专利公开了摩罗丹制剂的以下配方
所述白术用麸炒，延胡索用醋炙，鸡内金选用炒鸡内金。
以及制备方法：
以上十八味，加水煎煮1-3次，每次1.5-3小时，合并煎液，滤过，滤液浓缩至适量，加入乙醇，使含醇量达60-80％，静置，滤过，回收乙醇，滤液浓缩，加水冷藏，滤过，最后经过常规工序直接或加入药学上可接受的赋型剂制成临床可接受的剂型。
中国专利200710120838.4公开了摩罗丹以下含量测定方法，
含量测定如下：
照高效液相色谱法测定；
色谱条件与系统适应性试验：用十八烷基硅烷键合硅胶为填充剂；以15-60:40-85的乙腈-水为流动相；检测波长为230nm，理论板数按芍药苷峰计算应不低于1000～5000；
对照品溶液的制备：精密称取芍药苷对照品适量，加溶剂甲醇、乙醇、正丁醇、水、三氯甲烷或乙酸乙酯制成每1ml含30-50μg的溶液，即得；
供试品溶液的制备：取摩罗丹小蜜丸或重量差异项下的大蜜丸，剪碎，精密称取1～10g，加入硅藻土1～10g，研匀，置具塞锥形瓶中，精密加入溶剂甲醇、乙醇、正丁醇、水、三氯甲烷或乙酸乙酯15-25ml，密塞，称重，超声处理或热回流或冷浸提取30分钟，取出放至室温后称重，用溶剂甲醇、乙醇、正丁醇、水、三氯甲烷或乙酸乙酯补足至15-25ml摇匀，滤过，精密吸取续滤液4-6ml，置10ml量瓶中，加溶剂甲醇、乙醇、正丁醇、水、三氯甲烷或乙酸乙酯稀释至刻度，摇匀，即得；
测定法：分别精密吸取对照品溶液与供试品溶液各20μl，注入液相色谱仪，测定，即得；摩罗丹每1g含白芍以芍药苷C23H28O11计，不得少于0.8mg。
本发明人在临床和生产实践中发现，现有技术在疗效，稳定性，原料的节约等方面需要改进，以提高药物的作用，延长储存期，减少药物的使用量，提高药物的适应性，为此本发明人对现有技术进行了改进，从而完成了本发明。
发明内容：
为改进现有技术的缺陷，本发明提供一种摩罗丹的新的制备方法，本发明所述方法，其配方如下：
其制备方法如下：
百合、三七、鸡内金、蒲黄、延胡索、九节菖蒲、白芍(20-100％)七味药粉碎成80-200目粉末；剩余药味加水煎煮2-4次，每次0.5-3小时，合并药液滤过浓缩至相对密度1.10-1.20的稀膏，加入乙醇使含醇量达50-80％，静置1-5天；乙醇液回收乙醇、浓缩至相对密度至1.10-1.50的浸膏；粉末与浸膏混合、得到药物活性物质，经过制剂方法，制备成药物制剂组合物。
优选的，本发明的制备方法如下：
百合、三七、鸡内金、蒲黄、延胡索、九节菖蒲、半量的白芍七味药粉碎成100目粉末；剩余药味加水煎煮3次，每次2小时，合并药液滤过浓缩至相对密度1.10-1.20的稀膏，加入乙醇使含醇量达65％，静置3天；乙醇液回收乙醇、浓缩至相对密度至1.10-1.50的浸膏；粉末与浸膏混合、得到药物活性物质，经过制剂方法，制备成药物制剂组合物。
本发明优选的制剂为浓缩丸，其制备方法如下，取粉末与浸膏混合的药物活性成分、粉碎后药粉每1重量份加0.6-1.5重量份炼蜜制成浓缩蜜丸。
本发明的方法和现有技术相比，主要活性成分明显增加，药效明显提高，制剂稳定性明显提高，
以下通过实验数据说明本发明的有益效果：
实验内容：
本发明和现有技术进行对比实验
实验1、对酸性乙醇致大鼠急性胃黏膜损伤的影响
动物分组给药，于给药第7天各组动物分别禁食不禁水48h，试验前各组动物再灌胃给药(水)1次，2h后每只大鼠灌胃酸性乙醇2ml(150mmol/L盐酸与60％乙醇按1∶1比例混合)，1h后分别用过量乙醚麻醉大鼠致死，开腹取胃，用夹子夹紧贲门，由幽门注入1％甲醛溶液5ml，夹紧幽门，将全胃置于1％甲醛溶液中固定10min，沿胃大弯剪开，将胃外翻，用清水轻轻洗去内容物，将胃平铺于玻璃板上，用精密卡尺测量胃黏膜损伤长度，以损伤长度(损伤宽度大于1mm者加倍计算)总和作为胃黏膜损伤指数，并计算抑制率。
实验结果如下：
从结果可见，各组大鼠胃黏膜均有不同程度损伤，本发明组和现有技术组均较模型对照组轻，损伤指数明显降低(P<0.05)。
大鼠再生粘膜厚度的比较
组别 动物数(只) 再生粘膜厚度(μm)
对照组 10 416
模型组 10 101
本发明组 10 346
现有技术组 10 302
溃疡灶肉芽瘢痕层厚度的比较
实验2、对大鼠胃液分泌的影响
动物分组给药，每组10只大鼠，末次给药后各组动物分别禁食禁水24h，用乙醚麻醉，沿腹中线剪开小口，轻轻拉出胃，结扎幽门，再由十二指肠给药1次，缝合腹壁切口，6h后拆线开腹结扎贲门，摘除全胃，用滤纸擦净血迹，沿胃大弯剪开胃壁，倾出胃内容物，收集于刻度离心管中，以1500r/min速度离心10min，精确记录胃液量，以酚红为指示剂测定胃液总酸度，采用麦特毛细管法测定胃蛋白酶活性。
实验结果如下：
从结果可见，本发明组和现有技术组均可降低胃液总酸度及胃蛋白酶活性。
实验3、体内抗菌试验：
本发明组和现有技术组均可以减少金黄色葡萄球菌感染小鼠死亡数,延长感染小鼠的存活天数；
实验结果如下：
组别 动物数(只) 死亡数(只) 存活率％
正常对照组 20 0 100
模型组 20 12 40
本发明组 20 8 60
现有技术组 20 9 55
实验4.抗炎试验结果：
本发明组和现有技术组均可降低二甲苯所致小鼠耳廓肿胀度。
对小鼠迟发型变态反应(足跖增厚法)影响(足跖厚度差值mm)
剂量组 动物数(只) 注射后24h足跖肿胀度(mm)
阴性对照组 10 0.212
本发明组 10 0.435
现有技术组 10 0.367
实验5、加速稳定性实验
将样品放置在40℃±2℃、相对湿度75％±5％的条件下放置于恒温恒湿箱中，以设定时间取样，对有关成分进行含量测定，试验后的初步稳定性试验结果如下
本发明样品试验后的初步稳定性试验结果
现有技术样品试验后的初步稳定性试验结果
本发明的优点主要表现在：
通过改进制备方法，取得了以下技术效果：降低了药物的服用量，活性成分的含量有所提高，制剂稳定性有所提高，药物的疗效有所提高。
具体实施方式：
以下通过实施例进一步说明本发明，但不作为对本发明的限制。
实施例1
其制备方法如下：
百合、三七、鸡内金、蒲黄、延胡索、九节菖蒲、半量的白芍七味药粉碎成100目粉末；剩余药味加水煎煮3次，每次2小时，合并药液滤过浓缩至相对密度1.10-1.20的稀膏，加入乙醇使含醇量达65％，静置3天；乙醇液回收乙醇、浓缩至相对密度至1.10-1.50的浸膏；粉末与浸膏混合、得到药物活性物质，制丸、干燥制成浓缩丸；或粉末与浸膏混合、制粒、干燥制成胶囊剂或片剂；
实施例2
其制备方法如下：
百合、三七、鸡内金、蒲黄、延胡索、九节菖蒲、白芍(20％)七味药粉碎成80目粉末；剩余药味加水煎煮2次，每次0.5小时，合并药液滤过浓缩至相对密度1.10-1.20的稀膏，加入乙醇使含醇量达50％，静置1天；乙醇液回收乙醇、浓缩至相对密度至1.10-1.50的浸膏；粉末与浸膏混合、得到药物活性物质，制丸、干燥制成浓缩丸；或粉末与浸膏混合、制粒、干燥制成胶囊剂或片剂；
实施例3
其制备方法如下：
百合、三七、鸡内金、蒲黄、延胡索、九节菖蒲、白芍(100％)七味药粉碎成200目粉末；剩余药味加水煎煮4次，每次3小时，合并药液滤过浓缩至相对密度1.10-1.20的稀膏，加入乙醇使含醇量达80％，静置5天；乙醇液回收乙醇、浓缩至相对密度至1.10-1.50的浸膏；粉末与浸膏混合、制丸、干燥制成浓缩丸；粉末与浸膏混合得到药物活性物质，制丸、干燥制成浓缩丸；或粉末与浸膏混合、制粒、干燥制成胶囊剂或片剂；
以上实施例方法制备的样品，经过含量测定法测定：每1g含白芍以芍药苷C23H28O11计，不少于1.4mg。

Claims (1)

1.一种治疗胃炎的中药组合物的制备方法，所述中药组合物由以下重量配比的中药原料药制备而成，
其制备方法如下：
百合、三七、鸡内金、蒲黄、延胡索、九节菖蒲、20％上述重量份的白芍七味药粉碎成80目粉末；剩余药味加水煎煮2次，每次0.5小时，合并药液滤过浓缩至相对密度1.10-1.20的稀膏，加入乙醇使含醇量达50％，静置1天；乙醇液回收乙醇、浓缩至相对密度至1.10-1.50的浸膏；粉末与浸膏混合、得到药物活性物质，制丸、干燥制成浓缩丸；或粉末与浸膏混合、制粒、干燥制成胶囊剂或片剂。
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