CN1237998C - 治疗小儿咳喘的泡腾片 - Google Patents
治疗小儿咳喘的泡腾片 Download PDFInfo
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Abstract
一种治疗小儿咳喘的泡腾片及其制备方法,它由麻黄、金银花、苦杏仁、板蓝根、石膏、甘草、瓜蒌制成,以上七味药,将君药麻黄进行了单独提取,其余仍采用水煎,合并煎液浓缩至规定的相对密度,醇沉,冷藏、离心,离心液浓缩至稠膏后再水沉,以提高最终制剂澄明度,离心后浓缩成稠膏后加入麻黄提取浸膏,真空干燥后粉碎成细粉,再与辅料混匀制成颗粒,干燥,压片即得,本发明是一种治疗效果好,服用方便、质量稳定,且运输、携带方便的治疗小儿咳喘的泡腾片及其制备方法。
Description
技术领域:本发明涉及一种中药,尤其是涉及一种治疗儿童气管炎、咳嗽、上呼吸道感染等疾病的治疗小儿咳喘的泡腾片。
背景技术:气管炎、咳嗽、上呼吸道感染等疾病是儿科常见病,多发病,也是儿科临床中的急、重症,目前,治疗小儿气管炎、咳嗽、上呼吸道感染等疾病的中药一般为口服液,由于口服液的提取工艺为简单的水提、浓缩的方法制备而成,成品沉淀多,在精制时药物的有效成分损失较大,影响疗效,加之运输、携带均不方便,限制了临床应用。
发明内容:为了解决上述存在的问题,本发明提供一种治疗效果好,服用方便、质量稳定,且运输、携带方便的治疗小儿咳喘的泡腾片。
具体技术方案如下:一种治疗小儿咳喘的泡腾片,其特征在于:由以下原料按重量份配伍,后经提取加工制成:
麻黄0.5-1.5 金银花5-15 苦杏仁1-9
板蓝根5-15 石膏10-20 甘草1-9
瓜蒌1-9;
制备方法:
以上七味药,麻黄加6倍量80%乙醇,回流提取3次,每次2小时,滤过,合并滤液,放置过夜,滤过,滤液回收乙醇并浓缩至60℃测时相对密度为1.05-1.06,趁热加入药液4倍量0.1%的盐酸溶液,搅均,冷藏过夜,滤过,滤液用氨水调节PH值至近中性,冷藏过夜,滤过,滤液备用;另取石膏,加水煎煮半小时后,再加入金银花、苦杏仁、板蓝根、瓜蒌、甘草,煎煮3次,每次1小时,加水量为药材量的10倍,滤过,合并煎液,浓缩至60℃测时相对密度为1.05-1.06,在150000rpm下高速离心,离心液继续浓缩至60℃测时相对密度为1.10-1.12,加入乙醇使含醇量达到65%,放置过夜,滤过,滤液回收乙醇并浓缩至60℃测时相对密度为1.03-1.05,加入药液3倍量的水,搅匀,冷藏过夜,在150000rpm下高速离心,离心液和上述麻黄的提取液合并,继续浓缩至60℃测时相对密度为1.20-1.25的稠膏,减压干燥,粉碎成细粉;取上述干膏粉,加入等量的酒石酸和等量的碳酸氢钠,以及阿斯帕坦30克、木糖醇适量,混匀,用无水乙醇制粒、干燥、压片,即得。
本发明将君药麻黄进行了单独提取,其余仍采用水煎,合并煎液浓缩至规定的相对密度,醇沉,冷藏、离心,离心液浓缩至稠膏后再水沉,以提高最终制剂澄明度,离心后浓缩成稠膏后加入麻黄提取浸膏,真空干燥后粉碎成细粉,再与辅料混匀制成颗粒,干燥,压片即得,本发明具有既可泡腾溶解于热水,又可泡腾溶解于冷水后直接服用的优点,适宜于小儿服用,同时又由于其为固体制剂,运输、携带方便,质量稳定,工艺改进后增加了有效成分的含量,提高疗效,克服了原制剂有效成分损失大,成品沉淀多,保存、携带不便的缺点。
本发明中麻黄主要含有麻黄碱、伪麻黄碱、麻黄次碱、L-N甲基麻黄碱、d-N-甲基伪麻黄碱、L-去甲基麻黄碱、d-去甲基伪麻黄碱等生物碱类成分以及挥发油类成分;此外,还含有黄酮类、有机酸类、儿茶质等成分;其中麻黄碱等生物碱类成分和挥发油类成分为麻黄的主要有效成分具有解热、抗炎、平喘镇咳作用;因挥发油含量低,难以提出,故提取工艺多以考虑生物碱的提取为主;麻黄生物碱常用的提取方法有酸水浸提、酸水渗漉、乙醇回流、水煎煮等,为比较各提取工艺的优劣,分别以上述四种主法对麻黄进行了提取比较,见表1:
不同提取方法提取麻黄碱数据表
提取方法 | 出膏率(%) | 盐酸麻黄碱含量(mg/g麻黄) |
酸水浸提 | 18.77 | 9.40 |
酸水渗漉 | 15.50 | 8.22 |
乙醇回流 | 16.83 | 10.25 |
水煎煮 | 19.33 | 8.35 |
由表2可知,以乙醇回流法盐酸麻黄碱的含量最高,且出膏率较低。
其他药物:
金银花:主要有效成分为绿原酸等有机酸类,溶于水,宜水提。
苦杏仁:主要含有苦杏仁苷及酶类、脂肪酸、挥发油、氨基酸等成分;其中苦杏仁苷为镇咳平喘的有效成分,易溶于水,宜水煎提取。
石膏:主要成分为含水硫酸钙,此外尚含有钛、铜、铁、铝、硅锰等策量元素,以及有机物、硫化物等;石膏煎液对伤寒菌苗引致发热家兔有一定的退热作用,且临床应用时传统以石膏先煎,再入其它药物同煎,故宜水煎提取并先煎。
甘草:主要含有甘草酸、甘草次酸等三萜皂苷类成分,以及黄酮类、生物碱类、多糖类等成分,多溶于水,宜水煎提取。
板蓝根:主要含有靛蓝、靛玉红(但量很少),及一些水溶性成分。其水煎液对金黄色葡萄球菌有抑菌作用,又能抑制病毒感染并且有犯制其增殖作用;故宜水煎提取。
瓜蒌:主要含有三萜皂苷类成分,溶于水,宜水提。
综上所述,上述6味药宜混合水煎提取,其中石膏应先煎半小时。
制剂稳定性实验:
将双铝复合薄膜包装的泡腾片置于40℃、相对湿度为75%的恒温箱中,放置1个月,取出,测定其试验前后的外观性状、泡腾时间和PH值变化,结果见表2:
表1:加速试验前后对比结果
样品 | 外观性状 | 泡腾时间 | PH值 |
试验前 | 棕色片剂 | 5分15秒 | 4.1 |
试验后 | 棕色片剂 | 5分08秒 | 4.0 |
结果表明:加速试验前后该药在外观颜色、物理性状、泡腾时间和PH值等方面均无明显变化,说明该药基本稳定,成型工艺合理。
急性毒性试验:
以3.8生药/ml浓度,0.4ml/10g体积灌胃给药,一日2次。累积剂量为304g生药/kg,相当于临床用量的238倍。观察7天,小鼠全部存活,未见明显毒性反应。
长期毒性试验:
大鼠分别灌胃给予治疗小儿咳喘的泡腾片94.35、47.175、23.5875g/kg(相当于人用剂量的74、27、18.5倍),连续90天,停药后观察14天,大鼠全部存活,未见明显毒性反应。
抗病毒试验:治疗小儿咳喘的泡腾片和口服液大、中剂量组对流感病毒感染小鼠引起肺炎均有明显的抑制作用,肺指数值明显降低。
抑菌作用:治疗小儿咳喘的泡腾片和口服液对所试肺炎链球菌等六种细菌19株菌株均有不同程度的抑制作用。泡腾片大剂量组可使感染金葡菌小鼠的死亡率明显降低,泡腾片抑菌作用强于口服液。
止咳作用:小儿咳喘灵泡腾片和口服液均能减少浓氨水、枸橼酸引发小鼠及豚鼠咳嗽反应次数及延长咳嗽潜伏期,提示有镇咳作用。
祛痰作用:小儿咳喘灵泡腾片和口服液均能增加小鼠气管内酚红排出量,提示有一定的祛痰作用。
抗炎作用:小儿咳喘灵泡腾片和口服液均可抑制HAC致毛细血管通透性增加的作用,提示有抗炎作用。
解热作用:小儿咳喘灵泡腾片和口服液对酵母致热大鼠有明显的解热作用。
本发明经过临床实践,总结了疾病种类与疗效、与疗程之间有如下关系,见表3、表4:
疾病种类与疗效关系
疾病 | 病例数 | 痊愈 | 显著效果 | 无效 | 有效率 |
上呼吸道感染 | 100 | 80 | 20 | 0 | 100% |
急性支气管炎 | 80 | 50 | 26 | 4 | 95% |
肺炎 | 50 | 25 | 23 | 2 | 96% |
咳嗽 | 50 | 27 | 21 | 2 | 96% |
疾病种类与疗程关系
疾病 | 病例数 | 治愈时间 | |||
一周 | 二周 | 三周 | 四周 | ||
上呼吸道感染 | 100 | 20 | 50 | 30 | |
急性支气管炎 | 80 | 5 | 20 | 40 | 11 |
肺炎 | 50 | 20 | 10 | 18 | |
咳嗽 | 50 | 20 | 20 | 8 |
用法与用量:
二岁以内一次1片;三至四岁一次1.5片;五至七岁一次2片;一日3-4次,每片1.5g;1个疗程为二周。
疗效判断标准:
痊愈:无发热、无咳嗽、无痰、平喘的症状;
显效:发热、咳嗽、痰、气喘明显减轻。
无效:继续有发热、咳嗽、有痰、气喘的症状。
具体实施方式:
实施例1:一种治疗小儿咳喘的泡腾片,由以下原料按重量配伍,后经提取加工制成(按克数计)
麻黄62.5g 金银花625g 苦杏仁312.5g
板蓝根625g 石膏937.5g 甘草312.5g
瓜蒌312.5g;
制备方法:
以上七味药,麻黄加6倍量80%乙醇,回流提取3次,每次2小时,滤过,合并滤液,放置过夜,滤过,滤液回收乙醇并浓缩至60℃测时相对密度为1.05-1.06,趁热加入药液4倍量0.1%的盐酸溶液,搅均,冷藏过夜,滤过,滤液用氨水调节PH值至近中性,冷藏过夜,滤过,滤液备用;另取石膏,加水煎煮半小时后,再加入金银花、苦杏仁、板蓝根、瓜蒌、甘草,煎煮3次,每次1小时,加水量为药材量的10倍,滤过,合并煎液,浓缩至60℃测时相对密度为1.05-1.06,在150000rpm下高速离心,离心液继续浓缩至60℃测时相对密度为1.10-1.12,加入乙醇使含醇量达到65%,放置过夜,滤过,滤液回收乙醇并浓缩至60℃测时相对密度为1.03-1.05,加入药液3倍量的水,搅匀,冷藏过夜,在150000rpm下高速离心,离心液和上述麻黄的提取液合并,继续浓缩至60℃测时相对密度为1.20-1.25的稠膏,减压干燥,粉碎成细粉;取上述干膏粉,加入等量的酒石酸和等量的碳酸氢钠,以及阿斯帕坦30克、木糖醇适量,混匀,用无水乙醇制粒、干燥、压片,即得。共制成泡腾片1000片。
实施例2:一种治疗小儿咳喘的泡腾片,由以下原料按重量配伍,后经提取加工制成(按克数计)
麻黄62.5g 金银花500g 苦杏仁250g
板蓝根562.5g 石膏875g 甘草250g
瓜萎250g;
制备方法同实施例1。
实施例3:一种治疗小儿咳喘的泡腾片,由以下原料按重量配伍,后经提取加工制成:(按克数计)
麻黄62.5g 金银花438g 苦杏仁188g
板蓝根438g 石膏750g 甘草188g
瓜蒌188g;
制备方法同实施例1。
实施例4:一种治疗小儿咳喘的泡腾片,由以下原料按重量配伍,后经提取加工制成(按克数计)
麻黄50g 金银花450g 苦杏仁200g
板蓝根450g 石膏750g 甘草200g
瓜萎200g;
制备方法同实施例1。
实施例5:一种治疗小儿咳喘的泡腾片,由以下原料按重量配伍,后经提取加工制成(按克数计)
麻黄40g 金银花320g 苦杏仁120g
板蓝根360g 石膏400g 甘草120g
瓜蒌120g;
制备方法同实施例1。
Claims (1)
1、一种治疗小儿咳喘的泡腾片,其特征在于:由以下原料按重量份配伍,后经提取加工制成
麻黄 0.5-1.5 金银花 5-15 苦杏仁 1-9
板蓝根 5-15 石膏 10-20 甘草 1-9
瓜蒌 1-9;
制备方法:
以上七味药,麻黄加6倍量80%乙醇,回流提取3次,每次2小时,滤过,合并滤液,放置过夜,滤过,滤液回收乙醇并浓缩至60℃测时相对密度为1.05-1.06,趁热加入药液4倍量0.1%的盐酸溶液,搅均,冷藏过夜,滤过,滤液用氨水调节PH值至近中性,冷藏过夜,滤过,滤液备用;另取石膏,加水煎煮半小时后,再加入金银花、苦杏仁、板蓝根、瓜蒌、甘草,煎煮3次,每次1小时,加水量为药材量的10倍,滤过,合并煎液,浓缩至60℃测时相对密度为1.05-1.06,在150000rpm下高速离心,离心液继续浓缩至60℃测时相对密度为1.10-1.12,加入乙醇使含醇量达到65%,放置过夜,滤过,滤液回收乙醇并浓缩至60℃测时相对密度为1.03-1.05,加入药液3倍量的水,搅匀,冷藏过夜,在150000rpm下高速离心,离心液和上述麻黄的提取液合并,继续浓缩至60℃测时相对密度为1.20-1.25的稠膏,减压干燥,粉碎成细粉;取上述干膏粉,加入等量的酒石酸和等量的碳酸氢钠,以及阿斯帕坦30克、木糖醇适量,混匀,用无水乙醇制粒、干燥、压片,即得。
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