CN113082087A - 一种治疗儿童上呼吸道感染的制剂及其制备方法 - Google Patents
一种治疗儿童上呼吸道感染的制剂及其制备方法 Download PDFInfo
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Abstract
Description
技术领域
本发明属于中医药制剂领域,尤其涉及治疗儿童上呼吸道感染的制剂及其制备方法。
背景技术
金芩花颗粒为北京宣武医院蒋守友副主任医师多年临床经验方。是一种已经上市的中成药,以黄芩、金银花为君药,紫花地丁、蒲公英、连翘、柴胡为臣药,大青叶、赤芍、野菊花、当归、大黄为佐药,诸药相合,使外热得散,内热得清,火毒得消,血瘀得怯,表里双解,诸证悉平。临床用于治疗急性卡他性扁桃体炎、急性咽炎,如咽痛或吞咽痛、扁桃体及咽部充血、咽干灼热等症状,并具有较好的疗效。
现有金芩花颗粒的制备方法如下:取连翘、野菊花煎煮,提取挥发油,将剩余的药液过滤后备用,并收集最后剩余的药渣,其中,挥发油用β-环糊精包合后制得挥发油β-环糊精包合物;金银花、黄芩、蒲公英、紫花地丁、柴胡、大青叶、赤芍、当归、大黄一起加水煎煮,过滤后得到药液;合并所得的药液均匀混合,静置,将混合液离心处理,取上清液浓缩至相对密度为1.0~1.5的清膏;取辅料和甜味剂与清膏一起使用喷雾干燥一步法制成颗粒;颗粒中加入制得的挥发油β-环糊精包合物,均匀混合,制成金芩花颗粒。
但该品种为传统的颗粒剂,需冲服给药,使用限制较大,日服用剂量为30g,且口感极苦,较难获得患者的青睐,尤其是儿童患者服用困难。同时该颗粒剂为传统成人服用剂量,未对儿童服用有效剂量进行研究,可能造成儿童在使用时不足量或者过量服用药物的情况。
针对现有技术的不足,本发明的首要目的在于对金芩花颗粒配方进行改进,并根据儿童的起效情况,改进配方的剂量,调整金芩花颗粒的口感,得到一种治疗儿童上呼吸道感染的中药制剂。
发明内容
本发明的目的是针对原金芩花颗粒,进行配方的改变,采用处方药材中有效成分的提取、纯化技术,最大限度的保留原药物有效成分,合理配方,达到疗效。为此,本发明提供一种治疗儿童上呼吸道感染的制剂及其制备方法。
本发明的一种治疗儿童上呼吸道感染的制剂,由以下重量配比的中药原料药制备而成:
优选的,由以下重量配比的中药原料药制备而成:
本发明进一步包括本发明的一种治疗儿童上呼吸道感染的制剂的制备方法,其中,所述方法包括:将其中连翘、野菊花提取挥发油并制成包合物,其余药物提取得到提取物,将包合物和提取物合并后加入药用辅料,制备成制剂。
优选的,所述连翘、野菊花提取挥发油并制备成包合物,并将包合物粉碎成细粉,所用辅料为β-环糊精。
优选的,所述余药提取采用水提得到的提取物。
更优选的,本发明的制备方法,步骤如下:
①取以下重量比例的连翘100~300g、野菊花100~300g,加8-24倍量水提取挥发油,将剩余的药液过滤后备用,其中,挥发油用β环糊精包合后制得挥发油包合物;
②取以下重量比例的金银花100~300g、黄芩100~300g、蒲公英100~300g、紫花地丁100~300g、柴胡100~200g、大青叶100~200g、赤芍100~300g、当归100~200g、大黄20~150g加水煎煮,过滤后得到药液;
③将步骤①和步骤②的药液合并所得的药液均匀混合,静置,将混合液离心处理,取上清液浓缩至相对密度为1.0~1.5的清膏;
④取辅料和矫味剂与步骤③清膏一起使用喷雾干燥一步法制成1000g颗粒,
⑤将步骤①包合物和步骤④的颗粒和适量矫味剂混合,颗粒包装,每包装5g。其中,所述的辅料为填充剂和矫味剂,填充剂为糊精,用量为600g;矫味剂为:阿司帕坦、三氯蔗糖、安赛蜜、食用香精、谷氨酸钠、柠檬酸,优选为阿司帕坦10g、三氯蔗糖5g、安赛蜜10g、食用香精10g、谷氨酸钠2.5g。
本发明首先综合分析原颗粒剂的不足,研究适用于儿童服用的配方和摄入剂量;
通过药效学、毒理学实验和临床试验证明本发明配方安全有效。
矫味剂的研究
通过对阿司帕坦、安赛蜜、三氯蔗糖、柠檬酸、谷氨酸钠、黑加仑香精、草莓香精等多种矫味剂的组合筛选研究,选出最适宜的配方,配比表如下:
通过对每个配方入口苦味、苦味残留、涩味等3个维度进行评判,选出最优的6个配方,结果如图1
2、本配方应用所制得的金芩花颗粒儿童制剂药物药理研究:
2.1金芩花对幼年小鼠耳廓肿胀的作用
金芩花动物实验用剂量 | 相当于儿童临床生药用量 |
幼小鼠=6g/kg | 相当于儿童45g生药/天 |
幼小鼠=3g/kg | 相当于儿童22.5g生药/天 |
幼小鼠=1.5g/kg | 相当于儿童11.25g生药/天 |
幼小鼠=0.75g/kg | 相当于儿童5.625g生药/天 |
6、3、1.5g/kg的金芩花可以降低小鼠耳廓肿胀率,与模型组相比,有极显著差异(P<0.01)或显著差异(P<0.05),表明儿童使用11.25g生药/天就能达到良好的治疗目的。
2.2金芩花对由内毒素诱发的幼年家兔发热的作用
实验采用内毒素致热法,用250ng/ml/kg内毒素注入家兔耳缘静脉引起发热。结果,金芩花颗粒在致热后1-6h有明显退热作用(P<0.05、P<0.01);金芩花胶囊在致热后1-6h有明显退热作用(P<0.05、P<0.01);小剂量金芩花颗粒有明显退热作用(P<0.05);双黄连口服液在药后1-4h有显著差异(P<0.01、P<0.05),阿司匹林在致热后1-6h有明显退热作用(P<0.05、P<0.01),表明金芩花颗粒对家兔内毒素致热有明显退热作用,退热维持时间长于双黄连口服液,同时0.49、0.98、
1.96g/kg的金芩花均对LPS导致兔体温升高有显著地改善作用,说明儿童使用11.25g生药/天就能达到良好的治疗目的。
金芩花动物实验用剂量 | 相当于儿童临床生药用量 |
幼兔=1.962g/kg | 相当于儿童45g生药/天 |
幼兔=0.981g/kg | 相当于儿童22.5g生药/天 |
幼兔=0.49g/kg | 相当于儿童11.25g生药/天 |
幼兔=0.25g/kg | 相当于儿童5.625g生药/天 |
2.3幼龄毒性初步试验
实验采用对幼龄大鼠经口给予金芩花浸膏粉四周重复给药,观察其毒性。试验结果结果表明,该复方不会明显影响幼年动物的生长发育;主要发现是高剂量组可能引起溶血性贫血,程度较轻且可逆,并且相关的组织病理学(骨髓,脾脏等)均无关联表现,因此是可以接受的不良反应。
由此可见,儿童使用11.25g生药/天就能达到良好的治疗目的,使用原金芩花颗粒将造成儿童过量服药的情况。通过按配方1的矫味剂的加入、并降低生药量,能有效的改善原金芩花颗粒的服用口感,适用于儿童患者的使用。
以下通过对比实验进一步说明本发明的有益效果:
实施例 | 苦味 | 苦味残留 | 涩味 |
本发明实施例1 | 0.6 | 0.5 | 0.2 |
本发明实施例2 | 1.1 | 0.7 | 0.3 |
本发明实施例3 | 1.1 | 0.9 | 0.4 |
本发明实施例4 | 1.2 | 1.0 | 0.5 |
本发明实施例5 | 1.3 | 1.5 | 0.9 |
本发明实施例6 | 0.8 | 1.4 | 0.8 |
现有技术 | 5 | 2 | 3 |
附图说明
图1为配方筛选结果图
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:
配方:
①取连翘、野菊花,加8-24倍量水提取挥发油,将剩余的药液过滤后备用,其中,挥发油用β环糊精包合后制得挥发油包合物;
②取金银花、黄芩、蒲公、紫花地丁、柴胡、大青叶、赤芍、当归、大黄加水煎煮,过滤后得到药液;
③将步骤①和步骤②的药液合并所得的药液均匀混合,静置,将混合液离心处理,取上清液浓缩至相对密度为1.0~1.5的清膏;
④取糊精和1%阿司帕坦、0.5%三氯蔗糖、1%安赛蜜与步骤③清膏一起使用喷雾干燥一步法制成1000g颗粒,
⑤将步骤①包合物和步骤④的颗粒和0.5%谷氨酸氨、1%黑加仑香精混合,颗粒包装,每包装5g。
实施例2:
①取以下重量比例的连翘100~300g、野菊花100~300g,加8-24倍量水提取挥发油,将剩余的药液过滤后备用,其中,挥发油用β环糊精包合后制得挥发油包合物;
②取以下重量比例的金银花100~300g、黄芩100~300g、蒲公英100~300g、紫花地丁100~300g、柴胡100~200g、大青叶100~200g、赤芍100~300g、当归100~200g、大黄20~150g加水煎煮,过滤后得到药液;
③将步骤①和步骤②的药液合并所得的药液均匀混合,静置,将混合液离心处理,取上清液浓缩至相对密度为1.0~1.5的清膏;
④取糊精和1%阿司帕坦、0.5%三氯蔗糖、1%安赛蜜、2%柠檬酸与步骤③清膏一起使用喷雾干燥一步法制成1000g颗粒,
⑤将步骤①包合物和步骤④的颗粒和1%黑加仑香精混合,颗粒包装,每包装5g。
实施例3:
①取以下重量比例的连翘100~300g、野菊花100~300g,加8-24倍量水提取挥发油,将剩余的药液过滤后备用,其中,挥发油用β环糊精包合后制得挥发油包合物;
②取以下重量比例的金银花100~300g、黄芩100~300g、蒲公英100~300g、紫花地丁100~300g、柴胡100~200g、大青叶100~200g、赤芍100~300g、当归100~200g、大黄20~150g加水煎煮,过滤后得到药液;
③将步骤①和步骤②的药液合并所得的药液均匀混合,静置,将混合液离心处理,取上清液浓缩至相对密度为1.0~1.5的清膏;
④取糊精和1%阿司帕坦、0.5%三氯蔗糖、1%安赛蜜与步骤③清膏一起使用喷雾干燥一步法制成1000g颗粒,
⑤将步骤①包合物和步骤④的颗粒和1%黑加仑香精混合,颗粒包装,每包装5g。
实施例4:
①取以下重量比例的连翘100~300g、野菊花100~300g,加8-24倍量水提取挥发油,将剩余的药液过滤后备用,其中,挥发油用β环糊精包合后制得挥发油包合物;
②取以下重量比例的金银花100~300g、黄芩100~300g、蒲公英100~300g、紫花地丁100~300g、柴胡100~200g、大青叶100~200g、赤芍100~300g、当归100~200g、大黄20~150g加水煎煮,过滤后得到药液;
③将步骤①和步骤②的药液合并所得的药液均匀混合,静置,将混合液离心处理,取上清液浓缩至相对密度为1.0~1.5的清膏;
④取糊精和1%阿司帕坦、0.5%三氯蔗糖、1%安赛蜜、2%柠檬酸与步骤③清膏一起使用喷雾干燥一步法制成1000g颗粒,
⑤将步骤①包合物和步骤④的颗粒和0.25%谷氨酸钠、1%黑加仑香精混合,颗粒包装,每包装5g。
实施例5:
①取以下重量比例的连翘100~300g、野菊花100~300g,加8-24倍量水提取挥发油,将剩余的药液过滤后备用,其中,挥发油用β环糊精包合后制得挥发油包合物;
②取以下重量比例的金银花100~300g、黄芩100~300g、蒲公英100~300g、紫花地丁100~300g、柴胡100~200g、大青叶100~200g、赤芍100~300g、当归100~200g、大黄20~150g加水煎煮,过滤后得到药液;
③将步骤①和步骤②的药液合并所得的药液均匀混合,静置,将混合液离心处理,取上清液浓缩至相对密度为1.0~1.5的清膏;
④取糊精和1%阿司帕坦、0.5%三氯蔗糖、2%柠檬酸与步骤③清膏一起使用喷雾干燥一步法制成1000g颗粒,
⑤将步骤①包合物和步骤④的颗粒和0.25%谷氨酸钠、1%黑加仑香精混合,颗粒包装,每包装5g。
实施例6:
①取以下重量比例的连翘100~300g、野菊花100~300g,加8-24倍量水提取挥发油,将剩余的药液过滤后备用,其中,挥发油用β环糊精包合后制得挥发油包合物;
②取以下重量比例的金银花100~300g、黄芩100~300g、蒲公英100~300g、紫花地丁100~300g、柴胡100~200g、大青叶100~200g、赤芍100~300g、当归100~200g、大黄20~150g加水煎煮,过滤后得到药液;
③将步骤①和步骤②的药液合并所得的药液均匀混合,静置,将混合液离心处理,取上清液浓缩至相对密度为1.0~1.5的清膏;
④取糊精和1%阿司帕坦、0.5%三氯蔗糖、1%安赛蜜、2%柠檬酸与步骤③清膏一起使用喷雾干燥一步法制成1000g颗粒,
⑤将步骤①包合物和步骤④的颗粒和0.25%谷氨酸钠、1%黑加仑香精、1%草莓香精混合,颗粒包装,每包装5g。
Claims (8)
3.权利要求1所述的制剂的制备方法,所述方法包括:将其中连翘、野菊花提取挥发油并制成包合物,其余药物提取得到提取物,将包合物和提取物合并后加入药用辅料,制备成制剂。
4.根据权利要求3所述的制备方法,其中,所述连翘、野菊花提取挥发油并制备成包合物,并将包合物粉碎成细粉,所用辅料为β-环糊精。
5.根据权利要求3所述的制备方法,其中,所述余药提取采用水提得到的提取物。
6.根据权利要求3所述的制备方法,步骤如下:
①取连翘100~300g、野菊花100~300g,加8-24倍量水提取挥发油,将剩余的药液过滤后备用,其中,挥发油用β环糊精包合后制得挥发油包合物;
②取金银花100~300g、黄芩100~300g、蒲公英100~300g、紫花地丁100~300g、柴胡100~200g、大青叶100~200g、赤芍100~300g、当归100~200g、大黄20~150g加水煎煮,过滤后得到药液;
③将步骤①和步骤②的药液合并所得的药液均匀混合,静置,将混合液离心处理,取上清液浓缩至相对密度为1.0~1.5的清膏;
④取辅料和矫味剂与步骤③清膏一起使用喷雾干燥一步法制成1000g颗粒,
⑤将步骤①包合物和步骤④的颗粒和适量矫味剂混合,颗粒包装,每包装5g;其中,所述的辅料为填充剂和矫味剂,填充剂为糊精,用量为600g;矫味剂为:阿司帕坦、三氯蔗糖、安赛蜜、食用香精、谷氨酸钠、柠檬酸。
7.根据权利要求6所述的制备方法,其中,所述的矫味剂为:阿司帕坦10g、三氯蔗糖5g、安赛蜜10g、食用香精10g、谷氨酸钠2.5g。
8.根据权利要求7所述的制备方法,其中,所述的食用香精是黑加仑香精。
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