CN112494573A - 一种无糖型咽舒合剂及其制备方法 - Google Patents
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Abstract
本发明涉及医药技术领域，具体涉及一种无糖型咽舒合剂及其制备方法,由以下组分构成：虎掌草、午香草、玄参、射干、牛蒡子、桔梗、陈皮、甘草，还添加有高甜度非营养型矫味剂,所述咽舒合剂制备方法具体包括煎煮、浓缩、纯化、调味、离心过滤、装罐灭菌、品检；本发明使得糖尿病和肥胖型的咽炎、扁桃体炎患者也可以适用，不会导致龋齿和肥胖，并且本发明生产的咽舒合剂经长期贮存不易产生沉淀现象，影响产品性状。
Description
技术领域
本发明涉及医药技术领域，具体涉及一种无糖型咽舒合剂及其制备方法。
背景技术
咽舒合剂是云南金碧制药有限公司自主研制和生产的治疗呼吸系统疾患的彝药产品，批准文号为国药准字Z20025601，具有清咽利喉，止咳化痰功效。用于风热证或痰热证引起的咽喉肿痛，咳嗽、痰多、发热、口苦；急慢性咽炎、扁桃体炎。彝医表述为“哦格诺勒摆诺，兹猜诺且”，具有独特的疗效。本品所用辅料为蔗糖和蜂蜜(矫味剂)，在长期的生产经营过程中发现，本品因含糖量高，不适用于糖尿病和肥胖型的咽炎、扁桃体炎患者，同时，本品贮存过程中易出现沉淀影响性状，因此为了增加该产品的适用范围以及解决长期存放的沉淀问题，需要对该技术进行改进提高。
发明内容
本发明提供一种无糖型咽舒合剂及其制备方法，以达到糖尿病和肥胖型的咽炎、扁桃体炎患者也可以适用的目的，同时避免长期贮存时出现沉淀现象，影响产品性状。
为实现上述目的，本发明采用的技术方案是：一种无糖型咽舒合剂，由以下组分构成：虎掌草、午香草、玄参、射干、牛蒡子、桔梗、陈皮、甘草，还添加有高甜度非营养型矫味剂。
进一步的：所述高甜度非营养型矫味剂为甜菊素、乙酰磺胺酸钾、三氯蔗糖、阿司帕坦中的一种或几种。
本发明还提供一种无糖型咽舒合剂的制备方法，具体包括以下步骤：
1)煎煮：取适量虎掌草、午香草、玄参、射干、牛蒡子、桔梗、陈皮、甘草，加水煎煮三次，第一次1.5h，第二次、第三次各1h；
2)浓缩：将上述三次煎煮后的煎液合并，200目以上过滤，滤液浓缩至相对密度为1.15-1.20(25℃)的清膏，冷却；
3)纯化：将上述清膏加乙醇溶液，使含醇量为60％，搅匀，静置36h，过滤，滤液回收乙醇，浓缩至相对密度1.15-1.17(25℃)的清膏；
4)调味：在上述清膏中加入矫味剂，用枸橼酸调节pH值至4.0～5.0，混匀，冷藏8h～24h；
5)离心过滤：将上述冷藏过的清膏离心、300目以上过滤，将滤液加水至总量，混匀；
6)装罐、灭菌；
7)品检。
本发明的有益技术效果是：
(1)本发明中将之前咽舒合剂中的辅料重新进行组配，去除了原来的蔗糖和蜂蜜，替换为高甜度非营养型矫味剂，特别是甜菊素、乙酰磺胺酸钾、三氯蔗糖、阿司帕坦中的一种或几种，使得糖尿病和肥胖型的咽炎、扁桃体炎患者也可以适用，同时经过跟踪调查发现，采用新组方之后，不仅可供糖尿病人食用，而且不会导致龋齿和肥胖；
(2)经过多次试验证实，现有技术中的咽舒合剂成品在灭菌后存放过程中易出现沉淀影响性状，采用本发明所述的组方之后，产品稳定性得到了明显的提高，产品在标准要求的PH4-5范围内很稳定，115℃灭菌20分钟，121℃灭菌15分钟样品均未产生沉淀，稳定性考察样品在40℃放置6个月和25℃放置12 个月，考察指标未出现明显波动。
具体实施方式
下面对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
实施例1：
一种无糖型咽舒合剂，其组分按照重量配比，具体包括虎掌草250g、午香草 200g、玄参200g、射干200g、牛蒡子200g、桔梗150g、陈皮150g、甘草150g，甜菊素0.1～10g。
上述无糖型咽舒合剂的具体制备方法为：
1)煎煮：取虎掌草250g、午香草200g、玄参200g、射干200g、牛蒡子 200g、桔梗150g、陈皮150g、甘草150g，加水煎煮三次，第一次1.5小时，第二次、第三次1小时；
2)浓缩：将上述三次煎煮后的煎液合并，过滤，将滤液浓缩至相对密度为 1.15-1.20(25℃)的清膏，冷却；
3)纯化：将上述清膏加乙醇溶液，使含醇量为60％，搅匀，静置36h，过滤，滤液回收乙醇，浓缩至相对密度1.15-1.17(25℃)的清膏；
4)调味：在上述清膏中加入矫味剂，所述矫味剂为甜菊素0.1～10g，用枸橼酸调节pH值至4.0～5.0，混匀，冷藏8h～24h；
5)离心过滤：将上述冷藏过的清膏离心、过滤，将滤液加水，混匀；
6)装罐、灭菌；
7)品检。
实施例2：
一种无糖型咽舒合剂，其组分按照重量配比，具体包括虎掌草250g、午香草 200g、玄参200g、射干200g、牛蒡子200g、桔梗150g、陈皮150g、甘草150g，乙酰磺胺酸钾0.1～10g。
上述无糖型咽舒合剂的具体制备方法为：
1)煎煮：取虎掌草250g、午香草200g、玄参200g、射干200g、牛蒡子 200g、桔梗150g、陈皮150g、甘草150g，加水煎煮三次，第一次1.5小时，第二次、第三次1小时；
2)浓缩：将上述三次煎煮后的煎液合并，过滤，将滤液浓缩至相对密度为 1.15-1.20(25℃)的清膏，冷却；
3)纯化：将上述清膏加乙醇溶液，使含醇量为60％，搅匀，静置36h，过滤，滤液回收乙醇，浓缩至相对密度1.15-1.17(25℃)的清膏；
4)调味：在上述清膏中加入矫味剂，所述矫味剂为乙酰磺胺酸钾0.1～10g，用枸橼酸调节pH值至4.0～5.0，混匀，冷藏8h～24h；
5)离心过滤：将上述冷藏过的清膏离心、过滤，将滤液加水，混匀；
6)装罐、灭菌；
7)品检。
实施例3：
一种无糖型咽舒合剂，其组分按照重量配比，具体包括虎掌草250g、午香草 200g、玄参200g、射干200g、牛蒡子200g、桔梗150g、陈皮150g、甘草150g，三氯蔗糖0.1～10g。
上述无糖型咽舒合剂的具体制备方法为：
1)煎煮：取虎掌草250g、午香草200g、玄参200g、射干200g、牛蒡子 200g、桔梗150g、陈皮150g、甘草150g，加水煎煮三次，第一次1.5小时，第二次、第三次1小时；
2)浓缩：将上述三次煎煮后的煎液合并，过滤，将滤液浓缩至相对密度为 1.15-1.20(25℃)的清膏，冷却；
3)纯化：将上述清膏加乙醇溶液，使含醇量为60％，搅匀，静置36h，过滤，滤液回收乙醇，浓缩至相对密度1.15-1.17(25℃)的清膏；
4)调味：在上述清膏中加入矫味剂，所述矫味剂为三氯蔗糖0.1～10g，用枸橼酸调节pH值至4.0～5.0，混匀，冷藏8h～24h；
5)离心过滤：将上述冷藏过的清膏离心、过滤，将滤液加水，混匀；
6)装罐、灭菌；
7)品检。
实施例4：
一种无糖型咽舒合剂，其组分按照重量配比，具体包括虎掌草250g、午香草 200g、玄参200g、射干200g、牛蒡子200g、桔梗150g、陈皮150g、甘草150g，阿司帕坦0.1～10g。
上述无糖型咽舒合剂的具体制备方法为：
1)煎煮：取虎掌草250g、午香草200g、玄参200g、射干200g、牛蒡子200g、桔梗150g、陈皮150g、甘草150g，加水煎煮三次，第一次1.5小时，第二次、第三次1小时；
2)浓缩：将上述三次煎煮后的煎液合并，过滤，将滤液浓缩至相对密度为 1.15-1.20(25℃)的清膏，冷却；
3)纯化：将上述清膏加乙醇溶液，使含醇量为60％，搅匀，静置36h，过滤，滤液回收乙醇，浓缩至相对密度1.15-1.17(25℃)的清膏；
4)调味：在上述清膏中加入矫味剂，所述矫味剂为阿司帕坦0.1～10g，用枸橼酸调节pH值至4.0～5.0，混匀，冷藏8h～24h；
5)离心过滤：将上述冷藏过的清膏离心、过滤，将滤液加水，混匀；
6)装罐、灭菌；
7)品检。
上述实施例中品检主要包括以下内容：
【性状】本品为棕褐色的粘稠液体；气微香，味苦、甜、微酸。
【鉴别】(1)检出齐墩果酸。(2)检出牛蒡子苷。(3)检出桔梗。(4) 检出玄参。
【检查】相对密度：应不低于1.05。pH值：应为4.0～6.0。
【含量测定】本品每ml含虎掌草以齐墩果酸(C30H48O3)计，不得少于1.5mg。
【微生物限度】需氧菌总数＜102cfu/ml；霉菌和酵母菌总数＜101cfu/ml；不得检出大肠埃希菌(1ml)。
上述实施例中相对密度1.15-1.20(25℃)表示浸膏为25℃条件下测定，相对密度1.15-1.17(25℃)表示浸膏为25℃条件下测定，所述调味步骤中冷藏8h～ 24h，其目的为通过降低温度，使温度对溶解度有影响的物质析出，除去。
将上述实施例产品以及现有技术产品进行检测，均符合质量标准要求，产品稳定性测试方法和结果如下：
1)稳定性加速实验：取供试品，置稳定性试验箱中，设置温度40℃(±2℃) 放置6个月。分别于0个月、3个月、6个月取样，按咽舒合剂质量标准草案检测，记录结果。
2)稳定性长期实验：取供试品，置稳定性试验箱中，设置温度25℃(±2℃) 放置12个月。分别于0个月、3个月、6个月、9个月、12个月取样，按咽舒合剂质量标准草案检测，记录结果。
表1品检结果
表2澄清度检查结果
注：“-”表示澄清，“+”微量沉淀，“++”少量沉淀，“+++”大量沉淀。
经检索，未发现方中药味对糖尿病人有明显影响或导致血糖升高的报道，所用矫味剂甜菊素、乙酰磺胺酸钾、三氯蔗糖、阿司帕坦均为高甜度矫味剂，无热量或低热量，且使用量极小，不会对糖尿病人和肥胖患者产生影响。
以上所述仅为本发明的较佳实施例而已，并不用以限制本发明，凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。
Claims (3)
1.一种无糖型咽舒合剂，由以下组分构成：虎掌草、午香草、玄参、射干、牛蒡子、桔梗、陈皮、甘草，其特征在于，还添加有高甜度非营养型矫味剂。
2.一种无糖型咽舒合剂，其特征在于，所述高甜度非营养型矫味剂为甜菊素、乙酰磺胺酸钾、三氯蔗糖、阿司帕坦中的一种或几种。
3.一种权利要求1-2所述的无糖型咽舒合剂的制备方法，其特征在于，包括以下步骤：
1)煎煮：取适量虎掌草、午香草、玄参、射干、牛蒡子、桔梗、陈皮、甘草，加水漫过药材，煎煮三次，第一次1.5h，第二次、第三次各1h；
2)浓缩：将上述三次煎煮后的煎液合并，200目以上过滤，滤液浓缩至相对密度为1.15～1.20(25℃)的清膏，冷却；
3)纯化：将上述清膏加乙醇溶液，使含醇量为60％，搅匀，静置36h，过滤，滤液回收乙醇，浓缩至相对密度1.15～1.17(25℃)的清膏；
4)调味：在上述清膏中加入矫味剂，用枸橼酸调节pH值至4.0～5.0，混匀，冷藏8h～24h；
5)离心过滤：将上述冷藏过的清膏离心、300目以上过滤，将滤液加水至总量，混匀；
6)装罐、灭菌；
7)品检。
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| CN115463183A (zh) * | 2022-09-17 | 2022-12-13 | 云南金碧制药有限公司 | 咽舒合剂用于新冠病毒治疗新用途 |
| CN116159100A (zh) * | 2022-09-17 | 2023-05-26 | 云南金碧制药有限公司 | 咽舒合剂用于上呼吸道病毒治疗新用途 |
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| CN1278443A (zh) * | 1999-06-17 | 2001-01-03 | 云南金碧制药厂 | 治疗上呼吸道疾病的药物及其制备方法 |
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| CN1278443A (zh) * | 1999-06-17 | 2001-01-03 | 云南金碧制药厂 | 治疗上呼吸道疾病的药物及其制备方法 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN115463183A (zh) * | 2022-09-17 | 2022-12-13 | 云南金碧制药有限公司 | 咽舒合剂用于新冠病毒治疗新用途 |
| CN116159100A (zh) * | 2022-09-17 | 2023-05-26 | 云南金碧制药有限公司 | 咽舒合剂用于上呼吸道病毒治疗新用途 |
| CN116159100B (zh) * | 2022-09-17 | 2023-09-15 | 云南金碧制药有限公司 | 咽舒合剂在制备用于治疗上呼吸道病毒感染的药物中的应用 |
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