CN112972439A - 一种愈美泡腾片及其制备方法 - Google Patents

一种愈美泡腾片及其制备方法 Download PDF

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CN112972439A
CN112972439A CN201911295227.2A CN201911295227A CN112972439A CN 112972439 A CN112972439 A CN 112972439A CN 201911295227 A CN201911295227 A CN 201911295227A CN 112972439 A CN112972439 A CN 112972439A
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parts
yumei
effervescent
effervescent tablet
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杨鹏辉
元和亮
王兵成
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Nanjing Yewin Pharmacentical Co ltd
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/075—Ethers or acetals
    • A61K31/085—Ethers or acetals having an ether linkage to aromatic ring nuclear carbon
    • A61K31/09—Ethers or acetals having an ether linkage to aromatic ring nuclear carbon having two or more such linkages
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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Abstract

本发明公开了一种愈美泡腾片及其制备方法，它由愈创木酚甘油醚、氢溴酸右美沙芬、酸碱泡腾剂、填充剂、粘合剂、矫味剂、润滑剂组成，其制备方法为将愈创木酚甘油醚、氢溴酸右美沙芬与粘合剂溶于乙醇中作为喷液，采用流化床对酸碱泡腾剂、矫味剂和填充剂的混合物进行顶喷制粒，将制粒好的物料与润滑剂混合并压片，从而制得产品。

Description

一种愈美泡腾片及其制备方法
技术领域
本发明涉及药物制剂领域中愈美泡腾片的制备方法。
背景技术
愈美泡腾片是泡腾片剂，主要成分为愈创木酚甘油醚和氢溴酸右美沙芬，愈创木酚甘油醚为恶心祛痰剂，通过刺激胃粘膜，引起轻微的恶心而反射性地使呼吸道腺体分泌增加，痰液稀释而易咳出.氢溴酸右美沙芬是吗啡类的制剂，主要通过抑制人体延髓的咳嗽中枢，而发挥中枢性的镇咳作用。
目前市场上有愈美颗粒、愈美胶囊、愈美片、愈美分散片。而将其制备成泡腾片有如下优点：①剂型新颖，服用方便、起效迅速；②口感好，患者依从性好，特别适用于儿童、老年人以及吞服固体制剂困难的患者；③1~5min内快速崩解；④便于携带、运输和贮存。
发明内容
本发明提供了一种愈美泡腾片及其制备方法。
本发明技术方案如下：
它由愈创木酚甘油醚、氢溴酸右美沙芬、酸碱泡腾剂、填充剂、粘合剂、润滑剂组成，具体的说，本发明的愈美泡腾片按1000片质量计：愈创木酚甘油醚为50g、氢溴酸右美沙芬7.5g，酸性泡腾剂为50~100g，碱性泡腾剂为50~100g，粘合剂为12~20g，润滑剂用量为12~20g，矫味剂用量为20~30g，填充剂用量为加至400g。
上述的酸性泡腾剂可以为柠檬酸、酒石酸，碱性泡腾片可以为碳酸氢钠，填充剂可以为乳糖、微晶纤维素、粘合剂可以为聚维酮K30、矫味剂可以为阿斯巴甜、润滑剂可以为聚乙二醇6000。
一种愈美泡腾片制备方法，它包括如下步骤：
步骤1：将酸碱泡腾剂、矫味剂与填充剂混合均与，放置于顶喷流化床制粒机中。
步骤2：配制粘合剂，将愈创木酚甘油醚、氢溴酸右美沙芬以及粘合剂溶于乙醇中备用。
步骤3：开启流化床制粒机，将上述粘合剂通过顶喷的方式喷于流化床中并制得颗粒（进风温度设置为50℃，引风频率设置为30Hz）。
步骤4：将步骤3中颗粒与润滑剂混合均匀，并压片制得产品。
本发明的特点：
通过利用将愈创木酚甘油醚、氢溴酸右美沙芬与喷洒于物料中的方式，确保了产品物料的均匀性，同时采用乙醇喷洒，避免了酸碱混合，采用本工艺能更好的确保产品的质量可靠性。
四：具体实施方式
下面通过具体实施方式对本发明进行进一步的说明，但只是用于帮助理解本发明，使本领域专业技术人员能够实现或者使用本发明，不对本发明构成任何限制。
实施例1.
愈创木酚甘油醚 50g
氢溴酸右美沙芬 7.5g
柠檬酸 50g
碳酸氢钠 50g
乳糖 198.5g
聚维酮K30 12g
阿斯巴甜 20g
聚乙二醇6000 12g
制成 1000片量
具体的愈美泡腾片制备方法如下所述：将柠檬酸、碳酸氢钠、阿斯巴甜与乳糖混合均匀，放置于顶喷流化床制粒机中；然后配制粘合剂，方法为将愈创木酚甘油醚、氢溴酸右美沙芬以及聚维酮K30溶于乙醇中备用；开启流化床制粒机，将上述粘合剂通过顶喷的方式喷于流化床中并制的颗粒（进风温度设置为50℃，引风频率设置为30Hz）；将制得的颗粒与聚乙二醇6000混合均匀，并压片制得产品。
实施例2.
愈创木酚甘油醚 50g
氢溴酸右美沙芬 7.5g
酒石酸 100g
碳酸氢钠 100g
微晶纤维素 72.5g
聚维酮K30 20g
阿斯巴甜 30g
聚乙二醇6000 20g
制成 1000片量
具体的愈美泡腾片制备方法如下所述：将酒石酸、碳酸氢钠、阿斯巴甜与微晶纤维素混合均与，放置于顶喷流化床制粒机中；然后配制粘合剂，方法为将愈创木酚甘油醚、氢溴酸右美沙芬以及聚维酮K30溶于乙醇中备用；开启流化床制粒机，将上述粘合剂通过顶喷的方式喷于流化床中并制的颗粒（进风温度设置为50℃，引风频率设置为30Hz）；将制得的颗粒与聚乙二醇6000混合均匀，并压片制得产品。

Claims (4)

1.一种愈美泡腾片及其制备方法，其特征是：它由愈创木酚甘油醚、氢溴酸右美沙芬、酸碱泡腾剂、填充剂、粘合剂、润滑剂组成，其制备方法为将愈创木酚甘油醚、氢溴酸右美沙芬与粘合剂溶于无水乙醇中作为喷液，采用流化床对酸碱泡腾剂、矫味剂、填充剂的混合物进行顶喷制粒，将制粒好的物料与润滑剂混合并压片，从而制得产品。
2.根据权利要求1所述的愈美泡腾片，其特征是：所述的酸性泡腾剂为柠檬酸、酒石酸，碱性泡腾片为碳酸氢钠，填充剂为乳糖、微晶纤维素、粘合剂为聚维酮K30、矫味剂为阿斯巴甜、润滑剂为聚乙二醇600。
3.根据权利要求1所述的愈美泡腾片，其特征是：愈创木酚甘油醚为50重量份、氢溴酸右美沙芬7.5重量份，酸性泡腾剂为50~100重量份，碱性泡腾剂为50~100重量份，粘合剂为12~20重量份，润滑剂用量为12~20重量份，矫味剂用量为20~30重量份，填充剂用量为加至400重量份。
4.根据权利要求1所述的愈美泡腾片的制备方法，其特征是：将愈创木酚甘油醚、氢溴酸右美沙芬与粘合剂溶于乙醇中作为喷液，采用流化床对酸碱泡腾剂、填充剂的混合物进行顶喷制粒（进风温度设置为50℃，引风频率设置为30Hz），将制粒好的物料与润滑剂混合并压片，从而制得产品。
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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1994008551A2 (en) * 1992-10-09 1994-04-28 The Procter & Gamble Company Pharmaceutical compositions and methods for treating cold symptoms
WO1995033446A1 (en) * 1994-06-03 1995-12-14 The Procter & Gamble Company Fast dissolving dosage forms
CN102038684A (zh) * 2009-10-16 2011-05-04 北京润德康医药技术有限公司 用于镇咳化痰的药物组合物
CN106727561A (zh) * 2015-11-19 2017-05-31 哈尔滨圣吉药业股份有限公司 一种愈美缓释片及其制备方法
CN207694978U (zh) * 2018-03-26 2018-08-07 赤峰维康生化制药有限公司 一种愈美分散片药粉磁滤器

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1994008551A2 (en) * 1992-10-09 1994-04-28 The Procter & Gamble Company Pharmaceutical compositions and methods for treating cold symptoms
WO1995033446A1 (en) * 1994-06-03 1995-12-14 The Procter & Gamble Company Fast dissolving dosage forms
CN102038684A (zh) * 2009-10-16 2011-05-04 北京润德康医药技术有限公司 用于镇咳化痰的药物组合物
CN106727561A (zh) * 2015-11-19 2017-05-31 哈尔滨圣吉药业股份有限公司 一种愈美缓释片及其制备方法
CN207694978U (zh) * 2018-03-26 2018-08-07 赤峰维康生化制药有限公司 一种愈美分散片药粉磁滤器

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
无: "愈美分散片说明书", 《HTTPS://WWW.YAOFANGWANG.COM/YONGYAO/1036933.SHTML》 *

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