CN116270487B - 一种小儿氨酚黄那敏颗粒及制备方法 - Google Patents
一种小儿氨酚黄那敏颗粒及制备方法 Download PDFInfo
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- CN116270487B CN116270487B CN202310248192.7A CN202310248192A CN116270487B CN 116270487 B CN116270487 B CN 116270487B CN 202310248192 A CN202310248192 A CN 202310248192A CN 116270487 B CN116270487 B CN 116270487B
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- parts
- sodium
- paracetamol
- calcium citrate
- granules
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- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 title claims abstract description 105
- 229960005489 paracetamol Drugs 0.000 title claims abstract description 78
- DBAKFASWICGISY-BTJKTKAUSA-N Chlorpheniramine maleate Chemical compound OC(=O)\C=C/C(O)=O.C=1C=CC=NC=1C(CCN(C)C)C1=CC=C(Cl)C=C1 DBAKFASWICGISY-BTJKTKAUSA-N 0.000 title claims abstract description 61
- 239000008187 granular material Substances 0.000 title claims abstract description 43
- 238000002360 preparation method Methods 0.000 title claims abstract description 22
- 229940046978 chlorpheniramine maleate Drugs 0.000 claims abstract description 39
- 206010004542 Bezoar Diseases 0.000 claims abstract description 29
- UEDUENGHJMELGK-HYDKPPNVSA-N Stevioside Chemical compound O([C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1O[C@]12C(=C)C[C@@]3(C1)CC[C@@H]1[C@@](C)(CCC[C@]1([C@@H]3CC2)C)C(=O)O[C@H]1[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O1)O)[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O UEDUENGHJMELGK-HYDKPPNVSA-N 0.000 claims abstract description 24
- 229940013618 stevioside Drugs 0.000 claims abstract description 24
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- 235000019202 steviosides Nutrition 0.000 claims abstract description 24
- FNAQSUUGMSOBHW-UHFFFAOYSA-H calcium citrate Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O.[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O FNAQSUUGMSOBHW-UHFFFAOYSA-H 0.000 claims description 31
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- AMTWCFIAVKBGOD-UHFFFAOYSA-N dioxosilane;methoxy-dimethyl-trimethylsilyloxysilane Chemical compound O=[Si]=O.CO[Si](C)(C)O[Si](C)(C)C AMTWCFIAVKBGOD-UHFFFAOYSA-N 0.000 claims description 9
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- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 2
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Classifications
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- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
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- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
- A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
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- 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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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
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- Rheumatology (AREA)
- Chemical Kinetics & Catalysis (AREA)
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Abstract
本发明涉及一种小儿氨酚黄那敏颗粒,由下列重量份的组分制备而成:对乙酰氨基酚125份、人工牛黄5份、马来酸氯苯那敏0.5份、甜菊苷20份、填充剂、崩解剂、粘合剂、润滑剂,并公开了其制备方法,本发明能掩盖对乙酰氨基酚的苦味,方便儿童服用,避免对乙酰氨基酚的降解为对氨基酚,含量均匀性好、粒度、溶化性等符合标准要求。
Description
技术领域
本发明涉及的是新制剂及其制备方法,具体涉及一种小儿氨酚黄那敏颗粒及制备方法。
背景技术
小儿氨酚黄那敏颗粒,标准号:WS-10001-(HD-0214)-2002,本品含对乙酰氨基酚(C8H9NO2)应为标示量的95.0%~105.0%。处方为:对乙酰氨基酚125g、人工牛黄5g、马来酸氯苯那敏0.5g、辅料适量,制成1000袋。本品不能同时服用含有本品及其他解热镇痛药的制剂。不宜大量或长期服用,以防引起造血系统和肝、肾脏损害。疗效不显著者宜就医检查。肝肾功能不全者慎用。
中国专利(CN 107126442 B)公开一种小儿氨酚黄那敏颗粒制备工艺,是由对乙酰氨基酚125g、马来酸氯苯那敏0.5g、人工牛黄5g、糖粉1765~1870g、粘合剂0.1~5%、香精0.01~0.03%,枸橼酸0.05~0.15%组成。中国专利(CN 108685856 B)公开小儿氨酚黄那敏颗粒由对乙酰氨基酚、人工牛黄包合物、马来酸氯苯那和剩余的蔗糖制成,所述人工牛黄包合物以具有不同取代度的羟丙基-β环糊精混合物为主体,人工牛黄为客体采用现有包合技术制备而成。中国专利(CN 109602709 B),涉及一种提高小儿氨酚黄那敏颗粒得率和均一性的制备方法,步骤如下:(1)马来酸氯苯那敏糖浆溶液的制备:取部分蔗糖制成糖浆,再加入马来酸氯苯那敏搅拌使充分溶解,制成马来酸氯苯那敏糖浆溶液。(2)剩余蔗糖用万能粉碎机过100目筛粉碎。(3)制粒:人工牛黄粉碎后与对乙酰氨基酚等量递增混匀后再与蔗糖粉至高速湿法制粒机内干混5-10分钟,加入马来酸氯苯那敏糖浆溶液湿混5-10分钟,制得软材,制粒,干燥,即得。可见现有小儿氨酚黄那敏颗粒生产技术中,添加了大量蔗糖,根据参考文献(孙煜,谭菊英,颜其双,王娟,何虹,卢日刚.小儿氨酚黄那敏颗粒评价性抽验结果及质量评价[J].大众科技,2021,23(09):78-81+55.)记载,对乙酰氨基酚是解热镇痛药,在小儿氨酚黄那敏颗粒在潮湿条件下会水解成对氨基酚,并进一步发生氧化降解,产生更多杂质。对氨基酚毒性较强,具有基因毒性,其毒性靶器官主要在肾脏、血液和中枢神经系统,可引起高铁血红蛋白血症以及肾损伤。处方中大量的蔗糖给样品带来易受潮的风险,间接导致产品中杂质含量增加的可能性。本课题组在大量实验的研究中,意外发现,使用甜菊苷代替蔗糖,不能能掩盖苦味,还能避免对乙酰氨基酚的降解。
发明内容
鉴于现有技术的不足,本发明通过对辅料的选择以及制备工艺的优化,提供一种掩盖苦味,避免降解、起效快、质量稳定的小儿氨酚黄那敏颗粒。
为了实现上述技术目的,本发明的技术方案概括如下:一种小儿氨酚黄那敏颗粒,由下列重量份的组分制备而成:对乙酰氨基酚125份、人工牛黄5份、马来酸氯苯那敏0.5份、甜菊苷20份、填充剂、崩解剂、粘合剂、润滑剂。
所述一种小儿氨酚黄那敏颗粒,填充剂包括羧甲基淀粉钠、羧甲基纤维素、羧甲基纤维素钙、羧甲基纤维素钠、二氧化硅、柠檬酸钙、羟乙基甲基纤维素中的一种或多种,优选为羧甲基淀粉钠、柠檬酸钙,分别为羧甲基淀粉钠15份、柠檬酸钙10份。
所述一种小儿氨酚黄那敏颗粒,崩解剂包括低取代羟丙基纤维素、微晶纤维素、羧甲基纤维素、羧甲基纤维素钙中的一种或多种,优选为低取代羟丙基纤维素、微晶纤维素,分别为低取代羟丙基纤维素15份、微晶纤维素15份。
所述一种小儿氨酚黄那敏颗粒,粘合剂包括阿拉伯树胶、海藻酸钠、羧乙烯基聚合物、明胶、糊精、果胶、聚丙烯酸钠、普鲁兰多糖、甲基纤维素、羟丙基纤维素、羟丙基甲基纤维素、聚乙烯醇、聚乙烯吡咯烷酮中的一种或多种,优选为海藻酸钠5份。
所述一种小儿氨酚黄那敏颗粒,润滑剂包括硬脂酸镁、硬脂酸钙、十八烷基富马酸钠和滑石粉的一种或多种。
所述一种小儿氨酚黄那敏颗粒,由下列重量份的组分制备而成:对乙酰氨基酚125份、人工牛黄5份、马来酸氯苯那敏0.5份、甜菊苷20份、羧甲基淀粉钠15份、柠檬酸钙10份、低取代羟丙基纤维素15份、微晶纤维素15份、海藻酸钠5份、十八烷基富马酸钠1份。
所述一种小儿氨酚黄那敏颗粒制备方法:人工牛黄5份、马来酸氯苯那敏0.5份,加羧甲基淀粉钠7.5份、柠檬酸钙5份,制备成微丸,包裹对乙酰氨基酚125份和甜菊苷,加羧甲基淀粉钠7.5份、柠檬酸钙5份、低取代羟丙基纤维素15份、微晶纤维素15份、海藻酸钠5份,制粒,添加十八烷基富马酸钠1份,分装。
与现有技术相比,本发明涉及的小儿氨酚黄那敏颗粒及其制备方法具有如下优点和显著进步性:
(1)本发明的小儿氨酚黄那敏颗粒,应用甜菊苷掩盖对乙酰氨基酚的苦味,方便儿童服用。
(2)本发明的小儿氨酚黄那敏颗粒,应用甜菊苷避免对乙酰氨基酚的降解为对氨基酚。
(3)本发明使用一定比例的填充剂、崩解剂、粘合剂、润滑剂进行制粒,解决了现有技术中存在的因粘性小产生的粒度不合格和使用乙醇有机溶剂带来的生产不安全,生产成本高等缺陷,含量均匀性好、粒度、溶化性等符合标准要求。
(4)本发明采用等量递增法,将人工牛黄、马来酸氯苯那敏、填充剂制备成微丸,再包裹对乙酰氨基酚和甜菊苷,使得对乙酰氨基酚解热效果发挥迅速,达到标本兼治的目的。
具体实施方式
下面通过实施例来进一步描述本发明的有益效果,应该正确理解的是:本发明的实施例仅仅是用于说明本发明而给出,而不是对本发明的限制。所以,本领域普通技术人员根据本发明所做的显而易见的改变和修饰也包含在本发明范围之内。
实施例1:一种小儿氨酚黄那敏颗粒,处方为:人工牛黄5份、马来酸氯苯那敏0.5份、对乙酰氨基酚125份、甜菊苷20份、羧甲基淀粉钠15份、柠檬酸钙10份、低取代羟丙基纤维素15份、微晶纤维素15份、海藻酸钠5份、十八烷基富马酸钠1份。
制备方法:取人工牛黄、马来酸氯苯那敏,加半份羧甲基淀粉钠、半份柠檬酸钙,采用等量递增法混合均匀,干混10min,加入二甲硅油,2000r/min剪切12min,得湿软材,将湿软材放入挤出滚圆机中进行制粒,以400r/min,时间为2min,得微丸,加对乙酰氨基酚、甜菊苷,另外半份羧甲基淀粉钠、半份柠檬酸钙、低取代羟丙基纤维素、微晶纤维素、海藻酸钠,制粒,添加十八烷基富马酸钠,制备成颗粒剂。
实施例2:一种小儿氨酚黄那敏颗粒,处方为:人工牛黄5份、马来酸氯苯那敏0.5份、对乙酰氨基酚125份、甜菊苷20份、羧甲基淀粉钠30份、柠檬酸钙10份、低取代羟丙基纤维素15份、微晶纤维素15份、海藻酸钠5份、十八烷基富马酸钠1份。
制备方法:取人工牛黄、马来酸氯苯那敏,加半份羧甲基淀粉钠、半份柠檬酸钙,采用等量递增法混合均匀,干混10min,加入二甲硅油,2000r/min剪切12min,得湿软材,将湿软材放入挤出滚圆机中进行制粒,以400r/min,时间为2min,得微丸,加对乙酰氨基酚、甜菊苷,另外半份羧甲基淀粉钠、半份柠檬酸钙、低取代羟丙基纤维素、微晶纤维素、海藻酸钠,制粒,添加十八烷基富马酸钠,制备成颗粒剂。
实施例3:一种小儿氨酚黄那敏颗粒,处方为:人工牛黄5份、马来酸氯苯那敏0.5份、对乙酰氨基酚125份、甜菊苷20份、羧甲基淀粉钠10份、柠檬酸钙20份、低取代羟丙基纤维素15份、微晶纤维素15份、海藻酸钠5份、十八烷基富马酸钠1份。
制备方法:取人工牛黄、马来酸氯苯那敏,加半份羧甲基淀粉钠、半份柠檬酸钙,采用等量递增法混合均匀,干混10min,加入二甲硅油,2000r/min剪切12min,得湿软材,将湿软材放入挤出滚圆机中进行制粒,以400r/min,时间为2min,得微丸,加对乙酰氨基酚、甜菊苷,另外半份羧甲基淀粉钠、半份柠檬酸钙、低取代羟丙基纤维素、微晶纤维素、海藻酸钠,制粒,添加十八烷基富马酸钠,制备成颗粒剂。
实施例4:一种小儿氨酚黄那敏颗粒,处方为:人工牛黄5份、马来酸氯苯那敏0.5份、对乙酰氨基酚125份、甜菊苷20份、羟乙基甲基纤维素15份、柠檬酸钙10份、低取代羟丙基纤维素15份、微晶纤维素15份、海藻酸钠5份、十八烷基富马酸钠1份。
制备方法:取人工牛黄、马来酸氯苯那敏,加半份羟乙基甲基纤维素、半份柠檬酸钙,采用等量递增法混合均匀,干混10min,加入二甲硅油,2000r/min剪切12min,得湿软材,将湿软材放入挤出滚圆机中进行制粒,以400r/min,时间为2min,得微丸,加对乙酰氨基酚、甜菊苷,另外半份羟乙基甲基纤维素、半份柠檬酸钙、低取代羟丙基纤维素、微晶纤维素、海藻酸钠,制粒,添加十八烷基富马酸钠,制备成颗粒剂。
对比实施例1:一种小儿氨酚黄那敏颗粒,处方为:人工牛黄5份、马来酸氯苯那敏0.5份、对乙酰氨基酚125份、蔗糖20份、羧甲基淀粉钠15份、柠檬酸钙10份、低取代羟丙基纤维素15份、微晶纤维素15份、海藻酸钠5份、十八烷基富马酸钠1份。
制备方法:取人工牛黄、马来酸氯苯那敏,加半份羧甲基淀粉钠、半份柠檬酸钙,采用等量递增法混合均匀,干混10min,加入二甲硅油,2000r/min剪切12min,得湿软材,将湿软材放入挤出滚圆机中进行制粒,以400r/min,时间为2min,得微丸,加对乙酰氨基酚、蔗糖,另外半份羧甲基淀粉钠、半份柠檬酸钙、低取代羟丙基纤维素、微晶纤维素、海藻酸钠,制粒,添加十八烷基富马酸钠,制备成颗粒剂。
对比实施例2:一种小儿氨酚黄那敏颗粒,处方为:人工牛黄5份、马来酸氯苯那敏0.5份、对乙酰氨基酚125份、甜菊苷20份、羧甲基淀粉钠15份、低取代羟丙基纤维素15份、微晶纤维素15份、海藻酸钠5份、十八烷基富马酸钠1份。
制备方法:取人工牛黄、马来酸氯苯那敏,加半份羧甲基淀粉钠,采用等量递增法混合均匀,干混10min,加入二甲硅油,2000r/min剪切12min,得湿软材,将湿软材放入挤出滚圆机中进行制粒,以400r/min,时间为2min,得微丸,加对乙酰氨基酚、甜菊苷,另外半份羧甲基淀粉钠、低取代羟丙基纤维素、微晶纤维素、海藻酸钠,制粒,添加十八烷基富马酸钠,制备成颗粒剂。
对比实施例3:一种小儿氨酚黄那敏颗粒,处方为:人工牛黄5份、马来酸氯苯那敏0.5份、对乙酰氨基酚125份、甜菊苷20份、羧甲基淀粉钠15份、柠檬酸钙10份、微晶纤维素15份、海藻酸钠5份、十八烷基富马酸钠1份。
制备方法:取人工牛黄、马来酸氯苯那敏,加半份羧甲基淀粉钠、半份柠檬酸钙,采用等量递增法混合均匀,干混10min,加入二甲硅油,2000r/min剪切12min,得湿软材,将湿软材放入挤出滚圆机中进行制粒,以400r/min,时间为2min,得微丸,加对乙酰氨基酚、甜菊苷,另外半份羧甲基淀粉钠、半份柠檬酸钙、微晶纤维素、海藻酸钠,制粒,添加十八烷基富马酸钠,制备成颗粒剂。
对比实施例4:一种小儿氨酚黄那敏颗粒,处方为:人工牛黄5份、马来酸氯苯那敏0.5份、对乙酰氨基酚125份、甜菊苷20份、柠檬酸钙10份、微晶纤维素15份、明胶5份、十八烷基富马酸钠1份。
制备方法:取人工牛黄、马来酸氯苯那敏,加半份柠檬酸钙,采用等量递增法混合均匀,干混10min,加入二甲硅油,2000r/min剪切12min,得湿软材,将湿软材放入挤出滚圆机中进行制粒,以400r/min,时间为2min,得微丸,加对乙酰氨基酚、甜菊苷,另外半份柠檬酸钙、微晶纤维素、明胶,制粒,添加十八烷基富马酸钠,制备成颗粒剂。
实验例1:
取上述实施例1、对比实施例1制备的小儿氨酚黄那敏颗粒,建立梯度洗脱HPLC法测定小儿氨酚黄那敏颗粒中对氨基酚含量的方法,经方法学研究结果显示方法可行。法采用C18色谱柱,流动相A为甲醇,流动相B为磷酸缓冲液(称取磷酸氢二钾3.4g,加0.05%三乙胺,加水1000mL,磷酸调pH=6.5),梯度洗脱,检测波长为对氨基酚232nm。
溶出度检查方法:取样品,照溶出度测定法(2015年版中国药典附录XC第二法),以2.4%盐酸溶液900ml为溶出介质,转速为每分钟50转,依法操作,经30分钟时,取溶液10ml,滤过,精密量取续滤液适量,用2.4%盐酸溶液定量稀释制成每ml中约含10μg的溶液。照紫外-可见分光光度法,立即在232nm的波长处测定吸光度;另取对乙酰氨基酚对照品适量,精密称定,用2.4%盐酸溶液溶解并定量稀释制成每ml中约含10μg的溶液,同法测定,计算颗粒的溶出量。限度为标示量的80%,应符合规定。
将上述实施例1、对比实施例1制备的小儿氨酚黄那敏颗粒进行了加速实验稳定性实验考察。加速实验条件下,将样品置于温度40℃±2℃、湿度75%±5%的智能恒温恒湿培养箱中6个月,取样进行含量和溶出度测定,于第1、3、6个月末取样分析,并与0月结果进行比较,结果如表1。
表1:小儿氨酚黄那敏颗粒加速试验(温度40℃±2℃、湿度75%±5%)考察结果对比统计表
结果:可见对比实施例1制备的小儿氨酚黄那敏颗粒放置半年后,对氨基酚总量明显增大,而且颗粒颜色变为黑褐色,实施例1颜色为黄色。按照实施例1制备的小儿氨酚黄那敏颗粒经6个月的加速试验,含量及溶出度均符合限度要求,证明本品在加速条件下稳定。
实验例2:本发明马来酸氯苯那敏含量均匀度检测、粒度检查、溶化性检测
取样方法:按国家药典规定的取样方法,分别对上述实施例1-4、对比实施例1-4总混后的颗粒进行取样,马来酸氯苯那敏含量均匀度检测方法:按中国药典(2015版)高效液相色谱法进行检验,检测结果(相当于标示量的百分含量);粒度检查按中国药典(2015版)颗粒剂项下的粒度检查方法进行检查;溶化性检测按中国药典(2015版)颗粒剂项下的溶化性检查方法进行检查,结果见表2。
表2本发明马来酸氯苯那敏含量均匀度检测、粒度检查、溶化性检测结果
上述实验结果表明,按实施例1-4工艺过程进行操作制备小儿氨酚黄那敏颗粒,经对其颗粒中马来酸氯苯那敏含量进行检测并对数据进行分析,说明其数值的精密度高,马来酸氯苯那敏的含量分布均匀度较好,其中实施例1与实施例2-4比较,含量分布均匀度更优,说明特定比例的羧甲基淀粉钠15份、柠檬酸钙10份、低取代羟丙基纤维素15份、微晶纤维素15份、海藻酸钠5份,能使马来酸氯苯那敏的含量分布均匀;对比实施例2-4采用单独的羧甲基淀粉钠、低取代羟丙基纤维素等达不到使马来酸氯苯那敏含量分布均匀得目的;粒度检查中,实施例1-4和对比实施例1的粒度检查均小于8%,溶化性检测合格,对比实施例2-4使用的一种填充剂、崩解剂、粘合剂时,达不到规定的粒度,说明填充剂、崩解剂、粘合剂的特定组合和特定比例,对于药物的均匀度检测、粒度检查、溶化性有非常显著的影响,本发明所使用的辅料及其工艺参数的设定是合理的。
上述实施例的作用在于具体介绍本发明的实质性内容,但本领域技术人员应当知道,不应将本发明的保护范围局限于该具体实施例。
Claims (1)
1.一种小儿氨酚黄那敏颗粒,其特征在于,由下列重量份的组分制备而成:对乙酰氨基酚125份、人工牛黄5份、马来酸氯苯那敏0.5份、甜菊苷20份、羧甲基淀粉钠15份、柠檬酸钙10份、低取代羟丙基纤维素15份、微晶纤维素15份、海藻酸钠5份、十八烷基富马酸钠1份,制备方法:取人工牛黄5份、马来酸氯苯那敏0.5份,加羧甲基淀粉钠7.5份、柠檬酸钙5份,采用等量递增法混合均匀,干混10min,加入二甲硅油,2000r/min剪切12min,得湿软材,将湿软材放入挤出滚圆机中进行制粒,以400r/min,时间为2min,得微丸,包裹对乙酰氨基酚125份和甜菊苷20份,加羧甲基淀粉钠7.5份、柠檬酸钙5份、低取代羟丙基纤维素15份、微晶纤维素15份、海藻酸钠5份,制粒,添加十八烷基富马酸钠1份,分装。
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