CN107669645A - 盐酸环丙沙星片的制备方法 - Google Patents
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- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 title claims abstract description 34
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- DIOIOSKKIYDRIQ-UHFFFAOYSA-N ciprofloxacin hydrochloride Chemical compound Cl.C12=CC(N3CCNCC3)=C(F)C=C2C(=O)C(C(=O)O)=CN1C1CC1 DIOIOSKKIYDRIQ-UHFFFAOYSA-N 0.000 claims abstract description 38
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Abstract
本发明涉及一种盐酸环丙沙星片的制备方法,属于医药制剂技术领域。本发明所述的盐酸环丙沙星片的制备方法,是以盐酸环丙沙星为主料,以填充剂、崩解剂和润滑剂为辅料,采用粉末直压工艺,制得所述的盐酸环丙沙星片;所述填充剂为乳糖或微晶纤维素中的一种或两种与淀粉的混合物;所述崩解剂为交联聚维酮、或低取代羟丙基纤维素中的一种或两种。本发明解决了裂片、粘冲、溶出度差异大等问题,工艺简单,易于实施,适宜于规模化生产。
Description
技术领域
本发明涉及一种盐酸环丙沙星片的制备方法,属于医药制剂技术领域。
背景技术
盐酸环丙沙星片为第三代喹诺酮类抗菌药物,杀菌力强、抗菌谱宽、临床效果好,是目前大中型医院的常用药物。然而国内生产厂家较多,不同厂家及相同厂家不同批号之间,溶出度有显著差异,特别是5min和10min取样点各制剂单位间溶出度差异较大[具体参见:中国新药杂志,3(3):51-54;天津药学,1996,8(2):64-66;中国医药工业杂志,1997,28(7):308;现代医药卫生,2011,27(7):1095-1096]。
因为盐酸环丙沙星片存在可压性差、易裂片、粘冲、溶出度差异大等缺点,所以现有的技术方案中多采用湿法制粒工艺。湿法制粒工艺存在物料粘性大、摇摆颗粒机经常发生故障、干燥需要蒸汽、耗能大、使用设备多、人员操作复杂、生产效率低等缺陷。
CN201410407134.5公开了一种盐酸环丙沙星口服固体制剂及其制备工艺,其采用的是固体分散体技术,即将盐酸环丙沙星与羟丙基纤维素制成了固体分散体,解决了盐酸环丙沙星在碱性条件下的析出问题,没有解决上述盐酸环丙沙星片存在的问题,而且也没有明确指出其制剂在体外溶出方面的优势。
发明内容
本发明的目的在于提供一种盐酸环丙沙星片的制备方法,其解决了裂片、粘冲、溶出度差异大等问题,工艺简单,易于实施,适宜于规模化生产。
本发明所述的盐酸环丙沙星片的制备方法,是以盐酸环丙沙星为主料,以填充剂、崩解剂和润滑剂为辅料,采用粉末直压工艺,制得所述的盐酸环丙沙星片;
所述填充剂为乳糖或微晶纤维素中的一种或两种与淀粉的混合物;淀粉的加入是在加入疏水性、可压性辅料的基础上添加的,此处的淀粉并不单独使用,即淀粉与其他辅料配合使用,可以增加孔道结构,从而实现片剂的快速崩解。
所述崩解剂为交联聚维酮、或低取代羟丙基纤维素中的一种或两种。现有技术中采用的交联羧甲基纤维素钠遇水不易形成凝胶;羧甲基淀粉钠在一般用量下不易形成凝胶,在片剂中比例较高时才有凝胶倾向。
所述的盐酸环丙沙星片的制备方法,包括以下步骤:
(1)将盐酸环丙沙星过筛,将填充剂、崩解剂和润滑剂分别过筛;
(2)称取盐酸环丙沙星、填充剂、崩解剂和润滑剂;
(3)将盐酸环丙沙星、填充剂和崩解剂加入至混合机中,于8-10rpm的转速下混合25-30min;
(4)将润滑剂加入至步骤(3)所得的混合物中,于8-10rpm的转速下混合5-10min;
(5)将步骤(4)所得的混合物直接进行压片。
步骤(1)中,将盐酸环丙沙星过80-120目筛。将填充剂、崩解剂和润滑剂分别过80-120目筛。
步骤(5)中,压片所得的片剂硬度控制在60-90N。
优选的,润滑剂为硬脂酸镁或硬脂酸。
本发明优选的一种处方组成为:盐酸环丙沙星588g、填充剂100-200g、崩解剂7-15g、润滑剂3-6g。可根据需要压制成不同规格的产品,如250mg、500mg等。
由于现有技术中采用的原料是亲水性的,遇水粘性较大,本发明选用疏水性且可压性好的填充剂,目的是避免片剂在崩解的过程中聚集成团,影响药物的释放;选用遇水不易形成凝胶的崩解剂;本发明在选用可压性辅料的基础上,也使用价格低廉同时可以提供孔道结构的辅料,如淀粉等,目的是为了水分快速渗透到片剂内容,从而实现片剂的快速崩解。
本发明与现有技术相比,具有以下有益效果:
本发明在优选辅料的基础上,采用粉末直接压片工艺,较好地解决了盐酸环丙沙星片易裂片、粘冲、溶出度差异大等缺点。本发明制备的盐酸环丙沙星片,药物释放平稳、均一,各时间点溶出度平均值符合质量标准要求,RSD值均小于5%,制剂单位间、批次间的差异均较小,质量优良。
具体实施方式
下面结合实施例对本发明作进一步的说明,但其并不限制本发明的实施。
实施例1
处方组成:
盐酸环丙沙星588g、乳糖40g、淀粉60g、交联聚维酮7g、硬脂酸镁3g;其中乳糖为Foremost315/316型。
所述的盐酸环丙沙星片的制备方法如下:
(1)盐酸环丙沙星过80目筛,乳糖、淀粉、交联聚维酮、硬脂酸镁分别过80目筛;
(2)称取盐酸环丙沙星、乳糖、淀粉、交联聚维酮、硬脂酸镁;
(3)将盐酸环丙沙星、乳糖、淀粉、交联聚维酮加入至混合机中,于8rpm的转速下混合25min;
(4)将硬脂酸镁加入至混合机中,于8rpm的转速下混合5min;
(5)混合物直接进行压片,片剂的平均硬度60N。
实施例2
处方组成:
盐酸环丙沙星588g、淀粉60g、乳糖40g、微晶纤维素50g、交联聚维酮12g、硬脂酸镁4g;其中淀粉为可压性淀粉、乳糖为Foremost 315/316型,微晶纤维素为PH102型。
所述的盐酸环丙沙星片的制备方法如下:
(1)盐酸环丙沙星过100目筛,淀粉、乳糖、微晶纤维素、交联聚维酮、硬脂酸镁分别过100目筛;
(2)称取盐酸环丙沙星、淀粉、乳糖、微晶纤维素、交联聚维酮、硬脂酸镁;
(3)将盐酸环丙沙星、淀粉、乳糖、微晶纤维素、交联聚维酮加入至混合机中,于8rpm的转速下混合25min;
(4)将硬脂酸镁加入至混合机中,于8rpm的转速下混合5min;
(5)混合物直接进行压片,片剂的平均硬度75N。
实施例3
处方组成:
盐酸环丙沙星588g、淀粉100g、乳糖50g、微晶纤维素50g、交联聚维酮15g、硬脂酸镁5g;其中淀粉为可压性淀粉、乳糖为Foremost 315/316型,微晶纤维素为PH102型。
所述的盐酸环丙沙星片的制备方法如下:
(1)盐酸环丙沙星过120目筛,淀粉、乳糖、微晶纤维素、交联聚维酮、硬脂酸镁分别过120目筛;
(2)称取盐酸环丙沙星、淀粉、乳糖、微晶纤维素、交联聚维酮、硬脂酸镁;
(3)将盐酸环丙沙星、淀粉、乳糖、微晶纤维素、交联聚维酮加入至混合机中,于8rpm的转速下混合25min;
(4)将硬脂酸镁加入至混合机中,于8rpm的转速下混合5min;
(5)混合物直接进行压片,片剂的平均硬度90N。
实施例4
处方组成:
盐酸环丙沙星588g、淀粉60g、乳糖40g、微晶纤维素50g、低取代羟丙基纤维素12g、硬脂酸4g;其中淀粉为可压性淀粉、乳糖为Foremost 315/316型,微晶纤维素为国产普通型号。
所述的盐酸环丙沙星片的制备方法如下:
(1)盐酸环丙沙星过100目筛,淀粉、乳糖、微晶纤维素、低取代羟丙基纤维素、硬脂酸分别过100目筛;
(2)称取盐酸环丙沙星、淀粉、乳糖、微晶纤维素、低取代羟丙基纤维素、硬脂酸;
(3)将盐酸环丙沙星、淀粉、乳糖、微晶纤维素、低取代羟丙基纤维素加入至混合机中,于8rpm的转速下混合25min;
(4)将硬脂酸加入至混合机中,于8rpm的转速下混合5min;
(5)混合物直接进行压片,片剂的平均硬度75N。
实施例5
处方组成:
盐酸环丙沙星588g、乳糖90g、淀粉60g、低取代羟丙基纤维素15g、硬脂酸镁4g;其中乳糖为Foremost 315/316型、淀粉为可压性淀粉。
所述的盐酸环丙沙星片的制备方法如下:
(1)盐酸环丙沙星过120目筛,乳糖、淀粉、低取代羟丙基纤维素、硬脂酸镁分别过80目筛;
(2)称取盐酸环丙沙星、乳糖、淀粉、低取代羟丙基纤维素、硬脂酸镁;
(3)将盐酸环丙沙星、乳糖、淀粉、低取代羟丙基纤维素加入至混合机中,于8rpm的转速下混合25min;
(4)将硬脂酸镁加入至混合机中,于8rpm的转速下混合5min;
(5)混合物直接进行压片,片剂的平均硬度75N。
实施例6
处方组成:
盐酸环丙沙星588g、微晶纤维素180g、淀粉20g、交联聚维酮5g、低取代羟丙基纤维素10g、硬脂酸3g;其中微晶纤维素为国产普通型号,淀粉为可压性淀粉。
所述的盐酸环丙沙星片的制备方法如下:
(1)盐酸环丙沙星过120目筛,微晶纤维素、淀粉、交联聚维酮、低取代羟丙基纤维素、硬脂酸镁分别过80目筛;
(2)称取盐酸环丙沙星、微晶纤维素、淀粉、交联聚维酮、低取代羟丙基纤维素、硬脂酸;
(3)将盐酸环丙沙星、微晶纤维素、淀粉、交联聚维酮、低取代羟丙基纤维素加入至混合机中,于8rpm的转速下混合25min;
(4)将硬脂酸镁加入至混合机中,于8rpm的转速下混合5min;
(5)混合物直接进行压片,片剂的平均硬度75N。
按照2015版中国药典,检测了实施例中盐酸环丙沙星片的溶出度,取样点分别为5min、10min、15min、20min和30min,检测结果见表1。
表1盐酸环丙沙星片溶出度检测结果
从表1中的数据可以看出,本发明制备的盐酸环丙沙星片,药物释放平稳、均一,各时间点溶出度平均值均一,RSD值均小于5%,制剂单位间、批次间的差异均较小,质量优良。
Claims (6)
1.一种盐酸环丙沙星片的制备方法,其特征在于:以盐酸环丙沙星为主料,以填充剂、崩解剂和润滑剂为辅料,采用粉末直压工艺,制得所述的盐酸环丙沙星片;
所述填充剂为乳糖或微晶纤维素中的一种或两种与淀粉的混合物;
所述崩解剂为交联聚维酮、或低取代羟丙基纤维素中的一种或两种。
2.根据权利要求1所述的盐酸环丙沙星片的制备方法,其特征在于包括以下步骤:
(1)将盐酸环丙沙星过筛,将填充剂、崩解剂和润滑剂分别过筛;
(2)称取盐酸环丙沙星、填充剂、崩解剂和润滑剂;
(3)将盐酸环丙沙星、填充剂和崩解剂加入至混合机中,于8-10rpm的转速下混合25-30min;
(4)将润滑剂加入至步骤(3)所得的混合物中,于8-10rpm的转速下混合5-10min;
(5)将步骤(4)所得的混合物直接进行压片。
3.根据权利要求2所述的盐酸环丙沙星片的制备方法,其特征在于:步骤(1)中,将盐酸环丙沙星过80-120目筛。
4.根据权利要求2所述的盐酸环丙沙星片的制备方法,其特征在于:步骤(1)中,将填充剂、崩解剂和润滑剂分别过80-120目筛。
5.根据权利要求2所述的盐酸环丙沙星片的制备方法,其特征在于:步骤(5)中,压片所得的片剂硬度控制在60-90N。
6.根据权利要求2所述的盐酸环丙沙星片的制备方法,其特征在于:润滑剂为硬脂酸镁或硬脂酸。
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CN114191400A (zh) * | 2021-12-22 | 2022-03-18 | 华裕(无锡)制药有限公司 | 一种巴洛沙星片剂及其制备工艺 |
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