CN109806235A - 一种氟康唑片及其制备方法 - Google Patents
一种氟康唑片及其制备方法 Download PDFInfo
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- CN109806235A CN109806235A CN201910173969.1A CN201910173969A CN109806235A CN 109806235 A CN109806235 A CN 109806235A CN 201910173969 A CN201910173969 A CN 201910173969A CN 109806235 A CN109806235 A CN 109806235A
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- fluconazole
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- RFHAOTPXVQNOHP-UHFFFAOYSA-N fluconazole Chemical compound C1=NC=NN1CC(C=1C(=CC(F)=CC=1)F)(O)CN1C=NC=N1 RFHAOTPXVQNOHP-UHFFFAOYSA-N 0.000 title claims abstract description 16
- 229960004884 fluconazole Drugs 0.000 title claims abstract description 16
- 238000002360 preparation method Methods 0.000 title claims abstract description 11
- 239000000463 material Substances 0.000 claims abstract description 9
- 229910052782 aluminium Inorganic materials 0.000 claims abstract description 7
- 239000000543 intermediate Substances 0.000 claims abstract description 7
- 238000004806 packaging method and process Methods 0.000 claims abstract description 7
- 239000004615 ingredient Substances 0.000 claims description 6
- 238000005265 energy consumption Methods 0.000 abstract description 3
- 238000004519 manufacturing process Methods 0.000 abstract description 3
- 238000003912 environmental pollution Methods 0.000 abstract description 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 abstract 2
- 229920000168 Microcrystalline cellulose Polymers 0.000 abstract 1
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 abstract 1
- 229920003081 Povidone K 30 Polymers 0.000 abstract 1
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 abstract 1
- FUFJGUQYACFECW-UHFFFAOYSA-L calcium hydrogenphosphate Chemical compound [Ca+2].OP([O-])([O-])=O FUFJGUQYACFECW-UHFFFAOYSA-L 0.000 abstract 1
- 239000001768 carboxy methyl cellulose Substances 0.000 abstract 1
- 238000004132 cross linking Methods 0.000 abstract 1
- 235000019359 magnesium stearate Nutrition 0.000 abstract 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 abstract 1
- 239000008108 microcrystalline cellulose Substances 0.000 abstract 1
- 229940016286 microcrystalline cellulose Drugs 0.000 abstract 1
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 abstract 1
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 abstract 1
- 239000003826 tablet Substances 0.000 description 8
- 239000000203 mixture Substances 0.000 description 5
- 239000003814 drug Substances 0.000 description 3
- 238000000034 method Methods 0.000 description 3
- 206010017533 Fungal infection Diseases 0.000 description 2
- 208000031888 Mycoses Diseases 0.000 description 2
- 230000000843 anti-fungal effect Effects 0.000 description 2
- 229940121375 antifungal agent Drugs 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 238000002347 injection Methods 0.000 description 2
- 239000007924 injection Substances 0.000 description 2
- 102000002004 Cytochrome P-450 Enzyme System Human genes 0.000 description 1
- 108010015742 Cytochrome P-450 Enzyme System Proteins 0.000 description 1
- 208000019505 Deglutition disease Diseases 0.000 description 1
- 241000233866 Fungi Species 0.000 description 1
- 101150056637 Hrh2 gene Proteins 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 229940069428 antacid Drugs 0.000 description 1
- 239000003159 antacid agent Substances 0.000 description 1
- 239000003429 antifungal agent Substances 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000000903 blocking effect Effects 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 210000000170 cell membrane Anatomy 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 239000007919 dispersible tablet Substances 0.000 description 1
- 239000006185 dispersion Substances 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 230000008686 ergosterol biosynthesis Effects 0.000 description 1
- -1 friability poor Substances 0.000 description 1
- 230000002538 fungal effect Effects 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 230000010534 mechanism of action Effects 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 238000012858 packaging process Methods 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 238000001228 spectrum Methods 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 150000003852 triazoles Chemical class 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
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Abstract
本发明涉及一种氟康唑片,包括氟康唑40‑50份;微晶纤维素30‑40份;无水磷酸氢钙5份;聚维酮K30 10‑15份;交联竣甲基纤维素钠8‑10份;硬脂酸镁1‑3份;还包括其制备方法,首先将上述物料按处方量投入总混机中混合均匀;测定中间体含量,计算片重;用压片机直接进行压片,铝塑,包装。本制备方法减少了操作工序,提高了生产效率,节约了物料,降低了能耗,减少了环境污染。
Description
技术领域
本发明属于药物制造新技术领域,具体涉及一种氟康唑片及其制备方法。
背景技术
氟康唑为新型三唑类抗真菌药物,由辉瑞公司开发,1988年首先在丹麦、法国、爱尔兰和英国上市,1990年经FDA批准在美国上市。本品是治疗真菌感染的一种药物,为广谱抗真菌药,对人和动物的真菌感染均有治疗作用,目前市场上有片剂、胶囊、粉针剂和注射液几种剂型。本品的作用机制主要为高度选择性干扰真菌的细胞色素P-450的活性,从而抑制真菌细胞膜上麦角固醇的生物合成。本品口服吸收良好,不受食物、抗酸药、H2受体阻断药的影响,在医院抗真菌治疗中应用广泛。
中国专利申请公告号CN103751132A公开了一种氟康唑分散片及其制备方法,该申请的氟康唑片具有优良的口感,使用方便,既可整体吞服,又可置于水中分散后送服,尤其适用于老人、小儿等有吞咽困难的患者。但是本申请的氟康唑片在压片过程中由于受到工艺、技术、设备等条件的限制,使分散片的可压性、脆碎度较差,片剂在包装过程中也容易碎裂,且工序复杂,能耗较高,导致成本居高不下。
发明内容
本发明所要解决的技术问题是提供一种氟康唑片及其制备方法,以解决现有技术中存在的缺陷。
本发明解决上述技术问题的技术方案如下:
一种氟康唑片,按照重量份计,包括如下成分:
一种氟康唑片的制备方法,包括如下步骤:
1)将上述物料按处方量投入总混机中混合均匀;
2)测定中间体含量,计算片重;
3)用压片机直接进行压片,铝塑,包装。
本发明的有益效果是:本制备方法减少了操作工序,提高了生产效率,节约了物料,降低了能耗,减少了环境污染。
具体实施方式
以下对本发明的原理和特征进行描述,所举实例只用于解释本发明,并非用于限定本发明的范围。
一种氟康唑片,按照重量份计,包括如下成分:
一种氟康唑片的制备方法,包括如下步骤:
1)将上述物料按处方量投入总混机中混合均匀;
2)测定中间体含量,计算片重;
3)用压片机直接进行压片,铝塑,包装。
具体实施例1:
按照重量份计,称取如下成分:
然后将上述物料按处方量投入总混机中混合均匀;测定中间体含量,计算片重;用压片机直接进行压片,铝塑,包装。
具体实施例2:
按照重量份计,称取如下成分:
然后将上述物料按处方量投入总混机中混合均匀;测定中间体含量,计算片重;用压片机直接进行压片,铝塑,包装。
具体实施例3:
按照重量份计,称取如下成分:
然后将上述物料按处方量投入总混机中混合均匀;测定中间体含量,计算片重;用压片机直接进行压片,铝塑,包装。
以上所述仅为本发明的较佳实施例,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 (2)
1.一种氟康唑片,其特征在于,包括如下成分:
2.一种氟康唑片的制备方法,其特征在于,包括如下步骤:
1)将上述物料按处方量投入总混机中混合均匀;
2)测定中间体含量,计算片重;
3)用压片机直接进行压片,铝塑,包装。
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| Application Number | Priority Date | Filing Date | Title |
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| CN201910173969.1A CN109806235A (zh) | 2019-03-13 | 2019-03-13 | 一种氟康唑片及其制备方法 |
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| CN201910173969.1A CN109806235A (zh) | 2019-03-13 | 2019-03-13 | 一种氟康唑片及其制备方法 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN116251067A (zh) * | 2023-04-23 | 2023-06-13 | 淄博市中心医院 | 一种氟康唑片、制备方法及用途 |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101711750A (zh) * | 2009-12-29 | 2010-05-26 | 南昌弘益科技有限公司 | 氟康唑分散片及其制备方法 |
| WO2011101862A1 (en) * | 2010-02-17 | 2011-08-25 | Fdc Limited | Stabilized fluconazole polymorph iii formulation |
| CN108578377A (zh) * | 2018-06-25 | 2018-09-28 | 遂成药业股份有限公司 | 一种氟康唑片及其制备方法 |
-
2019
- 2019-03-13 CN CN201910173969.1A patent/CN109806235A/zh active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101711750A (zh) * | 2009-12-29 | 2010-05-26 | 南昌弘益科技有限公司 | 氟康唑分散片及其制备方法 |
| WO2011101862A1 (en) * | 2010-02-17 | 2011-08-25 | Fdc Limited | Stabilized fluconazole polymorph iii formulation |
| CN108578377A (zh) * | 2018-06-25 | 2018-09-28 | 遂成药业股份有限公司 | 一种氟康唑片及其制备方法 |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN116251067A (zh) * | 2023-04-23 | 2023-06-13 | 淄博市中心医院 | 一种氟康唑片、制备方法及用途 |
| CN116251067B (zh) * | 2023-04-23 | 2024-06-07 | 淄博市中心医院 | 一种氟康唑片、制备方法及用途 |
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| PB01 | Publication | ||
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| CB02 | Change of applicant information |
Address after: 1118, langgong Road, Jinshan Industrial Zone, Jinshan District, Shanghai, 201506 Applicant after: Shanghai Huanhua Pharmaceutical Co.,Ltd. Address before: 1118, langgong Road, Jinshan Industrial Zone, Jinshan District, Shanghai, 201506 Applicant before: YOUCARE PHARMACEUTICAL GROUP SHANGHAI PHARMACEUTICAL Co.,Ltd. |
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Application publication date: 20190528 |
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