CN104606160A - Drug composition containing fenoprofen calcium - Google Patents
Drug composition containing fenoprofen calcium Download PDFInfo
- Publication number
- CN104606160A CN104606160A CN201510041175.1A CN201510041175A CN104606160A CN 104606160 A CN104606160 A CN 104606160A CN 201510041175 A CN201510041175 A CN 201510041175A CN 104606160 A CN104606160 A CN 104606160A
- Authority
- CN
- China
- Prior art keywords
- fenoprofen calcium
- place
- magnesium stearate
- hydroxypropyl cellulose
- carboxymethyl starch
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 229960005341 fenoprofen calcium Drugs 0.000 title claims abstract description 23
- VHUXSAWXWSTUOD-UHFFFAOYSA-L fenoprofen calcium (anhydrous) Chemical compound [Ca+2].[O-]C(=O)C(C)C1=CC=CC(OC=2C=CC=CC=2)=C1.[O-]C(=O)C(C)C1=CC=CC(OC=2C=CC=CC=2)=C1 VHUXSAWXWSTUOD-UHFFFAOYSA-L 0.000 title claims abstract description 23
- 239000000203 mixture Substances 0.000 title claims abstract description 13
- 239000003814 drug Substances 0.000 title abstract description 5
- 229940079593 drug Drugs 0.000 title abstract description 3
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical group [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims abstract description 21
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims abstract description 11
- 229920002472 Starch Polymers 0.000 claims abstract description 11
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims abstract description 11
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims abstract description 11
- 239000011734 sodium Substances 0.000 claims abstract description 11
- 229910052708 sodium Inorganic materials 0.000 claims abstract description 11
- 239000008107 starch Substances 0.000 claims abstract description 11
- 235000019698 starch Nutrition 0.000 claims abstract description 11
- 239000008194 pharmaceutical composition Substances 0.000 claims abstract description 7
- 238000002360 preparation method Methods 0.000 claims abstract description 5
- 239000008187 granular material Substances 0.000 claims description 12
- 235000019359 magnesium stearate Nutrition 0.000 claims description 10
- 238000005469 granulation Methods 0.000 claims description 6
- 230000003179 granulation Effects 0.000 claims description 6
- 239000000463 material Substances 0.000 claims description 6
- 239000007779 soft material Substances 0.000 claims description 6
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 5
- 239000004677 Nylon Substances 0.000 claims description 3
- 238000001035 drying Methods 0.000 claims description 3
- 229920001778 nylon Polymers 0.000 claims description 3
- 239000002994 raw material Substances 0.000 claims description 3
- 239000000843 powder Substances 0.000 claims description 2
- 238000004519 manufacturing process Methods 0.000 abstract description 6
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 abstract description 2
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 abstract description 2
- 235000015424 sodium Nutrition 0.000 abstract description 2
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 3
- HEDRZPFGACZZDS-UHFFFAOYSA-N Chloroform Chemical compound ClC(Cl)Cl HEDRZPFGACZZDS-UHFFFAOYSA-N 0.000 description 2
- 208000002193 Pain Diseases 0.000 description 2
- 206010003246 arthritis Diseases 0.000 description 2
- XBDQKXXYIPTUBI-UHFFFAOYSA-N dimethylselenoniopropionate Natural products CCC(O)=O XBDQKXXYIPTUBI-UHFFFAOYSA-N 0.000 description 2
- 201000008482 osteoarthritis Diseases 0.000 description 2
- 206010039073 rheumatoid arthritis Diseases 0.000 description 2
- RDJGLLICXDHJDY-NSHDSACASA-N (2s)-2-(3-phenoxyphenyl)propanoic acid Chemical compound OC(=O)[C@@H](C)C1=CC=CC(OC=2C=CC=CC=2)=C1 RDJGLLICXDHJDY-NSHDSACASA-N 0.000 description 1
- MQWCQFCZUNBTCM-UHFFFAOYSA-N 2-tert-butyl-6-(3-tert-butyl-2-hydroxy-5-methylphenyl)sulfanyl-4-methylphenol Chemical compound CC(C)(C)C1=CC(C)=CC(SC=2C(=C(C=C(C)C=2)C(C)(C)C)O)=C1O MQWCQFCZUNBTCM-UHFFFAOYSA-N 0.000 description 1
- 206010002556 Ankylosing Spondylitis Diseases 0.000 description 1
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical group [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 1
- 208000005171 Dysmenorrhea Diseases 0.000 description 1
- 206010013935 Dysmenorrhoea Diseases 0.000 description 1
- 201000005569 Gout Diseases 0.000 description 1
- 208000001294 Nociceptive Pain Diseases 0.000 description 1
- WQCXKULBCSMYIP-UHFFFAOYSA-N O(C1=CC=CC=C1)C=1C=C(C=CC1)C(C(=O)O)C.O.O Chemical compound O(C1=CC=CC=C1)C=1C=C(C=CC1)C(C(=O)O)C.O.O WQCXKULBCSMYIP-UHFFFAOYSA-N 0.000 description 1
- 208000027418 Wounds and injury Diseases 0.000 description 1
- 229940035676 analgesics Drugs 0.000 description 1
- 239000000730 antalgic agent Substances 0.000 description 1
- 239000002260 anti-inflammatory agent Substances 0.000 description 1
- 229940124599 anti-inflammatory drug Drugs 0.000 description 1
- 230000003110 anti-inflammatory effect Effects 0.000 description 1
- -1 aryl propionic acid Chemical compound 0.000 description 1
- 239000011575 calcium Substances 0.000 description 1
- 229910052791 calcium Inorganic materials 0.000 description 1
- 230000006378 damage Effects 0.000 description 1
- 229960001419 fenoprofen Drugs 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 230000000813 microbial effect Effects 0.000 description 1
- 239000000041 non-steroidal anti-inflammatory agent Substances 0.000 description 1
- 229940021182 non-steroidal anti-inflammatory drug Drugs 0.000 description 1
- 230000009965 odorless effect Effects 0.000 description 1
- 235000019260 propionic acid Nutrition 0.000 description 1
- 210000004872 soft tissue Anatomy 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 230000009967 tasteless effect Effects 0.000 description 1
- 208000004371 toothache Diseases 0.000 description 1
- 230000000472 traumatic effect Effects 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
本发明涉及药品的制造领域，尤其涉及一种非诺洛芬钙药物组合物及其制备方法，现有技术因配比不合理，溶解性差，生物利用度低。为克服现有技术问题，本发明提供一种非诺洛芬钙药物组合物，其特征在于，非诺洛芬钙、羧甲基淀粉钠、羟丙基纤维素、硬脂酸镁组成的混合物，本发明配比合理，组方科学，溶解性好，生物利用度高，患者药品顺应性好。The invention relates to the field of medicine manufacture, in particular to a fenoprofen calcium pharmaceutical composition and a preparation method thereof. The prior art has poor solubility and low bioavailability due to unreasonable proportioning. For overcoming prior art problem, the invention provides a kind of fenoprofen calcium pharmaceutical composition, it is characterized in that, the mixture that fenoprofen calcium, carboxymethyl starch sodium, hydroxypropyl cellulose, magnesium stearate form , the invention has reasonable proportioning ratio, scientific prescription, good solubility, high bioavailability, and good drug compliance of patients.
Description
技术领域 technical field
本发明涉及药品的制造领域，尤其涉及一种非诺洛芬钙药物组合物及其制备方法，主要适用于各种关节炎，包括类风湿性关节炎、骨关节炎、强直性脊柱炎、痛风性关节炎及其他软组织疼痛，亦用于其他疼痛如：痛经、牙痛、损伤及创伤性痛等。 The present invention relates to the field of medicine manufacture, in particular to a fenoprofen calcium pharmaceutical composition and a preparation method thereof, which are mainly applicable to various arthritis, including rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout Arthritis and other soft tissue pain, also used for other pain such as: dysmenorrhea, toothache, injury and traumatic pain.
背景技术 Background technique
非诺洛芬钙 (Fenoprofen Calcium)为一种消炎镇痛药，该产品为白色结晶性粉末；无臭，无味。在乙醇中溶解，在甲醇中微溶，在水中极微溶解，在氯仿中几乎不溶。本品为α-甲基-3- 苯氧基 -苯乙酸钙二水合物。按无水物计算，含C30H26CaO6不得少于97.5％。 Fenoprofen Calcium is an anti-inflammatory and analgesic drug, the product is white crystalline powder; odorless and tasteless. Soluble in ethanol, slightly soluble in methanol, very slightly soluble in water, almost insoluble in chloroform. This product is calcium α-methyl-3-phenoxy-phenylacetate dihydrate. Calculated as anhydrous matter, the content of C 30 H 26 CaO 6 shall not be less than 97.5%.
非诺洛芬是一种芳基丙酸类非甾体抗炎药物，临床应用十分广泛,主要用于治疗风湿性关节炎与骨关节炎。现有技术因配比不合理，溶解性差，生物利用度低。本发明旨在提供一种配比合理，组方科学的非诺洛芬钙药物组合物，溶解性好，生物利用度高，患者药品顺应性好。本发明制备工艺简单，对生产设备要求简单，生产成本低，适合工业化推广。 Fenoprofen is an aryl propionic acid non-steroidal anti-inflammatory drug, which is widely used clinically, mainly for the treatment of rheumatoid arthritis and osteoarthritis. The prior art has poor solubility and low bioavailability due to unreasonable proportioning. The invention aims to provide a fenoprofen calcium pharmaceutical composition with reasonable proportion and scientific formula, which has good solubility, high bioavailability and good drug compliance of patients. The invention has simple preparation process, simple requirements on production equipment, low production cost and is suitable for industrial promotion.
发明内容 Contents of the invention
为克服现有技术问题，本发明提供一种非诺洛芬钙药物组合物，其特征在于，由非诺洛芬钙、羧甲基淀粉钠、羟丙基纤维素、硬脂酸镁组成的混合物，各组分的质量百分比如下： For overcoming prior art problem, the invention provides a kind of fenoprofen calcium pharmaceutical composition, it is characterized in that, is made up of fenoprofen calcium, carboxymethyl starch sodium, hydroxypropyl cellulose, magnesium stearate Mixture, the mass percent of each component is as follows:
非诺洛芬钙 15.1-90.3% Fenoprofen Calcium 15.1-90.3%
羧甲基淀粉钠 2.1-35.9% Sodium carboxymethyl starch 2.1-35.9%
羟丙基纤维素 8.1-43.1% hydroxypropyl cellulose 8.1-43.1%
硬脂酸镁 0.5-5.9%，以下各组份之和为100%。 Magnesium stearate 0.5-5.9%, the sum of the following components is 100%.
制作方法为如下步骤： The production method is as follows:
a)按质量百分比称取非诺洛芬钙原料，磨粉过100目筛； a) take fenoprofen calcium raw material by mass percentage, grind and cross 100 mesh sieves;
b)将非诺洛芬钙、羧甲基淀粉钠、羟丙基纤维素干混，混合均匀； b) dry mix fenoprofen calcium, sodium carboxymethyl starch, and hydroxypropyl cellulose, and mix well;
c)将混合均匀的原辅料用50%-95%酒精制软材，湿度以摇摆式颗粒机制粒湿度为准； c) Use 50%-95% alcohol to make soft materials from the uniformly mixed raw and auxiliary materials, and the humidity is based on the granulation humidity of the swinging granulator;
d)将制好的软材置于摇摆式颗粒机，通过16目-20目尼龙筛制粒； d) Place the prepared soft material in a swinging granulator, and pass through a 16-20 mesh nylon sieve to granulate;
e)将制好的颗粒置于沸腾床干燥，进风温度60-65℃，料温55-60℃，出料温度30-32℃； e) Place the prepared granules in a fluidized bed for drying, the inlet air temperature is 60-65°C, the material temperature is 55-60°C, and the output temperature is 30-32°C;
f)将干颗粒置于16目-20目筛整粒； f) Place the dry granules in a 16-20 mesh sieve for granulation;
g)将干颗粒置于二维混合机中并加入硬脂酸镁混合15-30分钟； g) place the dry granules in a two-dimensional mixer and add magnesium stearate and mix for 15-30 minutes;
h)采用异型压片机压片。 h) Tablets are pressed using a special-shaped tablet press.
具体实施方式： Detailed ways:
实施例1 Example 1
非诺洛芬钙 68% Fenoprofen Calcium 68%
羧甲基淀粉钠 12% Sodium Carboxymethyl Starch 12%
羟丙基纤维素 18% hydroxypropyl cellulose 18%
硬脂酸镁 2% Magnesium stearate 2%
实施例2 Example 2
非诺洛芬钙 68% Fenoprofen Calcium 68%
羧甲基淀粉钠 22% Sodium carboxymethyl starch 22%
羟丙基纤维素 9% hydroxypropyl cellulose 9%
硬脂酸镁 1% Magnesium stearate 1%
实施例3 Example 3
非诺洛芬钙 68% Fenoprofen Calcium 68%
羧甲基淀粉钠 7% Sodium carboxymethyl starch 7%
羟丙基纤维素 24% hydroxypropyl cellulose 24%
硬脂酸镁 1% Magnesium stearate 1%
实施例1-3制备方法： Embodiment 1-3 preparation method:
制作方法为如下步骤： The production method is as follows:
a)按质量百分比称取非诺洛芬钙原料，磨粉过100目筛； a) take fenoprofen calcium raw material by mass percentage, grind and cross 100 mesh sieves;
b)将非诺洛芬钙、羧甲基淀粉钠、羟丙基纤维素干混，混合均匀； b) dry mix fenoprofen calcium, sodium carboxymethyl starch, and hydroxypropyl cellulose, and mix well;
c)将混合均匀的原辅料用50%-95%酒精制软材，湿度以摇摆式颗粒机制粒湿度为准； c) Use 50%-95% alcohol to make soft materials from the uniformly mixed raw and auxiliary materials, and the humidity is based on the granulation humidity of the swinging granulator;
d)将制好的软材置于摇摆式颗粒机，通过16目-20目尼龙筛制粒； d) Place the prepared soft material in a swinging granulator, and pass through a 16-20 mesh nylon sieve to granulate;
e)将制好的颗粒置于沸腾床干燥，进风温度60-65℃，料温55-60℃，出料温度30-32℃； e) Place the prepared granules in a fluidized bed for drying, the inlet air temperature is 60-65°C, the material temperature is 55-60°C, and the output temperature is 30-32°C;
f)将干颗粒置于16目-20目筛整粒； f) Place the dry granules in a 16-20 mesh sieve for granulation;
g)将干颗粒置于二维混合机中并加入硬脂酸镁混合15-30分钟； g) place the dry granules in a two-dimensional mixer and add magnesium stearate and mix for 15-30 minutes;
h)采用异型压片机压片。 h) Tablets are pressed using a special-shaped tablet press.
质量检验：
Claims (2)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510041175.1A CN104606160B (en) | 2015-01-28 | A kind of fenoprofen calcium medicine compound |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510041175.1A CN104606160B (en) | 2015-01-28 | A kind of fenoprofen calcium medicine compound |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN104606160A true CN104606160A (en) | 2015-05-13 |
| CN104606160B CN104606160B (en) | 2018-06-01 |
Family
ID=
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4753801A (en) * | 1985-10-25 | 1988-06-28 | Eli Lilly And Company | Sustained release tablets |
| CN102940612A (en) * | 2012-12-10 | 2013-02-27 | 昆明振华制药厂有限公司 | Method for preparing norfloxacin tablets |
| CN102973529A (en) * | 2012-11-28 | 2013-03-20 | 康普药业股份有限公司 | Azithromycin dispersible tablet and preparation method thereof |
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4753801A (en) * | 1985-10-25 | 1988-06-28 | Eli Lilly And Company | Sustained release tablets |
| US4753801B1 (en) * | 1985-10-25 | 1992-07-14 | Lilly Co Eli | |
| CN102973529A (en) * | 2012-11-28 | 2013-03-20 | 康普药业股份有限公司 | Azithromycin dispersible tablet and preparation method thereof |
| CN102940612A (en) * | 2012-12-10 | 2013-02-27 | 昆明振华制药厂有限公司 | Method for preparing norfloxacin tablets |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN107875136B (en) | Amoxicillin medicinal preparation and preparation method thereof | |
| CN105496975B (en) | A kind of Rui Gefeini tablet and preparation method thereof | |
| KR20070113297A (en) | Aggregated Starch Composition | |
| CN103610658B (en) | Immunomodulator slow-release preparation and preparation method thereof | |
| CN106389369A (en) | Ferrous fumarate folic acid compound film coated tablet preparation method | |
| CN102488686B (en) | Compound alpha-keto acid tablet and preparation process thereof | |
| CN104606160A (en) | Drug composition containing fenoprofen calcium | |
| CN103961351A (en) | Preparation method of amoxicillin and clavulanate potassium tablets | |
| GB2546513A (en) | Process of preparing active pharmaceutical ingredient salts | |
| CN104606160B (en) | A kind of fenoprofen calcium medicine compound | |
| JP4774739B2 (en) | Kampo extract-containing tablet composition and method for producing the same | |
| CN101305986A (en) | Lafutidine Tablet and its preparation method | |
| CN109730969B (en) | A kind of levofloxacin lactate dispersible tablet and preparation method thereof | |
| CN104606145B (en) | ibuprofen granule and preparation method thereof | |
| CN100453116C (en) | Compound aminophylline tablet and preparation method thereof | |
| CN102614143B (en) | High-stability vitamin C tablet and preparing process thereof | |
| CN103142533B (en) | Enteric coated tablet of etoposide | |
| CN109157519B (en) | Preparation method of ofloxacin tablets | |
| CN106038523B (en) | A kind of potassium citrate sodium citrate piece and preparation method thereof | |
| CN104288118A (en) | Tenofovir disoproxil fumarate tablet and preparation method thereof | |
| RU2228191C1 (en) | Method for preparing anti-influenza agent | |
| CN116370417A (en) | A kind of rasagiline granular composition and its pharmaceutical composition | |
| CN103989639A (en) | Diphenhydramine hydrochloride particles and preparation method thereof | |
| CN103142545B (en) | Enteric capsule of etoposide | |
| CN111012748B (en) | Vitamin B12 preparation and preparation method thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| EXSB | Decision made by sipo to initiate substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| GR01 | Patent grant | ||
| GR01 | Patent grant | ||
| PE01 | Entry into force of the registration of the contract for pledge of patent right | ||
| PE01 | Entry into force of the registration of the contract for pledge of patent right |
Denomination of invention: Fenoprofen calcium pharmaceutical composition Effective date of registration: 20210730 Granted publication date: 20180601 Pledgee: Hunan Hanshou Rural Commercial Bank Co.,Ltd. Pledgor: KAMP PHARMACEUTICALS Co.,Ltd. Registration number: Y2021430000029 |
|
| PC01 | Cancellation of the registration of the contract for pledge of patent right |
Date of cancellation: 20211014 Granted publication date: 20180601 Pledgee: Hunan Hanshou Rural Commercial Bank Co.,Ltd. Pledgor: KAMP PHARMACEUTICALS Co.,Ltd. Registration number: Y2021430000029 |
|
| PC01 | Cancellation of the registration of the contract for pledge of patent right | ||
| CP02 | Change in the address of a patent holder | ||
| CP02 | Change in the address of a patent holder |
Address after: No.8 Kangpu Avenue, high tech Industrial Park, Hanshou County, Changde City, Hunan Province, 415900 Patentee after: KAMP PHARMACEUTICALS Co.,Ltd. Address before: 12 / F, building B, Lugu information port, 658 Lugu Avenue, high tech Zone, Changsha City, Hunan Province, 410205 Patentee before: KAMP PHARMACEUTICALS Co.,Ltd. |
|
| PE01 | Entry into force of the registration of the contract for pledge of patent right | ||
| PE01 | Entry into force of the registration of the contract for pledge of patent right |
Denomination of invention: Fenoprofen calcium pharmaceutical composition Effective date of registration: 20211028 Granted publication date: 20180601 Pledgee: Hunan Hanshou Rural Commercial Bank Co.,Ltd. Pledgor: KAMP PHARMACEUTICALS Co.,Ltd. Registration number: Y2021980011259 |
|
| PC01 | Cancellation of the registration of the contract for pledge of patent right | ||
| PC01 | Cancellation of the registration of the contract for pledge of patent right |
Granted publication date: 20180601 Pledgee: Hunan Hanshou Rural Commercial Bank Co.,Ltd. Pledgor: KAMP PHARMACEUTICALS Co.,Ltd. Registration number: Y2021980011259 |
|
| PE01 | Entry into force of the registration of the contract for pledge of patent right | ||
| PE01 | Entry into force of the registration of the contract for pledge of patent right |
Denomination of invention: A non nifedipine calcium drug combination Granted publication date: 20180601 Pledgee: Hunan Hanshou Rural Commercial Bank Co.,Ltd. Pledgor: KAMP PHARMACEUTICALS Co.,Ltd. Registration number: Y2024980045611 |