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
- magnesium stearate
- carboxymethyl starch
- drug composition
- hydroxypropyl cellulose
- 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 24
- 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 24
- 239000003814 drug Substances 0.000 title claims abstract description 16
- 239000000203 mixture Substances 0.000 title claims abstract description 16
- 229940079593 drug Drugs 0.000 title abstract description 9
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims abstract description 22
- 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
- 235000019359 magnesium stearate Nutrition 0.000 claims abstract description 11
- 235000019698 starch Nutrition 0.000 claims abstract description 11
- 239000008107 starch Substances 0.000 claims abstract description 11
- 239000011734 sodium Substances 0.000 claims abstract description 10
- 229910052708 sodium Inorganic materials 0.000 claims abstract description 10
- 238000002360 preparation method Methods 0.000 claims abstract description 6
- 239000008187 granular material Substances 0.000 claims description 12
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 claims description 10
- 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 claims description 9
- 150000001875 compounds Chemical class 0.000 claims description 6
- 238000002156 mixing Methods 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
- 239000000463 material Substances 0.000 claims description 3
- 229920001778 nylon Polymers 0.000 claims description 3
- 238000010298 pulverizing process Methods 0.000 claims description 3
- 239000002994 raw material Substances 0.000 claims description 3
- 235000015424 sodium Nutrition 0.000 claims description 2
- 229940071676 hydroxypropylcellulose Drugs 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 description 5
- 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
- 238000005516 engineering process Methods 0.000 description 2
- 238000000034 method Methods 0.000 description 2
- 201000008482 osteoarthritis Diseases 0.000 description 2
- 230000036407 pain Effects 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
- 206010002556 Ankylosing Spondylitis Diseases 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
- 206010018634 Gouty Arthritis Diseases 0.000 description 1
- 208000001294 Nociceptive Pain Diseases 0.000 description 1
- ARLZGEXVMUDUQZ-UHFFFAOYSA-N O.O.[Ca] Chemical compound O.O.[Ca] ARLZGEXVMUDUQZ-UHFFFAOYSA-N 0.000 description 1
- 230000000202 analgesic effect Effects 0.000 description 1
- 150000008064 anhydrides Chemical class 0.000 description 1
- 239000002260 anti-inflammatory agent Substances 0.000 description 1
- 230000003110 anti-inflammatory effect Effects 0.000 description 1
- 230000001741 anti-phlogistic effect Effects 0.000 description 1
- 206010003246 arthritis Diseases 0.000 description 1
- 125000003118 aryl group Chemical group 0.000 description 1
- 229960001419 fenoprofen Drugs 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 238000002844 melting Methods 0.000 description 1
- 230000008018 melting Effects 0.000 description 1
- 230000000813 microbial effect Effects 0.000 description 1
- 230000009965 odorless effect Effects 0.000 description 1
- 229960003424 phenylacetic acid Drugs 0.000 description 1
- 239000003279 phenylacetic acid Substances 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 201000003068 rheumatic fever Diseases 0.000 description 1
- 206010039073 rheumatoid arthritis Diseases 0.000 description 1
- KEAYESYHFKHZAL-BJUDXGSMSA-N sodium-22 Chemical compound [22Na] KEAYESYHFKHZAL-BJUDXGSMSA-N 0.000 description 1
- 210000004872 soft tissue Anatomy 0.000 description 1
- 150000003431 steroids Chemical class 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
The invention relates to the field of drug preparation, in particular to drug composition containing fenoprofen calcium and a preparation method for the drug composition, and solves existing technical problems of poor dissolubility and low bioavailability due to unreasonable ratio in the prior art. The drug composition is characterized in that the drug composition is a mixture containing fenoprofen calcium, sodium carboxymethyl starch, hydroxy propyl cellulose and magnesium stearate. The drug composition is reasonable in ratio, scientific in formula, good in dissolubility, high in bioavailability and good in drug compliance of patients.
Description
Technical field
The present invention relates to the manufacture field of medicine, particularly relate to a kind of fenoprofen calcium medicine compound and preparation method thereof, mainly be applicable to various arthritis, comprise rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gouty arthritis and other soft tissue pains, also for other pain as dysmenorrhea, toothache, damage and traumatic pain etc.
Background technology
Fenoprofen calcium (Fenoprofen Calcium) is a kind of anti-inflammatory analgesic, and this product is white crystalline powder; Odorless, tasteless.Dissolve in ethanol, slightly soluble in methanol, soluble,very slightly in water, almost insoluble in chloroform.This product is Alpha-Methyl-3-phenoxy group-phenylacetic acid calcium dihydrate.Calculate, containing C by anhydride
30h
26caO
6must not 97.5% be less than.
Fenoprofen is a kind of aryl propionic non-steroid antiphlogistic thing, and clinical practice is very extensive, is mainly used in treatment rheumatic arthritis and osteoarthritis.Prior art because of proportioning unreasonable, poorly soluble, bioavailability is low.The present invention aims to provide a kind of reasonable mixture ratio, the fenoprofen calcium medicine compound of scientific formula, and dissolubility is good, and bioavailability is high, and patient drug's compliance is good.Preparation technology of the present invention is simple, and require simple to production equipment, production cost is low, is applicable to industrialization promotion.
Summary of the invention
For overcoming prior art problem, the invention provides a kind of fenoprofen calcium medicine compound, it is characterized in that, the mixture be made up of fenoprofen calcium, carboxymethyl starch sodium, hydroxypropyl cellulose, magnesium stearate, the mass percent of each component is as follows:
Fenoprofen calcium 15.1-90.3%
Carboxymethyl starch sodium 2.1-35.9%
Hydroxypropyl cellulose 8.1-43.1%
Magnesium stearate 0.5-5.9%, following component sum is 100%.
Manufacture method is following steps:
A) take fenoprofen calcium raw material by mass percentage, pulverizing crosses 100 mesh sieves;
B) fenoprofen calcium, carboxymethyl starch sodium, hydroxypropyl cellulose are dry mixed, mix homogeneously;
C) by the supplementary material of mix homogeneously 50%-95% alcohol soft material, humidity is as the criterion with oscillating granulator Granulating Humidity Craft;
D) soft material made is placed in oscillating granulator, is granulated by 16 order-20 order nylon mesh;
E) granule made is placed in boiled bed drying, inlet temperature 60-65 DEG C, material temperature 55-60 DEG C, drop temperature 30-32 DEG C;
F) dry granule is placed in 16 order-20 mesh sieve granulate;
G) dry granule be placed in two-dimensional mixing machine and add magnesium stearate mixing 15-30 minute;
H) special-shaped tabletting machine is adopted.
Detailed description of the invention:
Embodiment 1
Fenoprofen calcium 68%
Carboxymethyl starch sodium 12%
Hydroxypropyl cellulose 18%
Magnesium stearate 2%
Embodiment 2
Fenoprofen calcium 68%
Carboxymethyl starch sodium 22%
Hydroxypropyl cellulose 9%
Magnesium stearate 1%
Embodiment 3
Fenoprofen calcium 68%
Carboxymethyl starch sodium 7%
Hydroxypropyl cellulose 24%
Magnesium stearate 1%
Embodiment 1-3 preparation method:
Manufacture method is following steps:
A) take fenoprofen calcium raw material by mass percentage, pulverizing crosses 100 mesh sieves;
B) fenoprofen calcium, carboxymethyl starch sodium, hydroxypropyl cellulose are dry mixed, mix homogeneously;
C) by the supplementary material of mix homogeneously 50%-95% alcohol soft material, humidity is as the criterion with oscillating granulator Granulating Humidity Craft;
D) soft material made is placed in oscillating granulator, is granulated by 16 order-20 order nylon mesh;
E) granule made is placed in boiled bed drying, inlet temperature 60-65 DEG C, material temperature 55-60 DEG C, drop temperature 30-32 DEG C;
F) dry granule is placed in 16 order-20 mesh sieve granulate;
G) dry granule be placed in two-dimensional mixing machine and add magnesium stearate mixing 15-30 minute;
H) special-shaped tabletting machine is adopted.
Quality inspection:
| Embodiment | Content uniformity | Disintegrate or melting | Content | Related substance | Microbial limit |
| Embodiment 1 | Conform with the regulations | Conform with the regulations | 103.5% | Conform with the regulations | Conform with the regulations |
| Embodiment 2 | Conform with the regulations | Conform with the regulations | 99.7% | Conform with the regulations | Conform with the regulations |
| Embodiment 3 | Conform with the regulations | Conform with the regulations | 100.1% | Conform with the regulations | Conform with the regulations |
Claims (2)
1. a fenoprofen calcium medicine compound, the mixture be made up of fenoprofen calcium, carboxymethyl starch sodium, hydroxypropyl cellulose, magnesium stearate, is characterized in that, the mass percent of each component is as follows:
Fenoprofen calcium 15.1-90.3%
Carboxymethyl starch sodium 2.1-35.9%
Hydroxypropyl cellulose 8.1-43.1%
Magnesium stearate 0.5-5.9%, following component sum is 100%.
2. the preparation method of a kind of fenoprofen calcium medicine compound according to claim 1, is characterized in that, comprise following steps:
A) take fenoprofen calcium raw material by mass percentage, pulverizing crosses 100 mesh sieves;
B) fenoprofen calcium, carboxymethyl starch sodium, hydroxypropyl cellulose are dry mixed, mix homogeneously;
C) by the supplementary material of mix homogeneously 50%-95% alcohol soft material, humidity is as the criterion with oscillating granulator Granulating Humidity Craft;
D) soft material made is placed in oscillating granulator, is granulated by 16 order-20 order nylon mesh;
E) granule made is placed in boiled bed drying, inlet temperature 60-65 DEG C, material temperature 55-60 DEG C, drop temperature 30-32 DEG C;
F) dry granule is placed in 16 order-20 mesh sieve granulate;
G) dry granule be placed in two-dimensional mixing machine and add magnesium stearate mixing 15-30 minute;
H) special-shaped tabletting machine is adopted.
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 |
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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 |
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 |
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| PE01 | Entry into force of the registration of the contract for pledge of patent right | ||
| 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 |
Date of cancellation: 20211014 Granted publication date: 20180601 Pledgee: Hunan Hanshou Rural Commercial Bank Co.,Ltd. Pledgor: KAMP PHARMACEUTICALS Co.,Ltd. Registration number: Y2021430000029 |
|
| 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 |