CN105581989A - Medicinal composition containing fenofibric acid - Google Patents
Medicinal composition containing fenofibric acid Download PDFInfo
- Publication number
- CN105581989A CN105581989A CN201410632734.1A CN201410632734A CN105581989A CN 105581989 A CN105581989 A CN 105581989A CN 201410632734 A CN201410632734 A CN 201410632734A CN 105581989 A CN105581989 A CN 105581989A
- Authority
- CN
- China
- Prior art keywords
- fenofibric acid
- pharmaceutical composition
- methylcellulose
- antierythrite
- fenofibric
- 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
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- MQOBSOSZFYZQOK-UHFFFAOYSA-N fenofibric acid Chemical compound C1=CC(OC(C)(C)C(O)=O)=CC=C1C(=O)C1=CC=C(Cl)C=C1 MQOBSOSZFYZQOK-UHFFFAOYSA-N 0.000 title claims abstract description 79
- 229960000701 fenofibric acid Drugs 0.000 title claims abstract description 79
- 239000000203 mixture Substances 0.000 title claims abstract description 20
- 229920000609 methyl cellulose Polymers 0.000 claims abstract description 31
- 239000001923 methylcellulose Substances 0.000 claims abstract description 31
- 239000000945 filler Substances 0.000 claims abstract description 10
- 239000000314 lubricant Substances 0.000 claims abstract description 9
- UNXHWFMMPAWVPI-UHFFFAOYSA-N Erythritol Natural products OCC(O)C(O)CO UNXHWFMMPAWVPI-UHFFFAOYSA-N 0.000 claims description 30
- UNXHWFMMPAWVPI-ZXZARUISSA-N erythritol Chemical compound OC[C@H](O)[C@H](O)CO UNXHWFMMPAWVPI-ZXZARUISSA-N 0.000 claims description 30
- 238000002360 preparation method Methods 0.000 claims description 20
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 19
- 239000008194 pharmaceutical composition Substances 0.000 claims description 19
- 239000000843 powder Substances 0.000 claims description 17
- 239000000741 silica gel Substances 0.000 claims description 15
- 229910002027 silica gel Inorganic materials 0.000 claims description 15
- LNAZSHAWQACDHT-XIYTZBAFSA-N (2r,3r,4s,5r,6s)-4,5-dimethoxy-2-(methoxymethyl)-3-[(2s,3r,4s,5r,6r)-3,4,5-trimethoxy-6-(methoxymethyl)oxan-2-yl]oxy-6-[(2r,3r,4s,5r,6r)-4,5,6-trimethoxy-2-(methoxymethyl)oxan-3-yl]oxyoxane Chemical compound CO[C@@H]1[C@@H](OC)[C@H](OC)[C@@H](COC)O[C@H]1O[C@H]1[C@H](OC)[C@@H](OC)[C@H](O[C@H]2[C@@H]([C@@H](OC)[C@H](OC)O[C@@H]2COC)OC)O[C@@H]1COC LNAZSHAWQACDHT-XIYTZBAFSA-N 0.000 claims description 12
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 claims description 8
- 235000009508 confectionery Nutrition 0.000 claims description 8
- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 claims description 8
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 7
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 7
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 7
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 7
- 229920002472 Starch Polymers 0.000 claims description 5
- 239000008107 starch Substances 0.000 claims description 5
- 235000019698 starch Nutrition 0.000 claims description 5
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 4
- 229920000881 Modified starch Polymers 0.000 claims description 4
- 239000008101 lactose Substances 0.000 claims description 4
- 239000003795 chemical substances by application Substances 0.000 abstract description 3
- 238000009776 industrial production Methods 0.000 abstract description 3
- 238000004519 manufacturing process Methods 0.000 abstract description 3
- 229940079593 drug Drugs 0.000 abstract description 2
- 239000003814 drug Substances 0.000 abstract description 2
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 abstract 1
- 229930195725 Mannitol Natural products 0.000 abstract 1
- 239000008187 granular material Substances 0.000 abstract 1
- 239000000594 mannitol Substances 0.000 abstract 1
- 235000010355 mannitol Nutrition 0.000 abstract 1
- 239000000243 solution Substances 0.000 description 17
- 238000012360 testing method Methods 0.000 description 17
- 238000000034 method Methods 0.000 description 10
- 239000000047 product Substances 0.000 description 10
- 239000012535 impurity Substances 0.000 description 9
- WEVYAHXRMPXWCK-UHFFFAOYSA-N acetonitrile Substances CC#N WEVYAHXRMPXWCK-UHFFFAOYSA-N 0.000 description 7
- 239000000126 substance Substances 0.000 description 7
- 238000004811 liquid chromatography Methods 0.000 description 6
- 239000002904 solvent Substances 0.000 description 6
- OAICVXFJPJFONN-UHFFFAOYSA-N Phosphorus Chemical compound [P] OAICVXFJPJFONN-UHFFFAOYSA-N 0.000 description 5
- 239000002253 acid Substances 0.000 description 5
- 238000004090 dissolution Methods 0.000 description 5
- 239000007924 injection Substances 0.000 description 5
- 238000002347 injection Methods 0.000 description 5
- 239000011574 phosphorus Substances 0.000 description 5
- 229910052698 phosphorus Inorganic materials 0.000 description 5
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 5
- 238000001514 detection method Methods 0.000 description 4
- 238000005286 illumination Methods 0.000 description 4
- 230000014759 maintenance of location Effects 0.000 description 4
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 3
- 238000003556 assay Methods 0.000 description 3
- 239000002775 capsule Substances 0.000 description 3
- 238000005516 engineering process Methods 0.000 description 3
- 239000000706 filtrate Substances 0.000 description 3
- 125000001997 phenyl group Chemical group [H]C1=C([H])C([H])=C(*)C([H])=C1[H] 0.000 description 3
- 239000013558 reference substance Substances 0.000 description 3
- BXWLVQXAFBWKSR-UHFFFAOYSA-N 2-methoxy-5-methylsulfonylbenzoic acid Chemical compound COC1=CC=C(S(C)(=O)=O)C=C1C(O)=O BXWLVQXAFBWKSR-UHFFFAOYSA-N 0.000 description 2
- -1 4-chlorphenyl Chemical group 0.000 description 2
- 230000000052 comparative effect Effects 0.000 description 2
- 238000013270 controlled release Methods 0.000 description 2
- 238000010790 dilution Methods 0.000 description 2
- 239000012895 dilution Substances 0.000 description 2
- 238000010812 external standard method Methods 0.000 description 2
- 229960002297 fenofibrate Drugs 0.000 description 2
- YMTINGFKWWXKFG-UHFFFAOYSA-N fenofibrate Chemical compound C1=CC(OC(C)(C)C(=O)OC(C)C)=CC=C1C(=O)C1=CC=C(Cl)C=C1 YMTINGFKWWXKFG-UHFFFAOYSA-N 0.000 description 2
- 238000001914 filtration Methods 0.000 description 2
- 239000012467 final product Substances 0.000 description 2
- YTJSFYQNRXLOIC-UHFFFAOYSA-N octadecylsilane Chemical compound CCCCCCCCCCCCCCCCCC[SiH3] YTJSFYQNRXLOIC-UHFFFAOYSA-N 0.000 description 2
- 238000004806 packaging method and process Methods 0.000 description 2
- 125000000951 phenoxy group Chemical group [H]C1=C([H])C([H])=C(O*)C([H])=C1[H] 0.000 description 2
- 239000008363 phosphate buffer Substances 0.000 description 2
- 238000012216 screening Methods 0.000 description 2
- 239000000377 silicon dioxide Substances 0.000 description 2
- 239000006228 supernatant Substances 0.000 description 2
- RUETVLNXAGWCDS-UHFFFAOYSA-N (4-chlorophenyl)-(4-hydroxyphenyl)methanone Chemical compound C1=CC(O)=CC=C1C(=O)C1=CC=C(Cl)C=C1 RUETVLNXAGWCDS-UHFFFAOYSA-N 0.000 description 1
- XDHYHJRKXJFCBM-UHFFFAOYSA-N (4-chlorophenyl)-[4-(2-hydroxypropan-2-yl)phenyl]methanone Chemical compound C1=CC(C(C)(O)C)=CC=C1C(=O)C1=CC=C(Cl)C=C1 XDHYHJRKXJFCBM-UHFFFAOYSA-N 0.000 description 1
- 125000000242 4-chlorobenzoyl group Chemical group ClC1=CC=C(C(=O)*)C=C1 0.000 description 1
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 description 1
- 208000035150 Hypercholesterolemia Diseases 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 230000000996 additive effect Effects 0.000 description 1
- 230000004888 barrier function Effects 0.000 description 1
- 229910001914 chlorine tetroxide Inorganic materials 0.000 description 1
- 229940121657 clinical drug Drugs 0.000 description 1
- 239000013078 crystal Substances 0.000 description 1
- 239000012738 dissolution medium Substances 0.000 description 1
- 238000011978 dissolution method Methods 0.000 description 1
- 230000000857 drug effect Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000010828 elution Methods 0.000 description 1
- 239000012055 enteric layer Substances 0.000 description 1
- WAROHEJQMZXNDT-UHFFFAOYSA-N ethyl 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoate Chemical compound C1=CC(OC(C)(C)C(=O)OCC)=CC=C1C(=O)C1=CC=C(Cl)C=C1 WAROHEJQMZXNDT-UHFFFAOYSA-N 0.000 description 1
- 239000000835 fiber Substances 0.000 description 1
- 229940125753 fibrate Drugs 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 238000004128 high performance liquid chromatography Methods 0.000 description 1
- 208000006575 hypertriglyceridemia Diseases 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 150000002576 ketones Chemical class 0.000 description 1
- 239000002207 metabolite Substances 0.000 description 1
- 229910000402 monopotassium phosphate Inorganic materials 0.000 description 1
- 235000019796 monopotassium phosphate Nutrition 0.000 description 1
- 238000005453 pelletization Methods 0.000 description 1
- PJNZPQUBCPKICU-UHFFFAOYSA-N phosphoric acid;potassium Chemical compound [K].OP(O)(O)=O PJNZPQUBCPKICU-UHFFFAOYSA-N 0.000 description 1
- 230000035479 physiological effects, processes and functions Effects 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
- 210000000813 small intestine Anatomy 0.000 description 1
- 238000001228 spectrum Methods 0.000 description 1
- 239000007921 spray Substances 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- 238000005550 wet granulation Methods 0.000 description 1
Abstract
The invention belongs to the technical field of medicines, and in particular relates to a medicinal composition containing fenofibric acid. The medicinal composition contains the fenofibric acid, a filling agent, a disintegrating agent, a lubricating agent, methylcellulose and mannitol granules. The medicinal composition is good in stability, dissolves out completely, and has excellent quality; the production of the medicinal composition is simple and feasible to operate, and the medicinal composition is suitable for industrial production.
Description
Technical field
The invention belongs to medical technical field, be specifically related to the preparation method of a kind of pharmaceutical composition that contains Fenofibric Acid and tablet thereof.
Background technology
Fenofibric Acid (English name FenofibricAcid), its chemical name is: 2-[4-(4-chlorobenzene formacyl) phenoxy group]-2 Methylpropionic acid. Molecular formula: C17H15ClO4, molecular weight: 318.75, its structural formula is as follows:
Fenofibric Acid is second generation fibrate drug, be used for the treatment of hypercholesterolemia and hypertriglyceridemia, metabolite and the active ingredient of fenofibrate in human body, there is high solubility in small intestine district, therefore, it is compared fenofibrate and has better bioavilability, and the impact of bioavilability unable to take food thing.
Chinese patent CN102172347A discloses a kind of preparation technology of Fenofibric Acid enteric-soluble controlled-release capsule, by pelletizing press sheet is formed to microplate, each microplate diameter 3mm, and then enteric coated on microplate, again the microplate after dressing is incapsulated, make enteric-soluble controlled-release capsule. But, adopt microplate technique also need to after prepare by microplate, it further be processed and record into capsule to facilitate patient to take, and need to use special mould and sheeting equipment, the lower and length consuming time of production efficiency.
Chinese patent CN101780049A discloses a kind of preparation method of Fenofibric Acid enteric coated preparations, wraps up Fenofibric Acid active component on micropill, and then wraps barrier gown and enteric layer, makes enteric supensoid agent. But, adopt micropill technique to need spray packaging technique at the bottom of fluid bed, dressing repeatedly on micropill, long processing time, made supensoid agent is unfavorable for that patient takes, dosage is wayward.
Above data is not all mentioned acceptable salt conventional tablet and preparation method thereof on Fenofibric Acid and physiology thereof. Although and employing wet granulation technology can improve dissolution rate, related substance is higher. Therefore, preparing a kind of common Fenofibric Acid sheet, and have that related substance is few, stripping is complete, stay-in-grade feature, to ensure stable, the safety of clinical drug effect, is to need those skilled in the art to put forth effort the technical problem solving.
Summary of the invention
For these reasons, applicant finds a kind of new Fenofibric Acid pharmaceutical composition through research, contains antierythrite and methylcellulose in this pharmaceutical composition, is ensureing on the basis of stripping, for the impurity spectrum stability that promotes Fenofibric Acid.
The object of this invention is to provide a kind of new pharmaceutical composition that contains Fenofibric Acid, said composition is prepared into preparation, has advantages of that dissolution rate is good, impurity is composed stable.
Another object of the present invention is to provide a kind of preparation method of the pharmaceutical composition that contains Fenofibric Acid, and the method is applicable to industrial production.
Particularly, the invention provides:
A pharmaceutical composition that contains Fenofibric Acid, contains: Fenofibric Acid, lubricant, methylcellulose and antierythrite.
The described pharmaceutical composition that contains Fenofibric Acid is tablet.
The weight ratio of described methylcellulose and antierythrite is (2 ~ 2.3): 1.
The described pharmaceutical composition that contains Fenofibric Acid, the weight ratio of each component is:
Fenofibric Acid 1 ~ 4 weight portion
Methylcellulose 3 ~ 8 weight portions
Antierythrite 1 ~ 5 weight portion
Filler 30 ~ 60 weight portions
Lubricant 1 ~ 5 weight portion.
Described filler is selected from one or more in starch, lactose, Icing Sugar, sweet mellow wine, microcrystalline cellulose, pregelatinized starch.
Described lubricant is selected from one or more in superfine silica gel powder, talcum powder, dolomol.
The described pharmaceutical composition that contains Fenofibric Acid is prepared into tablet, its preparation method comprises the following steps: Fenofibric Acid, methylcellulose, antierythrite, filler, lubricant are sieved respectively, mixed, sieve, mix, compressing tablet obtains Fenofibric Acid tablet.
The present invention compared with prior art has the following advantages and good effect:
1, product stability of the present invention is good, and stripping is complete.
2, operation is simple for production of the present invention, is suitable for industrial production.
Detailed description of the invention
Below the invention will be further described for the description by detailed description of the invention, but this is not limitation of the present invention, those skilled in the art are according to basic thought of the present invention, can make various amendments or improvement, but only otherwise depart from basic thought of the present invention, all within the scope of the present invention.
Test method
Dissolution rate is got this product, according to dissolution method (two annex XC the second methods of Chinese pharmacopoeia version in 2010), (gets 0.2mol/L potassium dihydrogen phosphate 250ml with pH6.8 phosphate buffer, add 0.2mol/L sodium hydroxide solution 112ml, being diluted with water to 1000ml, shaking up, to obtain final product) 900ml is dissolution medium, rotating speed is per minute 75 to turn, operation, in the time of 15 minutes, gets solution 10ml in accordance with the law, filter, filtrate is as need testing solution; Separately get the about 10mg of Fenofibric Acid reference substance, accurately weighed, put in brown measuring bottle, add pH6.8 phosphate buffer and dissolve and dilute the solution of making in every 1ml containing 0.04mg, shake up, in contrast product solution. Taking water (with phosphorus acid for adjusting pH value to 2.5) ,-acetonitrile (50:50) is as mobile phase, and detection wavelength is 286nm. Precision measures need testing solution and each 10 μ 1 of reference substance solution, and injection liquid chromatography, records chromatogram respectively. Stripping quantity by external standard method with every of calculated by peak area.
Related substance is got fine powder appropriate (being approximately equivalent to Fenofibric Acid 50mg) under this product assay item, accurately weighed, put in the brown measuring bottle of 100ml, solubilizer ((with phosphorus acid for adjusting pH value to 2.5)-acetonitrile (30:70)) is appropriate, ultrasonic (or jolting) makes to dissolve for 10 minutes, with solvent dilution, to scale, centrifugal (or filtration) gets supernatant (or subsequent filtrate) as need testing solution; Precision measures in right amount, makes the solution that approximately contains 1 μ g in every 1ml, solution in contrast with solvent dilution; Get need testing solution appropriate, add impurity IV by 0.1%, mix, get this solution illumination 5～10 minutes, as system suitability solution. Measure according to high performance liquid chromatography (two annex V D of Chinese pharmacopoeia version in 2010), using octadecylsilane chemically bonded silica (recommending TC-C18,5 μ m, 4.6 × 250mm) is filler; Taking water (with phosphorus acid for adjusting pH value to 2.5), as mobile phase A, acetonitrile is Mobile phase B, and according to the form below carries out linear gradient elution; Detection wavelength is 286nm. Get system suitability solution 10 μ l injection liquid chromatographies, record chromatogram, the retention time at Fenofibric Acid peak is about 16～18 minutes, and the separating degree at Fenofibric Acid peak and impurity II peak (relative retention time is about 0.9), impurity III peak (relative retention time is about 2.36) and impurity IV peak (relative retention time is about 2.42) should meet the requirements. Get contrast solution 10 μ l, injection liquid chromatography, regulates detection sensitivity, makes the peak height of principal component chromatographic peak be about 10% of full scale; Precision measures need testing solution and the each 10 μ l of contrast solution again, and injection liquid chromatography, records chromatogram respectively.
Impurity I (RRT=0.65)
The chloro-4` dihydroxy benaophenonel of Chinese: 4-
English name: 4-Chloro-4'-hydroxybenzophenone
Impurity II (RRT=0.9)
Chinese: (4-chlorphenyl) [4-(2-hydroxypropyl-2-yl) phenyl] ketone
English name: (4-chlorophenyl) (4-(2-hydroxypropan-2-yl) phenyl) methanone
Impurity III (RRT=2.36)
Chinese: 2-[4-(4-chlorphenyl) phenoxy group]-2 Methylpropionic acid ethyl ester
English name: Ethyl2-[4-(4-chlorobenzoyl) phenoxy]-2-methylpropanoate
Impurity IV (RRT=2.42)
Chinese: (4-chlorphenyl) [4-(1-methoxyl group) phenyl]-ketone
English name: (4-chlorobenzoyl) [4-(1-methylthoxy) phenyl]-methanone
Assay is measured according to high effective liquid chromatography for measuring (two annex V D of Chinese pharmacopoeia version in 2010).
Chromatographic condition and system suitability are with being filler with octadecylsilane chemically bonded silica; Taking water (with phosphorus acid for adjusting pH value to 2.5) ,-acetonitrile (50:50) is as mobile phase, and detection wavelength is 286nm. Get this product fine powder appropriate (being approximately equivalent to Fenofibric Acid 10mg), put in 100ml measuring bottle, solubilizer dissolves and is diluted to scale, shake up, illumination 5～10 minutes, precision measures 10 μ l injection liquid chromatographies, and number of theoretical plate calculates and is not less than 3000 by Fenofibric Acid peak, and the separating degree of Fenofibric Acid peak and adjacent impurity peaks should meet the requirements.
Determination method is got 20 of this product, accurately weighed, porphyrize, precision takes in right amount (being approximately equivalent to Fenofibric Acid 10mg), puts in the brown measuring bottle of 100ml, and solubilizer (water (with phosphorus acid for adjusting pH value to 2.5)-acetonitrile (30:70)) is appropriate, ultrasonic (or jolting) makes to dissolve and be diluted to scale for 10 minutes, shake up, centrifugal (or filtration), gets supernatant (or subsequent filtrate) 10 μ 1 and measures according to chromatographic condition under Fenofibric Acid assay item; Separately get the about 10mg of Fenofibric Acid reference substance, accurately weighed, to put in the brown measuring bottle of 100ml, solubilizer dissolves and is diluted to scale, shakes up, and is measured in the same method. , to obtain final product with calculated by peak area by external standard method.
Test example 1: prescription screening test
Get respectively Fenofibric Acid 3g(content 99.9%, always assorted 0.09%), starch 35g, superfine silica gel powder 1.8g, make the tablet that contains Fenofibric Acid by following prescription, detect related substance and dissolution rate, the results are shown in Table 2:
Table 1 prescription screening
Table 2 related substance result of the test
Result of the test shows: Fenofibric Acid and methylcellulose are dissolved in to related substance and the dissolution rate that antierythrite makes and are better than additive method.
Test example 2: influence factor test
Get embodiment 3,5,6,8 products and carry out influence factor test, the results are shown in Table 3.
Table 3 influence factor test data
Conclusion: road as seen from the above table, the product of preparing by the inventive method, the stability under high temperature and illumination is better than comparative example.
Test example 3: accelerated test
Get embodiment 5,6,8 products and carry out accelerated test, the results are shown in Table 4.
Table 4 accelerated test data
Packaging: commercially available back, investigation condition: 40 DEG C of temperature, humidity 75%
Conclusion: road as seen from the above table, the product of preparing by the inventive method, the stability under high temperature and illumination is better than comparative example.
Preparation example
Embodiment 1
Prescription
Fenofibric Acid 1.0g
Methylcellulose 7.2g
Antierythrite 3.6g
Starch 35g
Superfine silica gel powder 1.8g.
Preparation method: Fenofibric Acid, methylcellulose, antierythrite, starch, superfine silica gel powder are sieved respectively, mixed, sieve, mix, compressing tablet obtains Fenofibric Acid tablet.
Embodiment 2
Prescription
Fenofibric Acid 1.5g
Methylcellulose 4.5g
Antierythrite 2.0g
Lactose 38g
Talcum powder 2.8g.
Preparation method: Fenofibric Acid, methylcellulose, antierythrite, lactose, talcum powder are sieved respectively, mixed, sieve, mix, compressing tablet obtains Fenofibric Acid tablet.
Embodiment 3
Prescription
Fenofibric Acid 2.0g
Methylcellulose 6.2g
Antierythrite 2.8g
Icing Sugar 45g
Superfine silica gel powder 2.5g.
Preparation method: Fenofibric Acid, methylcellulose, antierythrite, Icing Sugar, superfine silica gel powder are sieved respectively, mixed, cross 20 mesh sieves, mix 20 minutes, compressing tablet obtains Fenofibric Acid tablet.
Embodiment 4
Prescription
Fenofibric Acid 2.5g
Methylcellulose 7.5g
Antierythrite 3.6g
Sweet mellow wine 54g
Dolomol 2.5g.
Preparation method: Fenofibric Acid, methylcellulose, antierythrite, sweet mellow wine, dolomol are sieved respectively, mixed, cross 20 mesh sieves, mix 20 minutes, compressing tablet obtains Fenofibric Acid tablet.
Embodiment 5
Prescription
Fenofibric Acid 3.0g
Methylcellulose 6.8g
Antierythrite 3.2g
Microcrystalline cellulose 37g
Superfine silica gel powder 1.2g
Dolomol 0.5g.
Preparation method: Fenofibric Acid, methylcellulose, antierythrite, microcrystalline cellulose, superfine silica gel powder and dolomol are sieved respectively, mixed, cross 20 mesh sieves, mix 20 minutes, compressing tablet obtains Fenofibric Acid tablet.
Embodiment 6
Prescription
Fenofibric Acid 3.5g
Methylcellulose 5.0g
Antierythrite 1.8g
Microcrystalline cellulose 85g
Talcum powder 0.8g
Dolomol 0.5g.
Preparation method: Fenofibric Acid, methylcellulose, antierythrite, microcrystalline cellulose, talcum powder, dolomol are sieved respectively, mixed, cross 20 mesh sieves, mix 20 minutes, compressing tablet obtains Fenofibric Acid tablet.
Embodiment 7
Prescription
Fenofibric Acid 4.0g
Methylcellulose 3.0g
Antierythrite 1.3g
Pregelatinized starch 53g
Superfine silica gel powder 4g.
Preparation method: Fenofibric Acid, methylcellulose, antierythrite, pregelatinized starch, superfine silica gel powder are sieved respectively, mixed, cross 20 mesh sieves, mix 20 minutes, compressing tablet obtains Fenofibric Acid tablet.
Embodiment 8
Prescription
Fenofibric Acid 1.0g
Methylcellulose 8.0g
Antierythrite 3.5g
Microcrystalline cellulose 48g
Superfine silica gel powder 1.5g.
Preparation method: Fenofibric Acid, methylcellulose, antierythrite, crystal fiber element, superfine silica gel powder are sieved respectively, mixed, cross 20 mesh sieves, mix 20 minutes, compressing tablet obtains Fenofibric Acid tablet.
Embodiment 9
Prescription
Fenofibric Acid 2.0g
Methylcellulose 3.0g
Antierythrite 1.2g
Sweet mellow wine 60g
Talcum powder 3g.
Preparation method: Fenofibric Acid, methylcellulose, antierythrite, sweet mellow wine, talcum powder are sieved respectively, mixed, cross 20 mesh sieves, mix 20 minutes, compressing tablet obtains Fenofibric Acid tablet.
Embodiment 10
Prescription
Fenofibric Acid 4.0g
Methylcellulose 7.1g
Antierythrite 3.1g
Sweet mellow wine 10g
Superfine silica gel powder 5g.
Preparation method: Fenofibric Acid, methylcellulose, antierythrite, sweet mellow wine, superfine silica gel powder are sieved respectively, mixed, cross 20 mesh sieves, mix 20 minutes, compressing tablet obtains Fenofibric Acid tablet.
Claims (7)
1. contain a pharmaceutical composition for Fenofibric Acid, it is characterized in that pharmaceutical composition contains: Fenofibric Acid, filler, lubricant, methylcellulose and antierythrite.
2. the pharmaceutical composition that contains Fenofibric Acid according to claim 1, is characterized in that pharmaceutical composition is prepared into tablet.
3. the pharmaceutical composition that contains Fenofibric Acid according to claim 1, is characterized in that the weight ratio of each component is:
Fenofibric Acid 1 ~ 4 weight portion
Methylcellulose 3 ~ 8 weight portions
Antierythrite 1 ~ 5 weight portion
Filler 30 ~ 60 weight portions
Lubricant 1 ~ 5 weight portion.
4. the pharmaceutical composition that contains Fenofibric Acid according to claim 1, is characterized in that: the weight ratio of described methylcellulose and antierythrite is (2 ~ 2.3): 1.
5. the pharmaceutical composition that contains Fenofibric Acid according to claim 1, is characterized in that described filler is selected from one or more in starch, lactose, Icing Sugar, sweet mellow wine, microcrystalline cellulose, pregelatinized starch.
6. the pharmaceutical composition that contains Fenofibric Acid according to claim 1, is characterized in that described lubricant is selected from one or more in superfine silica gel powder, talcum powder, dolomol.
7. the preparation method of the pharmaceutical composition that contains Fenofibric Acid according to claim 1, comprise the following steps: Fenofibric Acid, methylcellulose, antierythrite, filler, lubricant are sieved respectively, mixed, sieve, mix, compressing tablet obtains Fenofibric Acid tablet.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410632734.1A CN105581989B (en) | 2014-11-12 | 2014-11-12 | A kind of pharmaceutical composition containing Fenofibric Acid |
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| CN201410632734.1A CN105581989B (en) | 2014-11-12 | 2014-11-12 | A kind of pharmaceutical composition containing Fenofibric Acid |
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| CN105581989A true CN105581989A (en) | 2016-05-18 |
| CN105581989B CN105581989B (en) | 2018-09-11 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107550875A (en) * | 2017-08-21 | 2018-01-09 | 赵剑锋 | A kind of Fenofibric Acid piece of stabilization and preparation method thereof |
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|---|---|---|---|---|
| CN1726024A (en) * | 2002-12-17 | 2006-01-25 | 阿伯特有限及两合公司 | Formulation comprising fenofibric acid, a physiologically acceptable salt or derivative thereof |
| US20070026062A1 (en) * | 2003-10-10 | 2007-02-01 | Lifecycle Pharma A/S | Tablet comprising a fibrate |
| CN103083275A (en) * | 2013-01-31 | 2013-05-08 | 扬子江药业集团有限公司 | Enteric coated tablet of fenofibric acid and physiologically acceptable salts and preparation method of enteric coated tablet |
| CN104013593A (en) * | 2014-05-16 | 2014-09-03 | 锦州博泽医药科技开发有限公司 | Composition containing fenofibric acid and preparation thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1726024A (en) * | 2002-12-17 | 2006-01-25 | 阿伯特有限及两合公司 | Formulation comprising fenofibric acid, a physiologically acceptable salt or derivative thereof |
| US20070026062A1 (en) * | 2003-10-10 | 2007-02-01 | Lifecycle Pharma A/S | Tablet comprising a fibrate |
| CN103083275A (en) * | 2013-01-31 | 2013-05-08 | 扬子江药业集团有限公司 | Enteric coated tablet of fenofibric acid and physiologically acceptable salts and preparation method of enteric coated tablet |
| CN104013593A (en) * | 2014-05-16 | 2014-09-03 | 锦州博泽医药科技开发有限公司 | Composition containing fenofibric acid and preparation thereof |
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| CN107550875A (en) * | 2017-08-21 | 2018-01-09 | 赵剑锋 | A kind of Fenofibric Acid piece of stabilization and preparation method thereof |
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| Publication number | Publication date |
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| CN105581989B (en) | 2018-09-11 |
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Address after: 130012, 672, pioneering street, hi tech Zone, Jilin, Changchun Applicant after: CHANGCHUN HAIYUE PHARMACEUTICAL Co.,Ltd. Address before: 130012, 672, pioneering street, hi tech Zone, Jilin, Changchun Applicant before: Changchun Haiyue Pharmaceutical Co.,Ltd. |
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Denomination of invention: A pharmaceutical composition containing non norbesylate Effective date of registration: 20231226 Granted publication date: 20180911 Pledgee: China Construction Bank Co.,Ltd. Changchun Science and Technology Sub branch Pledgor: CHANGCHUN HAIYUE PHARMACEUTICAL Co.,Ltd. Registration number: Y2023220000149 |