CN104490808A - Cefixime composition chewable tablets and preparation method thereof - Google Patents
Cefixime composition chewable tablets and preparation method thereof Download PDFInfo
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- CN104490808A CN104490808A CN201410735361.0A CN201410735361A CN104490808A CN 104490808 A CN104490808 A CN 104490808A CN 201410735361 A CN201410735361 A CN 201410735361A CN 104490808 A CN104490808 A CN 104490808A
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- cefixime
- medicinal liquid
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- OKBVVJOGVLARMR-QSWIMTSFSA-N cefixime Chemical compound S1C(N)=NC(C(=N\OCC(O)=O)\C(=O)N[C@@H]2C(N3C(=C(C=C)CS[C@@H]32)C(O)=O)=O)=C1 OKBVVJOGVLARMR-QSWIMTSFSA-N 0.000 title claims abstract description 48
- 229960002129 cefixime Drugs 0.000 title claims abstract description 48
- 239000007910 chewable tablet Substances 0.000 title claims abstract description 47
- 239000000203 mixture Substances 0.000 title claims abstract description 33
- 238000002360 preparation method Methods 0.000 title claims abstract description 12
- 239000003814 drug Substances 0.000 claims abstract description 42
- 229940079593 drug Drugs 0.000 claims abstract description 31
- 229920002472 Starch Polymers 0.000 claims abstract description 10
- 239000008107 starch Substances 0.000 claims abstract description 10
- 235000019698 starch Nutrition 0.000 claims abstract description 10
- 229930006000 Sucrose Natural products 0.000 claims abstract description 8
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims abstract description 8
- 239000000463 material Substances 0.000 claims abstract description 6
- 229940068682 chewable tablet Drugs 0.000 claims description 42
- 239000007788 liquid Substances 0.000 claims description 36
- 238000003756 stirring Methods 0.000 claims description 20
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 16
- 239000005720 sucrose Substances 0.000 claims description 15
- 238000010792 warming Methods 0.000 claims description 14
- 238000000034 method Methods 0.000 claims description 12
- 210000000582 semen Anatomy 0.000 claims description 9
- 229920002261 Corn starch Polymers 0.000 claims description 8
- 239000008120 corn starch Substances 0.000 claims description 8
- 239000012153 distilled water Substances 0.000 claims description 8
- 239000008213 purified water Substances 0.000 claims description 8
- 238000001035 drying Methods 0.000 claims description 6
- 230000008569 process Effects 0.000 claims description 6
- 206010013786 Dry skin Diseases 0.000 claims description 5
- 239000000706 filtrate Substances 0.000 claims description 5
- 239000003002 pH adjusting agent Substances 0.000 claims description 5
- 229920000742 Cotton Polymers 0.000 claims description 4
- 239000002253 acid Substances 0.000 claims description 4
- 239000005030 aluminium foil Substances 0.000 claims description 4
- 238000004108 freeze drying Methods 0.000 claims description 4
- 238000011068 loading method Methods 0.000 claims description 4
- 150000002923 oximes Chemical class 0.000 claims description 4
- 238000004806 packaging method and process Methods 0.000 claims description 4
- 239000004033 plastic Substances 0.000 claims description 4
- 229920003023 plastic Polymers 0.000 claims description 4
- 239000000843 powder Substances 0.000 claims description 4
- 150000003839 salts Chemical class 0.000 claims description 4
- 238000005070 sampling Methods 0.000 claims description 4
- 238000007789 sealing Methods 0.000 claims description 4
- 238000005406 washing Methods 0.000 claims description 4
- 239000002994 raw material Substances 0.000 claims description 2
- 239000003826 tablet Substances 0.000 abstract description 10
- 239000000825 pharmaceutical preparation Substances 0.000 abstract description 4
- 238000004519 manufacturing process Methods 0.000 abstract description 3
- 230000007547 defect Effects 0.000 abstract description 2
- 229940032147 starch Drugs 0.000 abstract 1
- 229960004793 sucrose Drugs 0.000 abstract 1
- 238000004090 dissolution Methods 0.000 description 14
- 229940085200 cefixime chewable tablet Drugs 0.000 description 12
- 239000002671 adjuvant Substances 0.000 description 10
- 239000000047 product Substances 0.000 description 8
- 238000012360 testing method Methods 0.000 description 5
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical group [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 3
- 239000003795 chemical substances by application Substances 0.000 description 3
- 208000019505 Deglutition disease Diseases 0.000 description 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
- 239000000853 adhesive Substances 0.000 description 2
- 230000001070 adhesive effect Effects 0.000 description 2
- 230000000844 anti-bacterial effect Effects 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 238000011835 investigation Methods 0.000 description 2
- 230000007774 longterm Effects 0.000 description 2
- 239000008363 phosphate buffer Substances 0.000 description 2
- 230000001105 regulatory effect Effects 0.000 description 2
- 238000011160 research Methods 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 108090000204 Dipeptidase 1 Proteins 0.000 description 1
- 241000588724 Escherichia coli Species 0.000 description 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- 206010018612 Gonorrhoea Diseases 0.000 description 1
- 241000588653 Neisseria Species 0.000 description 1
- 206010033078 Otitis media Diseases 0.000 description 1
- 206010035664 Pneumonia Diseases 0.000 description 1
- 206010039587 Scarlet Fever Diseases 0.000 description 1
- 241000194017 Streptococcus Species 0.000 description 1
- 241000193998 Streptococcus pneumoniae Species 0.000 description 1
- 206010064921 Urinary tract inflammation Diseases 0.000 description 1
- 238000002835 absorbance Methods 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 230000001133 acceleration Effects 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 230000002421 anti-septic effect Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- 102000006635 beta-lactamase Human genes 0.000 description 1
- 206010006451 bronchitis Diseases 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 239000003153 chemical reaction reagent Substances 0.000 description 1
- 230000001055 chewing effect Effects 0.000 description 1
- 208000003167 cholangitis Diseases 0.000 description 1
- 201000001352 cholecystitis Diseases 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 238000001816 cooling Methods 0.000 description 1
- 239000003085 diluting agent Substances 0.000 description 1
- 239000007919 dispersible tablet Substances 0.000 description 1
- 239000012738 dissolution medium Substances 0.000 description 1
- 238000011978 dissolution method Methods 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 230000000857 drug effect Effects 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
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- 239000000284 extract Substances 0.000 description 1
- 239000000945 filler Substances 0.000 description 1
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- 238000009472 formulation Methods 0.000 description 1
- 230000006870 function Effects 0.000 description 1
- 230000002496 gastric effect Effects 0.000 description 1
- 230000007661 gastrointestinal function Effects 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 208000001786 gonorrhea Diseases 0.000 description 1
- 239000008187 granular material Substances 0.000 description 1
- 239000012535 impurity Substances 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 239000000314 lubricant Substances 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 229910000402 monopotassium phosphate Inorganic materials 0.000 description 1
- 235000019796 monopotassium phosphate Nutrition 0.000 description 1
- 229910000403 monosodium phosphate Inorganic materials 0.000 description 1
- 235000019799 monosodium phosphate Nutrition 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- 210000000214 mouth Anatomy 0.000 description 1
- PJNZPQUBCPKICU-UHFFFAOYSA-N phosphoric acid;potassium Chemical compound [K].OP(O)(O)=O PJNZPQUBCPKICU-UHFFFAOYSA-N 0.000 description 1
- 230000008092 positive effect Effects 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 239000013558 reference substance Substances 0.000 description 1
- 239000004576 sand Substances 0.000 description 1
- 201000009890 sinusitis Diseases 0.000 description 1
- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 238000002798 spectrophotometry method Methods 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
- 229940031000 streptococcus pneumoniae Drugs 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 229940041007 third-generation cephalosporins Drugs 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
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- Medicinal Preparation (AREA)
Abstract
The invention provides cefixime composition chewable tablets and a preparation method thereof and relates to the technical field of medicines and medical production. The cefixime composition chewable tablets comprise cefixime, starch and cane sugar, the defects of common chewable tablets are overcome by virtue of the tablets disclosed by the invention, the types and amount of auxiliary materials in the cefixime chewable tablets are reduced, and the pharmaceutical preparation is excellent in performance, high in bioavailability, high in stability and high in patient acceptance, does not have a sense of gravel and has important clinical application value.
Description
Technical field
The present invention relates to medicine and medical production technical field, be specifically related to a kind of cefixime composition chewable tablet and preparation method thereof.
Background technology
Tablet quality is stable, taking convenience, is basic, the most the most frequently used a kind of dosage form.But for the patient of child, old man and dysphagia, conventional tablet often takes difficulty, and Long-term taking medicine even can make it produce psychological phenomenon of refusing to take medicine, and chewable tablet then can remedy such and insufficient.Chewable tablet is the tablet under a class can chew posterior phraynx in oral cavity, and size is general identical with conventional tablet, can make difform Special-shaped sheet as required.Tablet is convenient to swallow after chewing, and coat tablets is long-pending to be increased, and can promote medicine dissolving in vivo, absorption.For the medicine of difficult disintegrate, make chewable tablet and can accelerate its disintegrate, improve drug effect.Chewable tablet taking convenience, even if also can medication on time under the condition of hydropenia, be specially adapted to the patient that children's, old man, dysphagia or gastrointestinal function are poor, can reduces medicine and bear gastrointestinal.Therefore, chewable tablet application is extensively got up gradually.
Cefixime is oral third generation cephalosporins, has broad-spectrum antiseptic feature, has good antibacterial action to streptococcus, streptococcus pneumoniae, gonococcus, escherichia coli etc., the beta-lactamase of antibacterial is stablized, untoward reaction is comparatively light, can be oral, and Clinical practice is convenient.The clinical pneumonia, bronchitis, urinary tract inflammation, gonorrhea, cholecystitis, cholangitis, scarlet fever, otitis media, nasal sinusitis etc. be mainly used in caused by sensitive organism.Its chemical structural formula formula is as follows:
C
16H
15N
5O
7S
2507.50
The pharmaceutical preparation of the cefixime gone on the market has conventional tablet, capsule, chewable tablet, dispersible tablet, dry suspension, granule, wherein Cefixime chewable tablet supplementary product kind and quantity more, generally to use filler, lubricant, disintegrating agent, adhesive, correctives etc., and at least will use 4 kinds of adjuvants.Increasing research shows that impurity in the incompatibility of the toxic and side effects of adjuvant itself, adjuvant and principal agent, adjuvant etc. all can have an impact to the safety of medicine,
Therefore, select suitable adjuvant and technique, reduce supplementary product kind and the consumption of Cefixime chewable tablet, improve bioavailability and the stability of Cefixime chewable tablet, for ensureing that the safety of clinical application has positive effect.
Starch is polymerized by glucose molecule, it is the basic adjuvant of oral solid formulation, be usually used in chewable tablet, making adhesive, diluent and disintegrating agent, and starch all extracts from the natural materials such as Semen Maydis, Maninot esculenta crantz., safe and reliable, cheap and easy to get, but being used alone starch has no report as adjuvant for the production of chewable tablet.
Summary of the invention
Technical problem to be solved by this invention is the defect overcoming prior art, and propose a kind of cefixime composition chewable tablet and preparation method thereof further, said preparation adjuvant is few, good stability, and bioavailability is high.
Technical problem to be solved by this invention realizes by the following technical solutions:
A kind of cefixime composition chewable tablet, comprise cefixime, starch, sucrose, this tablet overcomes the shortcoming of above-mentioned common chewable tablet, decrease supplementary product kind and consumption in Cefixime chewable tablet, this pharmaceutical preparation function admirable, bioavailability is high, have good stability, patient acceptance is high, without sand type, has important clinical value.
A kind of cefixime composition chewable tablet, is prepared from by following raw material:
A preparation method for cefixime composition chewable tablet, comprises step as follows:
A, take the starch of component amount, add a certain amount of purified water and stir, by pH adjusting agent, the pH value of solution is controlled between 4 ~ 9, be then heated to 72 DEG C, be incubated 120 minutes, make the gelatinizing corn starch solution of 5 ~ 15% (W/V);
B, measure purified water 45ml, boil, add 85g sucrose, stir, after dissolving, continue to be heated to 100 DEG C, filter with purified cotton, the appropriate hot distilled water of filter is cleaned, and washing liquid and filtrate merge, and let cool, add appropriate distilled water, make full dose become 100mL, stir evenly, obtain B solution;
The solution that C, the medicinal liquid and the step B that steps A are obtained obtain mixes, and fully stirs 30 minutes, after medicinal liquid be down to room temperature obtain gelatinizing Semen Maydis-sucrose system medicinal liquid;
D, take cefixime 100 grams, add 1L gelatinizing Semen Maydis-sucrose system medicinal liquid, stir 25 ~ 35 minutes;
E, the medicinal liquid sampling and measuring cefixime content obtained step D, with salt acid for adjusting pH to 2.5 ~ 4.5;
After cephalo gram oxime content measured by F, medicinal liquid, be sub-packed in drug-containing dish by loading amount by medicinal liquid, each drug-containing dish fills about 1.0ml, then utilizes drug-containing dish lid malcompression state to cover drug-containing dish, and drug-containing dish is the cylindric medicine carrying packaging that plastics or other materials are made;
G, the drug-containing dish that medicinal liquid is housed is put into freeze drying box, be cooled to subzero 45 DEG C, keep 2 hours, evacuation, then 0 DEG C is warming up to gradually, keep 2 hours, then be cooled to subzero 45 DEG C, keep 2 hours, be warming up to 0 DEG C gradually again, keep 2 ~ 4 hours, then be warming up to 28 ~ 32 DEG C of dryings 4 ~ 6 hours gradually, whole process vacuum remains on below 10 handkerchiefs; Finally the drug-containing dish lid of powder charge is covered tightly, and load aluminium foil bag and carry out sealing and obtain cefixime composition chewable tablet.
The preparation method of a kind of cefixime composition chewable tablet of the present invention, in described steps A, pH adjusting agent is sodium hydroxide or hydrochloric acid, preferably controls 6.5 by the pH value of solution; Mixing time preferably 30 minutes in step C; Preferably pH to 3.5 is regulated in step e; Preferably be warming up to 0 DEG C gradually again in step F, keep 3 hours, then be warming up to 30 DEG C of dryings 5 hours gradually; Described starch selects corn starch.
Beneficial effect of the present invention is:
The preparation method of a kind of cefixime composition chewable tablet of the present invention, it adopts unique processing step, carries out special process process, can improve the bonding of starch in chewable tablet, disintegration to common corn starch, improves the molding of chewable tablet.And dosage of sucrose is 8.5% (W/V) in cefixime composition chewable tablet, it is the hardness reinforcer of this tablet, and plays flavored action.Cefixime composition chewable tablet only needs starch and sucrose two kinds of adjuvants, reduces the kind of required adjuvant; Because the technique of two liters falls in freeze-dry process employing two, twice cooling, twice intensification can make chewable tablet mouldability better, and improve stability and the dissolution of product, improve quality and the bioavailability of product.Therefore the preparation method of a kind of cefixime composition chewable tablet provided by the invention has easy to operate, and prescription is simple, and technique is unique, the feature that product stability, safety are high.
Accompanying drawing explanation
Fig. 1 is the dissolution correlation curve figure of cefixime in experiment.
Detailed description of the invention
The technological means realized to make the present invention, creation characteristic, reaching object and effect is easy to understand, below in conjunction with specific embodiment, set forth the present invention further, but following embodiment being only the preferred embodiments of the present invention, and not all.Based on the embodiment in embodiment, those skilled in the art under the prerequisite not making creative work obtain other embodiment, all belong to the protection domain of this patent.
Cefixime content is for 100mg/ sheet.
Embodiment 1
Prescription: 1000 amounts
A, take the corn starch of 100g, the purified water adding 900ml stirs, and controls 6.5, is then heated to 72 DEG C, keep 120 minutes, make the gelatinizing corn starch solution of about 10% (W/V) by pH adjusting agent by the pH value of solution.
B, measure purified water 45ml, boil, add 85g sucrose, stir, after dissolving, continue to be heated to 100 DEG C, filter with purified cotton, the appropriate hot distilled water of filter is cleaned, and washing liquid and filtrate merge, and let cool, add appropriate distilled water, make full dose become 100mL, stir evenly, obtain B solution.
The solution that C, the medicinal liquid and the step B that steps A are obtained obtain mixes, and fully stirs 30 minutes, after medicinal liquid be down to room temperature obtain gelatinizing Semen Maydis-sucrose system medicinal liquid.
D, take cefixime 100g (by 1000 calculations), add 1L gelatinizing Semen Maydis-sucrose system medicinal liquid, stir 30 minutes.
E, the medicinal liquid sampling and measuring cefixime content obtained step D, with salt acid for adjusting pH to 3.5.
After cephalo gram oxime content measured by F, medicinal liquid, be sub-packed in drug-containing dish by loading amount by medicinal liquid, each drug-containing dish fills about 1.0ml, then utilizes drug-containing dish lid malcompression state to cover drug-containing dish, and drug-containing dish is the cylindric medicine carrying packaging that plastics or other materials are made.
G, the drug-containing dish that medicinal liquid is housed is put into freeze drying box, be cooled to subzero 45 DEG C, keep 2 hours, evacuation, then 0 DEG C is warming up to gradually, keep 2 hours, be cooled to subzero 45 DEG C, keep 2 hours, be warming up to 0 DEG C gradually again, keep 3 hours, then be warming up to 30 DEG C of dryings 5 hours gradually, whole process vacuum remains on below 10 handkerchiefs.Finally the drug-containing dish lid of powder charge is covered tightly, and load aluminium foil bag and carry out sealing and obtain a kind of cefixime composition chewable tablet.
Embodiment 2
Prescription: 1000 amounts
A, take the corn starch of 150g, the purified water adding 900ml stirs, and controls 6.5, is then heated to 72 DEG C, keep 120 minutes, make the gelatinizing corn starch solution of about 5 ~ 15% (W/V) by pH adjusting agent by the pH value of solution.
B, measure purified water 45ml, boil, add 85g sucrose, stir, after dissolving, continue to be heated to 100 DEG C, filter with purified cotton, the appropriate hot distilled water of filter is cleaned, and washing liquid and filtrate merge, and let cool, add appropriate distilled water, make full dose become 100mL, stir evenly, obtain B solution.
The solution that C, the medicinal liquid and the step B that steps A are obtained obtain mixes, and fully stirs 30 minutes, after medicinal liquid be down to room temperature obtain gelatinizing Semen Maydis-sucrose system medicinal liquid.
D, take cefixime 100g (by 1000 calculations), add 1L gelatinizing Semen Maydis-sucrose system medicinal liquid, stir 30 minutes.
E, the medicinal liquid sampling and measuring cefixime content obtained step D, with salt acid for adjusting pH to 3.5.
After cephalo gram oxime content measured by F, medicinal liquid, be sub-packed in drug-containing dish by loading amount by medicinal liquid, each drug-containing dish fills about 1.0ml, then utilizes drug-containing dish lid malcompression state to cover drug-containing dish, and drug-containing dish is the cylindric medicine carrying packaging that plastics or other materials are made.
G, the drug-containing dish that medicinal liquid is housed is put into freeze drying box, be cooled to subzero 45 DEG C, keep 2 hours, evacuation, then 0 DEG C is warming up to gradually, keep 2 hours, be cooled to subzero 45 DEG C, keep 2 hours, be warming up to 0 DEG C gradually again, keep 3 hours, then be warming up to 30 DEG C of dryings 5 hours gradually, whole process vacuum remains on below 10 handkerchiefs.Finally the drug-containing dish lid of powder charge is covered tightly, and load aluminium foil bag and carry out sealing and obtain a kind of cefixime composition chewable tablet.
Experimental data
The cefixime composition chewable tablet that above-described embodiment is obtained carries out following quality research test:
1, hardness, friability, mouthfeel contrast test
The cefixime composition chewable tablet prepared according to above-described embodiment and commercially available Cefixime chewable tablet (commercially available) detect friability and hardness by " Chinese Pharmacopoeia " version in 2010 two annex X G inspection techniques, contrast, the results are shown in following table:
Experimental data shows, the more commercially available Cefixime chewable tablet of cefixime composition chewable tablet is at friability without significant difference, and hardness is slightly low, meets " Chinese Pharmacopoeia " version in 2010 to the requirement of chewable tablet, and mouthfeel is greatly improved, make it the demand more meeting patient.
2, dissolution contrast test
Get Cefixime chewable tablet (commercially available) respectively and cefixime composition chewable tablet (is prepared to No. 3 for embodiment 1 for No. 1, prepare to No. 6 for embodiment 2 for No. 4) each 6, respectively according to dissolution method (" Chinese Pharmacopoeia " version in 2010 two annex X C second methods), [potassium dihydrogen phosphate (17 → 3500) is got with phosphate buffer, pH to 6.5 is regulated with sodium dihydrogen phosphate (7 → 1000)] 1000ml is dissolution medium, rotating speed is 100r/min, operates in accordance with the law.
Sample respectively at 5min, 10min, 15min, 25min, 40min, 60min, get dissolution fluid appropriate, filter, precision measures subsequent filtrate, is diluted to about containing 10 μ g in every 1ml, as need testing solution with above-mentioned phosphate buffer.Another cefixime reference substance is appropriate, the solution containing 10 μ g in every 1ml is made with identical reagent, get above-mentioned two solution, according to " Chinese Pharmacopoeia " version in 2010 two annex IV A ultraviolet spectrophotometrys, trap is measured at the wavelength place of 288nm, calculate the dissolution of every sheet by the ratio meter of both absorbances, investigate stripping curve, result is as follows.
Cefixime composition chewable tablet (No. 1 to No. 3 is embodiment 1, and No. 4 to No. 6 is embodiment 2)
Cefixime chewable tablet (commercially available)
Respectively with catch cropping Dissolution profiles during average dissolution pair, as Fig. 1.
As stated above to the cefixime composition chewable tablet comparative determination of cefixime composition chewable tablet of the present invention and commercial reference preparation, the dissolution of cefixime composition chewable tablet of the present invention when 25min (86.7%) is suitable with Cefixime chewable tablet (commercially available) dissolution when 60min (87.1%), and the dissolution of cefixime composition chewable tablet of the present invention when 60min (96.9%) comparatively Cefixime chewable tablet (commercially available) dissolution when 60min (87.1%) is higher, comparatively Cefixime chewable tablet (commercially available) dissolution time is shorter to show cefixime composition chewable tablet of the present invention, dissolution is higher, further show that cefixime composition chewable tablet bioavailability of the present invention is better than Cefixime chewable tablet (commercially available).
2, stability study
Sample source: self-control
Sample lot number: 20130701 (embodiments 1), 20130702 (embodiments 2)
Investigation project: character, content, related substance, hardness, dissolution
Investigation method: according to " Chinese Pharmacopoeia " version in 2010 two annex XIX C crude drug and pharmaceutical preparation stability test guideline, investigate the accelerated stability (January, February, March, June) of this product and long-time stability (March, June, JIUYUE, December), result of the test is as following table:
As can be seen from the above table, in acceleration 6 months, all there is not significant change in long-term 12 months, show that this product has good stability in cefixime composition chewable tablet indices of the present invention.
More than show and describe ultimate principle of the present invention, principal character and advantage of the present invention.The technical staff of the industry should understand; the present invention is not restricted to the described embodiments; what describe in above-described embodiment and description is only preference of the present invention; be not used for limiting the present invention; without departing from the spirit and scope of the present invention; the present invention also has various changes and modifications, and these changes and improvements all fall in the claimed scope of the invention.Application claims protection domain is defined by appending claims and equivalent thereof.
Claims (2)
1. a cefixime composition chewable tablet, is characterized in that, is prepared from by following raw material:
2. a preparation method for cefixime composition chewable tablet according to claim 1, is characterized in that, comprise step as follows:
A, take the starch of component amount, add a certain amount of purified water and stir, by pH adjusting agent, the pH value of solution is controlled between 4 ~ 9, be then heated to 72 DEG C, be incubated 120 minutes, make the gelatinizing corn starch solution of 5 ~ 15% (W/V);
B, measure purified water 45ml, boil, add 85g sucrose, stir, after dissolving, continue to be heated to 100 DEG C, filter with purified cotton, the appropriate hot distilled water of filter is cleaned, and washing liquid and filtrate merge, and let cool, add appropriate distilled water, make full dose become 100ml, stir evenly, obtain B solution;
The solution that C, the medicinal liquid and the step B that steps A are obtained obtain mixes, and fully stirs 30 minutes, after medicinal liquid be down to room temperature obtain gelatinizing Semen Maydis-sucrose system medicinal liquid;
D, take cefixime 100 grams, add 1L gelatinizing Semen Maydis-sucrose system medicinal liquid, stir 25 ~ 35 minutes;
E, the medicinal liquid sampling and measuring cefixime content obtained step D, with salt acid for adjusting pH to 2.5 ~ 4.5;
After cephalo gram oxime content measured by F, medicinal liquid, be sub-packed in drug-containing dish by loading amount by medicinal liquid, each drug-containing dish fills about 1.0ml, then utilizes drug-containing dish lid malcompression state to cover drug-containing dish, and drug-containing dish is the cylindric medicine carrying packaging that plastics or other materials are made;
G, the drug-containing dish that medicinal liquid is housed is put into freeze drying box, be cooled to subzero 45 DEG C, keep 2 hours, evacuation, then 0 DEG C is warming up to gradually, keep 2 hours, then be cooled to subzero 45 DEG C, keep 2 hours, be warming up to 0 DEG C gradually again, keep 2 ~ 4 hours, then be warming up to 28 ~ 32 DEG C of dryings 4 ~ 6 hours gradually, whole process vacuum remains on below 10 handkerchiefs; Finally the drug-containing dish lid of powder charge is covered tightly, and load aluminium foil bag and carry out sealing and obtain cefixime composition chewable tablet.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN106420642A (en) * | 2016-10-14 | 2017-02-22 | 全椒先奇医药科技有限公司 | Cefixime chewable tablet and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1286629A (en) * | 1997-12-29 | 2001-03-07 | 宝洁公司 | Tablet composition |
| CN103735524A (en) * | 2013-12-30 | 2014-04-23 | 海南葫芦娃制药有限公司 | Cefixime chewable tablet and preparation method thereof |
-
2014
- 2014-12-05 CN CN201410735361.0A patent/CN104490808A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1286629A (en) * | 1997-12-29 | 2001-03-07 | 宝洁公司 | Tablet composition |
| CN103735524A (en) * | 2013-12-30 | 2014-04-23 | 海南葫芦娃制药有限公司 | Cefixime chewable tablet and preparation method thereof |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106420642A (en) * | 2016-10-14 | 2017-02-22 | 全椒先奇医药科技有限公司 | Cefixime chewable tablet and preparation method thereof |
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