CN103893132A - Cefdinir granule and preparation technology thereof - Google Patents
Cefdinir granule and preparation technology thereof Download PDFInfo
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- CN103893132A CN103893132A CN201410169858.0A CN201410169858A CN103893132A CN 103893132 A CN103893132 A CN 103893132A CN 201410169858 A CN201410169858 A CN 201410169858A CN 103893132 A CN103893132 A CN 103893132A
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Abstract
The invention discloses a cefdinir granule, comprising the following compositions in parts by weight: 45 to 60 parts of cefdinir, 800 to 900 parts of cane sugar, 5 to 15 parts of sodium cyclamate, 3 to 8 parts of citric acid, 3 to 8 parts of sodium citrate, 0.04 to 0.06 part of carmine, 3 to 8 parts of double-strength apple flavor, and a right amount of 20 percent ethanol solution. The invention further discloses a preparation technology of the cefdinir granule. The cefdinir granule of the invention can speed up absorption of the cefdinir, enhance antibacterial performance, and strengthen immunity of the inflammatory part of the patient so as to speed up the recovery, thus the efficacy is more significant. Moreover, the cefdinir granule is free of toxicant and side effect, has moderate medicinal property, refreshing and sweet taste, low cost, simple and safe processing technology.
Description
Technical field
The invention belongs to pharmaceutical preparations technology field, relate to a kind of cefdinir granules, also relate to the preparation technology of this kind of cefdinir granules.
Background technology
Cefdinir; English Cefdinir by name; chemistry (6R, 7R)-7-[[(2-amino-4-thiazolyl by name)-(oximido) acetyl group] amino]-3-vinyl-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid.That cefdinir belongs to is semisynthetic, the oral third generation cephalosporin of wide spectrum, and it is by the synthetic generation antibacterial action of anti-bacteria cell wall.This product all has antibacterial activity to gram positive bacteria and negative bacterium, and stable to most of beta-lactamase, so the microorganism of many penicillin resistants and cephalosporin is to this product sensitivity.Clinical tonsillitis, sinusitis, otitis media, acute bronchitis, pneumonia, abdominal cavity, the urogenital infections etc. of being used for the treatment of.
Cefdinir raw material is micro-yellow powder shape, and poorly water-soluble easily produces static, poor fluidity, and unstable under hot and humid condition, related substance raises, and affects its safety and effectiveness.Therefore, suitable appropriate drug component just becomes the key factor that affects cefdinir preparation quality, develops a kind of cefdinir granule being made up of phase suitable drugs component and can bring positive effect for the safe and effective application of cefdinir undoubtedly.
Application number is that 201010176154.8 Chinese patent discloses a kind of cephalosporin suspension granule and preparation method thereof, the various ingredients such as active component, stabilizing agent, excipient, suspending agent, disintegrating agent, correctives, coloring agent, binding agent, spice are adopted, wherein embodiment 4 specifically discloses a kind of technical scheme of cefdinir mix suspension grain, although can bring certain improvement for cefdinir preparation quality, too much compositional selecting also becomes the influence factor that cefdinir stability, dissolution are not high.And the Chinese patent application that application number is 201310248312.X discloses a kind of cefdinir composition granule and preparation method thereof, improve for this kind of technical problem, in prescription, select cefdinir, pregelatinized starch, 50% ethanol, HPMC, sucrose as effective ingredient, utilize its mutual synergism to improve stability and the dissolution of cefdinir, and the mouthfeel of preparation is improved.But above prior art is only improved the stability of cefdinir itself, if can the resume speed of the absorption of preparation and patient's inflammation part further be improved, will make the drug effect of preparation more remarkable.
Summary of the invention
Technical problem to be solved by this invention is just to provide a kind of cefdinir granules, taking cefdinir, sucrose, cyclamate, citric acid, sodium citrate as primary raw material, and add carmine, double dense apple essence as adjuvant, in antibacterial, the immunity of patient's inflammation part obtains fast quick-recovery, and drug effect is remarkable.
Another object of the present invention is to provide the preparation technology of this kind of cefdinir granules, simple to operate, with low cost.
For solving the problems of the technologies described above, the present invention adopts following technical scheme: a kind of cefdinir granules, comprise following component, and each component is by weight:
In this preparation, add citric acid, sodium citrate, citric acid is also citric acid, can play the effect that regulates pH value, the mouthfeel of regulating agent, can accelerate the absorption of cefdinir, strengthen anti-microbial property, strengthen the immunity of patient's inflammation part simultaneously, it is restored more and accelerate, thereby make drug effect more remarkable.And cefdinir, sucrose, cyclamate, citric acid, sodium citrate coordinate the preparation obtaining to have no side effect, property of medicine gentleness, coordinating carmine, double dense apple essence, has refrigerant fragrant and sweet mouthfeel.20% alcoholic solution is used for dissolving carmine, can, according to appropriate 20% alcoholic solution of the how many interpolation of the consumption of carmine, in preparation process, can volatilization remove.
Preferably, each component is by weight:
Preferably, each component is by weight:
Preferably, each component is by weight:
Preferably, each component is by weight:
The preparation technology of this kind of cefdinir granules, comprises the following steps successively:
Step 1, that cefdinir is crossed to 200 mesh sieves is for subsequent use, sucrose, cyclamate, citric acid and sodium citrate is crossed to 80 mesh sieves for subsequent use, and carmine is dissolved in 20% alcoholic solution for subsequent use;
Step 2, by cefdinir, sucrose, cyclamate, citric acid and sodium citrate mix homogeneously, with the 20% alcoholic solution soft material processed, the 24 order wet granulations that are dissolved with carmine, by granule 60 DEG C of forced air dryings 2～3 hours, dry granule 20 order granulate, control pellet moisture and be less than 0.5%, add double dense apple essence, fully mix, detect intermediate content, subpackage and get final product.
Compared with prior art, advantage of the present invention is: in cefdinir granules of the present invention, add citric acid, sodium citrate, can accelerate the absorption of cefdinir, strengthen anti-microbial property, strengthen the immunity of patient's inflammation part, it is restored more and accelerate, thereby make drug effect more remarkable.And cefdinir, sucrose, cyclamate, citric acid, sodium citrate coordinate the preparation obtaining to have no side effect, property of medicine gentleness, coordinating carmine, double dense apple essence, has refrigerant fragrant and sweet mouthfeel.And with low cost, production process is simple, safety.
Below in conjunction with detailed description of the invention, the invention will be further described:
Detailed description of the invention
A kind of cefdinir granules embodiment 1 of the present invention, comprises following component, and each component is by weight:
In this preparation, add citric acid, sodium citrate, citric acid is also citric acid, can play the effect that regulates pH value, the mouthfeel of regulating agent, can accelerate the absorption of cefdinir, strengthen anti-microbial property, strengthen the immunity of patient's inflammation part simultaneously, it is restored more and accelerate, thereby make drug effect more remarkable.And cefdinir, sucrose, cyclamate, citric acid, sodium citrate coordinate the preparation obtaining to have no side effect, property of medicine gentleness, coordinating carmine, double dense apple essence, has refrigerant fragrant and sweet mouthfeel.20% alcoholic solution is used for dissolving carmine, can, according to appropriate 20% alcoholic solution of the how many interpolation of the consumption of carmine, in preparation process, can volatilization remove.
The preparation technology of this kind of cefdinir granules, comprises the following steps successively:
Step 1, that cefdinir is crossed to 200 mesh sieves is for subsequent use, sucrose, cyclamate, citric acid and sodium citrate is crossed to 80 mesh sieves for subsequent use, and carmine is dissolved in 20% alcoholic solution for subsequent use;
Step 2, by cefdinir, sucrose, cyclamate, citric acid and sodium citrate mix homogeneously, with the 20% alcoholic solution soft material processed, the 24 order wet granulations that are dissolved with carmine, by granule 60 DEG C of forced air dryings 2～3 hours, dry granule 20 order granulate, control pellet moisture and be less than 0.5%, add double dense apple essence, fully mix, detect intermediate content, subpackage and get final product.
A kind of cefdinir granules embodiment 2 of the present invention, comprises following component, and each component is by weight:
The preparation technology of this kind of cefdinir granules is identical with embodiment 1.
A kind of cefdinir granules embodiment 3 of the present invention, comprises following component, and each component is by weight:
The preparation technology of this kind of cefdinir granules is identical with embodiment 1.
A kind of cefdinir granules embodiment 4 of the present invention, comprises following component, and each component is by weight:
The preparation technology of this kind of cefdinir granules is identical with embodiment 1.
Show through test, cefdinir granules of the present invention, the absorption of cefdinir and anti-microbial property increase by 20～30% than preparation of the prior art, there is notable synergistic effect, strengthen the immunity of patient's inflammation part, it is restored more and accelerate, thereby make drug effect more remarkable.And cefdinir granules of the present invention has no side effect, property of medicine gentleness, has refrigerant fragrant and sweet mouthfeel, and crowd's likability on probation increases by 25～30% than preparation of the prior art.Further preparation of the present invention is carried out to stability test below.
Test example 1
Stability test
(1) influence factor's test
Investigation project: character, dissolution, moisture, assay and related substances.Placement condition: know principle test according to two annex XIX C medicine stability tests of Chinese Pharmacopoeia version in 2010.The cefdinir granules of example of formulations 1 of the present invention is tested respectively under high temperature, high humidity and strong illumination environment, according to above investigation project, sample is investigated.
(1.1) exposure experiments to light:
The cefdinir granules of getting example of formulations 1 of the present invention is placed in illumination 10d under 4500LX, and respectively at the 5th day, the tenth day sampling and measuring indices, measurement result was compared with 0d result.
(1.2) hot test:
The cefdinir granules of example of formulations 1 of the present invention is placed in respectively under 40 DEG C, 60 DEG C constant temperatures and places 10d, and respectively at the 5th day, the tenth day sampling and measuring indices, measurement result was compared with 0d result.
(1.3) high wet test:
The cefdinir granules of example of formulations 1 of the present invention is placed under 25 DEG C, RH75%, RH92.5% constant humidity condition and places 10d, and respectively at the 5th day, the tenth day sampling and measuring indices, measurement result was compared with 0d result.Influence factor's result of the test (in table 1).
Table 1
Note: "----" represent not detect.
Conclusion: cefdinir granules influence factor result of the test shows: place this product under high light, 60 DEG C of hot conditionss, its appearance color does not almost have significant change phenomenon, related substance slightly increases, all other indexs are showed no and change, and prompting this product should be avoided preserving in illumination and hot environment.Under 40 DEG C of hot conditionss, all other indexs are showed no and change, and it is stable that sample keeps.Under super-humid conditions, indices is showed no and changes after testing, and it is stable that sample keeps.
(2) accelerated test
Get 3 batches of the cefdinir granules (110901,110902,110903) of example of formulations 1 of the present invention, press commercially available back, be to place 6 months under 40 ± 2 DEG C, the relative humidity condition that is 75 ± 5% in temperature, respectively at sampling respectively 1 time for 0,1,2,3,6 the end of month, measure result (in table 2) by stability high spot reviews project.
Table 2
Conclusion: above-mentioned result of the test shows, 3 batches of this product are to place 6 months under 40 ± 2 DEG C, the relative humidity condition that is 75 ± 5% in temperature, detect through sampling, indices is without significant change, illustrate that this product stablizes with this understanding.
(3) long term test
Get 3 batches of the cefdinir granules (110901,110902,110903) of example of formulations 1 of the present invention, commercially available back, be that 25 DEG C ± 2 DEG C, relative humidity are 60% ± 10% to place 9 months in temperature, respectively at sampling respectively 1 time for 0,3,6,9 the end of month, measure result (in table 3) by stability high spot reviews project.
Table 3
Conclusion: above-mentioned result of the test shows, 3 batches of this product are to place 9 months under 25 ± 2 DEG C, the relative humidity condition that is 60% ± 10% in temperature, detect through sampling, indices is without significant change, illustrate that this product stablizes with this understanding.
In sum, the factors influencing result of cefdinir granules stability test shows: cefdinir granules under the condition of illumination, high temperature, high humility in its outward appearance, content, release and catabolite inspection compared with 0d without significant change, indices is all qualified.The result of accelerated test and long term test further shows: cefdinir granules has good chemical stability and physical stability.
The foregoing is only specific embodiments of the invention, but technical characterictic of the present invention is not limited to this, any those skilled in the art is in the field of the invention, and the variation of doing or modification are all encompassed among the scope of the claims of the present invention.
Claims (6)
1. a cefdinir granules, is characterized in that: comprise following component, each component is by weight:
2. a kind of cefdinir granules as claimed in claim 1, is characterized in that: each component is by weight:
3. a kind of cefdinir granules as claimed in claim 1, is characterized in that: each component is by weight:
4. a kind of cefdinir granules as claimed in claim 1, is characterized in that: each component is by weight:
5. a kind of cefdinir granules as claimed in claim 1, is characterized in that: each component is by weight:
6. a kind of preparation technology of cefdinir granules as claimed in claim 1, is characterized in that: comprise the following steps successively:
Step 1, that cefdinir is crossed to 200 mesh sieves is for subsequent use, sucrose, cyclamate, citric acid and sodium citrate is crossed to 80 mesh sieves for subsequent use, and carmine is dissolved in 20% alcoholic solution for subsequent use;
Step 2, by cefdinir, sucrose, cyclamate, citric acid and sodium citrate mix homogeneously, with the 20% alcoholic solution soft material processed, the 24 order wet granulations that are dissolved with carmine, by granule 60 DEG C of forced air dryings 2～3 hours, dry granule 20 order granulate, control pellet moisture and be less than 0.5%, add double dense apple essence, fully mix, detect intermediate content, subpackage and get final product.
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| CN103893132B CN103893132B (en) | 2016-04-13 |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104473901A (en) * | 2014-12-26 | 2015-04-01 | 石药集团中诺药业（石家庄）有限公司 | Cefdinir capsule and preparation method thereof |
| CN114983964A (en) * | 2022-06-24 | 2022-09-02 | 广东恒健制药有限公司 | Cefdinir granules and preparation method thereof |
| CN115607553A (en) * | 2021-07-16 | 2023-01-17 | 广州白云山天心制药股份有限公司 | Cefdinir-containing medicine |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103349646A (en) * | 2013-05-24 | 2013-10-16 | 海口市制药厂有限公司 | Medicinal composition containing cefaclor particles, and preparation method and application thereof |
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2014
- 2014-04-25 CN CN201410169858.0A patent/CN103893132B/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103349646A (en) * | 2013-05-24 | 2013-10-16 | 海口市制药厂有限公司 | Medicinal composition containing cefaclor particles, and preparation method and application thereof |
Non-Patent Citations (1)
| Title |
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| 马瑞蓉等: "头孢地尼颗粒剂与胶囊的人体生物等效性", 《中国抗生素杂志》, vol. 27, no. 11, 30 November 2002 (2002-11-30) * |
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104473901A (en) * | 2014-12-26 | 2015-04-01 | 石药集团中诺药业（石家庄）有限公司 | Cefdinir capsule and preparation method thereof |
| CN104473901B (en) * | 2014-12-26 | 2017-02-22 | 石药集团中诺药业（石家庄）有限公司 | Cefdinir capsule and preparation method thereof |
| CN115607553A (en) * | 2021-07-16 | 2023-01-17 | 广州白云山天心制药股份有限公司 | Cefdinir-containing medicine |
| CN115607553B (en) * | 2021-07-16 | 2024-02-23 | 广州白云山天心制药股份有限公司 | Medicine containing cefdinir |
| CN114983964A (en) * | 2022-06-24 | 2022-09-02 | 广东恒健制药有限公司 | Cefdinir granules and preparation method thereof |
| CN114983964B (en) * | 2022-06-24 | 2024-05-03 | 广东恒健制药有限公司 | Cefdinir granule and preparation method thereof |
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Effective date of registration: 20171110 Address after: 324002 Zhejiang province Kecheng District of Quzhou City New Street Rainbow Road No. 4 Patentee after: Zhejiang Ju Tai pharmaceutcal corporation, Ltd Address before: Guangyuan Road 321025 in Zhejiang province Jinhua city Wucheng District Linjiang Industrial Zone No. 666 Patentee before: YOSEMADE PHARMACEUTICAL CO., LTD. |