CN103893132B - A kind of cefdinir granules and preparation technology thereof - Google Patents
A kind of cefdinir granules and preparation technology thereof Download PDFInfo
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- CN103893132B CN103893132B CN201410169858.0A CN201410169858A CN103893132B CN 103893132 B CN103893132 B CN 103893132B CN 201410169858 A CN201410169858 A CN 201410169858A CN 103893132 B CN103893132 B CN 103893132B
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Abstract
The invention discloses a kind of cefdinir granules, comprise following component, each component is by weight: cefdinir 45 ~ 60 weight portion; Sucrose 800 ~ 900 weight portion; Cyclamate 5 ~ 15 weight portion; Citric acid 3 ~ 8 weight portion; Sodium citrate 3 ~ 8 weight portion; Carmine 0.04 ~ 0.06 weight portion; Double dense apple essence 3 ~ 8 weight portion; 20% alcoholic solution is appropriate.Also disclose the preparation technology of this kind of cefdinir granules.Cefdinir granules of the present invention can accelerate the absorption of cefdinir, strengthens anti-microbial property, strengthens the immunity of patient's inflammation part, makes it restore and more accelerate, thus make drug effect more remarkable.And have no side effect, the property of medicine is gentle, has refrigerant fragrant and sweet mouthfeel.With low cost, production process is simple, safety.
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-by name [[(2-amino-4-thiazolyl)-(oximido) acetyl group] is amino]-3-vinyl-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid.Cefdinir belongs to semisynthetic, the oral third generation cephalosporin of wide spectrum, and its synthesis by anti-bacteria cell wall produces antibacterial action.This product all has antibacterial activity to gram positive bacteria and negative bacterium, and stablizes most of beta-lactamase, so the microorganism of many penicillin resistants and cephalosporin is responsive to this product.Clinically be used for the treatment of tonsillitis, sinusitis, otitis media, acute bronchitis, pneumonia, abdominal cavity, urogenital infections etc.
Cefdinir raw material is micro-yellow powder shape, and poorly water-soluble, easily produces electrostatic, poor fluidity, and unstable under hot and humid condition, and related substance raises, and affects its safety and effectiveness.Therefore, suitable appropriate drug component just becomes the key factor affecting cefdinir preparation quality, develops a kind of cefdinir granule be made up of phase suitable drugs component and can bring positive effect for the safe and effective application of cefdinir undoubtedly.
Application number be 201010176154.8 Chinese patent disclose a kind of cephalosporin suspension granule and preparation method thereof, have employed the various ingredients such as active component, stabilizing agent, excipient, suspending agent, disintegrating agent, correctives, coloring agent, binding agent, spice, 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 not high influence factor of cefdinir stability, dissolution.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, select cefdinir, pregelatinized starch, 50% ethanol, HPMC, sucrose as effective ingredient in prescription, 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 improve further the resume speed of the absorption of preparation and patient's inflammation part, the drug effect of preparation will be made more remarkable.
Summary of the invention
Technical problem to be solved by this invention is just to provide a kind of cefdinir granules, with cefdinir, sucrose, cyclamate, citric acid, sodium citrate for primary raw material, and add carmine, double dense apple essence as adjuvant, while 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, comprises following component, and each component is by weight:
Citric acid, sodium citrate is added in this preparation, citric acid is also citric acid, the effect of adjust ph can be played, the mouthfeel of regulating agent, the absorption of cefdinir can be accelerated simultaneously, strengthen anti-microbial property, strengthen the immunity of patient's inflammation part, make it restore more to accelerate, thus make drug effect more remarkable.And cefdinir, sucrose, cyclamate, citric acid, sodium citrate coordinate the preparation obtained to have no side effect, the property of medicine is gentle, at cooperation carmine, double dense apple essence, has refrigerant fragrant and sweet mouthfeel.How many 20% alcoholic solution, for dissolving carmine, can add appropriate 20% alcoholic solution according to the consumption of carmine, removing of volatilizing in preparation process.
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 one, cefdinir to be crossed 200 mesh sieves for subsequent use, sucrose, cyclamate, citric acid and sodium citrate crossed 80 mesh sieves for subsequent use, be dissolved in by carmine 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, 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 intermediates content, subpackage and get final product.
Compared with prior art, advantage of the present invention is: add citric acid, sodium citrate in cefdinir granules of the present invention, can accelerate the absorption of cefdinir, strengthen anti-microbial property, strengthen the immunity of patient's inflammation part, make it restore and more accelerate, thus make drug effect more remarkable.And cefdinir, sucrose, cyclamate, citric acid, sodium citrate coordinate the preparation obtained to have no side effect, the property of medicine is gentle, at cooperation 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, comprise following component, each component is by weight:
Citric acid, sodium citrate is added in this preparation, citric acid is also citric acid, the effect of adjust ph can be played, the mouthfeel of regulating agent, the absorption of cefdinir can be accelerated simultaneously, strengthen anti-microbial property, strengthen the immunity of patient's inflammation part, make it restore more to accelerate, thus make drug effect more remarkable.And cefdinir, sucrose, cyclamate, citric acid, sodium citrate coordinate the preparation obtained to have no side effect, the property of medicine is gentle, at cooperation carmine, double dense apple essence, has refrigerant fragrant and sweet mouthfeel.How many 20% alcoholic solution, for dissolving carmine, can add appropriate 20% alcoholic solution according to the consumption of carmine, removing of volatilizing in preparation process.
The preparation technology of this kind of cefdinir granules, comprises the following steps successively:
Step one, cefdinir to be crossed 200 mesh sieves for subsequent use, sucrose, cyclamate, citric acid and sodium citrate crossed 80 mesh sieves for subsequent use, be dissolved in by carmine 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, 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 intermediates content, subpackage and get final product.
A kind of cefdinir granules embodiment 2 of the present invention, comprise following component, 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, comprise following component, 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, comprise following component, 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, make it restore and more accelerate, thus make drug effect more remarkable.And cefdinir granules of the present invention has no side effect, the property of medicine is gentle, has refrigerant fragrant and sweet mouthfeel, and crowd's likability on probation increases by 25 ~ 30% than preparation of the prior art.Further stability test is carried out to invention formulation below.
Test example 1
Stability test
(1) influence factor's test
Investigation project: character, dissolution, moisture, assay and related substances.Placement condition: know that principle is tested according to Chinese Pharmacopoeia version in 2010 two annex XIXC medicine stability tests.The cefdinir granules of invention formulation embodiment 1 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 getting invention formulation embodiment 1 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:
Place 10d under the cefdinir granules of invention formulation embodiment 1 being placed in respectively 40 DEG C, 60 DEG C constant temperatures, 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 invention formulation embodiment 1 is placed in 25 DEG C, places 10d under RH75%, RH92.5% constant humidity condition, 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 (see table 1).
Table 1
Note: "----" represent and do 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, samples remained stable.Under super-humid conditions, indices is showed no and changes after testing, samples remained stable.
(2) accelerated test
Get the cefdinir granules 3 batches (110901,110902,110903) of invention formulation embodiment 1, by commercially available back, in temperature be 40 ± 2 DEG C, relative humidity be the condition of 75 ± 5% under place 6 months, 1 time is sampled respectively respectively at 0,1,2,3,6 the end of month, measure by stability high spot reviews project, result (see table 2).
Table 2
Conclusion: above-mentioned result of the test shows, this product 3 batches temperature be 40 ± 2 DEG C, relative humidity be the condition of 75 ± 5% under place 6 months, through sampling detect, indices, without significant change, illustrates that this product is stablized with this understanding.
(3) long term test
Get the cefdinir granules 3 batches (110901,110902,110903) of invention formulation embodiment 1, commercially available back, in temperature be 25 DEG C ± 2 DEG C, relative humidity be 60% ± 10% place 9 months, 1 time is sampled respectively respectively at 0,3,6,9 the end of month, measure by stability high spot reviews project, result (see table 3).
Table 3
Conclusion: above-mentioned result of the test shows, this product 3 batches temperature be 25 ± 2 DEG C, relative humidity be the condition of 60% ± 10% under place 9 months, through sampling detect, indices, without significant change, illustrates that this product is stablized 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 shows further: cefdinir granules has good chemical stability and physical stability.
The foregoing is only specific embodiments of the invention, but technical characteristic of the present invention is not limited thereto, any those skilled in the art is in the field of the invention, and the change done 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, and 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. the preparation technology of a kind of cefdinir granules as claimed in claim 1, is characterized in that: comprise the following steps successively:
Step one, cefdinir to be crossed 200 mesh sieves for subsequent use, sucrose, cyclamate, citric acid and sodium citrate crossed 80 mesh sieves for subsequent use, be dissolved in by carmine 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, 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 intermediates content, subpackage and get final product.
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| 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 |
| 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 |
| 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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| 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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| 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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| 头孢地尼颗粒剂与胶囊的人体生物等效性;马瑞蓉等;《中国抗生素杂志》;20021130;第27卷(第11期);第677页第1.3栏 * |
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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. |
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