CN103284958A - Cefdinir composition granule and preparation method thereof - Google Patents
Cefdinir composition granule and preparation method thereof Download PDFInfo
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- CN103284958A CN103284958A CN201310248312XA CN201310248312A CN103284958A CN 103284958 A CN103284958 A CN 103284958A CN 201310248312X A CN201310248312X A CN 201310248312XA CN 201310248312 A CN201310248312 A CN 201310248312A CN 103284958 A CN103284958 A CN 103284958A
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- RTXOFQZKPXMALH-GHXIOONMSA-N cefdinir Chemical compound S1C(N)=NC(C(=N\O)\C(=O)N[C@@H]2C(N3C(=C(C=C)CS[C@@H]32)C(O)=O)=O)=C1 RTXOFQZKPXMALH-GHXIOONMSA-N 0.000 title claims abstract description 68
- 229960003719 cefdinir Drugs 0.000 title claims abstract description 68
- 239000008187 granular material Substances 0.000 title claims abstract description 53
- 239000000203 mixture Substances 0.000 title claims abstract description 24
- 238000002360 preparation method Methods 0.000 title claims abstract description 22
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract description 46
- 229930006000 Sucrose Natural products 0.000 claims abstract description 37
- 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 37
- 239000005720 sucrose Substances 0.000 claims abstract description 37
- 229920000881 Modified starch Polymers 0.000 claims abstract description 23
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 21
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 21
- 239000004615 ingredient Substances 0.000 claims description 16
- 238000005550 wet granulation Methods 0.000 claims description 8
- 238000007605 air drying Methods 0.000 claims description 7
- 238000002156 mixing Methods 0.000 claims description 7
- 239000007779 soft material Substances 0.000 claims description 7
- 238000005303 weighing Methods 0.000 claims description 7
- 238000004090 dissolution Methods 0.000 abstract description 11
- 239000003814 drug Substances 0.000 abstract description 9
- 230000007774 longterm Effects 0.000 abstract description 8
- 229940079593 drug Drugs 0.000 abstract description 4
- 238000003860 storage Methods 0.000 abstract description 3
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 abstract 2
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 abstract 2
- 239000001863 hydroxypropyl cellulose Substances 0.000 abstract 2
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 abstract 2
- 229940071676 hydroxypropylcellulose Drugs 0.000 abstract 2
- 229910052708 sodium Inorganic materials 0.000 abstract 2
- 239000011734 sodium Substances 0.000 abstract 2
- 230000002195 synergetic effect Effects 0.000 abstract 1
- 239000000047 product Substances 0.000 description 25
- 238000012360 testing method Methods 0.000 description 19
- 239000000126 substance Substances 0.000 description 10
- 239000013068 control sample Substances 0.000 description 9
- 238000001514 detection method Methods 0.000 description 5
- 238000012856 packing Methods 0.000 description 5
- 238000012552 review Methods 0.000 description 5
- 238000005070 sampling Methods 0.000 description 5
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 5
- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 description 4
- 239000003795 chemical substances by application Substances 0.000 description 4
- 238000002474 experimental method Methods 0.000 description 4
- 239000013558 reference substance Substances 0.000 description 4
- 229930186147 Cephalosporin Natural products 0.000 description 3
- 229920002472 Starch Polymers 0.000 description 3
- 229940124587 cephalosporin Drugs 0.000 description 3
- 150000001780 cephalosporins Chemical class 0.000 description 3
- 238000005286 illumination Methods 0.000 description 3
- 230000006872 improvement Effects 0.000 description 3
- 235000019698 starch Nutrition 0.000 description 3
- 239000008107 starch Substances 0.000 description 3
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 description 2
- 241000894006 Bacteria Species 0.000 description 2
- 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 2
- 238000010521 absorption reaction Methods 0.000 description 2
- 230000000844 anti-bacterial effect Effects 0.000 description 2
- 229910002092 carbon dioxide Inorganic materials 0.000 description 2
- 239000001569 carbon dioxide Substances 0.000 description 2
- 230000008859 change Effects 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 239000008103 glucose Substances 0.000 description 2
- 210000004185 liver Anatomy 0.000 description 2
- VUZPPFZMUPKLLV-UHFFFAOYSA-N methane;hydrate Chemical compound C.O VUZPPFZMUPKLLV-UHFFFAOYSA-N 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 239000000843 powder Substances 0.000 description 2
- 239000000725 suspension Substances 0.000 description 2
- BSYNRYMUTXBXSQ-UHFFFAOYSA-N Aspirin Chemical compound CC(=O)OC1=CC=CC=C1C(O)=O BSYNRYMUTXBXSQ-UHFFFAOYSA-N 0.000 description 1
- ZZZCUOFIHGPKAK-UHFFFAOYSA-N D-erythro-ascorbic acid Natural products OCC1OC(=O)C(O)=C1O ZZZCUOFIHGPKAK-UHFFFAOYSA-N 0.000 description 1
- 108090000204 Dipeptidase 1 Proteins 0.000 description 1
- 241000192125 Firmicutes Species 0.000 description 1
- 229920002527 Glycogen Polymers 0.000 description 1
- 206010033078 Otitis media Diseases 0.000 description 1
- 229930182555 Penicillin Natural products 0.000 description 1
- JGSARLDLIJGVTE-MBNYWOFBSA-N Penicillin G Chemical compound N([C@H]1[C@H]2SC([C@@H](N2C1=O)C(O)=O)(C)C)C(=O)CC1=CC=CC=C1 JGSARLDLIJGVTE-MBNYWOFBSA-N 0.000 description 1
- 206010035664 Pneumonia Diseases 0.000 description 1
- 229930003268 Vitamin C Natural products 0.000 description 1
- 210000000683 abdominal cavity Anatomy 0.000 description 1
- 125000002777 acetyl group Chemical group [H]C([H])([H])C(*)=O 0.000 description 1
- 229960001138 acetylsalicylic acid Drugs 0.000 description 1
- 102000006635 beta-lactamase Human genes 0.000 description 1
- 239000011230 binding agent Substances 0.000 description 1
- 206010006451 bronchitis Diseases 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 150000001720 carbohydrates Chemical class 0.000 description 1
- 235000014633 carbohydrates Nutrition 0.000 description 1
- 210000004027 cell Anatomy 0.000 description 1
- 210000002421 cell wall Anatomy 0.000 description 1
- 239000007795 chemical reaction product Substances 0.000 description 1
- 239000003086 colorant Substances 0.000 description 1
- 239000000306 component Substances 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 230000002950 deficient Effects 0.000 description 1
- 238000001784 detoxification Methods 0.000 description 1
- 102000038379 digestive enzymes Human genes 0.000 description 1
- 108091007734 digestive enzymes Proteins 0.000 description 1
- 238000007907 direct compression Methods 0.000 description 1
- 230000000857 drug effect Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000000284 extract Substances 0.000 description 1
- 229940096919 glycogen Drugs 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 239000013067 intermediate product Substances 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 238000005461 lubrication Methods 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 230000004060 metabolic process Effects 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 244000005700 microbiome Species 0.000 description 1
- 235000015097 nutrients Nutrition 0.000 description 1
- 239000005416 organic matter Substances 0.000 description 1
- 229940049954 penicillin Drugs 0.000 description 1
- 239000000546 pharmaceutical excipient Substances 0.000 description 1
- 230000008092 positive effect Effects 0.000 description 1
- 125000002924 primary amino group Chemical group [H]N([H])* 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 239000000523 sample Substances 0.000 description 1
- 239000012047 saturated solution Substances 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
- 201000009890 sinusitis Diseases 0.000 description 1
- 238000001228 spectrum Methods 0.000 description 1
- 235000013599 spices Nutrition 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 230000003068 static effect Effects 0.000 description 1
- 239000000375 suspending agent Substances 0.000 description 1
- 235000019605 sweet taste sensations Nutrition 0.000 description 1
- 206010044008 tonsillitis Diseases 0.000 description 1
- 235000019154 vitamin C Nutrition 0.000 description 1
- 239000011718 vitamin C Substances 0.000 description 1
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention relates to the medicinal preparation field, and concretely discloses a cefdinir composition granule and a preparation method thereof. The effective components of the cefdinir composition granule comprise cefdinir, pregelatinized starch, 50% ethanol, sodium hydroxy propyl cellulose and sucrose. In the invention, cefdinir, pregelatinized starch, 50% ethanol, sodium hydroxy propyl cellulose and sucrose are preferably selected as the effective components of the cefdinir composition granule, the mutual synergistic effect of the effective components increases the stability and the dissolution of cefdinir, and the mouthfeel is better than that of present products, so the medicine use compliance of patients is improved, and it is in favor of the safe use and long-term storage of clinic medicines.
Description
Technical field
The present invention relates to field of medicine preparations, be specifically related to a kind of cefdinir composition granule and preparation method thereof.
Background technology
Cefdinir; English Cefdinir Capsules by name; chemical being called (6R, 7R)-7-[[(2-amino-4-thiazolyl)-(oximido) acetyl group] amino]-3-vinyl-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid, chemical constitution is as follows:
That cefdinir belongs to is semisynthetic, the oral third generation cephalosporin of wide spectrum, and it is by suppressing the synthetic generation antibacterial action of 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.
The cefdinir raw material is the micro-yellow powder shape, and poorly water-soluble easily produces static, and is mobile poor, and unstable under hot and humid condition, and related substance raises, and influences its safety and effectiveness.Therefore, suitable appropriate drug component just becomes the key factor that influences cefdinir preparation quality, develops a kind of cefdinir granule of being made up of phase suitable drugs component and can bring positive effect for the safe and effective application of cefdinir undoubtedly.CN201010176154.8 discloses a kind of cephalosporin suspension granule and preparation method thereof as patent, it has adopted active component, stabilizing agent, excipient, suspending agent, disintegrating agent, correctives coloring agent binding agent, spice various ingredients, wherein embodiment 4 specifically discloses a kind of technical scheme of cefdinir mix suspension grain, though can bring certain improvement for cefdinir preparation quality, too much component selects also to become the not high influence factor of cefdinir stability, dissolution.
Summary of the invention
In view of this, the object of the present invention is to provide a kind of cefdinir composition granule and preparation method thereof, make described cefdinir granule can improve the stability of cefdinir (as aspects such as labelled amount, related substances) and dissolution.
For achieving the above object, the invention provides following technical scheme:
A kind of cefdinir composition granule, effective ingredient comprise cefdinir, pregelatinized starch, 50% ethanol, HPMC, sucrose.
As preferably, in weight portion, described effective ingredient comprises 40-100 part cefdinir, 5-20 part pregelatinized starch, 50-70 part 50% ethanol, 15-20 part HPMC, 400-450 part sucrose.
More preferably, described effective ingredient comprises 50 parts of cefdinirs, 5 parts of pregelatinized starchs, 60 part of 50% ethanol, 20 parts of HPMC, 430 portions of sucrose.
At existing cefdinir granule stability and the not high defective of dissolution, particularly aspect the labelled amount under long term storage and extreme environment, the related substance equistability, the present invention is through long-term further investigation, considered the influence between the various effective ingredients, optimized the compositing formula of cefdinir granule, select cefdinir, pregelatinized starch, 50% ethanol, HPMC, sucrose as effective ingredient, improved its stability and dissolution under hot and humid environment.
The various components that the present invention adopts, not only synergism has increased the stability of cefdinir granule, and it also has some advantages separately, is the nutrient substance of needed by human as starch.Under the effect of the digestive enzyme in human body, starch can become glucose molecule gradually.Glucose has critical role in field of biology, be energy source and the metabolism intermediate product of living cells, it is a kind of can directly absorbing, replenish the carbohydrate of heat energy, it is the main source of needed by human body energy, be oxidized to carbon dioxide and water in vivo, and supply with heat simultaneously, or store with the glycogen form.Can promote the function of detoxification of liver, liver is had protective effect.Be energy goods and materials the most common in the organism.Pregelatinized starch is compared with native starch, and it has many advantages: 1. good fluidity, that no matter do or wet, flowability is all fine, and has concurrently bonding and disintegrating property.2. compressibility is good, is applicable to direct compression of full-powder.3. self-lubrication is arranged, reduce the strength that tablet ejects from the mould circle.4. good disintegrative.5. to the solubility of part cold water.6. inoperative with principal agent, and the function of stable medicine is arranged, wet, heat sensitive medicine such as vitamin C, aspirin etc. are easily caused variable color with wet granulation, content and drug effect descend, and after using this product instead, have promoted the stability of principal agent, have prolonged the useful life.
Sucrose is a kind of natural organic matter, and sucrose extracts from sugar crop Radix Betae or Caulis Sacchari sinensis, and the end product that the people decomposes edible back is carbon dioxide and water.Sucrose has unique function, and is pure stable as the sweet taste of sucrose, is easy to dissolving and toning, can also crystallize out rapidly from saturated solution; Sucrose has osmosis, can suppress the harmful microbe growth; Sucrose has water absorption and water-retaining property.Sucrose in the cefdinir composition granule of the present invention is with low cost, but also can make granule have good water absorption and water-retaining property.
In addition, the present invention also provides a kind of preparation method of cefdinir composition granule, be effective ingredient with cefdinir, pregelatinized starch, 50% ethanol, HPMC, sucrose, it is standby that cefdinir is crossed 120 mesh sieves, and it is standby that sucrose was pulverized 80 orders; Take by weighing cefdinir, pregelatinized starch, HPMC, the abundant mixing of sucrose, with 50% ethanol soft material processed, 20 order wet granulations, granule 65 ℃ of left and right sides forced air dryings, dried granule 16 order granulate, is sieved 80 orders namely.
As preferably, in weight portion, each effective ingredient content is:
40-100 part cefdinir, 5-20 part pregelatinized starch, 50-70 part 50% ethanol, 15-20 part HPMC, 400-450 part sucrose.
More preferably, in weight portion, each effective ingredient content is:
50 parts of cefdinirs, 5 parts of pregelatinized starchs, 60 part of 50% ethanol, 20 parts of HPMC, 430 portions of sucrose.
The present invention carries out high humidity high temperature exposure experiments to light, accelerated test and long term test with the product of prepared cefdinir composition granule and CN201010176154.8 patent disclosure, the result shows, when accelerated test and long term test, indexs such as principal agent labelled amount and related substance are more stable, compare with the control sample of prior art for preparing, the present invention's amplitude of variation in every respect all is less than the amplitude of variation of control sample, and stability is stronger.Simultaneously, the result shows that also product dissolution of the present invention is higher than control sample.Thus, the present invention also provides a kind of cefdinir composition granule by preparation method preparation of the present invention.
By above technical scheme as can be known, the preferred cefdinir of the present invention, pregelatinized starch, 50% ethanol, HPMC, sucrose are as the effective ingredient of cefdinir granule, synergism improves stability and the dissolution of cefdinir mutually, and mouthfeel is better than existing product, improve the compliance of patient's medication, be conducive to safe handling and the long term storage of clinical medicine.
The specific embodiment
The invention discloses a kind of cefdinir composition granule and preparation method thereof, those skilled in the art can use for reference this paper content, suitably improve technological parameter and realize.Special needs to be pointed out is that all similarly replace and change apparent to those skilled in the art, they all are regarded as being included in the present invention.The method of the invention is described by preferred embodiment, the related personnel obviously can be in not breaking away from content of the present invention, spirit and scope to chemical compound as herein described with preparation method is changed or suitably change and combination, realize and use the technology of the present invention.
The amount of all cefdinirs is all with C among the present invention
14H
13N
5O
5S
2Meter.Below in conjunction with embodiment, further set forth the present invention.
Embodiment 1: prepare cefdinir composition granule of the present invention
It is standby that cefdinir is crossed 120 mesh sieves, and it is standby that sucrose was pulverized 80 orders; Take by weighing cefdinir, pregelatinized starch, HPMC, the abundant mixing of sucrose, with 50% ethanol soft material processed, 20 order wet granulations, with granule 65 ℃ of left and right sides forced air dryings, dried granule 16 order granulate, 80 orders that sieve, middle product detection, packing is namely.
Embodiment 2: prepare cefdinir composition granule of the present invention
It is standby that cefdinir is crossed 120 mesh sieves, and it is standby that sucrose was pulverized 80 orders; Take by weighing cefdinir, pregelatinized starch, HPMC, the abundant mixing of sucrose, with 50% ethanol soft material processed, 20 order wet granulations, with granule 65 ℃ of left and right sides forced air dryings, dried granule 16 order granulate, 80 orders that sieve, middle product detection, packing is namely.
Embodiment 3: prepare cefdinir composition granule of the present invention
It is standby that cefdinir is crossed 120 mesh sieves, and it is standby that sucrose was pulverized 80 orders; Take by weighing cefdinir, pregelatinized starch, HPMC, the abundant mixing of sucrose, with 50% ethanol soft material processed, 20 order wet granulations, with granule 65 ℃ of left and right sides forced air dryings, dried granule 16 order granulate, 80 orders that sieve, middle product detection, packing is namely.
Embodiment 4: prepare cefdinir composition granule of the present invention
It is standby that cefdinir is crossed 120 mesh sieves, and it is standby that sucrose was pulverized 80 orders; Take by weighing cefdinir, pregelatinized starch, HPMC, the abundant mixing of sucrose, with 50% ethanol soft material processed, 20 order wet granulations, with granule 65 ℃ of left and right sides forced air dryings, dried granule 16 order granulate, 80 orders that sieve, middle product detection, packing is namely.
Embodiment 5: preparation contrast cefdinir composition granule
It is standby that cefdinir is crossed 120 mesh sieves, and it is standby that sucrose was pulverized 80 orders; Take by weighing cefdinir, HPMC, the abundant mixing of sucrose, with 50% ethanol soft material processed, 20 order wet granulations, with granule 65 ℃ of left and right sides forced air dryings, dried granule 16 order granulate, 80 orders that sieve, middle product detection, packing is namely.
Embodiment 6: the product testing result
Get embodiment of the invention 1-4 sample and embodiment 5 samples (reference substance 1), CN201010176154.8 patent working example 4 products (reference substance 2), carry out product and detect, the results are shown in Table 1.
Table 1 product testing result
As seen from the above table, before the test of product under not carrying out various extreme environments of the present invention's preparation, testing result and existing reference substance no significant differences such as its stability and dissolution, and mouthfeel is better than reference substance, increased the compliance that the patient takes, shown that the cefdinir granule quality that the present invention prepares meets existing standard.
Embodiment 7: high temperature, high humidity, exposure experiments to light
Get the embodiment of the invention 4 samples and embodiment 5 samples (control sample 1), CN201010176154.8 patent working example 4 products (control sample 2), put respectively in the clean container of sealing, carry out high temperature, high humidity, exposure experiments to light, experimental condition is as follows:
High temperature: under 60 ℃ of temperature, placed 10 days, in the 5th day and sampling in the 10th day, detect by stable high spot reviews project, result of the test and comparison in 0 day.
High humidity: placed 10 days under respectively at the condition of relative humidity 90% ± 5% at 25 ℃,, detect result of the test and comparison in 0 day by stable high spot reviews project in the 5th day and sampling in the 10th day.
Illumination: placing illumination is to place 10 days under the condition of 4500Lx,, detects result of the test and comparison in 0 day in the 5th day and sampling in the 10th day by stable high spot reviews project.
Testing result sees Table 2
The hot and humid exposure experiments to light testing result of table 2
By table 2 data as can be seen, the embodiment of the invention 4 products will compare all at aspects such as moisture, dissolution, related substance and labelled amounts that product are stable in the same old way under high temperature, high humidity, illumination condition.
Embodiment 8: accelerated test
Get the embodiment of the invention 4 samples and embodiment 5 samples (control sample 1), CN201010176154.8 patent working example 4 products (control sample 2), be to place 6 months under 75% ± 5% the condition at 40 ℃ ± 2 ℃ of temperature, relative humidity respectively, respectively at the 1st, 2,3,6 sampling at the end of month once, measure by stable high spot reviews project.Result of the test sees Table 3.
Table 3 accelerated test result
By table 3 data as can be seen, the embodiment of the invention 3 products are under 75% ± 5% the condition at 40 ℃ ± 2 ℃ of temperature, relative humidity, will compare all at aspects such as moisture, dissolution, related substance and labelled amounts that product are stable in the same old way.
Embodiment 9: long term test
Get the embodiment of the invention 4 samples and embodiment 5 samples (control sample 1), CN201010176154.8 patent working example 4 products (control sample 2), it is 20 ℃ in temperature respectively, relative humidity is to place 12 months under 60% ± 10% the condition, respectively at the 3rd, 6,9,12 sampling at the end of month once, measure by stable high spot reviews project.Result of the test sees Table 4.
Table 4 long-term test results
By table 4 data as can be seen, the embodiment of the invention 4 products are 20 ℃ in temperature, and relative humidity is under 60% ± 10% the condition, will compare all at aspects such as moisture, dissolution, related substance and labelled amounts that product are stable in the same old way.
The above only is preferred implementation of the present invention; should be pointed out that for those skilled in the art, under the prerequisite that does not break away from the principle of the invention; can also make some improvements and modifications, these improvements and modifications also should be considered as protection scope of the present invention.
Claims (7)
1. a cefdinir composition granule is characterized in that, effective ingredient comprises cefdinir, pregelatinized starch, 50% ethanol, HPMC, sucrose.
2. according to the described cefdinir composition granule of claim 1, it is characterized in that, in weight portion, described effective ingredient comprises 40-100 part cefdinir, 5-20 part pregelatinized starch, 50-70 part 50% ethanol, 15-20 part HPMC, 400-450 part sucrose.
3. according to the described cefdinir composition granule of claim 2, it is characterized in that in weight portion, described effective ingredient comprises 50 parts of cefdinirs, 5 parts of pregelatinized starchs, 60 part of 50% ethanol, 20 parts of HPMC, 430 portions of sucrose.
4. the preparation method of a cefdinir composition granule, it is characterized in that, be effective ingredient with cefdinir, pregelatinized starch, 50% ethanol, HPMC, sucrose, it is standby that cefdinir is crossed 120 mesh sieves, and it is standby that sucrose was pulverized 80 orders; Take by weighing cefdinir, pregelatinized starch, HPMC, the abundant mixing of sucrose, with 50% ethanol soft material processed, 20 order wet granulations, granule 65 ℃ of left and right sides forced air dryings, dried granule 16 order granulate, is sieved 80 orders namely.
5. according to the described preparation method of claim 4, it is characterized in that in weight portion, each effective ingredient content is:
40-100 part cefdinir, 5-20 part pregelatinized starch, 50-70 part 50% ethanol, 15-20 part HPMC, 400-450 part sucrose.
6. according to the described preparation method of claim 5, it is characterized in that in weight portion, each effective ingredient content is:
50 parts of cefdinirs, 5 parts of pregelatinized starchs, 60 part of 50% ethanol, 20 parts of HPMC, 430 portions of sucrose.
7. the cefdinir composition granule of any described preparation method preparation of claim 4-6.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103637992A (en) * | 2013-12-19 | 2014-03-19 | 石家庄市华新药业有限责任公司 | Cefdinir granular preparation 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 (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101816635A (en) * | 2010-05-17 | 2010-09-01 | 广东恒健制药有限公司 | Cephalosporin suspension granule and preparation method thereof |
| CN102058561A (en) * | 2010-12-30 | 2011-05-18 | 江苏亚邦强生药业有限公司 | Cefdinir capsule and preparation method thereof |
| CN102266306A (en) * | 2011-07-13 | 2011-12-07 | 石家庄四药有限公司 | Cefdinir capsules and preparation method thereof |
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2013
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101816635A (en) * | 2010-05-17 | 2010-09-01 | 广东恒健制药有限公司 | Cephalosporin suspension granule and preparation method thereof |
| CN102058561A (en) * | 2010-12-30 | 2011-05-18 | 江苏亚邦强生药业有限公司 | Cefdinir capsule and preparation method thereof |
| CN102266306A (en) * | 2011-07-13 | 2011-12-07 | 石家庄四药有限公司 | Cefdinir capsules and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| 周永健等: "第三代口服头孢菌素－头孢地尼", 《天津药学》, vol. 15, no. 2, 30 April 2003 (2003-04-30), pages 66 - 68 * |
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103637992A (en) * | 2013-12-19 | 2014-03-19 | 石家庄市华新药业有限责任公司 | Cefdinir granular preparation and preparation method thereof |
| CN103637992B (en) * | 2013-12-19 | 2015-04-08 | 石家庄市华新药业有限责任公司 | Cefdinir granular preparation 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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|---|---|
| CN103284958B (en) | 2015-07-29 |
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