CN101862307A - Bisulfate Cefdinir sodium capsule and preparation method thereof - Google Patents
Bisulfate Cefdinir sodium capsule and preparation method thereof Download PDFInfo
- Publication number
- CN101862307A CN101862307A CN 201010128910 CN201010128910A CN101862307A CN 101862307 A CN101862307 A CN 101862307A CN 201010128910 CN201010128910 CN 201010128910 CN 201010128910 A CN201010128910 A CN 201010128910A CN 101862307 A CN101862307 A CN 101862307A
- Authority
- CN
- China
- Prior art keywords
- cefdinir
- sodium
- bisulfate
- capsule
- adjuvant
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Images
Abstract
The invention provides a bisulfate Cefdinir sodium capsule and a preparation method thereof. The capsule is formed by taking bisulfate Cefdinir sodium as a main drug and taking a proper quantity of auxiliary materials, such as filler, disintegrating agent, lubricant and the like, and the auxiliary material sodium carboxymethyl starch and pregelatinization starch are dried and are respectively screened by an 80-mesh sieve with raw material bisulfate Cefdinir sodium. The capsule of the invention obviously changes the pharmacokinetics characteristics of Cefdinir and has the characteristics of high adsorption speed, large blood medicine density and high bioavailability. The capsule of the invention has stable quality, favorable aqueous solution, high dissolution, simple preparation technology and favorable feasibility and is suitable for industrialized production.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, relate to bisulfate Cefdinir sodium capsule and preparation method thereof, this capsule has the advantage that dissolution is big, bioavailability is high.
Background technology
Cefdinir (cefdinir) be Japanese rattan pool company in 1988 synthetic first third generation oral cephalosporin, be to come by structure transformation to cefixime, introduce vinyl female the ring on the C position of cephalosporin, increased the oral absorption rate; Hydroxylamino on its side chain, ammonia thiophene base have not only strengthened to the antibacterial activity of gram-negative bacteria with to the stability of beta-lactamase, and have strengthened gram positive coccus, especially the antibacterial activity of staphylococcus aureus.First in Japan's listing, in December, 1997 obtains drugs approved by FDA and goes on the market in the U.S. this product preparation in December, 1991, goes on the market in Korea S in 1999; Tianjin central authorities medicine company limited and Tianjin Inst. of Materia Medica cooperation for many years, the production synthetic technology of cefdinir has been developed in joint research, its capsule commodity generation by name is held up the Buddhist nun, 2001 listings at home.Preparation has capsule and granule.
The cefdinir has a broad antifungal spectrum, active strong, drug resistance is good, and common clinically pathogenic bacterium are had antibiotic advantage.Cefdinir is 15～267 times of cefalexin, 8～133 times of cefaclor, 32～67 times of cefuroxime, 62～533 times of cefixime, 2～8 times of the amoxicillin to the activity of laboratory standard bacterial strain staphylococcus epidermidis 89; To the activity of laboratory standard bacterial strain staphylococcus epidermidis 209PJC-1 is 2 times of the amoxicillin, 15.6 times of cefaclor, 31.2 times of cefalexin, 500 times of cefixime; To the activity of staphylococcus hominis is 64 times of cefalexin, 16 times of cefaclor, 128 times of cefixime, 4 times of the amoxicillin; To its activity of staphylococcus haemolyticus is 2 times of the amoxicillin, 4 times of cefaclor, 8 times of cefalexin, 128 times of cefixime.
Cefdinir is 4 times of 8～31.3 times of cefalexin, 2～8 times of cefaclor, cefixime to the property of streptococcus pneumoniae, the activity of streptococcus pyogenes is 31～66 times of cefalexin, 8 times of cefaclor, 4 times of cefixime, identical with cefuroxime and amoxicillin.
Cefdinir is to the MIC of Escherichia coli
90Be 0.39～1mg/L, this product activity is similar to cefixime.Wherein, its amoxicillin Resistant strain is still to this product sensitivity.
Cefdinir is to the MIC of Klebsiella Pneumoniae
90Be 0.12～1mg/L, and its cefaclor persister and cefalexin persister are still to this product sensitivity.
Cefdinir is to the MIC of hemophilus influenza
90Be 0.25～1mg/L.No matter whether the beta-lactamase-producing strain still is that the amoxicillin persister is all to the cefdinir sensitivity.No matter haemophilus parainfluenzae produces or does not produce beta-lactamase, all to the cefdinir sensitivity.
Cefdinir is to the MIC of Moraxella
90Be 0.12～1mg/L, even beta-lactamase-producing strain and amoxicillin persister are all still to the cefdinir sensitivity.
Some intestinal, as citrobacter freundii, Enterobacter, morganella morganii, proteus vulgaris and serratia marcescens also to the cefdinir sensitivity, its MIC
90Be 16mg/L, ground Buddhist nun's activity is 2-4 a times of cefixime, has stronger curative effect and wider antimicrobial spectrum than pioneer's class antibiotic, cefaclor and cefuroxime.
In addition, beta hemolytic streptococcus and proteus mirabilis be Buddhist nun's sensitivity over the ground also, its MIC
90Be respectively 0.06mg/L and 0.015～0.125mg/L.Pseudomonas aeruginosa, the Buddhist nun is insensitive over the ground for the strain of staphylococcus percentage of methicillin-resistant, enterococcus and Fructus Hordei Germinatus Xanthomonas campestris.
Secondly the cefdinir cefdinir is stable to 13 kinds of common beta-lactamases such as TEM-1, TEM-2, TEM-6, TEM-7, TEM-9, TEM-10, CAZ-2, SHV-1, HMS-1, OXA-1, OXA-2, OXA-3 and P99 type la, is not destroyed by these enzyme hydrolysiss.Antibacterial is to the less generation drug resistance of cefdinir, and, cefalexin fixed with cefixime, cefaclor, cefuroxime, cephalo position, amoxicillin are compared, the responsive rate height of cefdinir, and resistant rate is low.
The defective of cefdinir maximum is exactly that dissolubility is little, and bioavailability is lower.The absolute bioavailability of bibliographical information Cefdinir capsule (300mg) is 21%, the absolute bioavailability of Cefdinir capsule (600mg) is 16%, the absolute bioavailability of cefdinir suspensoid is 25%, the lot of domestic and international researcher has carried out unremitting effort for this reason, disclose a lot of patents, but do not seen that fruitful product emerges.The low waste that not only causes the medicine resource of bioavailability, unnecessary antibiotic also can cause the intestinal microbial population disorder, causes gastrointestinal side effects such as diarrhoea.
Summary of the invention
The object of the present invention is to provide fast, high, the eutherapeutic bisulfate Cefdinir sodium capsule of blood drug level of a kind of absorption.
This described bisulfate Cefdinir sodium capsule, its capsule 's content by weight percentage, each component form and ratio as follows:
Bisulfate Cefdinir sodium 25-70%
Filler 10-60%
Disintegrating agent 0.1-60%
Lubricant 0.1-10%
Wherein, filler is one or more in glucose, lactose, starch, the pregelatinized Starch; Disintegrating agent is one or more of crospolyvinylpyrrolidone, hydroxyethyl-cellulose, ethyl cellulose, low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, carboxymethylcellulose calcium, microcrystalline Cellulose sodium, cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, amylum pregelatinisatum, alginic acid, sodium alginate; Lubricant is a kind of in Pulvis Talci, magnesium stearate, the micropowder silica gel.
As another kind of preferred embodiment of the present invention, the bisulfate Cefdinir sodium capsule component form and ratio can for:
Bisulfate Cefdinir sodium 25-70%
Carboxymethyl starch sodium 10-60%
Pregelatinized Starch 0.1-60%
Micropowder silica gel 0.1-10%
Another object of the present invention provides the preparation method of bisulfate Cefdinir sodium capsule, realizes by following steps:
1., with adjuvant carboxymethyl starch sodium and pregelatinized Starch drying for standby, it is standby that raw material sulphuric acid hydrogen Cefdinir sodium and adjuvant are crossed 80 mesh sieves respectively;
2., according to the prescription weighing, with bisulfate Cefdinir sodium and adjuvant mix homogeneously;
3., middle product conventional sense;
4., fill, polishing, packing, warehouse-in.
Capsule quality of the present invention is stable, and aqueous solution is good, the dissolution height.Preparation process is simple, feasibility good, is fit to suitability for industrialized production.
Capsule of the present invention has significantly changed the medicine of cefdinir for characteristic, has the characteristics fast, that blood drug level is big, bioavailability is high that absorb.Oral bisulfate Cefdinir sodium capsule 100mg (in cefdinir) Beagle dog peak time is 2.9 ± 0.2h, oral former factory's Cefdinir capsule (Quan Zefu) 100mgBeagle dog peak time 3.6 ± 1.1h that grinds illustrates that bisulfate Cefdinir sodium capsule is rapid-action.
The highest blood drug level of oral bisulfate Cefdinir sodium capsule 100mg (in cefdinir) Beagle dog is 29.17 ± 4.05 μ g/ml, it is oral that former to grind the highest blood drug level of factory's Cefdinir capsule (Quan Zefu) 100mgBeagle dog be 19.50 ± 5.68 μ g/ml, sour hydrogen Cefdinir sodium capsule blood drug level height is described, antibiotic effectiveness is more secure.
Oral bisulfate Cefdinir sodium capsule 100mg (in cefdinir) and former factory's Cefdinir capsule (Quan Zefu) 100mg that grinds of cefdinir compare at intravital blood drug level of Beagle dog and pharmacokinetics process analysis, the relative bioavailability of bisulfate Cefdinir sodium capsule is 141.4% ± 9.8%, has improved 41% than the former factory's preparation that grinds of cefdinir.
Description of drawings
Fig. 1 is the dissolution determination curve chart.
Fig. 2 be 6 grow up, healthy Beagle dog single oral dose administration 100mg/ dog is subjected to the average blood drug level-time comparison curves behind reagent thing A (in cefdinir) and the 100mg/ dog reference medicine B.
The specific embodiment
The present invention is further described in conjunction with the accompanying drawings and embodiments.Can not limit the invention with its any form.
Embodiment 1
Bisulfate Cefdinir sodium has been open in 200810164211.3 the patent at application number, and its method for making is as follows: weighing 2.0g cefdinir, drop in the 100ml reaction bulb, and add the 20ml absolute methanol again, stir, mixing; Take by weighing sulphuric acid 0.496g, be diluted to vitriolic absolute methanol solution, under ice bath, slowly be added drop-wise in the above-mentioned cefdinir solution with absolute methanol 10ml, after treating the solution clarification, add the 0.273g Feldalat NM, reacted 15 minutes, stopped reaction, 35 ℃ of reclaim under reduced pressure methanol concentrate, drip the ether crystallize with Dropping funnel, drip while stirring, separate out solid, filtration, drying, pulverize, promptly get the cefdinir sodium bisulfate.Yield 99%, content 98.7%, purity 〉=99%.
Embodiment 2
Prescription:
Title recipe quantity (g)
Bisulfate Cefdinir sodium 67.4 is (in cefdinir, 50g)
Carboxymethyl starch sodium 44
Pregelatinized Starch 21
Micropowder silica gel 1
Make 1000
1., with adjuvant carboxymethyl starch sodium, pregelatinized Starch in 105 ℃ of dry 2h (the control loss on drying is less than 4%), be chilled to room temperature after, it is standby that each adjuvant is crossed 80 mesh sieves, it is standby that bisulfate Cefdinir sodium is also crossed 80 mesh sieves;
2., according to the prescription weighing, with bisulfate Cefdinir sodium 67.4g and adjuvant carboxymethyl starch sodium 44g, pregelatinized Starch 21g, micropowder silica gel 1g mix homogeneously;
3., middle product check content;
4., fill, polishing, packing, must be bisulfate Cefdinir sodium capsule, specification 50mg (in cefdinir).
Embodiment 3
Get the foregoing description 1 made bisulfate Cefdinir sodium capsule and the former factory's Cefdinir capsule (trade name: Quan Zefu) of grinding, carry out dissolution determination with reference to 2005 editions dissolution determination methods of Chinese Pharmacopoeia, with water is dissolution medium 900ml, and rotating speed is that per minute 50 changes.Through sampling in 5,10,15,30,45,60,90,120 minutes.Get solution 5ml, filter, precision is measured subsequent filtrate 2ml, puts in the brown volumetric flask of 10ml, is diluted with water to scale, according to ultraviolet visible spectrophotometry (two appendix IV of Chinese Pharmacopoeia version in 2005 A), measures absorbance at the wavelength place of 280nm; It is an amount of that in addition precision takes by weighing the cefdinir reference substance, puts in the brown bottle, is dissolved in water and dilutes and make the solution that contains 10 μ g among every 1ml, measures with method, calculates the stripping quantity of every capsules, the results are shown in Table 1.
Dissolution determination result in table 1 water
Embodiment 4
Own control, the design of cross matching method are at random adopted in this test, promptly 6 grow up, healthy Beagle dog is divided into two groups at random, every group 3, promptly embodiment 1 made bisulfate Cefdinir sodium capsule (A medicine) is subjected to examination group, Cefdinir capsule (B medicine, Quan Zefu) matched group.After being tried dog overnight fasting (fasting 14 hours), matched group oral administration Cefdinir capsule 100mg/ dog, be subjected to examination group oral administration bisulfate Cefdinir sodium capsule 100mg/ dog (in the effective ingredient cefdinir), complete capsule directly filled in tried the dog bottleneck throat, take with 200ml warm water; Period 1 tests two groups and takes B, A medicine respectively, tests two groups second round and takes A, B medicine respectively, and each test period is 1 all cleaning phases at interval.
Get the blood time: 0.5,1.0,1.5,2.0,2.5,3.0,5.0,8.0,10.0,12.0,24.0 hour blood sampling 1ml puts in the heparinization test tube before administration and after the administration, and is centrifugal, divides and gets about 400 μ l blood plasma.Press the operation of Beagle dog plasma sample pretreating method, measure cefdinir concentration in the blood plasma.
Statistical procedures is carried out in three-factor analysis of variance and two one-side t check of data statistic analysis employing self cross-over experiment design.Use the pharmacokinetic parameter lnC of the bioavailability study date processing general program (BAPP2.0) of China Medicine University's exploitation to CS007 capsule trial drug and commercially available Cefdinir capsule control drug
Max, lnAUC
0～24Carry out three-factor analysis of variance and two one-side t checks (α=0.05).
The result is referring to table 2, table 3, table 4.
Table 2 single oral dose administration 100mg/ dog (in cefdinir)
Be subjected to behind reagent thing A and the 100mg/ dog reference medicine B AUC relatively
Table 3 single oral dose administration 100mg/ dog (in cefdinir) be subjected to reagent thing A and
LnC behind the 100mg/ dog reference medicine B
MaxThree-factor analysis of variance and the check of two one-side t
Table 4 single oral dose administration 100mg/ dog (in cefdinir) be subjected to reagent thing A and
LnAUC behind the 100mg/ dog reference medicine B
0～24Three-factor analysis of variance and the check of two one-side t
Prescription:
Title recipe quantity (g)
Bisulfate Cefdinir sodium 134.8 is (in cefdinir, 100g)
Carboxymethyl starch sodium 88
Pregelatinized Starch 42
Micropowder silica gel 2
Make 1000
1., with adjuvant carboxymethyl starch sodium, pregelatinized Starch in 105 ℃ of dry 2h (the control loss on drying is less than 4%), be chilled to room temperature after, it is standby that each adjuvant is crossed 80 mesh sieves, it is standby that bisulfate Cefdinir sodium is also crossed 80 mesh sieves;
2., according to the prescription weighing, with bisulfate Cefdinir sodium 134.8g and adjuvant carboxymethyl starch sodium 88g, pregelatinized Starch 42g, micropowder silica gel 2g mix homogeneously;
3., middle product check content;
4., fill, polishing, packing, must be bisulfate Cefdinir sodium capsule, specification 100mg (in cefdinir).
Embodiment 6
Prescription:
Title recipe quantity (g)
Bisulfate Cefdinir sodium 337 is (in cefdinir, 250g)
Carboxymethyl starch sodium 220
Pregelatinized Starch 105
Make 1000
1., with adjuvant carboxymethyl starch sodium, pregelatinized Starch in 105 ℃ of dry 2h (the control loss on drying is less than 4%), be chilled to room temperature after, it is standby that each adjuvant is crossed 80 mesh sieves, it is standby that bisulfate Cefdinir sodium is also crossed 80 mesh sieves;
2., according to the prescription weighing, with bisulfate Cefdinir sodium 337g and adjuvant carboxymethyl starch sodium 220g, pregelatinized Starch 105g, micropowder silica gel 5g mix homogeneously;
3., middle product check content;
4., fill, polishing, packing, must be bisulfate Cefdinir sodium capsule, specification 250mg (in cefdinir).
Embodiment 7
Prescription:
Title recipe quantity (g)
Bisulfate Cefdinir sodium 67.4 is (in cefdinir, 50g)
Carboxymethyl starch sodium 44
Pregelatinized Starch 21
Pulvis Talci 1
Make 1000
1., with adjuvant carboxymethyl starch sodium, pregelatinized Starch in 105 ℃ of dry 2h (the control loss on drying is less than 4%), be chilled to room temperature after, it is standby that each adjuvant is crossed 80 mesh sieves, it is standby that bisulfate Cefdinir sodium is also crossed 80 mesh sieves;
2., according to the prescription weighing, with bisulfate Cefdinir sodium 67.4g and adjuvant carboxymethyl starch sodium 44g, pregelatinized Starch 21g, Pulvis Talci 1g mix homogeneously;
3., middle product check content;
4., fill, polishing, packing, must be bisulfate Cefdinir sodium capsule, specification 50mg (in cefdinir).
Embodiment 8
Prescription:
Title recipe quantity (g)
Bisulfate Cefdinir sodium 67.4 is (in cefdinir, 50g)
Starch 44
Carboxymethyl starch sodium 21
Magnesium stearate 1
Make 1000
1., with adjuvant carboxymethyl starch sodium, pregelatinized Starch in 105 ℃ of dry 2h (the control loss on drying is less than 4%), be chilled to room temperature after, it is standby that each adjuvant is crossed 80 mesh sieves, it is standby that bisulfate Cefdinir sodium is also crossed 80 mesh sieves;
2., according to the prescription weighing, with bisulfate Cefdinir sodium 67.4g and ingredient powder sodium 44g, carboxymethyl starch sodium 21g, magnesium stearate 1g mix homogeneously;
3., middle product check content;
4., fill, polishing, packing, must be bisulfate Cefdinir sodium capsule, specification 50mg (in cefdinir).
Embodiment 9
Prescription:
Title recipe quantity (g)
Bisulfate Cefdinir sodium 67.4 is (in cefdinir, 50g)
Pregelatinized Starch 44
Microcrystalline Cellulose sodium 21
Magnesium stearate 1
Make 1000
1., with adjuvant carboxymethyl starch sodium, pregelatinized Starch in 105 ℃ of dry 2h (the control loss on drying is less than 4%), be chilled to room temperature after, it is standby that each adjuvant is crossed 80 mesh sieves, it is standby that bisulfate Cefdinir sodium is also crossed 80 mesh sieves;
2., according to the prescription weighing, with bisulfate Cefdinir sodium 67.4g and adjuvant pregelatinized Starch 44g, microcrystalline Cellulose sodium 21g, magnesium stearate 1g mix homogeneously;
3., middle product check content;
4., fill, polishing, packing, must be bisulfate Cefdinir sodium capsule, specification 50mg (in cefdinir).
Prescription:
Title recipe quantity (g)
Bisulfate Cefdinir sodium 67.4 is (in cefdinir, 50g)
Carboxymethyl starch sodium 13.4
Pregelatinized Starch 51.6
Micropowder silica gel 1
Make 1000
1., with adjuvant carboxymethyl starch sodium, pregelatinized Starch in 105 ℃ of dry 2h (the control loss on drying is less than 4%), be chilled to room temperature after, it is standby that each adjuvant is crossed 80 mesh sieves, it is standby that bisulfate Cefdinir sodium is also crossed 80 mesh sieves;
2., according to the prescription weighing, with bisulfate Cefdinir sodium 67.4g and adjuvant carboxymethyl starch sodium 13.4g, pregelatinized Starch 51.6g, micropowder silica gel 1g mix homogeneously;
3., middle product check content;
4., fill, polishing, packing, must be bisulfate Cefdinir sodium capsule, specification 50mg (in cefdinir).
Embodiment 11
Prescription:
Title recipe quantity (g)
Bisulfate Cefdinir sodium 67.4 is (in cefdinir, 50g)
Carboxymethyl starch sodium 63
Pregelatinized Starch 2
Micropowder silica gel 1
Make 1000
1., with adjuvant carboxymethyl starch sodium, pregelatinized Starch in 105 ℃ of dry 2h (the control loss on drying is less than 4%), be chilled to room temperature after, it is standby that each adjuvant is crossed 80 mesh sieves, it is standby that bisulfate Cefdinir sodium is also crossed 80 mesh sieves;
2., according to the prescription weighing, with bisulfate Cefdinir sodium 67.4g and adjuvant carboxymethyl starch sodium 63g, pregelatinized Starch 2g, micropowder silica gel 1g mix homogeneously;
3., middle product check content;
4., fill, polishing, packing, must be bisulfate Cefdinir sodium capsule, specification 50mg (in cefdinir).
Embodiment 12
Prescription:
Title recipe quantity (g)
Bisulfate Cefdinir sodium 67.4 is (in cefdinir, 50g)
Carboxymethylcellulose calcium 44
Lactose 21
Micropowder silica gel 1
Make 1000
1., with adjuvant carboxymethyl starch sodium, pregelatinized Starch in 105 ℃ of dry 2h (the control loss on drying is less than 4%), be chilled to room temperature after, it is standby that each adjuvant is crossed 80 mesh sieves, it is standby that bisulfate Cefdinir sodium is also crossed 80 mesh sieves;
2., according to the prescription weighing, with bisulfate Cefdinir sodium 67.4g and adjuvant carboxymethylcellulose calcium 44g, lactose 21g, micropowder silica gel 1g mix homogeneously;
3., middle product check content;
4., fill, polishing, packing, must be bisulfate Cefdinir sodium capsule, specification 50mg (in cefdinir).
Embodiment 13
Prescription:
Title recipe quantity (g)
Bisulfate Cefdinir sodium 67.4 is (in cefdinir, 50g)
Microcrystalline Cellulose sodium 44
Glucose 21
Micropowder silica gel 1
Make 1000
1., with adjuvant carboxymethyl starch sodium, pregelatinized Starch in 105 ℃ of dry 2h (the control loss on drying is less than 4%), be chilled to room temperature after, it is standby that each adjuvant is crossed 80 mesh sieves, it is standby that bisulfate Cefdinir sodium is also crossed 80 mesh sieves;
2., according to the prescription weighing, with bisulfate Cefdinir sodium 67.4g and microcrystalline cellulose excipients sodium 44g, glucose 21g, micropowder silica gel 1g mix homogeneously;
3., middle product check content;
4., fill, polishing, packing, must be bisulfate Cefdinir sodium capsule, specification 50mg (in cefdinir).
Embodiment 14
Prescription:
Title recipe quantity (g)
Bisulfate Cefdinir sodium 67.4 is (in cefdinir, 50g)
Hydroxyethyl-cellulose 44
Pregelatinized Starch 21
Micropowder silica gel 1
Make 1000
1., with adjuvant carboxymethyl starch sodium, pregelatinized Starch in 105 ℃ of dry 2h (the control loss on drying is less than 4%), be chilled to room temperature after, it is standby that each adjuvant is crossed 80 mesh sieves, it is standby that bisulfate Cefdinir sodium is also crossed 80 mesh sieves;
2., according to the prescription weighing, with bisulfate Cefdinir sodium 67.4g and adjuvant hydroxyethyl-cellulose 44g, pregelatinized Starch 21g, micropowder silica gel 1g mix homogeneously;
3., middle product check content;
4., fill, polishing, packing, must be bisulfate Cefdinir sodium capsule, specification 50mg (in cefdinir).
Prescription:
Title recipe quantity (g)
Bisulfate Cefdinir sodium 67.4 is (in cefdinir, 50g)
Hydroxyethyl-cellulose 29
Pregelatinized Starch 21
Micropowder silica gel 1
Make 1000
1., with adjuvant carboxymethyl starch sodium, pregelatinized Starch in 105 ℃ of dry 2h (the control loss on drying is less than 4%), be chilled to room temperature after, it is standby that each adjuvant is crossed 80 mesh sieves, it is standby that bisulfate Cefdinir sodium is also crossed 80 mesh sieves;
2., according to the prescription weighing, with bisulfate Cefdinir sodium 67.4g and adjuvant hydroxyethyl-cellulose 29g, microcrystalline Cellulose sodium 15g, pregelatinized Starch 21g, micropowder silica gel 1g mix homogeneously;
3., middle product check content;
4., fill, polishing, packing, must be bisulfate Cefdinir sodium capsule, specification 50mg (in cefdinir).
Embodiment 16
Prescription:
Title recipe quantity (g)
Bisulfate Cefdinir sodium 67.4 is (in cefdinir, 50g)
Cross-linking sodium carboxymethyl cellulose 29
Starch 21
Micropowder silica gel 1
Make 1000
1., with adjuvant carboxymethyl starch sodium, pregelatinized Starch in 105 ℃ of dry 2h (the control loss on drying is less than 4%), be chilled to room temperature after, it is standby that each adjuvant is crossed 80 mesh sieves, it is standby that bisulfate Cefdinir sodium is also crossed 80 mesh sieves;
2., according to the prescription weighing, with bisulfate Cefdinir sodium 67.4g and adjuvant cross-linking sodium carboxymethyl cellulose 29g, amylum pregelatinisatum 15g, starch 21g, micropowder silica gel 1g mix homogeneously;
3., middle product check content;
4., fill, polishing, packing, must be bisulfate Cefdinir sodium capsule, specification 50mg (in cefdinir).
Embodiment 17
Prescription:
Title recipe quantity (g)
Bisulfate Cefdinir sodium 67.4 is (in cefdinir, 50g)
Crospolyvinylpyrrolidone 9
Starch 46
Micropowder silica gel 1
Make 1000
1., with adjuvant carboxymethyl starch sodium, pregelatinized Starch in 105 ℃ of dry 2h (the control loss on drying is less than 4%), be chilled to room temperature after, it is standby that each adjuvant is crossed 80 mesh sieves, it is standby that bisulfate Cefdinir sodium is also crossed 80 mesh sieves;
2., according to the prescription weighing, with bisulfate Cefdinir sodium 67.4g and adjuvant crospolyvinylpyrrolidone 9g, sodium alginate 10g, starch 46g, micropowder silica gel 1g mix homogeneously;
3., middle product check content;
4., fill, polishing, packing, must be bisulfate Cefdinir sodium capsule, specification 50mg (in cefdinir).
Claims (3)
1. a bisulfate Cefdinir sodium capsule is characterized in that, this capsule 's content is formed and the percentage by weight of each composition is:
Bisulfate Cefdinir sodium 25-70%
Filler 10-60%
Disintegrating agent 0.1-60%
Lubricant 0.1-10%
Wherein: filler is one or more in glucose, lactose, starch or the pregelatinized Starch; Disintegrating agent is one or more of crospolyvinylpyrrolidone, hydroxyethyl-cellulose, ethyl cellulose, low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, carboxymethylcellulose calcium, microcrystalline Cellulose sodium, cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, amylum pregelatinisatum, alginic acid or sodium alginate; Lubricant is a kind of in Pulvis Talci, magnesium stearate or the micropowder silica gel.
2. a kind of bisulfate Cefdinir sodium capsule according to claim 1 is characterized in that, this capsule 's content is formed and the percentage by weight of each composition is:
Bisulfate Cefdinir sodium 25-70%
Carboxymethyl starch sodium 10-60%
Pregelatinized Starch 0.1-60%
Micropowder silica gel 0.1-10%
3. the preparation method of bisulfate Cefdinir sodium capsule according to claim 1 and 2 is characterized in that realizing by following steps:
1., with adjuvant carboxymethyl starch sodium and pregelatinized Starch drying for standby, it is standby that raw material sulphuric acid hydrogen Cefdinir sodium and adjuvant are crossed 80 mesh sieves respectively;
2., according to the prescription weighing, with bisulfate Cefdinir sodium and adjuvant mix homogeneously;
3., middle product conventional sense;
4., fill, polishing, packing, warehouse-in.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201010128910 CN101862307A (en) | 2010-03-19 | 2010-03-19 | Bisulfate Cefdinir sodium capsule and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201010128910 CN101862307A (en) | 2010-03-19 | 2010-03-19 | Bisulfate Cefdinir sodium capsule and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN101862307A true CN101862307A (en) | 2010-10-20 |
Family
ID=42954371
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 201010128910 Pending CN101862307A (en) | 2010-03-19 | 2010-03-19 | Bisulfate Cefdinir sodium capsule and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN101862307A (en) |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| WO2012078121A3 (en) * | 2010-12-08 | 2012-08-23 | Mahmut Bilgic | Solid oral dosage form comprising cefdinir |
| CN103720695A (en) * | 2012-10-16 | 2014-04-16 | 江苏豪森药业股份有限公司 | Drug combination containing cefdinir |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101002745A (en) * | 2005-09-26 | 2007-07-25 | 刘凤鸣 | Slow release preparation of cefdinir |
| CN101481383A (en) * | 2008-12-31 | 2009-07-15 | 浙江奥默生物医药有限公司 | Cefdinir acid type double salt compound and preparation |
-
2010
- 2010-03-19 CN CN 201010128910 patent/CN101862307A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101002745A (en) * | 2005-09-26 | 2007-07-25 | 刘凤鸣 | Slow release preparation of cefdinir |
| CN101481383A (en) * | 2008-12-31 | 2009-07-15 | 浙江奥默生物医药有限公司 | Cefdinir acid type double salt compound and preparation |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2012078121A3 (en) * | 2010-12-08 | 2012-08-23 | Mahmut Bilgic | Solid oral dosage form comprising cefdinir |
| 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 |
| CN103720695A (en) * | 2012-10-16 | 2014-04-16 | 江苏豪森药业股份有限公司 | Drug combination containing cefdinir |
| CN103720695B (en) * | 2012-10-16 | 2017-07-21 | 江苏豪森药业集团有限公司 | pharmaceutical composition containing Cefdinir |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN101816635B (en) | Cephalosporin suspension granule and preparation method thereof | |
| CN101780085B (en) | Cefprozil medicinal composition | |
| CN103349646B (en) | A kind of pharmaceutical composition of cefaclor granule, its preparation method and application | |
| CN102266306A (en) | Cefdinir capsules and preparation method thereof | |
| CN101862307A (en) | Bisulfate Cefdinir sodium capsule and preparation method thereof | |
| CN103417512B (en) | A kind of Biomox and preparation method thereof | |
| CN110613697A (en) | Cefalexin capsule and preparation method thereof | |
| CN103330685B (en) | Cefaclor granule and preparation method thereof | |
| CN103446075B (en) | A kind of Cefaclor Capsules and preparation method thereof | |
| CN109248150B (en) | Amoxicillin and clavulanate potassium preparation and preparation method thereof | |
| CN103977009B (en) | Composition for oral liquid containing cefdinir and preparation method thereof | |
| CN103524533A (en) | Cefprozil compound, and dispersible tablets, dry suspension and preparation method thereof | |
| CN102697736A (en) | Cefixime granule and preparation method thereof | |
| CN104688713A (en) | Cefradine capsule and preparation method thereof | |
| CN112156082A (en) | Amoxicillin capsule preparation method and amoxicillin capsule | |
| CN103145733A (en) | Amoxicillin compound and pharmaceutical composition of amoxicillin compound and potassium clavulanate | |
| CN104784144B (en) | A kind of cefadroxil coated tablet and preparation method thereof | |
| CN103622916A (en) | Cefixime dry suspension and preparation method thereof | |
| CN1319533C (en) | Cefetamet pivoxil hydrochloride dispersion dispersion tablets and preparation method | |
| CN103432076A (en) | Cefprozil dry suspension and preparation method thereof | |
| CN103263398B (en) | Cefdinir composition capsule and preparation method thereof | |
| CN112546018A (en) | Cefaclor capsule and preparation method thereof | |
| CN103497204B (en) | A kind of Cefdinir compound, its dispersible tablet and preparation method | |
| CN104546862A (en) | Ceftibuten pharmaceutical composition and preparation method thereof | |
| CN111467316A (en) | Cefadroxil dispersible tablet and preparation method thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Open date: 20101020 |