CN102138924B - Cefcapene pivoxil hydrochloride composition and preparation method thereof - Google Patents
Cefcapene pivoxil hydrochloride composition and preparation method thereof Download PDFInfo
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- CN102138924B CN102138924B CN 201110035286 CN201110035286A CN102138924B CN 102138924 B CN102138924 B CN 102138924B CN 201110035286 CN201110035286 CN 201110035286 CN 201110035286 A CN201110035286 A CN 201110035286A CN 102138924 B CN102138924 B CN 102138924B
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Abstract
The invention relates to a cefcapene pivoxil hydrochloride composition and a preparation method thereof. The composition consists of a tablet core and a coating layer, wherein the tablet core contains cefcapene pivoxil hydrochloride, a filler, a disintegrating agent, an antisticking agent and a lubricating agent; the grain diameter of the cefcapene pivoxil hydrochloride serving as a raw material is less than 100 micrometers; and the antisticking agent is in an amount which is 3 to 15 percent of the weight of the tablet core. The prepared cefcapene pivoxil hydrochloride tablets have excellent disintegrative property and dissolution of over 75 percent.
Description
Technical field
The present invention relates to field of pharmaceutical preparations, be specifically related to a kind of Method of cefcapene pivoxil hydrochloride composition and method of making the same.
Background technology
Method of cefcapene pivoxil hydrochloride (cefcapene pivoxil hydrochloride), its chemistry (6R by name, 7R)-7-[(Z)-2-(thiazolamine-4-yl)-pentenyl is amino]-the 3-[(amino carbonyl) oxygen] methyl-8-oxo-5-thia-1-azabicyclic [4.2.0] oct-2-ene-2-carboxylic acid (2,2-dimethyl oxygen propoxyl group methyl) ester hydrochloride monohydrate, be the wild adopted company of Japanese salt (Shionogi) exploitation have the third penta oxygen methyl and to the stable oral broad ectrum antibiotic of beta-lactamase, go on the market with trade name Flomox in Japan in July, 1997, it brings into play antibacterial action by the blocking-up bacteria cell wall is synthetic, mainly is applicable to the respiratory tract infection due to the sensitive organism, otitis media, sinusitis, urinary tract infection, skin and skin histology infect, biliary tract infection etc.That uses clinically at present is tablet.
Method of cefcapene pivoxil hydrochloride is slightly soluble in ethanol, and is water-soluble hardly, therefore, how to improve its dissolubility, increases the dissolution of tablet, is a great problem of pendulum in face of the preparation work person.
Existing Japan listing Method of cefcapene pivoxil sheet Flomox, adopted the particle diameter of crude drug has been controlled, improve the way of stripping (if only the particle diameter of crude drug is controlled with a large amount of starch based filleies simultaneously, medicine after the pulverizing reassembles under the surface free energy effect easily because surface area increases).The consisting of of the Method of cefcapene pivoxil hydrochloride sheet of describing such as this product description (take the 100mg specification as example): contain effective composition cefcapene 100mg (being equivalent to the about 137mg of hydrochloric Method of cefcapene pivoxil); The label adjuvant is: filler corn starch, disintegrating agent carboxymethyl base cellulose calcium (CMC-Ca), binding agent hydroxypropyl cellulose (HPC), magnesium stearate lubricant; The coating adjuvant is: hydroxypropyl methylcellulose 2910 (HPMC2910), TiO
2, polyethylene glycol 6000 (PEG6000), Icing Sugar.But form the Method of cefcapene pivoxil hydrochloride sheet for preparing according to above adjuvant and still have the disintegrate difficulty, cause dissolution defective.
Summary of the invention
In view of the problem that prior art exists, the inventor has carried out a large amount of research work, as:
1, crude drug aspect:
1. raw material is prepared into behind the solid dispersion again tabletting.At first this method is applicable to the less medicine of preparation specification, and namely solid dispersion Chinese medicine content should be too not high, be generally 5-20%, and the medicament contg in the Method of cefcapene pivoxil hydrochloride sheet is more than 25%; Secondly, generally need heating and melting in the medicine solid dispersion preparation process, and cephalosporins medicine is to thermally labile.Therefore this method is not suitable for the preparation of Method of cefcapene pivoxil hydrochloride tablet.
2. adopt cyclodextrin inclusion technique.The applicable drug molecule amount of cyclodextrin inclusion technique should be between 100～400, and the Method of cefcapene pivoxil hydrochloride molecular weight is 622.11, is not suitable for adopting the method; And therefore the method Chinese medicine and cyclodextrin mole proportioning, even if Method of cefcapene pivoxil hydrochloride adopts this technology can carry out the part enclose, the heavy overweight phenomenon of sheet also can occur generally more than 1: 1.
2. adjuvant aspect: select to have filler, the disintegrating agent of good disintegrating property, and suitable fluidizer, antiplastering aid, lubricant, surfactant and hydrophilic adhesive etc.
1. in the selection of filler, we have attempted using the microcrystalline Cellulose with better disintegrate effect, experimental result shows, the use of this kind filler, really improved the disintegrate effect of Method of cefcapene pivoxil hydrochloride sheet, but not improving its dissolution, reduced on the contrary its dissolubility, may be because microcrystalline Cellulose has produced stronger adsorption to medicine.We attempt again adding surfactant such as sodium lauryl sulphate, poloxamer etc., but the stripping of tablet is not improved.
2. in the selection of disintegrating agent, we have attempted the multiple disintegrating agents such as cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone singlely uses and unites use, and experimental result shows, also is to improve the disintegrate situation, and can not improve stripping.
3. in the selection of fluidizer, antiplastering aid, lubricant, we adopt the micropowder silica gel (0.1%-0.3%) of convention amount, Pulvis Talci (0.1%-3%), magnesium stearate (0.1%-1%) etc., to the stripping of tablet all less than improving.
4. in wet granulation, we also test hydrophilic binding agent hydroxypropyl cellulose, and the result shows, the dissolution of Method of cefcapene pivoxil hydrochloride sheet is improved.
Accidental, the inventor finds: when the crude drug particle diameter being controlled at below the 100 μ m, and in label, use starch based filler, disintegrating agent, lubricant, when the antiplastering aid of simultaneously adding breakthrough conventional amount used such as micropowder silica gel, can significantly improve the dissolution of Method of cefcapene pivoxil hydrochloride sheet.
(the starch based filler is take starch as example as example take the Method of cefcapene pivoxil hydrochloride sheet dry granulation of 100mg specification for the inventor, disintegrating agent is take cross-linking sodium carboxymethyl cellulose as example, lubricant is take magnesium stearate as example), consumption to antiplastering aid in the label (take micropowder silica gel as example) is investigated, again the antiplastering aid kind is investigated subsequently, experimentation and result are as follows:
The prescription screening design:
For the impact on the disintegrate of Method of cefcapene pivoxil hydrochloride sheet and dissolution of the consumption of investigating antiplastering aid (take micropowder silica gel as example), in the situation that keeps other supplementary product kinds and content constant (content of starch adjusts accordingly with the consumption of antiplastering aid), the consumption of adjusting antiplastering aid carries out Formulation, and is as shown in table 1.
Table 1 prescription screening table of the present invention (antiplastering aid consumption) (weight: g)
In order to investigate different antiplastering aid supplementary product kinds to the impact of the disintegrate of Method of cefcapene pivoxil sheet and dissolution, carried out following Formulation.Keeping in the constant situation of various supplementary product kinds and content, adjusting the kind (having on the basis of preliminary test data, take comparatively preferred antiplastering aid weight content 5% as example) of antiplastering aid, measuring respectively its disintegrate and dissolution.Concrete Formulation is as shown in table 2:
Table 2 prescription screening table of the present invention (antiplastering aid supplementary product kind) (weight: g)
Annotate: supplementary material is per 1000 preparation unit's consumptions in the form.
Formula preparation technique:
At first the Method of cefcapene pivoxil hydrochloride raw material pulverizing is sieved, the control particle diameter is less than 100 μ m, then behind the Method of cefcapene pivoxil hydrochloride and antiplastering aid mix homogeneously with recipe quantity, add filler and disintegrating agent, dry granulation behind the mix homogeneously again, it is even to add mix lubricant, tabletting, film coating (the film-coat material is the Opadry Y-1-7000 of Shanghai Colorcon Coating Technology Co., Ltd, consumption be sheet heavy 1～7%).
Detection method:
The Method of cefcapene pivoxil sheet that will prepare according to prescription and the preparation technology of above design carries out the mensuration of disintegration and dissolution according to following detection method.
1, disintegration
Get this product, according to Film coated tablets inspection technique, in accordance with the law operation in two appendix X of Chinese Pharmacopoeia version in 2010 A inspection technique disintegration.Should all disintegrates in 30 minutes.
2, dissolution
Get this product, take phosphate buffer as solvent, rotating speed is that per minute 50 turns according to dissolution method (two appendix X of Chinese Pharmacopoeia version in 2010 C the second method), in accordance with the law operation.In the time of 30 minutes, get solution 5ml, filter, get subsequent filtrate as need testing solution; Measure according to the method under the assay item, calculate respectively the stripping quantity of every middle Method of cefcapene pivoxil hydrochloride, limit is 75% of labelled amount, should be up to specification.
Experimental result:
Each experimental result of writing out a prescription is as shown in table 3:
Table 3 experimental result
| Prescription 5 | 4 | 78 |
| Prescription 6 | 4 | 78 |
| Prescription 7 | 4 | 79 |
| Prescription 8 | 3 | 78 |
| Prescription 9 | 3 | 77 |
| Prescription 10 | 3 | 75 |
| Prescription 11 | 3 | 70 |
| Prescription 12 | 3 | 65 |
| Prescription 13 | 4 | 78 |
| Prescription 14 | 4 | 78 |
Experiment conclusion:
Testing result shows that in percentage by weight 3～15% scopes of antiplastering aid, the dissolution of Method of cefcapene pivoxil hydrochloride sheet can reach more than 75%, meets drug standard; In 5～10% scopes, the dissolution of Method of cefcapene pivoxil hydrochloride sheet is best, near 80% at the percentage by weight of antiplastering aid.The Method of cefcapene pivoxil hydrochloride sheet dissolution that obtains in all the other scopes is defective.
In antiplastering aid, micropowder silica gel is suitable with the sodium stearyl fumarate effect, from cost consideration, and preferred micropowder silica gel.
Therefore, one aspect of the present invention provides a kind of Method of cefcapene pivoxil hydrochloride compositions, formed by label and coatings, described label comprises Method of cefcapene pivoxil hydrochloride, filler, disintegrating agent, antiplastering aid and lubricant, wherein, the Method of cefcapene pivoxil hydrochloride raw material particle size is less than 100 μ m, and the percentage by weight that antiplastering aid accounts for label is 3～15%, preferably, the Method of cefcapene pivoxil hydrochloride raw material particle size is less than 80 μ m; The percentage by weight that antiplastering aid accounts for label is 5～10%.
Wherein, described antiplastering aid is selected from one or both the mixture in micropowder silica gel, the sodium stearyl fumarate, from cost consideration, is preferably micropowder silica gel.
Described filler is the starch based filler, is selected from one or more the mixture in starch, pregelatinized Starch, the partially pregelatinized starch, is preferably starch; Described disintegrating agent is selected from one or more the mixture in cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, carboxymethylcellulose calcium, the polyvinylpolypyrrolidone; Described lubricant is selected from one or more the mixture in magnesium stearate, Pulvis Talci, the hydrogenated vegetable oil, from cost consideration, is preferably magnesium stearate.
The used film-coat material of coatings is the polymer coating material that comprises hydroxypropyl emthylcellulose, Polyethylene Glycol, Pulvis Talci, titanium dioxide and pigment, or buys the Opadry Y-1-7000 that produces such as Shanghai Ka Lekang packaging technique company limited commercially.The film-coat material uses with the amount of about 1～7% film coating that film-coated tablet weight can be provided.
Preferably, described Method of cefcapene pivoxil hydrochloride compositions is pressed the weight percent meter of label, and described label is composed of the following components:
Method of cefcapene pivoxil hydrochloride 25～67.5%
Filler 7～66%
Disintegrating agent 3～15%
Micropowder silica gel 3～15%
Lubricant 0.1～2%.
Further, described Method of cefcapene pivoxil hydrochloride compositions is pressed the weight percent meter of label, and described label is composed of the following components:
Method of cefcapene pivoxil hydrochloride 35～67.5%
Filler 15～55%
Disintegrating agent 5～10%
Micropowder silica gel 5～10%
Lubricant 0.5～1%.
Wherein, the definition of filler, disintegrating agent, lubricant is the same.
Method of cefcapene pivoxil hydrochloride compositions of the present invention can be pressed into the tablet of any suitable specification, is preferably 75mg and 100mg specification (being converted to the amount of cefcapene).
The present invention also provides the preparation method of Method of cefcapene pivoxil hydrochloride tablet composition of the present invention on the other hand, can adopt following two kinds of methods to be prepared:
One, at first the Method of cefcapene pivoxil hydrochloride raw material pulverizing is sieved, the control particle diameter is less than 100 μ m, be preferably less than 80 μ m, then behind the Method of cefcapene pivoxil hydrochloride and antiplastering aid mix homogeneously with recipe quantity, add filler and disintegrating agent, dry granulation behind the mix homogeneously again, it is even to add mix lubricant, tabletting, film coating.
Two, at first the Method of cefcapene pivoxil hydrochloride raw material pulverizing is sieved, the control particle diameter is less than 100 μ m, be preferably less than 80 μ m, then behind the Method of cefcapene pivoxil hydrochloride and antiplastering aid mix homogeneously with recipe quantity, add filler and disintegrating agent, again wet granulation behind the mix homogeneously, dry, add mix lubricant, tabletting, film coating.
Method of cefcapene pivoxil hydrochloride tablet of the present invention, by add the antiplastering aid of unconventional amount in compositions, the products obtained therefrom disintegrative is good, and dissolution can reach more than 75%, meets drug standard.
The specific embodiment
Further set forth the present invention by the following example, but should not consist of any limitation of the invention.
Embodiment 1: the Method of cefcapene pivoxil hydrochloride sheet
Prescription forms (1000) weight (g) percentage by weights (%)
Method of cefcapene pivoxil hydrochloride 137 62.3
Starch 58.8 26.7
Cross-linking sodium carboxymethyl cellulose 11 5
Micropowder silica gel 11 5
30% alcoholic solution is an amount of
Magnesium stearate 2.2 1
Preparation method: at first the Method of cefcapene pivoxil hydrochloride raw material pulverizing is sieved, the control particle diameter then with Method of cefcapene pivoxil hydrochloride and the micropowder silica gel mixing of recipe quantity, adds starch, the cross-linking sodium carboxymethyl cellulose of recipe quantity less than 80 μ m, mixing, it is an amount of to add 30% alcoholic solution, wet granulation, 40 ℃ of dryings, the magnesium stearate that adds recipe quantity, mixing, tabletting, film coating.
Dissolution determination: the 1000ml pH value is in 6.8 the buffer salt solution, and the oar method is measured, 50 rev/mins of rotating speeds.Disintegration time 3 minutes, dissolution 78%.
Embodiment 2: the Method of cefcapene pivoxil hydrochloride sheet
Prescription forms (1000) weight (g) percentage by weights (%)
Method of cefcapene pivoxil hydrochloride 137 62.3
Starch 58.8 26.7
Carboxymethyl starch sodium 11 5
Micropowder silica gel 11 5
3% hydroxypropyl cellulose is an amount of
Pulvis Talci 2.2 1
Preparation method: at first the Method of cefcapene pivoxil hydrochloride raw material pulverizing is sieved, the control particle diameter then with Method of cefcapene pivoxil hydrochloride and the micropowder silica gel mixing of recipe quantity, adds starch, the carboxymethyl starch sodium of recipe quantity less than 80 μ m, mixing, it is an amount of to add 3% hydroxypropyl cellulose, wet granulation, 40 ℃ of dryings, the Pulvis Talci that adds recipe quantity, mixing, tabletting, film coating.
Dissolution determination: the 1000ml pH value is in 6.8 the buffer salt solution, and the oar method is measured, 50 rev/mins of rotating speeds.Disintegration time 3 minutes, dissolution 78%.
Embodiment 3: the Method of cefcapene pivoxil hydrochloride sheet
Prescription forms (1000) weight (g) percentage by weights (%)
Method of cefcapene pivoxil hydrochloride 137 62.3
Starch 58.8 26.7
Carboxymethylcellulose calcium 11 5
Sodium stearyl fumarate 11 5
Pulvis Talci 2.2 1
Preparation method: at first the Method of cefcapene pivoxil hydrochloride raw material pulverizing is sieved, the control particle diameter is less than 80 μ m, then with Method of cefcapene pivoxil hydrochloride and the sodium stearyl fumarate mixing of recipe quantity, add starch, the carboxymethylcellulose calcium mixing of recipe quantity, dry granulation is after the granulation, the Pulvis Talci that adds recipe quantity, mixing, tabletting, film coating.
Dissolution determination: the 1000ml pH value is in 6.8 the buffer salt solution, and the oar method is measured, 50 rev/mins of rotating speeds.Disintegration time 3 minutes, dissolution 77%.
Embodiment 4: the Method of cefcapene pivoxil hydrochloride sheet
Prescription forms (1000) weight (g) percentage by weights (%)
Method of cefcapene pivoxil hydrochloride 137 62.3
Starch 58.8 26.7
Carboxymethyl starch sodium 5.5 2.5
Cross-linking sodium carboxymethyl cellulose 5.5 2.5
Micropowder silica gel 11 5
Magnesium stearate 2.2 1
Preparation method: at first the Method of cefcapene pivoxil hydrochloride raw material pulverizing is sieved, the control particle diameter is less than 80 μ m, then with Method of cefcapene pivoxil hydrochloride and the micropowder silica gel mixing of recipe quantity, add starch, carboxymethyl starch sodium, the cross-linking sodium carboxymethyl cellulose mixing of recipe quantity, dry granulation is after the granulation, the magnesium stearate that adds recipe quantity, mixing, tabletting, film coating.
Dissolution determination: the 1000ml pH value is in 6.8 the buffer salt solution, and the oar method is measured, 50 rev/mins of rotating speeds.Disintegration time 3 minutes, dissolution 77%.
Embodiment 5: the Method of cefcapene pivoxil hydrochloride sheet
Prescription forms (1000) weight (g) percentage by weights (%)
Method of cefcapene pivoxil hydrochloride 137 62.3
Microcrystalline Cellulose 58.8 26.7
Cross-linking sodium carboxymethyl cellulose 22 10
Micropowder silica gel 2.2 1
Preparation method: at first the Method of cefcapene pivoxil hydrochloride raw material pulverizing is sieved, the control particle diameter is less than 80 μ m, then with the Method of cefcapene pivoxil hydrochloride of recipe quantity and microcrystalline Cellulose, the cross-linking sodium carboxymethyl cellulose of recipe quantity, mixing, dry granulation is after the granulation, the micropowder silica gel that adds recipe quantity, mixing, tabletting, film coating.
Dissolution determination: the 1000ml pH value is in 6.8 the buffer salt solution, and the oar method is measured, 50 rev/mins of rotating speeds.Disintegration time 2 minutes, dissolution 30%.
Embodiment 6: the Method of cefcapene pivoxil hydrochloride sheet
Prescription forms (1000) weight (g) percentage by weights (%)
Method of cefcapene pivoxil hydrochloride 137 62.3
Microcrystalline Cellulose 58.8 26.7
Polyvinylpolypyrrolidone 11 5
Sodium lauryl sulphate 11 5
30% alcoholic solution is an amount of
Pulvis Talci 2.2 1
Preparation method: at first the Method of cefcapene pivoxil hydrochloride raw material pulverizing is sieved, the control particle diameter is less than 80 μ m, then with microcrystalline Cellulose, the polyvinylpolypyrrolidone of the Method of cefcapene pivoxil hydrochloride recipe quantity of recipe quantity, mixing, the solution that adds sodium lauryl sulphate and 30% ethanol is an amount of, wet granulation, 40 ℃ of dryings, the Pulvis Talci of adding recipe quantity, mixing, tabletting, film coating.
Dissolution determination: the 1000ml pH value is in 6.8 the buffer salt solution, and the oar method is measured, 50 rev/mins of rotating speeds.Disintegration time 2 minutes, dissolution 32%.
Embodiment 7: the Method of cefcapene pivoxil hydrochloride sheet
Prescription forms (1000) weight (g) percentage by weights (%)
Method of cefcapene pivoxil hydrochloride 137 62.3
Microcrystalline Cellulose 47.8 21.7
Cross-linking sodium carboxymethyl cellulose 11 5
Micropowder silica gel 22 10
Magnesium stearate 2.2 1
Preparation method: at first the Method of cefcapene pivoxil hydrochloride raw material pulverizing is sieved, the control particle diameter is less than 80 μ m, then with Method of cefcapene pivoxil hydrochloride and the micropowder silica gel mixing of recipe quantity, add microcrystalline Cellulose, the cross-linking sodium carboxymethyl cellulose mixing of recipe quantity, dry granulation is after the granulation, the magnesium stearate that adds recipe quantity, mixing, tabletting, film coating.
Dissolution determination: the 1000ml pH value is in 6.8 the buffer salt solution, and the oar method is measured, 50 rev/mins of rotating speeds.Disintegration time 2 minutes, dissolution 33%.
Embodiment 8: the Method of cefcapene pivoxil hydrochloride sheet
Prescription forms (1000) weight (g) percentage by weights (%)
Method of cefcapene pivoxil hydrochloride 137 62.3
Starch 69.8 31.7
Carboxymethylcellulose calcium 11 5
3% hydroxypropyl cellulose is an amount of
Magnesium stearate 2.2 1
Preparation method: at first the Method of cefcapene pivoxil hydrochloride raw material pulverizing is sieved, the control particle diameter is less than 80 μ m, then with the Method of cefcapene pivoxil hydrochloride of recipe quantity and starch, the carboxymethylcellulose calcium of recipe quantity, mixing adds 3% hydroxypropyl cellulose, wet granulation, 40 ℃ of dryings, the magnesium stearate of adding recipe quantity, mixing, tabletting, film coating.
Dissolution determination: the 1000ml pH value is in 6.8 the buffer salt solution, and the oar method is measured, 50 rev/mins of rotating speeds.Fully disintegrate in 30 minutes, dissolution 50%.
Embodiment 9: the Method of cefcapene pivoxil hydrochloride sheet
Prescription forms (1000) weight (g) percentage by weights (%)
Method of cefcapene pivoxil hydrochloride 137 62.3
Starch 69.8 31.7
Cross-linking sodium carboxymethyl cellulose 11 5
Magnesium stearate 2.2 1
Preparation method: at first the Method of cefcapene pivoxil hydrochloride raw material pulverizing is sieved, the control particle diameter is less than 80 μ m, then with Method of cefcapene pivoxil hydrochloride, starch, the cross-linking sodium carboxymethyl cellulose of recipe quantity, and mixing, dry granulation after the granulation, adds the magnesium stearate of recipe quantity, mixing, tabletting, film coating.
Dissolution determination: the 1000ml pH value is in 6.8 the buffer salt solution, and the oar method is measured, 50 rev/mins of rotating speeds.Fully disintegrate in 30 minutes, dissolution 50%.
Claims (9)
1. the compositions of a Method of cefcapene pivoxil hydrochloride, formed by label and coatings, it is characterized in that: described label comprises Method of cefcapene pivoxil hydrochloride, filler, disintegrating agent, antiplastering aid and lubricant, wherein, the Method of cefcapene pivoxil hydrochloride raw material particle size is less than 80 μ m, and is 25～67.5% by the weight percent meter content of label; The percentage by weight that described antiplastering aid accounts for label is 3～15%, is selected from one or both the mixture in micropowder silica gel, the sodium stearyl fumarate; Described filler is starch; Described disintegrating agent is selected from one or more the mixture in cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, the carboxymethylcellulose calcium.
2. compositions as claimed in claim 1, it is characterized in that: the percentage by weight that antiplastering aid accounts for label is 5～10%.
3. compositions as claimed in claim 1, it is characterized in that: press the weight percent meter of label, described label is composed of the following components:
4. compositions as claimed in claim 3, it is characterized in that: press the weight percent meter of label, described label is composed of the following components:
5. such as the arbitrary described compositions of claim 1～4, it is characterized in that: described lubricant is selected from one or more the mixture in magnesium stearate, Pulvis Talci, the hydrogenated vegetable oil.
6. compositions as claimed in claim 1, it is characterized in that: the used film-coat material of described coatings comprises hydroxypropyl emthylcellulose, Polyethylene Glycol, Pulvis Talci, titanium dioxide and pigment.
7. compositions as claimed in claim 6, it is characterized in that: described film-coat material accounts for 1～7% of composition weight.
8. the preparation method of the described compositions of claim 1, that the Method of cefcapene pivoxil hydrochloride raw material pulverizing is sieved, the control particle diameter, then behind the Method of cefcapene pivoxil hydrochloride and antiplastering aid mix homogeneously with recipe quantity, add filler and disintegrating agent, dry granulation behind the mix homogeneously again, it is even to add mix lubricant, tabletting, film coating.
9. the preparation method of the described compositions of claim 1, that the Method of cefcapene pivoxil hydrochloride raw material pulverizing is sieved, the control particle diameter, then behind the Method of cefcapene pivoxil hydrochloride and antiplastering aid mix homogeneously with recipe quantity, add filler and disintegrating agent, again wet granulation behind the mix homogeneously, dry, add mix lubricant, tabletting, film coating.
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| CN110974803A (en) * | 2019-12-31 | 2020-04-10 | 山东罗欣药业集团股份有限公司 | Cefcapene pivoxil hydrochloride granules and preparation method thereof |
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| CN101120927A (en) * | 2007-09-03 | 2008-02-13 | 江苏正大清江制药有限公司 | Wet granulation technology for cefuroxime axetil tablets |
| JP4336380B1 (en) * | 2008-11-06 | 2009-09-30 | 塩野義製薬株式会社 | Fine granules with improved water suspension |
| CN101756906B (en) * | 2009-11-02 | 2011-11-16 | 严洁 | Pharmaceutical composition of cefcapene pivoxil hydrochloride granules and preparation method thereof |
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| CN110974803A (en) * | 2019-12-31 | 2020-04-10 | 山东罗欣药业集团股份有限公司 | Cefcapene pivoxil hydrochloride granules and preparation method thereof |
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