CN100484574C - Hydrochloric acid cefetamet pivoxil dispersible tablet and method for preparing the same - Google Patents
Hydrochloric acid cefetamet pivoxil dispersible tablet and method for preparing the same Download PDFInfo
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- CN100484574C CN100484574C CNB2008100091819A CN200810009181A CN100484574C CN 100484574 C CN100484574 C CN 100484574C CN B2008100091819 A CNB2008100091819 A CN B2008100091819A CN 200810009181 A CN200810009181 A CN 200810009181A CN 100484574 C CN100484574 C CN 100484574C
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Abstract
The invention discloses a cefetamet pivoxil hydrochloride tablet and a preparation method thereof. On the premise of specific active ingredients of the cefetamet pivoxil hydrochloride, the invention takes into account the varieties and dosages of disintegrating agents and joint usage thereof, suitable components and ratios of bonding agents and other filling agents, and the micronization treatment of the raw and auxiliary materials and selection of corresponding optimized process conditions. Experiment results indicate that compared with the prior art, the product of the invention has quick disintegration and dissolution and stable quality.
Description
Technical field
What the present invention relates to is a kind of hydrochloric acid cefetamet pivoxil dispersible tablet, and the preparation method of described dispersible tablet.
Background technology
In the prior art, beta-lactam antibiotic is clinical use amount maximum, most widely used, kind is maximum, the class antibiotic that curative effect is preferably the highest with evaluation, wherein, the cephalosporin series of products account for 70%, in various cephalosporins, Cefetamet Pivoxil Hydrochloride is oral third generation broad-spectrum cephalosporin class antibiotic, has wide spectrum, efficiently, anti-enzyme, characteristics such as low toxicity, with the veriety cefalexin, it is stronger that cefradines etc. have an antibacterial activity, advantages such as dosage is littler, having overcome pioneer's series of products to the unsettled shortcoming of beta-lactamase, is cefalexin, the ideal succedaneum of cefradine.
On the market, the cefetamet ester formulation has dosage forms such as tablet, dry suspension, capsule.The other forms of cefetamet ester formulation of part manufacturer production is also arranged, for example:
CN03134097.0 discloses a kind of hydrochloric acid cefetamet pivoxil dispersible tablet and preparation method thereof, and the percentage by weight that this dispersible tablet contains raw material consists of: active component; 25-35%, filler: 55-70%, disintegrating agent: 2.0-5.0%, correctives: 1.0-2.0%, lubricant: 0.5-2.0%, binding agent: 0.2-0.4%.Preparation method adopts boiling granulating technology, adds adjuvant simultaneously and mixes compacting in flakes, and technology is simple, easy operating, constant product quality.Dispersible tablet can be dispersed in the water fast, and taking convenience, absorption are rapidly.Be particularly suitable for infant and swallow inconvenient patient's use.
CN200410081382.1 discloses a kind of ambroxol hydrochloride and cephalo-type antibiotics active component, weight proportion by 1:1～20 is made, described cephalo-type antibiotics is selected cefixime, Ro 15-8074/001 or Cefetamet Pivoxil Hydrochloride for use, it is that active component and adjuvant are made various dosage forms by the universal method on the galenic pharmacy, comprise peroral dosage forms such as tablet, dispersible tablet, chewable tablet, capsule, granule, oral liquid, dry suspension, and various injection, injectable sterile powder, freeze-dried powder etc.; The present invention has strengthened the antibacterial activity of infected pulmonary greatly, and therapeutic effect is remarkable, and clinical practice simultaneously is more convenient, taking dose is less relatively and accurate.
CN200510020565.7 discloses a kind of Compound of dual functional esterified prodrug of cefetamet, and oral preparation, the chemical name of this medical compounds is: (6R, 7R)-3-methyl-7-[(2-(S)-alanyl amino-4-thiazolyl)-(methoxyimino) acetylamino]-8-oxo-5-thia-1-azabicyclo [4,2,0] suffering-2-alkene-2-formic acid pivaloyl oxygen methyl ester hydrochloride; The present invention has provided the general structure and the various peroral dosage form of compound of dual functional esterified prodrug of Cefetamet simultaneously.The water solublity of medical compounds of the present invention has obtained effective raising, absorb fast, the blood drug level height, oral administration biaavailability significantly is better than Cefetamet Pivoxil Hydrochloride, has stronger and antibacterial activity efficiently, simultaneously, its sugariness obviously improves, can develop multiple peroral dosage form, especially be more suitable for the child and dysphagia patients is taken, expand the range of application of oral solid formulation of the present invention.
But, because the viscosity of Cefetamet Pivoxil Hydrochloride raw material is strong excessively, and under hot and humid condition the chemical property instability.Based on this point, prior art it has been generally acknowledged that the employing wet granulation technology, not only is difficult to make granule, and in the granulation dry run, contained active component is easy to degraded.Therefore, CN03134097.0 provides a kind of boiling granulating technology of hydrochloric acid cefetamet pivoxil dispersible tablet.And after the inventor carried out a large amount of tests, screening by prescription screening, adjuvant and consumption thereof and strict control wet granulation technology condition have prepared not only that drug content is even, the uniform hydrochloric acid cefetamet pivoxil dispersible tablet of product content, and the dispersive property of prepared hydrochloric acid cefetamet pivoxil dispersible tablet and dissolution all increase than prior art, overcome the prejudice of prior art.In view of this, special proposition the present invention.
Summary of the invention
Main purpose of the present invention provides a kind of hydrochloric acid cefetamet pivoxil dispersible tablet, and this dispersible tablet has the stripping property of better dispersive property and Geng Gao.
Hydrochloric acid cefetamet pivoxil dispersible tablet provided by the present invention, disintegrate fully in 2 minutes and 20 seconds average time, and can cross No. 2 sieves (2000 editions two appendix IA of Chinese Pharmacopoeia), accumulation stripping percentage rate can reach 100% (adopting Chinese Pharmacopoeia appendix XC dissolution determination method second method) in the time of 2 minutes.
For the present invention clearly is described, below carry out some explanations with regard to thinking of the present invention earlier.
Dispersible tablet of the present invention (dispersible tablets), claim water dispersion tablet (water dis-persibletablets) again, mean a kind of tablet of meeting the even stickiness suspension of water rapid disintegrate formation, dispersible tablet has the advantage of tablet and liquid preparation concurrently, that is: taking convenience, absorb soon, bioavailability height and untoward reaction are little etc.
The active component of dispersible tablet, regulation is generally arranged, therefore, the research that the present invention is carried out to the branch assembly with regard to integral formula to the stripping and the dispersion effect of described dispersible tablet, dispersible tablet of the present invention, require to meet behind the water as soon as possible that disintegrate becomes granule, and form uniform suspension, so design of components is important.
At first, the kind of disintegrating agent and consumption are most important to disintegrate, the result of extraction of dispersible tablet, from composition, the most frequently used have carboxymethyl starch sodium (CMS-Na), low-substituted hydroxypropyl cellulose (L-HPC), cross-linked carboxymethyl cellulose sodium (cCMC-Na), a crospolyvinylpyrrolidone (PVPP) etc.
Prior art shows that the difference on the disintegrating agent consumption also may produce diametrically opposite effect to the disintegrate behavior of dispersible tablet.As a kind of quickly disintegrated efficiently CMS-Na, its consumption be 1%～2% o'clock not obvious to the influence of disintegration of tablet; Can obviously accelerate disintegrate at 3%～7% o'clock, 8%～10% has postponed disintegrate on the contrary.
Studies show that several disintegrating agents with different performance are united use, adjust its composition or consumption separately, can reach better disintegrate effect at active component.
Test shows that the suitable composition of binding agent and other inserts and ratio are influential to the disintegrate of dispersible tablet.
Before tabletting, insoluble or insoluble drug can be ground with hydrophilicity condiment, can make the former medicine of crystalline state be transformed into amorphous state, can prevent aggregation of particles again, increase the wettability of particle surface, greatly improve the dissolution of medicine.
Dispersible tablet not only requires disintegrate fast, and it is fast that stripping is equally also wanted.Though a lot of dispersible tablet disintegrates are very fast, stripping is slower, in this case, can consider earlier former medicine to be made solid dispersion in advance.
The wet granular of wet granulation gained below the 1mm (18 order), dried granule is below 0.6mm (30 order).As adopt the fluid bed one-step palletizing, particulate quality is improved greatly, press slice, thin piece disintegrate better, stripping.
Dispersible tablet should disintegrate and stripping in the short as far as possible time, therefore the hardness of described dispersible tablet is influential, suitably hardness both can guarantee that described dispersible tablet has enough porositys and disintegrate fast, but can keep outward appearance again, improve fineness etc., taking all factors into consideration the proportioning of tabletting pressure and each adjuvant, is suitable to obtain disintegration time and all satisfactory dispersible tablet of hardness.Experiment shows that hardness does not have obvious influence to disintegrate and stripping in 3.0～7.5kg scope; When hardness big (9,10.5kg), then disintegrate is slowed down, and stripping reduces.
Dispersible tablet is except that need meet the quality standard of ordinary tablet, and its dispersive property should meet: answer disintegrate fully in the 3min in the time of in 19～21 ℃ of water; The uniformity or the suspension ability of tackling simultaneously after the disintegrate detect: get 2 of dispersible tablets, put among 20 ℃ of water 100ml, to being poured on the screen cloth in 710mm aperture after the disintegrate fully, discrete particles can pass through screen cloth fully.
Based on described consideration, the present invention is in order to obtain the best prescription combination of described dispersible tablet, is kind and best proportioning or the consumption that index adopts quadrature, method for designing screening disintegrating agent such as even with disintegration time, suspension ability or uniformity, stripping.Screening test sees Table 1 and table 2 (consumption in table 1 and the table 2 is per 1000 consumption):
Table 1. prescription screening result of the test
Table 2. supplementary product consumption screening test result
| Composition and test item | Prescription 1 | Prescription 2 | Prescription 3 | Prescription 4 | Prescription 5 |
| Cefetamet Pivoxil Hydrochloride | 125 | 125 | 125 | 125 | 125 |
| Starch | 30 | 40 | 25 | 25 | 20 |
| Microcrystalline Cellulose | 110 | 100 | 50 | 50 | 50 |
| Hyprolose | —— | —— | 50 | 50 | 50 |
| Ammonia match honey | In right amount | In right amount | In right amount | In right amount | In right amount |
| Ethanol | In right amount | In right amount | In right amount | In right amount | In right amount |
| Carboxymethylstach sodium | - | - | 15 | 25 | 30 |
| Magnesium stearate | In right amount | In right amount | In right amount | In right amount | In right amount |
| Substrate's appearance | Difference | Better | Better | Better | Difference |
| Hardness | Relatively poor | Relatively poor | Better | Better | Relatively poor |
| Dispersing uniformity | Difference | Difference | Better | Well | Better |
By above-mentioned screening, the component that obtains hydrochloric acid cefetamet pivoxil dispersible tablet provided by the present invention is as follows:
Cefetamet Pivoxil Hydrochloride 125 weight portions
Starch 25-40 weight portion
Microcrystalline Cellulose 50-100 weight portion
Hyprolose 10-50 weight portion
Ammonia match honey is an amount of
Ethanol is an amount of
Carboxymethylstach sodium 5-25 weight portion
Magnesium stearate is an amount of;
Preferably, in the component of dispersible tablet of the present invention:
Starch 25 weight portions
Microcrystalline Cellulose 50 weight portions
Hyprolose 50 weight portions
Carboxymethylstach sodium 15-25 weight portion.
Most preferred, in the component of dispersible tablet of the present invention, carboxymethylstach sodium is 25 weight portions.
Among the present invention, ethanol is used as binding agent, preferred 95% ethanol, as long as its consumption can satisfy the amount that supplementary material can reach the system soft material, this point can both be expected for those skilled in the art.
Among the present invention, carboxymethylstach sodium, microcrystalline Cellulose and starch use in conjunction as disintegrating agent, and are adjusted its composition or consumption separately by prescription screening, thereby make product of the present invention reach better disintegrate effect.Optimizing prescriptions of the present invention and most preferably the prescription promptly obtain by above-mentioned screening.
Though adjuvant provided by the present invention is the adjuvant that those skilled in the art use always, the prescription that is provided is also similar to prior art, no evident difference, but all increase than prior art according to the stripping property and the dispersive property of the prepared hydrochloric acid cefetamet pivoxil dispersible tablet of prescription provided by the invention.
Another object of the present invention provides a kind of hydrochloric acid cefetamet pivoxil dispersible tablet preparation method.
The preparation method of hydrochloric acid cefetamet pivoxil dispersible tablet provided by the present invention is a wet processing, principal agent is made granule earlier after, mix tabletting with other adjuvants again.
The preparation method of hydrochloric acid cefetamet pivoxil dispersible tablet of the present invention comprises raw material Cefetamet Pivoxil Hydrochloride and supplementary product starch, microcrystalline Cellulose, hyprolose, ammonia match honey and carboxymethylstach sodium pulverize separately, sieves, makes wet granular, makes dried granule, tabletting and packing.
Said method, wherein said raw material is crossed 100 mesh sieves, and adjuvant is crossed 120 mesh sieves.
Earlier remix behind former, the adjuvant crushing screening is granulated among the present invention, former, adjuvant is evenly distributed, mix more even.
In the said method, described system wet granular also comprises mixing.Described being mixed into done mixed wet mixing more earlier.
Married operation is a purpose with the content uniformity.Mixing resultant influences the presentation quality and the inherent quality of preparation.Mix bad meeting and speckle occurs, disintegration, intensity are defective, influence drug effect etc., and it is inhomogeneous to mix the inhomogeneous drug content that causes, and bioavailability and therapeutic effect are all brought great influence.Do earlier among the present invention and mix wet mixing again, make supplementary material mix more evenly, drug content is more even, thereby makes its dispersive property and dissolution better.
Described system wet granular be take by weighing recipe quantity Cefetamet Pivoxil Hydrochloride, starch, microcrystalline Cellulose, ammonia match honey and hyprolose; insert in the high-speed mixing granulating machine; the sealing high-speed dry was mixed 5-15 minute; added then an amount of wet mixing 1-5 of ethanol minute; after the wet mixing; granule is emitted in wet mixing cutting 1-3 minute, obtains wet granular.
The preparation method of hydrochloric acid cefetamet pivoxil dispersible tablet provided by the present invention specifically comprises the steps:
1) gets the raw materials ready
Cefetamet Pivoxil Hydrochloride is pulverized, crossed 100 mesh sieves,, cross 120 mesh sieves, obtain standby former, adjuvant starch, microcrystalline Cellulose, hyprolose, ammonia match honey and carboxymethylstach sodium pulverize separately;
2) system wet granular
Take by weighing above-mentioned standby Cefetamet Pivoxil Hydrochloride, starch, microcrystalline Cellulose, ammonia match honey and the hyprolose of recipe quantity, insert in the high-speed mixing granulating machine, the sealing high-speed dry was mixed 5-15 minute, added then an amount of wet mixing 1-5 of ethanol minute, after the wet mixing, granule is emitted in wet mixing cutting 1-3 minute, obtains wet granular;
3) make dried granule
The wet granular that the last step was made changes in the ebullated dryer, and temperature is controlled at 60-70 ℃ of baking 17-20 minute, shuts down, clear filter bag, and blowing obtains dried granule;
4) tabletting, packing
To go up prepared dried granule of step and add pelletizing machine, start button carries out granulate, adds the carboxymethylstach sodium of recipe quantity and an amount of magnesium stearate again, and add three-dimensional mixer with suction feeding and mix, tabletting, packing promptly gets hydrochloric acid cefetamet pivoxil dispersible tablet.
The viscosity of Cefetamet Pivoxil Hydrochloride raw material is strong excessively, and under hot and humid condition the chemical property instability.Based on this point, prior art it has been generally acknowledged that the employing wet granulation technology, not only is difficult to make granule, and in the granulation dry run, contained active component is easy to degraded.Therefore, CN03134097.0 provides a kind of boiling granulating technology of hydrochloric acid cefetamet pivoxil dispersible tablet.And among the present invention, prescription, adjuvant and consumption thereof are screened, and get the raw materials ready, make wet granular among the preparation technology, system has all been carried out strict control in its each step of dried granule, in melting process, supplementary material is distinguished different sieves; In the system wet granular process, do earlier and mix wet mixing again, and the time of dry blend wet mixing is carried out strictness control; Make in the dried particle drying process, strict control baking temperature etc., not only well overcome and be difficult to make granule, the active component problem of degraded easily, and the result of extraction of prepared hydrochloric acid cefetamet pivoxil dispersible tablet and dispersive property all are improved than prior art, thereby overcome in the above-mentioned prior art and it has been generally acknowledged that " viscosity of Cefetamet Pivoxil Hydrochloride raw material is strong excessively, and under hot and humid condition the chemical property instability.Adopts wet granulation technology, not only be difficult to make granule, and in the granulation dry run, contained active component is easy to degraded " technology prejudice.
Hydrochloric acid cefetamet pivoxil dispersible tablet of the present invention and preparation method thereof compared with prior art has following advantage:
1, drug content is even, the product content good uniformity;
2, production efficiency height, and drying time is short;
3, disintegrate and result of extraction are good, and dispersive property is good.
The specific embodiment
Below be the specific embodiment of the present invention, described embodiment is in order to further describe the present invention, rather than restriction the present invention.
Embodiment 1
Prescription:
Preparation technology:
1) gets the raw materials ready
Cefetamet Pivoxil Hydrochloride is pulverized, crossed 100 mesh sieves,, cross 120 mesh sieves, obtain standby former, adjuvant starch, microcrystalline Cellulose, hyprolose, ammonia match honey and carboxymethylstach sodium pulverize separately;
2) system wet granular
Take by weighing above-mentioned standby Cefetamet Pivoxil Hydrochloride, starch, microcrystalline Cellulose, ammonia match honey and the hyprolose of recipe quantity, insert in the high-speed mixing granulating machine, the sealing high-speed dry was mixed 10 minutes, add an amount of wet mixing of ethanol 3 minutes then, after the wet mixing, granule is emitted in wet mixing cutting 2 minutes, obtains wet granular;
3) make dried granule
The wet granular that the last step was made changes in the ebullated dryer, and temperature is controlled at 65 ℃ of bakings 17 minutes, shuts down, clear filter bag, and blowing obtains dried granule;
4) tabletting, packing
To go up prepared dried granule of step and add pelletizing machine, start button carries out granulate, adds the carboxymethylstach sodium of recipe quantity and an amount of magnesium stearate again, and add three-dimensional mixer with suction feeding and mix, tabletting, packing promptly gets hydrochloric acid cefetamet pivoxil dispersible tablet.
Embodiment 2
Prescription:
Preparation technology:
1) gets the raw materials ready
Cefetamet Pivoxil Hydrochloride is pulverized, crossed 100 mesh sieves,, cross 120 mesh sieves, obtain standby former, adjuvant starch, microcrystalline Cellulose, hyprolose, ammonia match honey and carboxymethylstach sodium pulverize separately;
2) system wet granular
Take by weighing above-mentioned standby Cefetamet Pivoxil Hydrochloride, starch, microcrystalline Cellulose, ammonia match honey and the hyprolose of recipe quantity, insert in the high-speed mixing granulating machine, the sealing high-speed dry was mixed 5 minutes, add an amount of wet mixing of ethanol 1 minute then, after the wet mixing, granule is emitted in wet mixing cutting 3 minutes, obtains wet granular;
3) make dried granule
The wet granular that the last step was made changes in the ebullated dryer, and temperature is controlled at 60 ℃ of bakings 17 minutes, shuts down, clear filter bag, and blowing obtains dried granule;
4) tabletting, packing
To go up prepared dried granule of step and add pelletizing machine, start button carries out granulate, adds the carboxymethylstach sodium of recipe quantity and an amount of magnesium stearate again, and add three-dimensional mixer with suction feeding and mix, tabletting, packing promptly gets hydrochloric acid cefetamet pivoxil dispersible tablet.
Embodiment 3
Prescription:
Preparation technology:
1) gets the raw materials ready
Cefetamet Pivoxil Hydrochloride is pulverized, crossed 100 mesh sieves,, cross 120 mesh sieves, obtain standby former, adjuvant starch, microcrystalline Cellulose, hyprolose, ammonia match honey and carboxymethylstach sodium pulverize separately;
2) system wet granular
Take by weighing above-mentioned standby Cefetamet Pivoxil Hydrochloride, starch, microcrystalline Cellulose, ammonia match honey and the hyprolose of recipe quantity, insert in the high-speed mixing granulating machine, the sealing high-speed dry was mixed 15 minutes, add an amount of wet mixing of ethanol 5 minutes then, after the wet mixing, granule is emitted in wet mixing cutting 1 minute, obtains wet granular;
3) make dried granule
The wet granular that the last step was made changes in the ebullated dryer, and temperature is controlled at 70 ℃ of bakings 17 minutes, shuts down, clear filter bag, and blowing obtains dried granule;
4) tabletting, packing
To go up prepared dried granule of step and add pelletizing machine, start button carries out granulate, adds the carboxymethylstach sodium of recipe quantity and an amount of magnesium stearate again, and add three-dimensional mixer with suction feeding and mix, tabletting, packing promptly gets hydrochloric acid cefetamet pivoxil dispersible tablet.
Embodiment 4
Prescription:
Preparation technology is with embodiment 1.
Embodiment 5
Prescription:
Preparation technology is with embodiment 1.
Below by comparative example the beneficial effect of product hydrochloric acid cefetamet pivoxil dispersible tablet of the present invention is described.
The dispersivity test of the hydrochloric acid cefetamet pivoxil dispersible tablet that [comparative example 1] the present invention and CN03134097 make relatively
This comparative example has carried out dispersivity test to the hydrochloric acid cefetamet pivoxil dispersible tablet that the embodiment of the invention 1 and CN03134097 make, and concrete test method is as follows, the results are shown in Table 3:
Dispersivity test: " method among 2000 editions two appendix IA of Chinese pharmacopoeia places the jolting of 100ml water with 2 of products of the present invention, in 20 ± 1 ℃ of water in employing.
Table 3. dispersivity test comparative result
| Documents | The present invention | |
| The dispersivity test result | Disintegrate fully in 3 minutes, and can cross sieve No. 2. | Disintegrate fully in 2 minutes and 5 seconds average time, and can cross sieve No. 2 |
The dissolution test of the hydrochloric acid cefetamet pivoxil dispersible tablet that [comparative example 2] the present invention and CN03134097 make relatively
This comparative example has carried out the dissolution test to the hydrochloric acid cefetamet pivoxil dispersible tablet that the embodiment of the invention 1 and CN03134097 make, and concrete test method is as follows, the results are shown in Table 4:
The dissolution test: adopt Chinese Pharmacopoeia appendix XC dissolution determination method second method, stripping matter: 0.1molHCl, 900ml, rotating speed: 75 rev/mins, temperature: 37 ℃ ± 2 ℃.Timing sampling 10m1, the 0.8um membrane filtration, replenish fresh medium 10ml: adopt ultraviolet spectrophotometry to detect this filtrate, absorbing wavelength is 263nm, measures its trap, according to criterion keying method, calculates different time accumulation stripping percentage rate.
Table 4. dissolution test comparative result
| Time (branch) | 2 | 5 | 10 | 20 | 30 |
| The accumulative total stripping percentage rate (%) of CN03134097 | 102.7 | 102.7 | 103.2 | 102.4 | 103.2 |
| Accumulative total stripping percentage rate (%) of the present invention | 104.1 | 104.2 | 104.2 | 103.9 | 103.8 |
As seen from the above table, the data that hydrochloric acid cefetamet pivoxil dispersible tablet dissolution rate of the present invention provides significantly better than CN03134097, accumulation stripping percentage rate can reach 100% in the time of 2 minutes.
The stability test of the hydrochloric acid cefetamet pivoxil dispersible tablet that [comparative example 3] the present invention and CN03134097 make relatively
Stability test: the hydrochloric acid cefetamet pivoxil dispersible tablet that the embodiment of the invention 1 and CN03134097 are made adopts two aluminum packings, under 40 ± 2 ℃ of RH:75 ± 5% condition, placed 6 months, placed 24 months under 25 ± 2 ℃ of RH:60 ± 5% condition, difference is indexs such as sampling and measuring sample size, related substance, dispersing uniformity, dissolution at the appointed time.Result of the test sees Table 5, table 6.
Table 5. accelerated stability test comparative result
The table 6. test comparative result that keeps sample for a long time
From table 5 and table 6 as can be seen, the data of the CN03134097 of the present invention and contrast are compared, the hydrochloric acid cefetamet pivoxil dispersible tablet accelerated stability test result of the test of the present invention and the almost indifference of result of the test that keeps sample for a long time.
Above-mentioned comparative test result shows that product of the present invention is compared with prior art, and disintegrate, stripping are rapid, steady quality.
Claims (9)
1, a kind of hydrochloric acid cefetamet pivoxil dispersible tablet is characterized in that: the component of described dispersible tablet is as follows:
Cefetamet Pivoxil Hydrochloride 125 weight portions
Starch 25-40 weight portion
Microcrystalline Cellulose 50-100 weight portion
Hyprolose 10-50 weight portion
Ammonia match honey is an amount of
Ethanol is an amount of
Carboxymethylstach sodium 5-25 weight portion
Magnesium stearate is an amount of.
2, dispersible tablet according to claim 1 is characterized in that: in the component of described dispersible tablet:
Starch 25 weight portions
Microcrystalline Cellulose 50 weight portions
Hyprolose 50 weight portions
Carboxymethylstach sodium 15-25 weight portion.
3, dispersible tablet according to claim 2 is characterized in that in the component of described dispersible tablet that carboxymethylstach sodium is 25 weight portions.
4, a kind of method for preparing the described dispersible tablet of claim 1 is characterized in that: described method comprises raw material Cefetamet Pivoxil Hydrochloride and supplementary product starch, microcrystalline Cellulose, hyprolose, ammonia match honey and carboxymethylstach sodium pulverize separately, sieves, makes wet granular, makes dried granule, tabletting and packing.
5, method according to claim 4 is characterized in that: described raw material is crossed 100 mesh sieves, and adjuvant is crossed 120 mesh sieves.
6, method according to claim 4 is characterized in that: described system wet granular also comprises mixing.
7, method according to claim 6 is characterized in that: described being mixed into done mixed wet mixing more earlier.
8, method according to claim 7; it is characterized in that: described system wet granular be take by weighing recipe quantity Cefetamet Pivoxil Hydrochloride, starch, microcrystalline Cellulose, ammonia match honey and hyprolose; insert in the high-speed mixing granulating machine; the sealing high-speed dry was mixed 5-15 minute; added then an amount of wet mixing 1-5 of ethanol minute, after the wet mixing, wet mixing cutting 1-3 minute; emit granule, obtain wet granular.
9, method according to claim 8 is characterized in that described method comprises the steps:
1) gets the raw materials ready
Cefetamet Pivoxil Hydrochloride is pulverized, crossed 100 mesh sieves,, cross 120 mesh sieves, obtain standby former, adjuvant starch, microcrystalline Cellulose, hyprolose, ammonia match honey and carboxymethylstach sodium pulverize separately;
2) system wet granular
Take by weighing above-mentioned standby Cefetamet Pivoxil Hydrochloride, starch, microcrystalline Cellulose, ammonia match honey and the hyprolose of recipe quantity, insert in the high-speed mixing granulating machine, the sealing high-speed dry was mixed 5-15 minute, added then an amount of wet mixing 1-3 of ethanol minute, after the wet mixing, granule is emitted in wet mixing cutting 2 minutes, obtains wet granular;
3) make dried granule
The wet granular that the last step was made changes in the ebullated dryer, and temperature is controlled at 60-70 ℃ of baking 17-20 minute, shuts down, clear filter bag, and blowing obtains dried granule;
4) tabletting, packing
To go up prepared dried granule of step and add pelletizing machine, start button carries out granulate, adds the carboxymethylstach sodium of recipe quantity and an amount of magnesium stearate again, and add three-dimensional mixer with suction feeding and mix, tabletting, packing promptly gets hydrochloric acid cefetamet pivoxil dispersible tablet.
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| CN102397249B (en) * | 2011-07-14 | 2013-01-23 | 海南美大制药有限公司 | Cefetamet pivoxil hydrochloride liposome solid preparation |
| CN102860990A (en) * | 2012-10-10 | 2013-01-09 | 浙江凯润制药有限公司 | Cefetamet pivoxil hydrochloride dispersible tablet and preparation method thereof |
| CN102895202A (en) * | 2012-10-10 | 2013-01-30 | 浙江凯润制药有限公司 | Cefetamet pivoxil hydrochloride dispersible tablet and preparation method thereof |
| CN104876947B (en) * | 2015-05-06 | 2017-09-29 | 山东罗欣药业集团股份有限公司 | Cefetamet Pivoxil Hydrochloride hydrate crystal and its dispersible tablet |
| CN106265574A (en) * | 2015-05-15 | 2017-01-04 | 烟台市华文欣欣医药科技有限公司 | A kind of method of the medicine Cefetamet Pivoxil Hydrochloride compositions preparing treatment sensitive organism infectious disease |
| CN105012245A (en) * | 2015-08-10 | 2015-11-04 | 青岛蓝盛洋医药生物科技有限责任公司 | Phlegm-dispersing drug ambroxol hydrochloride composition granules and preparing method thereof |
| GB2617603A (en) * | 2022-04-13 | 2023-10-18 | Univ Brunel | Compositions for preventing and treating infection |
-
2008
- 2008-02-04 CN CNB2008100091819A patent/CN100484574C/en active Active
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105168147A (en) * | 2015-09-11 | 2015-12-23 | 青岛蓝盛洋医药生物科技有限责任公司 | Pharmaceutical cefetamet pivoxil hydrochloride composite granule for treating bacterial infection |
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