CN101711748A - Method for preparing cefaclor dispersible tablets by dry method direct tablet compressing and cefaclor dispersible tablets prepared by same - Google Patents
Method for preparing cefaclor dispersible tablets by dry method direct tablet compressing and cefaclor dispersible tablets prepared by same Download PDFInfo
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- CN101711748A CN101711748A CN200910185664A CN200910185664A CN101711748A CN 101711748 A CN101711748 A CN 101711748A CN 200910185664 A CN200910185664 A CN 200910185664A CN 200910185664 A CN200910185664 A CN 200910185664A CN 101711748 A CN101711748 A CN 101711748A
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Abstract
The invention relates to the field of medicinal preparations, in particular to a method for preparing cefaclor dispersible tablets by dry method direct tablet compressing and cefaclor dispersible tablets prepared by the same. The method comprises the following steps of: firstly, respectively sieving cefaclor and various auxiliary materials by a sieve of 80 meshes for later use; then respectively drying the auxiliary materials and cooling to room temperature; and finally, mixing the dried and cooled auxiliary materials with the cefaclor and then directly pressing tablets. The method has less production working procedures, simple equipment, short period and smaller medicament loss. The cefaclor dispersible tablets prepared by the dry method direct tablet compressing have quick disintegration and high stability.
Description
Technical field
The present invention relates to field of pharmaceutical preparations, be specifically related to a kind of dry method direct compression and prepare the method for cefaclor dispersible tablet and the cefaclor dispersible tablet for preparing by this method.
Background technology
The cefaclor dispersible tablet is compared with its common tablet, capsule, have taking convenience, absorb very fast, onset early, bioavailability is than advantages such as height, is specially adapted to the child, the old man takes.
China produces the technology that the cefaclor dispersible tablet is the employing wet granule compression tablet at present, it is with after adjuvant mixes with medicine, add binding agent and make soft material, through granulation, dry, mixing, carry out tabletting again, but its processing step is more again, cycle is long, the medicine loss is bigger, owing in this technology, need the process of high temperature drying, and stable influential to the cefaclor dispersible tablet.
Summary of the invention
The purpose of this invention is to provide the method that a kind of dry method direct compression prepares the cefaclor dispersible tablet, this preparation method is to adopt the dry method direct compression, and production process is few, equipment is simple, and the cycle is short, and the medicine loss is less, cefaclor dispersible tablet disintegrate by this method preparation is fast, and stability is high.
Dry method direct compression of the present invention prepares the method for cefaclor dispersible tablet, may further comprise the steps:
A, cross behind 80 mesh sieves cefaclor and various adjuvant standby respectively;
B, various adjuvants are dry respectively and be cooled to room temperature;
C, with the cooled various adjuvants of drying mix with cefaclor the back direct compression.
Dry method direct compression of the present invention prepares the method for cefaclor dispersible tablet, be to be used in the powder direct compression, so-called dry powder direct tabletting be with drug powder with handle after adjuvant mix after, need not through system soft material, granulation, drying and other steps, directly carry out tabletting, dry method direct compression of the present invention prepares the method for cefaclor dispersible tablet, production process is few, equipment is simple, cycle is short, the medicine loss is less, and fast by the cefaclor dispersible tablet disintegrate of the method for dry method direct compression of the present invention preparation, stability is high.
Another object of the present invention provides a kind of cefaclor dispersible tablet that is prepared by the method for above-mentioned dry method direct compression, and the disintegrate of this cefaclor dispersible tablet is fast, and stability is high.
By the cefaclor dispersible tablet of the method for above-mentioned dry method direct compression preparation, may further comprise the steps and be prepared from:
A, with cefaclor: microcrystalline Cellulose: carboxymethylstach sodium: micropowder silica gel: Pulvis Talci: magnesium stearate is 25: 58: 6 according to mass ratio: after preparing at 3: 4: 1, cross behind 80 mesh sieves standby respectively;
B, the microcrystalline Cellulose with standby, carboxymethylstach sodium, micropowder silica gel, Pulvis Talci, magnesium stearate are dry respectively and be cooled to room temperature;
C, the more cooled microcrystalline Cellulose of drying, carboxymethylstach sodium, micropowder silica gel, Pulvis Talci, magnesium stearate are mixed with cefaclor the back direct compression get the cefaclor dispersible tablet.
By the cefaclor dispersible tablet of the method for above-mentioned dry method direct compression preparation, may further comprise the steps and be prepared from:
A, with cefaclor: microcrystalline Cellulose: carboxymethylstach sodium: micropowder silica gel: Pulvis Talci: magnesium stearate is 100: 84: 10.4 according to mass ratio: after preparing at 6: 6: 1, cross behind 80 mesh sieves standby respectively;
B, microcrystalline Cellulose, carboxymethylstach sodium, micropowder silica gel, Pulvis Talci, magnesium stearate is dry respectively and be cooled to room temperature;
C, the more cooled microcrystalline Cellulose of drying, carboxymethylstach sodium, micropowder silica gel, Pulvis Talci, magnesium stearate are mixed with cefaclor the back direct compression get the cefaclor dispersible tablet.
The prescription of two kinds of above-mentioned different quality ratios, it is the cefaclor dispersible tablet of two kinds of specifications of the present invention, cefaclor wherein is a crude drug, microcrystalline Cellulose is a diluent, carboxymethylstach sodium is a disintegrating agent, and micropowder silica gel, Pulvis Talci and magnesium stearate are lubricants, and the cefaclor dispersible tablet disintegrate of making according to the method for above-mentioned dry method direct compression is fast, stability is high, and taking convenience, absorb fast, onset early, the bioavailability height.
Figure of description
Fig. 1 is the dissolution rate curve comparison diagram of cefaclor dispersible tablet.
The specific embodiment
The cefaclor dispersible tablet of the method preparation of dry method direct compression of the present invention, its concrete mass ratio of forming is as follows:
Cefaclor: microcrystalline Cellulose: carboxymethylstach sodium: micropowder silica gel: Pulvis Talci: magnesium stearate=25: 58: 6: 3: 4: 1.
Cefaclor: microcrystalline Cellulose: carboxymethylstach sodium: micropowder silica gel: Pulvis Talci: magnesium stearate=100: 84: 10.4: 6: 6: 1.
The composition of the cefaclor dispersible tablet of above-mentioned two kinds of different quality ratios of the present invention, can be made into the cefaclor dispersible tablet of two kinds of different sizes, wherein cefaclor: microcrystalline Cellulose: carboxymethylstach sodium: micropowder silica gel: Pulvis Talci: magnesium stearate=25: 58: 6: the cefaclor dispersible tablet that can make the 0.125g specification at 3: 4: 1; Cefaclor: microcrystalline Cellulose: carboxymethylstach sodium: micropowder silica gel: Pulvis Talci: magnesium stearate=100: 84: 10.4: can make the dispersible tablet of 0.25g specification at 6: 6: 1; After preparing raw material according to said ratio, at first cefaclor crude drug and microcrystalline Cellulose, carboxymethylstach sodium, micropowder silica gel, Pulvis Talci, magnesium stearate are crossed 80 mesh sieves respectively, can screen out bigger granule and crystalline solid like this, the fineness crossed behind 80 mesh sieves of crude drug and adjuvant just helps mix homogeneously like this; Again with microcrystalline Cellulose, carboxymethylstach sodium, micropowder silica gel, Pulvis Talci, magnesium stearate is dry respectively, be cooled to room temperature then, again each adjuvant is mixed in three-dimensional mixer with the cefaclor crude drug, at last blended material direct compression is got final product the cefaclor dispersible tablet, cefaclor wherein is a crude drug, microcrystalline Cellulose is a diluent, carboxymethylstach sodium is a disintegrating agent, micropowder silica gel, Pulvis Talci and magnesium stearate are lubricants, the cefaclor dispersible tablet disintegrate made according to above-mentioned preparation method is fast, good stability, and taking convenience, absorb fast, onset early, the bioavailability height.
Preparation method of the present invention is to adopt dry powder direct tabletting to prepare the cefaclor dispersible tablet, so-called dry powder direct tabletting be with the material medicine powder with handle after adjuvant mixes after, need not to pass through and make soft material, granulation, drying and other steps, directly carry out tabletting; In the present invention, at first cefaclor crude drug and adjuvant are crossed 80 mesh sieves respectively, can screen out bigger granule and crystalline solid like this, the fineness that crude drug and adjuvant are crossed behind 80 mesh sieves just helps mix homogeneously; Again that each adjuvant is dry respectively, be cooled to room temperature then, again each adjuvant is mixed in three-dimensional mixer with the cefaclor crude drug, at last blended material direct compression is got final product, the method for preparing the cefaclor dispersible tablet of the present invention, be to adopt the dry method direct compression, production process is few, and equipment is simple, cycle is short, the dry method direct compression has avoided the cefaclor crude drug to need the process of drying, and the medicine loss is less, and stability is improved, according to said method the disintegration time of the cefaclor dispersible tablet of preparation is short simultaneously, the stripping homogeneity is good, can make medicine rapid-action like this, absorb soon, can increase its bioavailability.
Prepare in the method for cefaclor dispersible tablet at dry method direct compression of the present invention, described drying is meant that the moisture that keeps microcrystalline Cellulose, carboxymethylstach sodium, micropowder silica gel, Pulvis Talci, magnesium stearate is below 2%; Drying generally is meant microcrystalline Cellulose, carboxymethylstach sodium, micropowder silica gel, Pulvis Talci, magnesium stearate be placed on respectively and carries out drying in the baking oven among the present invention, keeping oven temperature when drying is 50-70 ℃, be 4-5 hour drying time, the good fluidity of the adjuvant of Chu Liing like this, be convenient to mix, also can not exert an influence the stability of cefaclor dispersible tablet.
Prepare in the method for cefaclor dispersible tablet at dry method direct compression of the present invention, described cooled microcrystalline Cellulose, carboxymethylstach sodium, micropowder silica gel, Pulvis Talci, magnesium stearate are mixed with cefaclor is meant it mixed 40 minutes at least, can in three-dimensional mixer, mix, guarantee that like this cefaclor crude drug can fully mix with various adjuvants.
Embodiment 1
Weighting raw materials cefaclor 125g, microcrystalline cellulose excipients 290g, carboxymethylstach sodium 30g, micropowder silica gel 15g, Pulvis Talci 20g, magnesium stearate 5g cross 80 mesh sieves respectively; 50-70 ℃ of baking oven inner drying pretreatment 4 hours, moisture Control was below 2% and be cooled to room temperature with each adjuvant; With the cefaclor crude drug fully mixes 40 minutes in three-dimensional mixer after, direct compression prepares 1000 altogether with pretreated adjuvant.
Embodiment 2
Weighting raw materials cefaclor 250g, microcrystalline cellulose excipients 210g, carboxymethylstach sodium 26g, micropowder silica gel 15g, Pulvis Talci 15g, magnesium stearate 2.5g; Cross 80 mesh sieves respectively.50-70 ℃ of baking oven inner drying pretreatment 5 hours, moisture Control was below 2% and be cooled to room temperature with adjuvant; With the cefaclor crude drug fully mixes 40 minutes in three-dimensional mixer after, direct compression prepares 1000 altogether with pretreated adjuvant.
It below is the comparison of the cefaclor dispersible tablet for preparing of cefaclor dispersible tablet and the traditional wet granule compression tablet method of dry method direct compression of the present invention preparation.
Table 1: preparation process is to the influence of cefaclor dispersible tablet
| Preparation method | Cefaclor inventory (%) | Theoretical content (%) | Actual measurement content (%) | Preparation process loss amount (%) |
| Wet granule compression tablet | ??100 | ??100 | ??96.4 | ??3.6％ |
| Dry powder direct tabletting | ??100 | ??100 | ??99.1 | ??0.9％ |
The result shows, adopt dry powder direct tabletting to compare with wet granule compression tablet, wet granule compression tablet preparation process Chinese medicine waste is 4 times of dry method direct compression, reduces so the waste of the medicine of the prepared cefaclor dispersible tablet of dry powder direct tabletting of the present invention has significantly.
Table 2: disintegration relatively
| Preparation method | Wet granule compression tablet | Dry powder direct tabletting |
| Disintegration (second) | ??106 | ??38 |
The result shows that be significantly less than wet granule compression tablet the disintegration of the cefaclor dispersible tablet of dry powder direct tabletting gained, and rapidly disintegrate of medicine is described, can make medicine rapid-action, absorb soon, can increase bioavailability.
Table 3: dissolution rate relatively
By table 3 and Fig. 1 as can be known, the cefaclor dispersible tablet of two kinds of preparation method gained is all strippings fully in 30 minutes, dissolution rate does not have significant change, but dry powder direct tabletting cefaclor dispersible tablet is better than the stripping homogeneity of wet granule compression tablet cefaclor dispersible tablet, explanation can make medicine rapid-action, absorb soon, and can increase bioavailability.
Press the cefaclor dispersible tablet of embodiment 1 preparation, press commercially available back, under 40 ℃ ± 2 ℃ of temperature, relative humidity 75% ± 5% condition, placed 6 months, the results are shown in Table 4.
Table 4: accelerated test result's (0.125g specification)
The result shows that cefaclor dispersible tablet (0.125g specification) is placed stable in properties under 40 ℃ ± 2 ℃ of temperature, relative humidity 75% ± 5% condition.
Press the cefaclor dispersible tablet of embodiment 2 preparations, press commercially available back, under 40 ℃ ± 2 ℃ of temperature, relative humidity 75% ± 5% condition, placed 6 months, the results are shown in Table 5.
Table 5: accelerated test result's (0.25g specification)
The result shows that cefaclor dispersible tablet (0.25g specification) is placed stable in properties under 40 ℃ ± 2 ℃ of temperature, relative humidity 75% ± 5% condition.
Cefaclor dispersible tablet of the present invention is when being used for the treatment of respiratory infection diseases, and case load is 86 examples, each oral 250mg, and every day 3 times, be 5-8 days the course of treatment; When the treatment gonorrhea, each oral 250mg, every day 3 times, be 10-14 days the course of treatment; When the treatment acute tonsillitis, each oral 250mg, every day 3 times, be 5-8 days the course of treatment; Therapeutic outcome sees table 6 for details.
Table 6: the efficacy analysis of cefaclor dispersible tablet of the present invention
| Symptom and sign | Case load before the medication | Routine number disappears after the medication | Disappearance rate/% |
| Respiratory tract infection | ??86 | ??76 | ??88.37 |
| Gonorrhea | ??37 | ??29 | ??78.38 |
| Acute tonsillitis | ??54 | ??54 | ??100.00 |
Claims (8)
1. a dry method direct compression prepares the method for cefaclor dispersible tablet, may further comprise the steps:
A, cross behind 80 mesh sieves cefaclor and various adjuvant standby respectively;
B, various adjuvants are dry respectively and be cooled to room temperature;
C, with the cooled various adjuvants of drying mix with cefaclor the back direct compression.
2. preparation method according to claim 1 is characterized in that: described drying is meant that the moisture that keeps various adjuvants is below 2%.
3. preparation method according to claim 1 is characterized in that: the described various adjuvants in drying cooling back are mixed with cefaclor is meant it mixed 40 minutes at least.
4. preparation method according to claim 2 is characterized in that: described drying is dry in 50-70 ℃ environment.
5. preparation method according to claim 4 is characterized in that: the described exsiccant time is 4-5 hour.
6. preparation method according to claim 5 is characterized in that: described drying is dry in baking oven.
7. cefaclor dispersible tablet according to the preparation of the described method of claim 1 may further comprise the steps and is prepared from:
A, with cefaclor: microcrystalline Cellulose: carboxymethylstach sodium: micropowder silica gel: Pulvis Talci: magnesium stearate is 25: 58: 6 according to mass ratio: after preparing at 3: 4: 1, cross behind 80 mesh sieves standby respectively;
B, the microcrystalline Cellulose with standby, carboxymethylstach sodium, micropowder silica gel, Pulvis Talci, magnesium stearate are dry respectively and be cooled to room temperature;
C, the more cooled microcrystalline Cellulose of drying, carboxymethylstach sodium, micropowder silica gel, Pulvis Talci, magnesium stearate are mixed with cefaclor the back direct compression get the cefaclor dispersible tablet.
8. cefaclor dispersible tablet according to the preparation of the described method of claim 1 may further comprise the steps and is prepared from:
A, with cefaclor: microcrystalline Cellulose: carboxymethylstach sodium: micropowder silica gel: Pulvis Talci: magnesium stearate is 100: 84: 10.4 according to mass ratio: after preparing at 6: 6: 1, cross behind 80 mesh sieves standby respectively;
B, the microcrystalline Cellulose with standby, carboxymethylstach sodium, micropowder silica gel, Pulvis Talci, magnesium stearate are dry respectively and be cooled to room temperature;
C, the more cooled microcrystalline Cellulose of drying, carboxymethylstach sodium, micropowder silica gel, Pulvis Talci, magnesium stearate are mixed with cefaclor the back direct compression get the cefaclor dispersible tablet.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106798732A (en) * | 2016-07-19 | 2017-06-06 | 四川赛卓药业股份有限公司 | A kind of cefixime dispersible tablet and preparation method |
| CN113750066A (en) * | 2021-10-12 | 2021-12-07 | 上海金城素智药业有限公司 | Cefaclor preparation with clinical advantages and preparation method and application thereof |
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2009
- 2009-11-27 CN CN200910185664A patent/CN101711748A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106798732A (en) * | 2016-07-19 | 2017-06-06 | 四川赛卓药业股份有限公司 | A kind of cefixime dispersible tablet and preparation method |
| CN113750066A (en) * | 2021-10-12 | 2021-12-07 | 上海金城素智药业有限公司 | Cefaclor preparation with clinical advantages and preparation method and application thereof |
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Open date: 20100526 |