CN1330306C - Moxifloxaci gelatin capsule and preparation process thereof - Google Patents
Moxifloxaci gelatin capsule and preparation process thereof Download PDFInfo
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- CN1330306C CN1330306C CNB2005100925249A CN200510092524A CN1330306C CN 1330306 C CN1330306 C CN 1330306C CN B2005100925249 A CNB2005100925249 A CN B2005100925249A CN 200510092524 A CN200510092524 A CN 200510092524A CN 1330306 C CN1330306 C CN 1330306C
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Abstract
The present invention discloses a moxifloxacin gelatin capsule. The content of the capsule contains moxifloxacin or the salt and/or the hydrate of the moxifloxacin, and additives, wherein the additives are selected from the following substances: sodium sulfite, sodium bisulfite, oligomeric anthocyanidin, L-glutathione, sesame polyphenol, tea polyphenol, tocopherol, ascorbic acid, isoascorbic acid, vitamin B1, vitamin B2, beta-carotene, soybean isoflavone, L-cysteine, pyrophosphoric acid, polyphosphoric acid and the medicinal salt of the polyphosphoric acid. The additives can be added into the content of the capsule by a conventional capsule preparation technique. The additives have an obvious inhibiting effect on no dissolution or the decrease of dissolution rate during the process of capsule storage to greatly improve the dissolution property of the capsule which is preserved for a long time.
Description
Technical field
The present invention relates to the pharmaceutical preparation of Moxifloxacin (moxifloxacin), concrete, the present invention relates to gelatine capsule agent of Moxifloxacin or its salt and/or its hydrate and preparation method thereof.
Background technology
Moxifloxacin (moxifloxacin) is a fluoroquinolone antimicrobial drug of new generation, at present these product ratify to be used for upper and lower respiratory tract infection due to the sensitive microbial abroad, as the treatment of acute episode of chronic bronchitis, community acquired pneumonia, acute bacterial sinusitis and uncomplicated skin and soft tissue infection.
The moxifloxacin oral preparation only has the moxifloxacin hydrochloride tablet at present, Chinese patent " pharmaceutical moxifloxacin preparation ", the patent No. 99813124.5, this oral drugs tablet is disclosed, and preparation method thereof, be that medicine and at least a no aqueous adhesive and lactose water are granulated, then with this granule and at least a disintegrating agent and at least a mix lubricant, and randomly tabletting and coating.
Other has Chinese patent application " Moxilfloxacin formulation containing common salt ", and application number 00811427.7 discloses moxifloxacin hydrochloride/sodium chloride transfusion, provides convenience for the patient with severe symptoms is difficult to oral this medicine.
Moxifloxacin capsule is not seen any report so far.The inventor discovers, in gelatine capsule shell, in the storage process, dissolving out capability descends, and can't reach medicinal requirements with the adjuvant filling of the pharmaceutical formulation of Moxifloxacin of the prior art.
Gelatine capsule shell is a capsule softgel shell commonly used, the inventor fills the pharmaceutical formulation of moxifloxacin hydrochloride of the prior art with gelatine capsule shell, the preparation capsule, and after carrying out 10 days 60 ℃ of stability experiments, measure dissolution, find that capsule softgel shell occurs and swells that to be the gum cover shape broken, content can't stripping, even or the softgel shell cut that has, stripping fully after 45 minutes, the room temperature reserved sample observing is placed and promptly to be begun to occur dissolution after 15 days and prolong the phenomenon that descends standing time with capsule.Fill capsule after further employing 3.5% of the inventor or 5%HPMC solution are granulated the capsule 's content of hydrochloric Moxifloxacin, the phenomenon that still existed not stripping of capsule or dissolution to descend behind the 60C stability experiment in 10 days.(all according to the first method-commentaries on classics blue laws 100rpm in two appendix XC of Chinese Pharmacopoeia version in 2000 dissolution method, dissolution fluid is a 0.1mol/L hydrochloric acid to above-mentioned dissolution determination method, and the content assaying method of the Moxifloxacin of stripping adopts the HPLC method).
Documents and materials do not see that the report of external stripping behavior change or stripping decline takes place for Moxifloxacin or its salt and/or its hydrate gelatine capsule agent in storage so far.
Summary of the invention
Purpose of the present invention is exactly in order to overcome the above problems, and provides a kind of and can improve the dissolution in storing, Moxifloxaci gelatin capsule of stripping stable in properties and preparation method thereof.
For achieving the above object, the present invention has adopted following technical scheme:
The invention discloses a kind of Moxifloxaci gelatin capsule, contain Moxifloxacin or its salt and/or its hydrate in the capsule 's content, and also contain additive in the capsule 's content, described additive is to be selected from least a in the following material:
Sodium sulfite, sodium sulfite, oligomeric anthocyanidin, L-glutathion, Semen Sesami polyphenol, tea polyphenols, tocopherol, ascorbic acid, arabo-ascorbic acid, vitamin B1, vitamin B2, beta-carotene, soybean isoflavone, L-cysteine, pyrophosphoric acid, polyphosphoric acids and pharmaceutical salts thereof.
Among the present invention, the additive that adds in the capsule 's content, can be one or more the mixing in the above-mentioned substance, keeping effect of the present invention, physical aspects change such as bonding, caking in the preparation process not to occur, and the stability that does not influence capsular dissolution and principal agent in study on the stability is standard.Among the present invention, the total amount of the additive that adds in the capsule 's content should be no more than the normal taking dose of human body.Institute's adding ingredient does not all find to influence the chemical stability of principal agent among the present invention.
The percentage by weight of described additive in capsule 's content is 0.1-20%.
When additive was vitamin B1, its preferable range that accounts for the percentage by weight of capsule 's content was 0.1-16%.
When additive was vitamin B2, its preferable range that accounts for the percentage by weight of capsule 's content was 0.1-6.5%.
The salt of Moxifloxacin comprises for example acid-addition salts, example hydrochloric acid salt, and/or its hydrate, for example preferred especially Moxifloxacin hydrochlorate of the present invention.
Moxifloxacin or its salt and/or its hydrate that contains survival dose of the present invention is meant and contains needed unit dose in the clinical practice in each capsule.Such as, in each capsule of the present invention, can contain this Moxifloxacin of 50～800mg or its salt and/or its hydrate, preferred 100～600mg, preferred especially 200～400mg.
Can also contain the pharmaceutic adjuvant of pharmaceutically acceptable amount in the capsule 's content of described capsule, described pharmaceutic adjuvant comprises one or more in diluent, disintegrating agent, adhesive, lubricant or the fluidizer.Diluent, disintegrating agent such as microcrystalline Cellulose, carboxymethylstach sodium commonly used; Described adhesive comprises hydroxypropyl cellulose (HPC), hydroxypropyl emthylcellulose (HPMC); Lubricant and fluidizer commonly used can be selected magnesium stearate and micropowder silica gel for use.Pharmaceutically acceptable amount specifically is meant in the prior art consumption of these adjuvants commonly used.
The invention also discloses the preparation method of above-mentioned Moxifloxaci gelatin capsule, described method comprises step: described Moxifloxacin or its salt and/or its hydrate are fully mixed with described additive or make granule, the gelatine capsule shell of packing into.
Further, with described Moxifloxacin or its salt and/or its hydrate and described additive, and fully mix with the pharmaceutic adjuvant of pharmaceutically acceptable amount or make granule, the gelatine capsule shell of packing into, described pharmaceutic adjuvant comprises one or more in diluent, disintegrating agent, adhesive, lubricant or the fluidizer.
The invention also discloses the another kind of preparation method of above-mentioned Moxifloxaci gelatin capsule; the method comprising the steps of: with described Moxifloxacin or its salt and/or its hydrate; prepare granule or carry out powder coating with the coating solution that contains described additive, be packed into gelatine capsule shell after the drying.
Further; behind the abundant mixing of pharmaceutic adjuvant with described Moxifloxacin or its salt and/or its hydrate and pharmaceutically acceptable amount; prepare granule or carry out powder coating with the coating solution that contains described additive; be packed into gelatine capsule shell after the drying, described pharmaceutic adjuvant comprises one or more in diluent, disintegrating agent, adhesive, lubricant or the fluidizer.
Owing to adopted above scheme, after having added the Moxifloxacin of additive or its salt and/or its hydrate and making the gelatine capsule agent, additive can play the obvious suppression effect to not stripping or dissolution decline that this capsule occurs in storage process, account for the additive of capsule 's content gross weight 0.1～20% in interpolation after, the dissolution that can make capsule is in 10 days 60 ℃ of stability experiments are investigated, insoluble broken during by doping not or be increased to more than 80% less than 50%, and investigate (40 ℃ at accelerated stability, relative humidity 75% accelerated stability is investigated three months) after, stripping character is still stable, and dissolution is more than 80%.
The specific embodiment
The present invention is described in further detail below by specific embodiment.
Used moxifloxacin hydrochloride structure is as follows among the present invention:
Molecular formula: C
21H
24FN
3O
4.HCl. molecular weight: 437.90
Used gelatine capsule is produced by Chinese Suzhou Capsule Co., Ltd among the present invention, and this gelatine capsule meets medicinal standard, and other adjuvants and additive are and meet medicinal or the food additive standard.
Test example 1
Component: moxifloxacin hydrochloride 218.4mg
Microcrystalline Cellulose 68.0mg
Lactose monohydrate 34.0mg
The interlinkage sodium carboxymethyl cellulose
*8mg
Magnesium stearate 2.4mg
Gross weight 330.8mg
It more than is the Chinese patent (patent No. 99813124.5, publication number CN1325306A) the uncoated tablets core of embodiment 4 prescription in, but in the disclosure text, the * place is a sodium carboxymethyl cellulose, it is translated by croscarmellose soldium, see this former patent specification page 2, and this translation error in fact just should indeed be translated as interlinkage sodium carboxymethyl cellulose (disintegrating agent).
Method for making: according to the uncoated tablets core granulating process of the moxifloxacin hydrochloride tablet of this patent documentation report, with medicine and microcrystalline Cellulose (the no aqueous adhesive that this patent documentation is alleged) and the granulation of lactose water, then this granule is mixed with interlinkage sodium carboxymethyl cellulose (disintegrating agent) and magnesium stearate (lubricant), get half and fill gelatine capsule., second half granule tabletting.
Study on the stability: the capsule of above-mentioned preparation and tablet are packed into and are sealed in the clad aluminum foil bag, study on the stability is after 30 days under 40 ℃ of environment, (promptly changeing blue laws according to first method in two appendix XC of Chinese Pharmacopoeia version in 2000 dissolution method measures to measure dissolution, rotating speed is 100rpm, dissolution fluid is a 0.1mol/L hydrochloric acid, be 45 minutes sample time, and the content assaying method of the Moxifloxacin of stripping adopts the HPLC method).
The result is as follows:
| Sample | The result is investigated in stripping |
| Tablet | Dissolution 99.8% |
| Capsule | Capsule shells swelling, not stripping of principal agent. |
The result shows: according to the formulation and technology of the moxifloxacin hydrochloride tablet embodiment of patent documentation (Chinese patent publication number CN1325306A) report, can not prepare simply that placement for a long time, dissolution are the same with tablet stablizes constant snap fit capsule.
Test example 2
Moxifloxacin hydrochloride is directly filled gelatine capsule
Form and preparation: get moxifloxacin hydrochloride 218.4mg, directly fill gelatine capsule.
Study on the stability: carry out according to method described in the test example 1.
Result: capsule shells swelling, not stripping of principal agent.
Test example 3
Component: moxifloxacin hydrochloride 218.4mg
Microcrystalline Cellulose 49.0mg
Carboxymethylstach sodium 56.0mg
Magnesium stearate 4.0mg
Micropowder silica gel 2.6mg
330.0mg
Method for making: get former, the adjuvant of above-mentioned amount, abundant mix homogeneously, dry granulation, mixing is filled gelatine capsule.
Study on the stability: the capsule of above-mentioned preparation is packed into and is sealed in the clad aluminum foil bag, and after 40 ℃, relative humidity 75% accelerated stability were investigated three months, dissolution was measured according to measuring method of dissolution described in the test example 1.
Result: capsule shells swelling, not stripping of principal agent.
Test example 4
Component: moxifloxacin hydrochloride 218.4mg
Microcrystalline Cellulose 40.0mg
Carboxymethylstach sodium 56.0mg
Magnesium stearate 4.0mg
Micropowder silica gel 2.6mg
HPMC 1.0mg
330.0mg
Method for making: get above-mentioned amount HPMC, add water and be mixed with 1% solution as adhesive; Get above-mentioned amount moxifloxacin hydrochloride, microcrystalline Cellulose and carboxymethylstach sodium, fully mix homogeneously adds adhesive system wet granular, drying, and granulate adds the magnesium stearate and the micropowder silica gel of above-mentioned amount, mix homogeneously, filling gelatine capsule.
The study on the stability result: the capsule of above-mentioned preparation is packed into and is sealed in the clad aluminum foil bag, and after 40 ℃, relative humidity 75% accelerated stability were investigated three months, dissolution was measured according to measuring method of dissolution described in the test example 1.
Result: capsule shells swelling, not stripping of principal agent.
Test example 5
Component: moxifloxacin hydrochloride 218mg
Carboxymethylstach sodium 15mg
HPMC 3.5mg
236.5mg
Method for making: get above-mentioned amount HPMC, add water and be mixed with 3.5% solution as adhesive; Get above-mentioned amount moxifloxacin hydrochloride and carboxymethylstach sodium, fully mix homogeneously adds adhesive system wet granular, drying, and granulate is filled gelatine capsule.
The study on the stability result: the capsule of above-mentioned preparation is packed into and is sealed in the clad aluminum foil bag, and after 40 ℃, relative humidity 75% accelerated stability were investigated three months, dissolution was measured according to measuring method of dissolution described in the test example 1.
Result: capsule shells swelling, not stripping of principal agent.
Embodiment 1～17 and reference examples
Respectively according to following table 1, listed each amounts of components of table 2, select for use sodium sulfite, sodium sulfite, oligomeric anthocyanidin, tea polyphenols, tocopherol, ascorbic acid, arabo-ascorbic acid, L-glutathion, Semen Sesami polyphenol, vitamin B1, vitamin B2, beta-carotene, soybean isoflavone, L-cysteine and tetrasodium pyrophosphate, polyphosphoric acids calcium as additive respectively, and do not add any additives (reference examples), prepare the gelatine capsule of moxifloxacin hydrochloride.
Method for making and study on the stability: be filled in the gelatine capsule shell behind former, the adjuvant mix homogeneously of the amount of getting described in table 1 and the table 2, use aluminium-plastic bubble plate packing, investigated dissolution behind 60 ℃ of stability experiments through 10 days.
The result shows, after 10 days, the dissolution of the capsule dissolution that adds the above-mentioned additive that accounts for the capsule 's content proper proportion during with firm preparation compared, and do not descend substantially, all greater than 95%; And insoluble broken, the average principal agent stripping quantity of not additivated capsule shells part seldom (36%).
Dissolution determination is measured according to measuring method of dissolution described in the test example 1.
Table 1. (every capsules group component, unit are mg)
Table 2. (every capsules group component, unit are mg)
Embodiment 18～42
Form: respectively shown in table 3～table 8
Method for making: get former, the abundant mix homogeneously of adjuvant of amount described in the table, filled capsules gets final product.
Study on the stability: the capsule of above-mentioned preparation is packed into and is sealed in the clad aluminum foil bag, after 40 ℃, relative humidity 75% accelerated stability are investigated three months, investigates dissolution, and dissolution determination is measured according to measuring method of dissolution described in the test example 1.
The result shows: dissolution is all greater than 80%.
Table 3. (every capsules group component, unit are mg)
Table 4 (every capsules group component, unit are mg)
Table 5 (every capsules group component, unit are mg)
Table 6 (every capsules group component, unit are mg)
Table 7 (every capsules group component, unit are mg)
Embodiment 43～47
Form: as table 8
Method for making: the amount of getting described in the table is former, adjuvant (removing oligomeric anthocyanidin), part of stearic acid magnesium, part micropowder silica gel, abundant mix homogeneously, and dry granulation adds oligomeric anthocyanidin and residue magnesium stearate, micropowder silica gel, and mixing is filled gelatine capsule.
Study on the stability: the capsule of above-mentioned preparation is packed into and is sealed in the clad aluminum foil bag, after 40 ℃, relative humidity 75% accelerated stability are investigated three months, investigates dissolution, and dissolution determination is measured according to measuring method of dissolution described in the test example 1.
The result shows: dissolution is all greater than 80%.Concrete outcome sees Table 8
Table 8 (every capsules group component, unit are mg)
Embodiment 48
Form: moxifloxacin hydrochloride 218.4mg
Microcrystalline Cellulose 29.0mg
Carboxymethylstach sodium 56.0mg
Magnesium stearate 6.6mg
310.0mg
Coating fluid prescription (%w/w)
HPMC 7.5
Propylene glycol 1.5
Sodium sulfite 5.0
Tea polyphenols (80%) 3.0
Distilled water 83.0
Total amount 100.0
Method for making: get that above-mentioned amount is former, the abundant mix homogeneously of adjuvant (getting 1/2 amount magnesium stearate), dry granulation behind coating solution bag granule, adds residue magnesium stearate mixing, fills gelatine capsule.
Study on the stability: the capsule of above-mentioned preparation is packed into and is sealed in the clad aluminum foil bag, after 40 ℃, relative humidity 75% accelerated stability are investigated three months, investigates dissolution, and dissolution determination is measured according to measuring method of dissolution described in the test example 1.
The result shows: dissolution is 98%, does not relatively have difference with capsule (0 day) data (99%) of firm preparation.
Embodiment 49～70
Form: respectively shown in table 9～table 10
Method for making: get former, the abundant mix homogeneously of adjuvant of amount described in the table, filled capsules gets final product.
Study on the stability: the capsule of above-mentioned preparation is packed into and is sealed in the clad aluminum foil bag, after 40 ℃, relative humidity 75% accelerated stability are investigated three months, investigates dissolution, and dissolution determination is measured according to measuring method of dissolution described in the test example 1.
The result shows: dissolution is all greater than 80%, and concrete outcome sees Table shown in the 9～table 10.
Table 9. (every capsules group component, unit are mg)
Table 10. (every capsules group component, unit are mg)
More than each embodiment show, after in capsule 's content, adding described additive, the obviously situation of decline can not appear in gelatine capsule agent dissolution in storage process, and the amount of the additive that is added only needs in content range of the present invention, all can reach the stripping stability action effect in the storage process improved much at one.
Claims (14)
1, a kind of Moxifloxaci gelatin capsule is characterized in that: contain Moxifloxacin or its salt and/or its hydrate in the capsule 's content, and be selected from additive at least a in the following material:
Sodium sulfite, sodium sulfite, oligomeric anthocyanidin, L-glutathion, Semen Sesami polyphenol, tea polyphenols, tocopherol, ascorbic acid, arabo-ascorbic acid, vitamin B
1, vitamin B
2, beta-carotene, soybean isoflavone, L-cysteine, pyrophosphoric acid, polyphosphoric acids and pharmaceutical salts thereof.
2, a kind of Moxifloxaci gelatin capsule according to claim 1 is characterized in that: the percentage by weight of described additive in capsule 's content is 0.1-20%.
3, a kind of Moxifloxaci gelatin capsule according to claim 2 is characterized in that: described additive is a vitamin B1, and the percentage by weight that this additive accounts for capsule 's content is 0.1-16%.
4, a kind of Moxifloxaci gelatin capsule according to claim 2 is characterized in that: described additive is a vitamin B2, and the percentage by weight that this additive accounts for capsule 's content is 0.1-6.5%.
5, according to the arbitrary described a kind of Moxifloxaci gelatin capsule of claim 1～4, it is characterized in that: described Moxifloxacin or its salt and/or its hydrate are meant moxifloxacin hydrochloride.
6, a kind of Moxifloxaci gelatin capsule according to claim 5, it is characterized in that: also contain the pharmaceutic adjuvant of pharmaceutically acceptable amount in the capsule 's content of described capsule, described pharmaceutic adjuvant comprises one or more in diluent, disintegrating agent, adhesive, lubricant or the fluidizer.
7, a kind of Moxifloxaci gelatin capsule according to claim 6, it is characterized in that: described diluent and disintegrating agent comprise microcrystalline Cellulose, carboxymethylstach sodium.
8, a kind of Moxifloxaci gelatin capsule according to claim 6, it is characterized in that: described adhesive comprises hydroxypropyl cellulose, hydroxypropyl emthylcellulose.
9, a kind of Moxifloxaci gelatin capsule according to claim 6, it is characterized in that: described lubricant comprises magnesium stearate.
10, a kind of Moxifloxaci gelatin capsule according to claim 6, it is characterized in that: described fluidizer comprises micropowder silica gel.
11, the preparation method of the described a kind of Moxifloxaci gelatin capsule of claim 1, described method comprises step: described Moxifloxacin or its salt and/or its hydrate are fully mixed with described additive or make granule, the gelatine capsule shell of packing into.
12, preparation method according to claim 11, it is characterized in that: described step further is meant: with described Moxifloxacin or its salt and/or its hydrate and described additive, and fully mix with the pharmaceutic adjuvant of pharmaceutically acceptable amount or make granule, the gelatine capsule shell of packing into, described pharmaceutic adjuvant comprises one or more in diluent, disintegrating agent, adhesive, lubricant or the fluidizer.
13, the preparation method of the described a kind of Moxifloxaci gelatin capsule of claim 1; described method comprises step: with described Moxifloxacin or its salt and/or its hydrate; prepare granule or carry out powder coating with the coating solution that contains described additive, be packed into gelatine capsule shell after the drying.
14, preparation method according to claim 13; it is characterized in that: described step further is meant: behind the abundant mixing of pharmaceutic adjuvant with described Moxifloxacin or its salt and/or its hydrate and pharmaceutically acceptable amount; prepare granule or carry out powder coating with the coating solution that contains described additive; be packed into gelatine capsule shell after the drying, described pharmaceutic adjuvant comprises one or more in diluent, disintegrating agent, adhesive, lubricant or the fluidizer.
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| Application Number | Priority Date | Filing Date | Title |
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| CNB2005100925249A CN1330306C (en) | 2004-08-11 | 2005-08-11 | Moxifloxaci gelatin capsule and preparation process thereof |
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| CN200410058049.9 | 2004-08-11 | ||
| CNB2005100925249A CN1330306C (en) | 2004-08-11 | 2005-08-11 | Moxifloxaci gelatin capsule and preparation process thereof |
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| CN1330306C true CN1330306C (en) | 2007-08-08 |
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Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1911102B (en) * | 2006-05-30 | 2010-07-14 | 安寿松 | Compounding agent for sobering and health-care, and its production method |
| CN102247314A (en) * | 2011-01-12 | 2011-11-23 | 北京润德康医药技术有限公司 | Oral solid preparation using moxifloxacin as active component |
| CN102908323B (en) * | 2012-10-30 | 2015-03-04 | 天津红日药业股份有限公司 | Moxifloxacin-containing pharmaceutical composition |
| CN103860520A (en) * | 2012-12-14 | 2014-06-18 | 南京长澳医药科技有限公司 | Moxifloxacin capsules, and preparation method thereof |
| CN104523653B (en) * | 2015-02-06 | 2017-03-29 | 杭州朱养心药业有限公司 | Acarbose capsules agent pharmaceutical composition |
| CN104546795B (en) * | 2015-02-06 | 2018-02-02 | 杭州朱养心药业有限公司 | Acarbose capsules agent and preparation method |
| CN105963320A (en) * | 2016-05-03 | 2016-09-28 | 黄爱苓 | Capsule for assisting CT locating radiotherapy of malignant tumor and preparation method of capsule |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1325306A (en) * | 1998-11-10 | 2001-12-05 | 拜尔公司 | Pharmaceutical moxifloxacin preparation |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1325306A (en) * | 1998-11-10 | 2001-12-05 | 拜尔公司 | Pharmaceutical moxifloxacin preparation |
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Application publication date: 20060222 Assignee: Jiangsu Tianyishi Pharm Co., Ltd. Assignor: Tianyishi Sci-Tech Development Co., Ltd., Shenzhen Contract record no.: 2010320000719 Denomination of invention: Moxifloxaci gelatin capsule and preparation process thereof Granted publication date: 20070808 License type: Exclusive License Record date: 20100602 |
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