CN100363001C - Moxifloxacin capsule and its preparation method - Google Patents
Moxifloxacin capsule and its preparation method Download PDFInfo
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- CN100363001C CN100363001C CNB2005100217391A CN200510021739A CN100363001C CN 100363001 C CN100363001 C CN 100363001C CN B2005100217391 A CNB2005100217391 A CN B2005100217391A CN 200510021739 A CN200510021739 A CN 200510021739A CN 100363001 C CN100363001 C CN 100363001C
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Abstract
The present invention discloses a moxifloxacin capsule. The capsule content comprises moxifloxacin or salts thereof and/or hydrates thereof. The capsule content also comprises at least one kind of disintegrating agent and at least one kind of lubricant, and the capsule shell of the capsule is made of hydroxypropyl methyl cellulose. The present invention also discloses a preparation method for the moxifloxacin capsule, and the method comprises the following steps: moxifloxacin or salts thereof and/or hydrates thereof, at least one kind of disintegrating agent and at least one kind of lubricant are thoroughly mixed or made into granules, and the mixture or the granules are filled in the hydroxypropyl methyl cellulose capsule shells. The moxifloxacin capsule which adopts the hydroxypropyl methyl cellulose capsule shell has stable dissolution performance, the dissolution condition of the moxifloxacin capsule is basically unchanged after long-term preservation (two years), the dissolution of the moxifloxacin capsule after long-term preservation is nearly the same as that of a freshly prepared moxifloxacin capsule, and the dissolution is above 90%.
Description
Technical field
The present invention relates to the pharmaceutical preparation of a kind of Moxifloxacin (moxifloxacin), concrete, the present invention relates to a kind of capsule dosage form 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 this product have gone on the market with tablet and injection and have been used for upper and lower respiratory tract infection due to the sensitive microbial, as the treatment of acute episode of chronic bronchitis, community acquired pneumonia, acute bacterial sinusitis and uncomplicated skin and soft tissue infection etc.
The oral formulations of Moxifloxacin listing at present only has the moxifloxacin hydrochloride tablet, 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.
But the common formulations capsule as oral drugs does not appear in the newspapers 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 supplementary material 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 60 ℃ of stability experiments in 10 days.Once strengthening the disintegrating agent consumption in moxifloxacin hydrochloride capsule prescription investigates, show that all the stripping behavior makes moderate progress though high temperature at that time and illumination accelerated tests and room temperature are placed the investigation of 20 days, 43 days and 3 months, room temperature is placed to observe after 1 year and is shown that still stripping is defective.(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 and the solution thereof of external stripping behavior change or stripping decline take place for Moxifloxacin or its salt and/or its hydrate gelatine capsule agent in storage so far.
Summary of the invention
The objective of the invention is in order to provide a kind of dissolution height and dissolving out capability to keep long-time stable Moxifloxacin or the capsule dosage form of its salt and/or its hydrate and the preparation method of this capsule.
For achieving the above object, the present invention has adopted following technical scheme:
The invention discloses a kind of moxifloxacin capsule, contain Moxifloxacin or its salt and/or its hydrate in the capsule 's content, also contain at least a disintegrating agent and at least a lubricant in the described capsule 's content, and the capsule shells of described capsule is the hydroxypropyl methylcellulose capsules shell.
Described Moxifloxacin or its salt and/or its hydrate are moxifloxacin hydrochloride.
Described disintegrating agent comprises carboxymethylstach sodium, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose, crospolyvinylpyrrolidone.
The addition of described disintegrating agent accounts for 5～50% of capsule 's content total amount.Further, the addition of described disintegrating agent accounts for 25～35% of capsule 's content total amount.
Described lubricant comprises magnesium stearate.
Can also contain one or more of the pharmaceutic adjuvant of other pharmaceutically acceptable amounts such as diluent, adhesive etc. in the capsule 's content of described capsule.Pharmaceutically acceptable amount specifically is meant in the prior art consumption of these adjuvants commonly used.
In embodiment preferred of the present invention, described capsule contains 65～74% Moxifloxacin or its salt and/or its hydrate, 25～34% disintegrating agent, and 1.0～1.5% lubricant; Described disintegrating agent is one or more mixture that are selected from carboxymethylstach sodium, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose, the crospolyvinylpyrrolidone, and described lubricant is a magnesium stearate.
Above-mentioned percentage composition all is weight percentage.
The invention also discloses the preparation method of above-mentioned moxifloxacin capsule, described method comprises step: Moxifloxacin or its salt and/or its hydrate are fully mixed with at least a disintegrating agent and at least a lubricant or make granule, fill the hydroxypropyl methylcellulose capsules shell.Granule can adopt the conventional dose section of learning to do, and comprises dry granulation or wet granulation.
Described Moxifloxacin or its salt and/or its hydrate are moxifloxacin hydrochloride.
Described disintegrating agent comprises carboxymethylstach sodium, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose, crospolyvinylpyrrolidone.
Described lubricant comprises magnesium stearate.
Because adopted above scheme, the beneficial effect that the present invention is possessed is:
The moxifloxacin capsule that the present invention is prepared adopts the hydroxypropyl methylcellulose capsules shell, can overcome existing pharmaceutical moxifloxacin preparation prescription is added the problem that causes capsule stripping behavior change, dissolution to descend after the gelatine capsule shell.The present invention adopts the moxifloxacin capsule of hydroxypropyl methylcellulose capsules shell, and the stripping time started, the dissolution height was all more than 90% at 8～12 minutes; The disintegrating agent of at least a appropriate amount that is contained can make softgel shell in a single day molten when broken, and content is stripping rapidly under the effect of disintegrating agent.And, the moxifloxacin capsule of employing hydroxypropyl methylcellulose capsules shell of the present invention, dissolving out capability is stable, and it is constant substantially that long-time (2 years) preserve back stripping situation, and dissolution is compared during with firm preparation, and no significant difference is all more than 90%.
The specific embodiment
Used moxifloxacin hydrochloride structure is as follows among the present invention:
Molecular formula: C21H24FN3O4.HCl. molecular weight: 437.90
Hydroxypropyl emthylcellulose (HPMC) capsule shells is also referred to as plant capsule (Vcaps
TM), main constituent is hydroxypropyl emthylcellulose.Used hydroxypropyl emthylcellulose (HPMC) capsule shells is the product that French capsule company limited is acted on behalf of by Suzhou Capsule Co., Ltd in the embodiment of the invention.
The hydroxypropyl methylcellulose capsules shell, the solution time in 0.1mol hydrochloric acid is slower slightly than gelatine capsule shell.For said preparation can moltenly better be loose under one's belt, make medicine dissolve back stripping rapidly in capsule shells, select at least a disintegrating agent for use in the present invention's prescription, or several disintegrating agent use in conjunction.They can be selected for use from following material: carboxymethylstach sodium, cross-linking sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, microcrystalline Cellulose etc., preferred carboxymethylstach sodium and microcrystalline Cellulose.The disintegrating agent addition can be 5～50% of capsule 's content total amount, and preferred amounts is 25～35%, describedly all is weight percentage.In the present invention, disintegrating agent is as neccessary composition, its role is to when the hydroxypropyl methylcellulose capsules shell in a single day molten when broken, content can be under the effect of disintegrating agent stripping rapidly, the disintegrating agent consumption that can realize this effect can change in a big way, and in this scope (5～50%), the change of disintegrating agent consumption is little to the disintegrate influential effect.
The lubricant of using always in this area in the prior art all can be used for the present invention.Wherein, magnesium stearate is the lubricant that arrives commonly used in this area.In capsule of the present invention, the consumption of lubricant also can add with reference to the addition commonly used of lubricant in the existing known technology.In embodiment preferred of the present invention, the percentage by weight that the addition of magnesium stearate lubricant accounts for the capsule content is 1.0～1.5%.
The moxifloxacin capsule that the present invention is prepared, contained Moxifloxacin or its salt and/or its hydrate are generally moxifloxacin hydrochloride, and its content can be gone up needed unit dose according to pharmacy or treatment application and determine.Common, its percentage by weight shared in capsule 's content is 30-75%.Of the present invention preferred embodiment in, moxifloxacin hydrochloride shared percentage by weight in capsule 's content is 65～74%.
The preparation method of capsule of the present invention, basic identical with the preparation method of the capsule of using always in the prior art.Can be with raw material in the capsule 's content and the abundant mixing of adjuvant, fill the hydroxypropyl methylcellulose capsules shell and make, the perhaps abundant mixing of raw material and adjuvant, behind the dry method system granule, recharge the hydroxypropyl methylcellulose capsules shell and make, also can adopt conventional wet granulation method to prepare granule and fill the hydroxypropyl methylcellulose capsules shell and make.Raw material described here is meant principal agent Moxifloxacin or its salt and/or its hydrate in the capsule 's content, and adjuvant is meant used disintegrating agent and lubricant, and wet granulation can directly prepare by water, can add some typical binders.
The present invention is described in further detail below by specific embodiment.
Embodiment 1
Component: moxifloxacin hydrochloride 218.4mg
Microcrystalline Cellulose 40.0mg
Carboxymethylstach sodium 68.0mg
Magnesium stearate 3.6mg
Total 330.0mg
Preparation method: get former, adjuvant in the said components, abundant mix homogeneously is filled in the hydroxypropyl methylcellulose capsules shell promptly.
Measure the dissolution of resulting capsule.And with resulting capsule after room temperature is placed 2 years, use with quadrat method and measure dissolution, the results are shown in hereinafter shown in the table 2.
Embodiment 2
Component: moxifloxacin hydrochloride 436.8mg
Microcrystalline Cellulose 55.0mg
Carboxymethylstach sodium 100.0mg
Magnesium stearate 8.2mg
Total amount 600.0mg
Preparation method: get former, adjuvant in the said components, abundant mix homogeneously, behind the dry method system granule, in the filling hydroxypropyl methylcellulose capsules shell promptly.
Measure the dissolution of resulting capsule.And with resulting capsule after room temperature is placed 2 years, use with quadrat method and measure dissolution, the results are shown in hereinafter shown in the table 2.
Embodiment 3
Component: moxifloxacin hydrochloride 218.4mg
Microcrystalline Cellulose 30.0mg
Carboxymethylstach sodium 68.0mg
Cross-linked carboxymethyl cellulose sodium 10.0mg
Magnesium stearate 3.6mg
Total amount 330.0mg
Preparation method: get former, adjuvant in the said components, abundant mix homogeneously is filled in the hydroxypropyl methylcellulose capsules shell promptly.
Measure the dissolution of resulting capsule.And with resulting capsule after room temperature is placed 2 years, use with quadrat method and measure dissolution, the results are shown in hereinafter shown in the table 2.
Embodiment 4
Component: moxifloxacin hydrochloride 436.8mg
Crosslinked polyethylene pyrrole Lip river alkane ketone 30.0mg
Carboxymethylstach sodium 125.0mg
Magnesium stearate 8.2mg
Total amount 600.0mg
Preparation method: get former, adjuvant in the said components, abundant mix homogeneously, behind the dry method system granule, in the filling hydroxypropyl methylcellulose capsules shell promptly.
Measure the dissolution of resulting capsule.And with resulting capsule after room temperature is placed 2 years, use with quadrat method and measure dissolution, the results are shown in hereinafter shown in the table 2.
Embodiment 5
Component: moxifloxacin hydrochloride 218.4mg
Carboxymethylstach sodium 108.0mg
Magnesium stearate 3.6mg
Total amount 330.0mg
Preparation method: get former, adjuvant in the said components, abundant mix homogeneously is filled in the hydroxypropyl methylcellulose capsules shell promptly.
Measure the dissolution of resulting capsule.And with resulting capsule after room temperature is placed 2 years, use with quadrat method and measure dissolution, the results are shown in hereinafter shown in the table 2.
Embodiment 6
Component: moxifloxacin hydrochloride 218.4mg
Microcrystalline Cellulose 180.6mg
Magnesium stearate 3.0mg
Total amount 402.0mg
Preparation method: get former, adjuvant in the said components, abundant mix homogeneously is filled in the hydroxypropyl methylcellulose capsules shell promptly.
Measure the dissolution of resulting capsule.And with resulting capsule after room temperature is placed 2 years, use with quadrat method and measure dissolution, the results are shown in hereinafter shown in the table 2.
Embodiment 7
Component: moxifloxacin hydrochloride 218.4.0mg
Carboxymethylstach sodium 15.6mg
Magnesium stearate 3.0mg
Total amount 237.0mg
Preparation method: get former, adjuvant in the said components, abundant mix homogeneously is filled in the hydroxypropyl methylcellulose capsules shell promptly.
Measure the dissolution of resulting capsule.And with resulting capsule after room temperature is placed 2 years, use with quadrat method and measure dissolution, the results are shown in hereinafter shown in the table 2.
Embodiment 8-13
With each component (except that magnesium stearate) mixing of each Example formulations in the following table 1, add then and make granule after suitable quantity of water is made suitable soft material, dry back adds the magnesium stearate mixing, fills in the hydroxypropyl methylcellulose capsules shell promptly.
Measure the dissolution of resulting capsule.And with resulting capsule after room temperature is placed 2 years, use with quadrat method and measure dissolution, the results are shown in hereinafter shown in the table 2.
Table 1. (unit of weight: mg)
| Supplementary material | Embodiment 8 | Embodiment 9 | Embodiment 10 | Embodiment 11 | Embodiment 12 | Embodiment 13 |
| Moxifloxacin hydrochloride | 54.6 | 54.6 | 54.6 | 218.4 | 218.4 | 218.4 |
| Microcrystalline Cellulose | 17.0 | 7.1 | 12.8 | 68.0 | 68.0 | 68.0 |
| Lactose | 8.5 | 3.6 | 12.8 | 34.0 | 34.0 | 34.0 |
| Cross-linked carboxymethyl cellulose sodium | 2.0 | 2.7 | 3.4 | 8.0 | 8.0 | 16.0 |
| HPMC(90SH100) | 4.0 | 22.0 | ||||
| Magnesium stearate | 0.6 | 0.4 | 0.5 | 2.4 | 2.4 | 3.0 |
| Total amount | 82.7 | 72.4 | 84.1 | 330.8 | 352.8 | 339.4 |
The granular recipe of remarks (1): embodiment 8,10,11,13 be respectively Chinese patent 99813124.5 embodiment 1,3,
4,6 uncoated tablets core prescription.
Remarks (2): the Chinese patent (patent No. 99813124.5, publication number CN1325306A) in the open text that the uncoated tablets core of embodiment is filled a prescription in, sodium carboxymethyl cellulose should be cross-linking sodium carboxymethyl cellulose, it is translated by croscarmellose soldium, see this former patent specification page 2, just should indeed be translated as cross-linking sodium carboxymethyl cellulose (disintegrating agent).
Comparative Examples 1
To be packed in the gelatin softgel shell behind embodiment 1 described each component mix homogeneously.Same mensuration has just prepared and the dissolution of room temperature placement after 2 years, and the result is as shown in table 2 below.
Comparative Examples 2
With each component (except that magnesium stearate) mixing of embodiment 8 described prescriptions, add then and make granule after suitable quantity of water is made suitable soft material, dry back adds the magnesium stearate mixing, is packed in the gelatin softgel shell.(the uncoated tablets slug particle preparation method basically identicals of preparation method of granules and Chinese patent 99813124.5 embodiment).Measure the dissolution of resulting capsule.And with resulting capsule after room temperature is placed 2 years, use with quadrat method and measure dissolution, the results are shown in hereinafter shown in the table 2.
Comparative Examples 3
With each component (except that magnesium stearate) mixing of embodiment 9 described prescriptions, add then and make granule after suitable quantity of water is made suitable soft material, dry back adds the magnesium stearate mixing, is packed in the gelatin softgel shell.Measure the dissolution of resulting capsule.And with resulting capsule after room temperature is placed 2 years, use with quadrat method and measure dissolution, the results are shown in hereinafter shown in the table 2.
Table 2. dissolution is (%) (just having prepared when finishing and room temperature investigation in 2 years) relatively
| Sample | 0 month | 24 months |
| Embodiment 1 | 99.5 | 99.2 |
| Embodiment 2 | 98.2 | 98.3 |
| Embodiment 3 | 99.2 | 98.9 |
| Embodiment 4 | 98.4 | 98.2 |
| Embodiment 5 | 98.1 | 97.6 |
| Embodiment 6 | 97.2 | 99.8 |
| Embodiment 7 | 101.3 | 98.3 |
| Embodiment 8 | 99.1 | 101.3 |
| Embodiment 9 | 98.7 | 100.4 |
| Embodiment 10 | 102.5 | 99.6 |
| Embodiment 11 | 100.2 | 99.1 |
| Embodiment 12 | 97.2 | 99.3 |
| Embodiment 13 | 98.8 | 100.1 |
| Comparative Examples 1 | 97.0 | 0 |
| Comparative Examples 2 | 94.0 | 0 |
| Comparative Examples 3 | 95.3 | 0 |
Annotate: dissolution determination method: measure according to first method in two appendix XC of Chinese Pharmacopoeia version in 2000 dissolution method, dissolution medium is the 0.1M hydrochloric acid solution, and rotating speed 100rpm measures 45 minutes stripping values.
Claims (8)
1. moxifloxacin capsule, contain Moxifloxacin or its salt and/or its hydrate in the capsule 's content, also contain at least a disintegrating agent and at least a lubricant in the described capsule 's content, it is characterized in that: the capsule shells of described capsule is the hydroxypropyl methylcellulose capsules shell.
2. a kind of moxifloxacin capsule according to claim 1 is characterized in that: described Moxifloxacin or its salt and/or its hydrate are moxifloxacin hydrochloride.
3. a kind of moxifloxacin capsule according to claim 1 and 2 is characterized in that: described disintegrating agent is selected from least a in carboxymethylstach sodium, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose or the crospolyvinylpyrrolidone.
4. a kind of moxifloxacin capsule according to claim 3 is characterized in that: the percentage by weight that the addition of described disintegrating agent accounts for the capsule 's content total amount is 5～50%.
5. a kind of moxifloxacin capsule according to claim 4 is characterized in that: the percentage by weight that the addition of described disintegrating agent accounts for the capsule 's content total amount is 25～35%.
6. a kind of moxifloxacin capsule according to claim 1 and 2 is characterized in that: described lubricant is a magnesium stearate.
7. a kind of moxifloxacin capsule according to claim 1 and 2 is characterized in that: described capsule contains
Percentage by weight is 65～74% Moxifloxacin or its salt and/or its hydrate,
Percentage by weight is 25～34% disintegrating agent, and
Percentage by weight is 1.0～1.5% lubricant;
Described disintegrating agent is one or more mixture that are selected from carboxymethylstach sodium, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose, the crospolyvinylpyrrolidone, and described lubricant is a magnesium stearate.
8. the preparation method of the arbitrary described a kind of moxifloxacin capsule of claim 1～7, described method comprises step: Moxifloxacin or its salt and/or its hydrate are fully mixed with at least a disintegrating agent and at least a lubricant or make granule, fill the hydroxypropyl methylcellulose capsules shell.
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| CNB2005100217391A CN100363001C (en) | 2005-09-21 | 2005-09-21 | Moxifloxacin capsule and its preparation method |
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| CN100363001C true CN100363001C (en) | 2008-01-23 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1149993C (en) * | 1998-11-10 | 2004-05-19 | 拜尔公司 | Pharmaceutical moxifloxacin preparation |
| WO2005020998A1 (en) * | 2003-09-03 | 2005-03-10 | Ranbaxy Laboratories Limited | Pharmaceutical compositions of moxifloxacin and processes for their preparation |
| CN1672681A (en) * | 2004-03-23 | 2005-09-28 | 深圳市天一时科技开发有限公司 | Moxixacin capsule and its prepn process |
-
2005
- 2005-09-21 CN CNB2005100217391A patent/CN100363001C/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1149993C (en) * | 1998-11-10 | 2004-05-19 | 拜尔公司 | Pharmaceutical moxifloxacin preparation |
| WO2005020998A1 (en) * | 2003-09-03 | 2005-03-10 | Ranbaxy Laboratories Limited | Pharmaceutical compositions of moxifloxacin and processes for their preparation |
| CN1672681A (en) * | 2004-03-23 | 2005-09-28 | 深圳市天一时科技开发有限公司 | Moxixacin capsule and its prepn process |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
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Application publication date: 20060426 Assignee: Jiangsu Tianyishi Pharm Co., Ltd. Assignor: Tianyishi Sci-Tech Development Co., Ltd., Shenzhen Contract record no.: 2010320000719 Denomination of invention: Moxifloxacin capsule and its preparation method Granted publication date: 20080123 License type: Exclusive License Record date: 20100602 |
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