CN108619104A - A kind of pharmaceutical composition and preparation method thereof based on Clindamycin Hydrochloride - Google Patents
A kind of pharmaceutical composition and preparation method thereof based on Clindamycin Hydrochloride Download PDFInfo
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- CN108619104A CN108619104A CN201810701613.6A CN201810701613A CN108619104A CN 108619104 A CN108619104 A CN 108619104A CN 201810701613 A CN201810701613 A CN 201810701613A CN 108619104 A CN108619104 A CN 108619104A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2009—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
- A61K31/7056—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing five-membered rings with nitrogen as a ring hetero atom
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
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Abstract
The pharmaceutical composition and preparation method thereof based on Clindamycin Hydrochloride that the present invention provides a kind of, belongs to pharmaceutical composition.The pharmaceutical composition includes：1000 parts of Clindamycin Hydrochloride, 230~540 parts of microcrystalline cellulose, 150~320 parts of croscarmellose sodium, 00~150 part of silica 1,24~53 parts of magnesium stearate, 12~28 parts of hydroxypropyl methyl cellulose.Preparation method includes：After Clindamycin Hydrochloride is mixed with microcrystalline cellulose and croscarmellose sodium, then mix with the aqueous solution of hydroxypropyl methyl cellulose, it is dry after wet granulation, obtain the dry particl that grain size is 30~45 mesh；After dry particl is mixed with silica, magnesium stearate and croscarmellose sodium, tabletting is carried out.Formulation preparation method provided by the invention, method is simple, easily operated, hence it is evident that improves the stability and dissolution rate of tablet, and suitable for industrial production.
Description
Technical field
The present invention relates to drug field, in particular to a kind of pharmaceutical composition based on Clindamycin Hydrochloride and its
Preparation method.
Background technology
Clindamycin Hydrochloride, alias：Clindamicin, clindamycin, lindamycin, belong to antibiotic, and molecular formula is
C18H33ClN2O5SHCl, molecular weight are 461.44.Clindamycin Hydrochloride is the derivative of lincomycin, antimicrobial spectrum and Lin Ke
Mycin is identical, but antibacterial action is strong, and clinic is mainly used for caused by the sensitive strains such as streptococcus, staphylococcus and anaerobic bacteria
Following infection：Tympanitis, nasosinusitis, suppurative tonsillitis, pneumonia；Skin soft-tissue infection；Feel in treatment bone and joint
Dye, abdominal cavity infection, pelvic infection, pyothorax, pulmonary abscess, osteomyelitis, septicemia etc., can according to circumstances be applied alone or with other antimicrobials
Use in conjunction.
Clindamycin Hydrochloride is white crystalline powder, and this product easily dissolves in water, and presently commercially available hydrochloric acid crin is mould
Plain oral preparation is mainly tablet, and with electrostatic, adherence is stronger, has bad shadow to the stability and dissolution rate of tablet
It rings.Accordingly, it is desirable to provide a kind of formula that can be solved the above problems and technique.
Invention content
The purpose of the present invention is to provide a kind of pharmaceutical composition and preparation method thereof, preparation preparation side provided by the invention
Method, method is simple, easily operated, suitable for industrial production.
In order to realize that the above-mentioned purpose of the present invention, spy use following technical scheme：
A kind of pharmaceutical composition based on Clindamycin Hydrochloride, which is characterized in that described pharmaceutical composition is in parts by weight
Meter includes：
1000 parts of Clindamycin Hydrochloride, 230~540 parts of microcrystalline cellulose, 150~320 parts of croscarmellose sodium,
00~150 part of silica 1,24~53 parts of magnesium stearate, 12~28 parts of hydroxypropyl methyl cellulose.
A kind of preparation method of aforementioned pharmaceutical compositions comprising：
After Clindamycin Hydrochloride is mixed with microcrystalline cellulose and croscarmellose sodium, then it is fine with hydroxypropyl methyl
The aqueous solution of dimension element mixes, dry after wet granulation, obtains the dry particl that grain size is 30~45 mesh；
After dry particl is mixed with silica, magnesium stearate and croscarmellose sodium, tabletting is carried out.
Compared with prior art, beneficial effects of the present invention are：
Clindamycin Hydrochloride has electrostatic, and adherence is stronger, has harmful effect to the stability and dissolution rate of tablet.
In the preparation process of this pharmaceutical composition provided by the invention, silica is added, on the one hand the substance can weaken electrostatic suction
It is attached, mitigate bonding die problem, on the other hand can increase material fluidity, furthermore significantly improve the stability and dissolution rate of tablet.
Formulation preparation method provided by the invention, method is simple, easily operated, suitable for industrial production.
Specific implementation mode
Embodiment of the present invention is described in detail below in conjunction with embodiment, but those skilled in the art will
Understand, the following example is merely to illustrate the present invention, and is not construed as limiting the scope of the invention.It is not specified in embodiment specific
Condition person carries out according to conventional conditions or manufacturer's recommended conditions.Reagents or instruments used without specified manufacturer is
The conventional products that can be obtained by commercially available purchase.
Present embodiment provides the pharmaceutical composition based on Clindamycin Hydrochloride, which counts packet in parts by weight
It includes：
1000 parts of Clindamycin Hydrochloride, 230~540 parts of microcrystalline cellulose, 150~320 parts of croscarmellose sodium,
00~150 part of silica 1,24~53 parts of magnesium stearate, 12~28 parts of hydroxypropyl methyl cellulose.
Wherein, Clindamycin Hydrochloride, molecular formula are C18H33ClN2O5SHCl is a kind of antibiotic that antimicrobial spectrum is wider,
To caused by the sensitive strains such as streptococcus, staphylococcus and anaerobic bacteria infected with good curative effect.
Further, 1000 parts of Clindamycin Hydrochloride, 280~500 parts of microcrystalline cellulose, croscarmellose sodium
180~300 parts, 10~140 parts of silica 1,30~48 parts of magnesium stearate, 15~24 parts of hydroxypropyl methyl cellulose, coating
55~73 parts of agent.
Alternatively, 1000 parts of Clindamycin Hydrochloride, 320~400 parts of microcrystalline cellulose, croscarmellose sodium 220~
270 parts, 20~130 parts of silica 1,36~43 parts of magnesium stearate, 17~21 parts of hydroxypropyl methyl cellulose, coating agent 60~
67 parts.
Herein, it is physiologically acceptable that term " pharmaceutically acceptable ", which refers to the compound when compound is to human administration,
, and the allergic reactions such as gastrointestinal disturbance, dizziness or these similar anaphylactoid systemic anaphylaxis will not occur.
In order to make the medical composition discharge active component, doctor of the invention rapidly, continuously and in a very long time
Drug composition can be manufactured according to those conventional methods in the art are disclosed in.The administration of the medical composition of the present invention
Approach is oral, nasal inhalation or parenteral administration.The preparation of the medical composition can be powder, particle, tablet, emulsion, sugar
Slurry, aerosol, soft capsule, hard capsule, sterile injectable preparation and sterilized powder etc..It is more preferred, the dosage form packet of the pharmaceutical composition
Include tablet, capsule or granule.
Pharmaceutical composition of the present invention, is preferably prepared to solid orally ingestible, more preferably tablet, and tablet is drying
Solid, the drug of Yi Chao can borrow coating be protected, and light, air, moisture etc. influence it smaller, and quality is more stable.
Present embodiment also provides a kind of preparation method of aforementioned pharmaceutical compositions comprising：
Step S1：After Clindamycin Hydrochloride is mixed with microcrystalline cellulose and croscarmellose sodium, then with hydroxypropyl
The aqueous solution of ylmethyl cellulose mixes, dry after wet granulation, obtains the dry particl that grain size is 30~45 mesh；
Further, the moisture of dry particl is less than 2.0%.
Step S2：After dry particl is mixed with silica, magnesium stearate and croscarmellose sodium, preparation.
Further, further include the steps that being coated gained tablet after tabletting in 45~55 DEG C of coating solution.It is excellent
Selection of land, a concentration of 12~15wt% of coating solution.The silica that the present invention uses is that auxiliary material is often used in pharmaceuticals industry, is also precipitation
Silica, price is relatively low, is recorded into existing《Chinese Pharmacopoeia》2015 editions, preparation process is the silicic acid precipitation method,
The silica of preparation, heap density is big, and grain size is thick, and quality meets《Chinese Pharmacopoeia》2015 editions provide, precipitation two is added in prescription
Silica, the one side substance can weaken Electrostatic Absorption, mitigate bonding die problem, on the other hand can increase material fluidity.
Formulation preparation method provided by the invention, method is simple, easily operated, suitable for industrial production.
The feature and performance of the present invention are described in further detail with reference to embodiments：
Embodiment 1
The present embodiment provides a kind of pharmaceutical compositions based on Clindamycin Hydrochloride comprising：
Clindamycin Hydrochloride is 1000g, microcrystalline cellulose 230g, croscarmellose sodium 320g, silica
100g, magnesium stearate 24g, hydroxypropyl methyl cellulose 12g, coating agent 80g.
The pharmaceutical composition is tablet, and preparation method includes：
After Clindamycin Hydrochloride is mixed with the croscarmellose sodium of microcrystalline cellulose and 50%, then with hydroxypropyl
The aqueous solution of methylcellulose mixes, dry after wet granulation, obtains the dry particl that grain size is 30 mesh, the moisture of gained dry particl
Less than 2.0%；
It is carried out after dry particl is mixed with the croscarmellose sodium of silica, magnesium stearate and residue 50%
Tabletting, and gained tablet after tabletting is coated in 45 DEG C of coating solution, the wherein a concentration of 15wt% of coating solution.
Embodiment 2
The present embodiment provides a kind of pharmaceutical compositions based on Clindamycin Hydrochloride comprising：
Clindamycin Hydrochloride is 1000g, microcrystalline cellulose 540g, croscarmellose sodium 150g, silica
150g, magnesium stearate 53g, hydroxypropyl methyl cellulose 28g, coating agent 50g.
The pharmaceutical preparation is tablet, and preparation method includes：
After Clindamycin Hydrochloride is mixed with the croscarmellose sodium of microcrystalline cellulose and 70%, then with hydroxypropyl
The aqueous solution of methylcellulose mixes, dry after wet granulation, obtains the dry particl that grain size is 45 mesh, the moisture of gained dry particl
Less than 2.0%；
It is carried out after dry particl is mixed with the croscarmellose sodium of silica, magnesium stearate and residue 30%
Tabletting, and gained tablet after tabletting is coated in 55 DEG C of coating solution, the wherein a concentration of 12wt% of coating solution.
Embodiment 3
The present embodiment provides a kind of pharmaceutical compositions based on Clindamycin Hydrochloride comprising：
Clindamycin Hydrochloride is 1000g, microcrystalline cellulose 320g, croscarmellose sodium 240g, silica
125g, magnesium stearate 38g, hydroxypropyl methyl cellulose 21g, coating agent 65g.
The pharmaceutical composition is tablet, and preparation method includes：
After Clindamycin Hydrochloride is mixed with the croscarmellose sodium of microcrystalline cellulose and 60%, then with hydroxypropyl
The aqueous solution of methylcellulose mixes, dry after wet granulation, obtains the dry particl that grain size is 40 mesh, the moisture of gained dry particl
Less than 2.0%；
It is carried out after dry particl is mixed with the croscarmellose sodium of silica, magnesium stearate and residue 40%
Tabletting, and gained tablet after tabletting is coated in 52 DEG C of coating solution, the wherein a concentration of 14wt% of coating solution.
Embodiment 4
The present embodiment provides a kind of pharmaceutical compositions based on Clindamycin Hydrochloride comprising：
Clindamycin Hydrochloride is 1000g, microcrystalline cellulose 410g, croscarmellose sodium 280g, silica
135g, magnesium stearate 34g, hydroxypropyl methyl cellulose 19g, coating agent 62g.
The pharmaceutical composition is tablet, and preparation method includes：
After Clindamycin Hydrochloride is mixed with the croscarmellose sodium of microcrystalline cellulose and 60%, then with hydroxypropyl
The aqueous solution of methylcellulose mixes, dry after wet granulation, obtains the dry particl that grain size is 40 mesh, the moisture of gained dry particl
Less than 2.0%；
It is carried out after dry particl is mixed with the croscarmellose sodium of silica, magnesium stearate and residue 40%
Tabletting, and gained tablet after tabletting is coated in 50 DEG C of coating solution, the wherein a concentration of 13wt% of coating solution.
Embodiment 5
The present embodiment provides a kind of pharmaceutical compositions based on Clindamycin Hydrochloride comprising：
Clindamycin Hydrochloride is 1000g, microcrystalline cellulose 320g, croscarmellose sodium 280g, silica
115g, magnesium stearate 43g, hydroxypropyl methyl cellulose 23g, coating agent 58g.
Preparation method and embodiment 4 are almost the same.
Embodiment 6
The present embodiment provides a kind of pharmaceutical compositions based on Clindamycin Hydrochloride comprising：
Clindamycin Hydrochloride is 1000g, microcrystalline cellulose 500g, croscarmellose sodium 187g, silica
130g, magnesium stearate 44g, hydroxypropyl methyl cellulose 19g, coating agent 55g.
Preparation method and embodiment 4 are almost the same.
Comparative example 1
This comparative example provide it is a kind of based on Clindamycin Hydrochloride pharmaceutical composition (compared with embodiment be free of titanium dioxide
Silicon), preparation method and embodiment 3 are almost the same, the difference is that：
By Clindamycin Hydrochloride and 80% croscarmellose sodium mix after, then with hydroxypropyl methyl cellulose
Aqueous solution mixes, dry after wet granulation, obtains the dry particl that grain size is 50 mesh, and the moisture of gained dry particl is less than 2.0%.
Comparative example 2
This comparative example provide it is a kind of based on Clindamycin Hydrochloride pharmaceutical composition (compared with embodiment be free of titanium dioxide
Silicon), preparation method and embodiment 3 are almost the same, the difference is that：
By Clindamycin Hydrochloride and 40% croscarmellose sodium mix after, then with hydroxypropyl methyl cellulose
Aqueous solution mixes, dry after wet granulation, obtains the dry particl that grain size is 25 mesh, and the moisture of gained dry particl is less than 2.0%.
Comparative example 3
This comparative example provide it is a kind of based on Clindamycin Hydrochloride pharmaceutical composition (compared with embodiment be free of titanium dioxide
Silicon), preparation composition is almost the same with embodiment 3, and preparation method includes：
By Clindamycin Hydrochloride and 40% croscarmellose sodium mix after, then with hydroxypropyl methyl cellulose
Aqueous solution mixes, dry after wet granulation, obtains the dry particl that grain size is 60 mesh, and the moisture of gained dry particl is less than 2.0%.
Tabletting is carried out after dry particl is mixed with the croscarmellose sodium of magnesium stearate and residue 60%, and will
Gained tablet is coated in 60 DEG C of coating solution after tabletting, the wherein a concentration of 14wt% of coating solution.
Test example 1
Study on the stability
The tablet provided embodiment 3 and comparative example 1 carries out accelerated test (40 DEG C ± 2 DEG C, RH 75% ± 5%), specifically
Test method is shown in Table 1：
Table 1：Accelerated test method
| Investigation project | Method and limit (it is required that) |
| Character | Range estimation (Film coated tablets removes whitening color or off-white color after coating) |
| Disintegration time limited | CP2015 versions three 0921 |
| Dissolution rate | CP2015 versions three 0931 |
| Moisture | Conventional method (must not cross 6.0%) |
| Assay | HPLC methods (should be labelled amount 95.0%~105.0%) |
The result of accelerated test investigation is carried out as shown in table 2 and table 3 to the tablet that embodiment 3 and comparative example 1 provide：
Table 2：3 sample accelerated test of embodiment investigates situation
Table 3：1 sample accelerated test of comparative example investigates situation
It is found that under accelerated test environment, the stability for the tablet that the embodiment of the present invention 3 provides is better than for contrast table 2 and table 3
The tablet that comparative example 1 provides.
Test example 2
Dissolution rate is investigated
1, dissolving-out method：2015 editions three 0,931 second methods of Chinese Pharmacopoeia
Rotating speed：50 revs/min；
Dissolution medium：0.1mol/L hydrochloric acid 900ml；
Take this product, every batch of 6 carries out stripping curve measurement as stated above, respectively through 5,10,15,30,45 minutes when,
Dissolution fluid 10ml is taken, is filtered through 0.45 μm of filter membrane, while adding equivalent equality of temperature solvent.
2, assay method：Precision measures subsequent filtrate 1ml, sets in 20ml volumetric flasks, is diluted to scale with dissolution medium, shakes
It is even, as test solution；It separately takes reference substance appropriate, dissolution medium dissolving is added to be made in every 1ml containing about 20 μ g solution, as right
According to product solution.Test solution and reference substance solution are taken respectively, according to UV-VIS spectrophotometry (Chinese Pharmacopoeia 2015 editions three
Portion 0401), absorbance is measured at 324nm wavelength, is calculated dissolution rate and is drawn accumulation stripping curve.
3, for record as a result, mapping is compared, the time the results are shown in Table 4.
Table 6：Dissolve out situation
| Time (min) | Embodiment 1 | Embodiment 2 | Embodiment 3 | Comparative example 1 | Comparative example 2 | Comparative example 3 |
| 5 | 82 | 81 | 78 | 79 | 84 | 82 |
| 10 | 94 | 94 | 93 | 86 | 89 | 88 |
| 15 | 99 | 99 | 98 | 91 | 92 | 91 |
| 30 | 99 | 99 | 99 | 97 | 98 | 96 |
| 45 | 100 | 100 | 99 | 99 | 99 | 99 |
| 60 | 100 | 100 | 100 | 100 | 99 | 100 |
It is shown by 6 result of table：The tablet that Examples 1 to 3 provides, the accumulative releasing degree under same time, better than comparison
Example 1~3 discloses tablet prepared by method, while prescription is more simple.Such as at 15 minutes, the tablet of Examples 1 to 3 is accumulative to be released
98~99% are put, the tablet of comparative example 1~3 is accumulative to discharge 91~92%.
The preparation method of Clindamycin Hydrochloride preparation provided by the invention, method is simple, easily operated, raw suitable for industry
Production.
Although illustrate and describing the present invention with specific embodiment, it will be appreciated that without departing substantially from the present invention's
Many other change and modification can be made in the case of spirit and scope.It is, therefore, intended that in the following claims
Including belonging to all such changes and modifications in the scope of the invention.
Claims (8)
1. a kind of pharmaceutical composition based on Clindamycin Hydrochloride, which is characterized in that described pharmaceutical composition is counted in parts by weight
Including：
1000 parts of Clindamycin Hydrochloride, 230~540 parts of microcrystalline cellulose, 150~320 parts of croscarmellose sodium, dioxy
100~150 parts of SiClx, 24~53 parts of magnesium stearate, 12~28 parts of hydroxypropyl methyl cellulose.
2. pharmaceutical composition according to claim 1, which is characterized in that count in parts by weight, Clindamycin Hydrochloride 1000
Part, 280~500 parts of microcrystalline cellulose, 180~300 parts of croscarmellose sodium, 10~140 parts of silica 1, tristearin
30~48 parts of sour magnesium, 15~24 parts of hydroxypropyl methyl cellulose, 55~73 parts of coating agent.
3. pharmaceutical composition according to claim 1, which is characterized in that described pharmaceutical composition further includes 50~80 weight
The coating agent of part.
4. pharmaceutical composition according to claim 1, which is characterized in that the dosage form of described pharmaceutical composition include tablet,
Capsule or granule.
5. a kind of preparation method according to Claims 1 to 4 any one of them pharmaceutical composition, which is characterized in that it includes：
In parts by weight, after the Clindamycin Hydrochloride being mixed with microcrystalline cellulose and croscarmellose sodium, then with
The aqueous solution of hydroxypropyl methyl cellulose mixes, dry after wet granulation, obtains the dry particl that grain size is 30~45 mesh；
After the dry particl is mixed with silica, magnesium stearate and croscarmellose sodium, tabletting is carried out.
6. the preparation method of pharmaceutical composition according to claim 5, which is characterized in that with Clindamycin Hydrochloride and crystallite
The quantity of the croscarmellose sodium of cellulose mixing is the 50%~70% of recipe quantity.
7. the preparation method of pharmaceutical composition according to claim 5, which is characterized in that further include by gained medicine after tabletting
The step of piece is coated in 45~55 DEG C of coating solution.
8. the preparation method of pharmaceutical composition according to claim 6, which is characterized in that the moisture of the dry particl is less than
2.0%.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201810701613.6A CN108619104A (en) | 2018-06-29 | 2018-06-29 | A kind of pharmaceutical composition and preparation method thereof based on Clindamycin Hydrochloride |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201810701613.6A CN108619104A (en) | 2018-06-29 | 2018-06-29 | A kind of pharmaceutical composition and preparation method thereof based on Clindamycin Hydrochloride |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1301149A (en) * | 1998-06-11 | 2001-06-27 | 法玛西雅厄普约翰美国公司 | Delavirdine tablet formulation |
| WO2006045006A1 (en) * | 2004-10-20 | 2006-04-27 | Wyeth | Antibiotic product formulation |
| CN105687224A (en) * | 2014-11-29 | 2016-06-22 | 康普药业股份有限公司 | Clindamycin hydrochloride medicine composition and preparation method thereof |
| CN108186661A (en) * | 2017-12-15 | 2018-06-22 | 哈尔滨珍宝制药有限公司 | A kind of pharmaceutical composition comprising Clindamycin Hydrochloride and preparation method thereof |
-
2018
- 2018-06-29 CN CN201810701613.6A patent/CN108619104A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1301149A (en) * | 1998-06-11 | 2001-06-27 | 法玛西雅厄普约翰美国公司 | Delavirdine tablet formulation |
| WO2006045006A1 (en) * | 2004-10-20 | 2006-04-27 | Wyeth | Antibiotic product formulation |
| CN105687224A (en) * | 2014-11-29 | 2016-06-22 | 康普药业股份有限公司 | Clindamycin hydrochloride medicine composition and preparation method thereof |
| CN108186661A (en) * | 2017-12-15 | 2018-06-22 | 哈尔滨珍宝制药有限公司 | A kind of pharmaceutical composition comprising Clindamycin Hydrochloride and preparation method thereof |
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