CN108186661A - A kind of pharmaceutical composition comprising Clindamycin Hydrochloride and preparation method thereof - Google Patents
A kind of pharmaceutical composition comprising Clindamycin Hydrochloride and preparation method thereof Download PDFInfo
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- CN108186661A CN108186661A CN201711352256.9A CN201711352256A CN108186661A CN 108186661 A CN108186661 A CN 108186661A CN 201711352256 A CN201711352256 A CN 201711352256A CN 108186661 A CN108186661 A CN 108186661A
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- pharmaceutical composition
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- clindamycin hydrochloride
- xylo
- oligosaccharide
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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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7016—Disaccharides, e.g. lactose, lactulose
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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
- A61K31/702—Oligosaccharides, i.e. having three to five saccharide radicals attached to each other by glycosidic linkages
-
- 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
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
Abstract
The present invention provides a kind of pharmaceutical compositions comprising Clindamycin Hydrochloride and preparation method thereof, belong to drug field, which includes：Clindamycin Hydrochloride and xylo-oligosaccharide.Preparation method includes：It is mixed after Clindamycin Hydrochloride is mixed with xylo-oligosaccharide with adhesive, partial disintegration agent with the aqueous solution of thickener, it is dry after wet granulation, obtain the dry particl that grain size is 16~25 mesh；After dry particl is mixed with glidant, lubricant and remaining disintegrant, tabletting.The pharmaceutical composition can improve the gastrointestinal tracts common adverse reactions such as Nausea and vomiting caused by Clindamycin Hydrochloride.
Description
Technical field
The present invention relates to drug field, in particular to a kind of pharmaceutical composition comprising 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；In treatment bone and joint sense
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.
Common adverse reaction is gastrointestinal reaction to Clindamycin Hydrochloride in the application, is mainly manifested in and has a stomach upset, dislikes
Pseudomembranous enteritis can occur for the heart, vomiting etc., minority, thus cause patient compliance poor.
Invention content
The first object of the present invention is to provide a kind of pharmaceutical composition for including Clindamycin Hydrochloride, the pharmaceutical composition
The gastrointestinal tracts common adverse reactions such as Nausea and vomiting caused by Clindamycin Hydrochloride can effectively be improved by xylo-oligosaccharide.
The second object of the present invention is to provide a kind of preparation method of aforementioned pharmaceutical compositions, this method preparation process letter
It is single, it is suitble to industrialized production.
The third object of the present invention is to provide a kind of drug of xylo-oligosaccharide preparing improvement chemical drug gastrointestinal side effect
In purposes.The side effects such as Nausea and vomiting, itself and chemical drug are applied in combination caused by xylo-oligosaccharide has alleviation chemical drug, can
Significantly improve the gastrointestinal side effect of chemical drug.
In order to realize the above-mentioned purpose of the present invention, spy uses following technical scheme：
A kind of pharmaceutical composition for including Clindamycin Hydrochloride, pharmaceutical composition include：Clindamycin Hydrochloride and oligomeric wood
Sugar.
A kind of preparation method of the pharmaceutical composition comprising Clindamycin Hydrochloride, including：
Water after the Clindamycin Hydrochloride, the xylo-oligosaccharide are mixed with adhesive, partial disintegration agent with thickener
Solution mixes, dry after wet granulation, obtains the dry particl that grain size is 16~25 mesh；
After the dry particl is mixed with glidant, lubricant and remaining disintegrant, tabletting.
Compared with prior art, beneficial effects of the present invention for example including：
In this pharmaceutical composition provided by the invention and preparation method thereof, using Clindamycin Hydrochloride as main pharmacodynamics into
Point, it can effectively treat the infection caused by the sensitive strains such as streptococcus, staphylococcus and anaerobic bacteria；Meanwhile match at it
Xylo-oligosaccharide is added in side, alimentary canal side reaction caused by being effectively improved Clindamycin Hydrochloride improves the compliance of patient, right
The nausea and vomiting that occur in therapeutic process, loss of appetite have good remission effect.
Specific embodiment
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, the condition suggested according to normal condition or manufacturer carry out.Reagents or instruments used without specified manufacturer is
The conventional products that can be obtained by commercially available purchase.
Present embodiment provides a kind of pharmaceutical composition for including Clindamycin Hydrochloride, which includes：Hydrochloric acid
Clindamycin and xylo-oligosaccharide.
Wherein, Clindamycin Hydrochloride, molecular formula are C18H33ClN2O5SHCl is a kind of wider antibiotic of antimicrobial spectrum,
To caused by the sensitive strains such as streptococcus, staphylococcus and anaerobic bacteria infected with it is good the effect of.
Xylo-oligosaccharide, also known as wood oligose are the functional polyalkylenes being combined by 2-7 xylose molecule with β-Isosorbide-5-Nitrae glycosidic bond
Sugar is closed, relative molecular mass is 300~2000.Due to the enzyme for not having to hydrolyze xylo-oligosaccharide in human gastrointestinal tract, so it can
It is preferably that Bifidobacterium utilizes to be directly entered big enteral, promotes the breeding of Bifidobacterium and that it is made to generate simultaneously is a variety of organic
Acid, and then promote gastrointestinal motility.Xylo-oligosaccharide can activate or promote body cell and the immune function of body fluid, be conducive to body
From the invasion and damage of the bacteria microorganism that causes a disease.Beneficial bacterium also has superoxide dismutase (SOD), peroxide in activation body cell
Change the effect of hydrogen enzyme and glutathione peroxidase, polyphenoils is promoted to generate, reduces the damage of free radical.Xylo-oligosaccharide exists
It also has certain effect in activation immune response.In the present invention, inventor is the study found that xylo-oligosaccharide can be reduced by hydrochloric acid
Digestive tract reaction caused by clindamycin improves the compliance of patient, to occur in therapeutic process nausea and vomiting, loss of appetite
With good result.
Further, the pharmaceutical composition count in parts by weight including：Clindamycin Hydrochloride is 10 parts, xylo-oligosaccharide 1
~30 parts.
Further, it counts in parts by weight, xylo-oligosaccharide is 5~20 parts or is 10~15 parts.Inventor's experimental study
Show the content when xylo-oligosaccharide in the range of 1~30 part, which has stronger preventing or arresting vomiting ability.
Further, pharmaceutical composition further includes pharmaceutically acceptable auxiliary material, auxiliary material count in parts by weight including：
1.3~6.8 parts of adhesive, 1.2~5.2 parts of disintegrant, 0.20~1.0 part of glidant, lubricant 0.14~0.72
Part, 0.06~0.40 part of thickener, 0.40-2.0 parts of coating agent.
Wherein, adhesive includes any one in microcrystalline cellulose, alginates, gelatin and polyvinylpyrrolidone；It collapses
Agent is solved to include in cross-linked pvp, crosslinked carboxymethyl fecula sodium, croscarmellose sodium and low-substituted hydroxypropyl cellulose
Any one；Glidant is including silica etc.；Lubricant includes magnesium stearate, aluminum stearate, talcum, polyethylene glycol, benzene first
Sour sodium etc.；Thickener is including hydroxypropyl methyl cellulose etc..
Further, auxiliary material count in parts by weight including：
1.3~6.8 parts of microcrystalline cellulose, 1.2~5.2 parts of croscarmellose sodium, silica 0.20~1.0
Part, 0.14~0.72 part of magnesium stearate, 0.06~0.40 part of hydroxypropyl methyl cellulose, 0.40~2.0 part of coating agent.
Preferably, auxiliary material count in parts by weight including：1.4~4.8 parts of microcrystalline cellulose, croscarmellose sodium
1.22~3.80 parts, 0.22~0.72 part of silica, 0.15~0.54 part of magnesium stearate, hydroxypropyl methyl cellulose 0.07~
0.27 part, 0.8~1.5 part of coating agent.
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 rapidly, continuously and the discharge active component in a very long time, doctor of the invention
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 shell capsules, sterile injectable preparation and sterilized powder etc..It is more preferred, the dosage form packet of the pharmaceutical composition
Include tablet, capsule or granule.
Present embodiment also provides a kind of preparation method of aforementioned pharmaceutical compositions, including：
Step S1, granulation：After Clindamycin Hydrochloride is mixed with xylo-oligosaccharide with adhesive, partial disintegration agent with thickener
Aqueous solution mixing, it is dry after wet granulation, obtain the dry particl that grain size is 16~25 mesh.
Preferably, temperature dry after wet granulation is 50~60 DEG C, and the moisture of the dry particl is less than 2.0%.
Further, it further includes before mixing, by the Clindamycin Hydrochloride and the xylo-oligosaccharide co-grinding, mistake
120 mesh sieve；Adhesive, disintegrant, glidant, lubricant are crushed, cross 80 mesh sieve respectively.
Step S2, tabletting：After dry particl is mixed with glidant, lubricant and remaining disintegrant, tabletting.
Further, can midbody particle content calculation be averaged piece weight, make the 95%- that two kinds of drug contents are recipe quantity
Between 105%.
Further, the step of being coated in coating solution to the tablet of gained after tabletting, the coating solution are further included
Temperature for 40~60 DEG C, a concentration of the 8~10% of coating agent in coating solution.
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 composition for including Clindamycin Hydrochloride, including：
Clindamycin Hydrochloride 100g, xylo-oligosaccharide 50.45g, microcrystalline cellulose 16.31g, croscarmellose sodium
13.44g, silica 2.6g, magnesium stearate 1.57g, hydroxypropyl methyl cellulose 0.88g, coating agent 8.23g.
The pharmaceutical composition is tablet, and preparation method includes：
1) supplementary material is handled：By above-mentioned formula ratio, Clindamycin Hydrochloride and xylo-oligosaccharide are crushed altogether, 120 mesh sieve is standby
With；Microcrystalline cellulose, croscarmellose sodium, silica, magnesium stearate cross 80 mesh sieve respectively, spare；
2) preparation of slurr：Hydroxypropyl methyl cellulose purified water wiring solution-forming, it is spare as slurr；
3) dry-mixed, granulation：Step (1) is obtained to Clindamycin Hydrochloride and xylo-oligosaccharide mixed powder, crystallite after oneself sieving
Stirring high-speed stirred in cellulose, 1/2 recipe quantity crosslinking shuttle sodium carboxymethylcellulose pyce input wet granulator, adds in whole slurrs
Softwood processed, using 20 mesh screen wet granular of oscillating granulator, wet granular is few to moisture in 50-60 DEG C of drying of heated-air circulation oven
In 2.0%, the dry particl that grain size is 16~25 mesh is obtained；
4) tabletting：The dry particl that step (3) is obtained and remaining crosslinking shuttle sodium carboxymethylcellulose pyce, silica, tristearin
The input movement mixer mixing of sour magnesium is averaged piece weight according to midbody particle content calculation, and it is prescription to make two kinds of drug contents
Between the 95%-105% of amount；
5) it is coated：Coating agent adds water, is configured to the coating solution of 8-10%, and temperature of charge is controlled always in 40- in coating pan
60 DEG C to get tablet.
Embodiment 2
The present embodiment provides a kind of pharmaceutical composition for including Clindamycin Hydrochloride, including：
Clindamycin Hydrochloride 100g, xylo-oligosaccharide 100.27, microcrystalline cellulose 19.02g, croscarmellose sodium
15.27g, silica 4.13g, magnesium stearate 2.13g, hydroxypropyl methyl cellulose 2.31g, coating agent 13.12g.
The preparation method of the pharmaceutical composition is as described in Example 1.
Embodiment 3
The present embodiment provides a kind of pharmaceutical composition for including Clindamycin Hydrochloride, including：
Clindamycin Hydrochloride 100g, xylo-oligosaccharide 300.53g, microcrystalline cellulose 33.04g, croscarmellose sodium
25.13g, silica 6.92g, magnesium stearate 4.71g, hydroxypropyl methyl cellulose 3.68g, coating agent 17.12g.
The preparation method of the pharmaceutical composition is as described in Example 1.
Embodiment 4
The present embodiment provides a kind of pharmaceutical composition for including Clindamycin Hydrochloride, including：
Clindamycin Hydrochloride 100g, xylo-oligosaccharide 100.27g, microcrystalline cellulose 14.56g, croscarmellose sodium
13.22g, silica 2.64g, magnesium stearate 1.82g, hydroxypropyl methyl cellulose 0.93g, coating agent 8.37g.
The preparation method of the pharmaceutical composition is as described in Example 1.
Embodiment 5
The present embodiment provides a kind of pharmaceutical composition for including Clindamycin Hydrochloride, including：
Clindamycin Hydrochloride 100g, xylo-oligosaccharide 100.24g, alginates 14.55g, crosslinked carboxymethyl fecula sodium 13.32g,
Silica 2.67g, aluminum stearate 1.83g, hydroxypropyl methyl cellulose 0.94g, coating agent 8.26g.
The pharmaceutical composition is tablet, and preparation method includes：
1) supplementary material is handled：By above-mentioned formula ratio, Clindamycin Hydrochloride and xylo-oligosaccharide are crushed altogether, 120 mesh sieve is standby
With；Alginates, crosslinked carboxymethyl fecula sodium, silica, aluminum stearate cross 80 mesh sieve respectively, spare；
2) preparation of slurr：Hydroxypropyl methyl cellulose purified water wiring solution-forming, it is spare as slurr；
3) dry-mixed, granulation：Step (1) is obtained to Clindamycin Hydrochloride and xylo-oligosaccharide mixed powder, alginic acid after oneself sieving
Stirring high-speed stirred in salt, 1/2 recipe quantity crosslinked carboxymethyl fecula sodium input wet granulator, it is soft to add in whole slurr systems
Material, using 20 mesh screen wet granular of oscillating granulator, wet granular is less than in 50-60 DEG C of drying to moisture of heated-air circulation oven
2.0%, obtain the dry particl that grain size is 16~25 mesh；
4) tabletting：The dry particl that step (3) is obtained and remaining crosslinking shuttle methyl starch sodium, silica, stearic acid
Aluminium input movement mixer mixing, is averaged piece weight, it is recipe quantity to make two kinds of drug contents according to midbody particle content calculation
95%-105% between；
5) it is coated：Coating agent adds water, is configured to the coating solution of 8-10%, and temperature of charge is controlled always in 40- in coating pan
60 DEG C to get tablet.
Comparative example 1
This comparative example provides a kind of pharmaceutical composition for including Clindamycin Hydrochloride, including：
Clindamycin Hydrochloride 100g, microcrystalline cellulose 16.31g, croscarmellose sodium 13.44g, silica
2.6g, magnesium stearate 1.57g, hydroxypropyl methyl cellulose 0.88g, coating agent 8.23g.
The preparation method of the pharmaceutical composition is as described in Example 1.
Comparative example 2
This comparative example provides a kind of pharmaceutical composition for including Clindamycin Hydrochloride, including：
Clindamycin Hydrochloride 100g, starch 50.66g, microcrystalline cellulose 16.31g, croscarmellose sodium
13.44g, silica 2.6g, magnesium stearate 1.57g, hydroxypropyl methyl cellulose 0.88g, coating agent 8.23g.
The preparation method of the pharmaceutical composition is as described in Example 1.
Comparative example 3
This comparative example provides a kind of pharmaceutical composition for including Clindamycin Hydrochloride, including：
Clindamycin Hydrochloride 100g, starch 100.34g, microcrystalline cellulose 19.02g, croscarmellose sodium
15.27g, silica 4.13g, magnesium stearate 2.13g, hydroxypropyl methyl cellulose 2.31g, coating agent 13.12g.
The preparation method of the pharmaceutical composition is as described in Example 1.
Comparative example 4
This comparative example provides a kind of pharmaceutical composition for including Clindamycin Hydrochloride, including：
Clindamycin Hydrochloride 100g, starch 300.26g, microcrystalline cellulose 33.04g, croscarmellose sodium
25.14g, silica 6.92g, magnesium stearate 4.71g, hydroxypropyl methyl cellulose 3.68g, coating agent 27.13g.
The preparation method of the pharmaceutical composition is as described in Example 1.
Experimental example
The pharmaceutical composition provided with reference to animal experiment the embodiment of the present invention 1~3 and comparative example 1~4 is improving
Effect in terms of the digestive tract reaction caused by the Clindamycin Hydrochloride is evaluated.
One, test methods：
The pigeon 84 of weight 200-300g is chosen, half male and half female is randomly divided into 7 groups, every group 12.Fasting is not before experiment
Prohibit water for 24 hours, pigeon administration each composition of gavage (Examples 1 to 3, comparative example 1~4, composition such as 1 institute of table of effective component
Show), it is 16mg/ to convert into Clindamycin Hydrochloride, and the vomiting number and number of elements of pigeon in 5h are recorded after administration, and experimental result carries out
Comparison among groups are shown in Table 2：
Effective component forms in 1. Examples 1 to 3 of table and comparative example 1~4
2. pigeon of table vomits situation
| Size of animal | Vomit number of elements | Average vomiting number | |
| Embodiment 1 | 12 | 5 | 3.40 |
| Embodiment 2 | 12 | 3 | 1.33 |
| Embodiment 3 | 12 | 5 | 1.20 |
| Comparative example 1 | 12 | 10 | 6.30 |
| Comparative example 2 | 12 | 9 | 5.11 |
| Comparative example 3 | 12 | 8 | 6.13 |
| Comparative example 4 | 12 | 8 | 5.13 |
By 2 result of table as it can be seen that embodiment 2,3 groups of pigeon vomiting numbers of elements of embodiment and average vomiting number are considerably less than other
Each group.
By above-mentioned animal experiment, pharmaceutical composition according to the present invention can promote gastroenteritic power, promote food digestion
And absorption, there is preventing or arresting vomiting effect, the alimentary canal side reaction that can be effectively improved caused by Clindamycin Hydrochloride improves patient's chemicotherapy
Compliance has good result to nausea and vomiting, loss of appetite
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 (10)
1. a kind of pharmaceutical composition for including Clindamycin Hydrochloride, which is characterized in that described pharmaceutical composition includes：Hydrochloric acid crin
Mycin and xylo-oligosaccharide.
2. pharmaceutical composition according to claim 1, which is characterized in that count in parts by weight, the Clindamycin Hydrochloride
10 parts, the xylo-oligosaccharide be 1~30 part.
3. pharmaceutical composition according to claim 2, which is characterized in that count in parts by weight, the xylo-oligosaccharide for 5~
20 parts.
4. pharmaceutical composition according to claim 2, which is characterized in that described pharmaceutical composition, which further includes, can pharmaceutically connect
The auxiliary material received, the auxiliary material count in parts by weight including：
1.3~6.8 portions of adhesive, 0.20~1.0 part of glidant, 0.14~0.72 part of lubricant, increases 1.2~5.2 parts of disintegrant
Thick dose 0.06~0.40 part, 0.40-2.0 parts of coating agent.
5. pharmaceutical composition according to claim 2, which is characterized in that described pharmaceutical composition, which further includes, can pharmaceutically connect
The auxiliary material received, the auxiliary material count in parts by weight including：
It is 1.3~6.8 parts of microcrystalline cellulose, 1.2~5.2 parts of croscarmellose sodium, 0.20~1.0 part of silica, hard
0.14~0.72 part of fatty acid magnesium, 0.06~0.40 part of hydroxypropyl methyl cellulose, 0.40~2.0 part of coating agent.
6. pharmaceutical composition according to claim 1, which is characterized in that the dosage form of described pharmaceutical composition include tablet,
Capsule or granule.
7. a kind of preparation method according to claim 1~6 any one of them pharmaceutical composition, which is characterized in that it includes：
Aqueous solution after the Clindamycin Hydrochloride, the xylo-oligosaccharide are mixed with adhesive, partial disintegration agent with thickener
It mixes, it is dry after wet granulation, obtain the dry particl that grain size is 16~25 mesh；
After the dry particl is mixed with glidant, lubricant and remaining disintegrant, tabletting.
8. the preparation method of pharmaceutical composition according to claim 7, which is characterized in that dry temperature after wet granulation
It it is 50~60 DEG C, the moisture of the dry particl is less than 2.0%.
9. the preparation method of pharmaceutical composition according to claim 7, which is characterized in that further include to gained after tabletting
The step of tablet is coated in coating solution, the temperature of the coating solution is 40~60 DEG C.
10. a kind of purposes of xylo-oligosaccharide in the drug for improving chemical drug gastrointestinal side effect is prepared.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201711352256.9A CN108186661A (en) | 2017-12-15 | 2017-12-15 | A kind of pharmaceutical composition comprising Clindamycin Hydrochloride and preparation method thereof |
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| CN201711352256.9A CN108186661A (en) | 2017-12-15 | 2017-12-15 | A kind of pharmaceutical composition comprising Clindamycin Hydrochloride and preparation method thereof |
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Cited By (1)
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| CN108619104A (en) * | 2018-06-29 | 2018-10-09 | 哈尔滨珍宝制药有限公司 | A kind of pharmaceutical composition and preparation method thereof based on Clindamycin Hydrochloride |
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Application publication date: 20180622 |