CN106913556A - A kind of Rifapentinum capsules and preparation method thereof - Google Patents
A kind of Rifapentinum capsules and preparation method thereof Download PDFInfo
- Publication number
- CN106913556A CN106913556A CN201710269004.3A CN201710269004A CN106913556A CN 106913556 A CN106913556 A CN 106913556A CN 201710269004 A CN201710269004 A CN 201710269004A CN 106913556 A CN106913556 A CN 106913556A
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- rifapentine
- rifapentinum
- capsules
- preparation
- coated
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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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
-
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5015—Organic compounds, e.g. fats, sugars
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
- A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
- A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
Abstract
The invention discloses a kind of Rifapentinum capsules and preparation method thereof, by Tween 80, HPMC and K12Melt into adhesive in straight alcohol is added, prepared Rifapentine particle of spraying is carried out to Rifapentine using the adhesive；Again by melt into coating solution in HPMC, BHA and vitamin C addition straight alcohol, and the prepared Rifapentine coated granule of hydrojet coating is carried out to the Rifapentine particle using the coating solution；Finally the Rifapentine coated granule is mixed and is filled after always being mixed with pregelatinized starch, Rifapentinum capsules are obtained.Using the inventive method be obtained Rifapentinum capsules solve the problems, such as it is original prepare Rifapentinum capsules intermediate powder mobility, solve the problems, such as that relevant material is exceeded and content uniformity is big with this, also had greatly improved simultaneously for dissolution rate.
Description
Technical field
The present invention relates to field of medicine preparations, more particularly to a kind of Rifapentinum capsules and preparation method thereof.
Background technology
, for powder directly mixes, the technique is through multidirectional fortune after supplementary material sieves to technique prepared by Rifapentinum capsules tradition
Dynamic mixer carries out the mixing of several minutes.Due to characteristic factor (brick-red or kermesinus the crystallinity powder of main ingredient in the product
End, powder is thin and specific certain viscosity) production difficulty of filling work procedure is increased, therefore the physicochemical property of main ingredient influences it to fill in itself
Amount difference, while also have impact on dissolution rate, former technique is difficult to be effectively improved the mobility of powder, easily causes filling work procedure to produce
When produce capsule content uniformity is exceeded, pill weight variation is big phenomenon.Meanwhile, Rifapentine hydrolabil, former technique is to raw material
Do not deal with, easily cause feed degradation in storage phase, cause relevant material exceeded.
The content of the invention
The Rifapentinum capsules loading amount that the present invention is produced to solve the direct mixing granulation of original powder in the prior art is poor
A kind of different big problem, there is provided Rifapentinum capsules and preparation method thereof.
To achieve the above object, the present invention uses following technical scheme：
The first aspect of the invention is to provide a kind of preparation method of Rifapentinum capsules, by Tween 80, HPMC and K12
Melt into adhesive in straight alcohol is added, prepared Rifapentine particle of spraying is carried out to Rifapentine raw material using the adhesive；Again
By melt into coating solution in HPMC, BHA and vitamin C addition straight alcohol, and the Rifapentine particle is entered using the coating solution
Row hydrojet is coated prepared Rifapentine coated granule；Finally the Rifapentine coated granule is mixed is carried out always with pregelatinized starch
It is filled after mixed, Rifapentinum capsules is obtained.
Further, the preparation method of described Rifapentinum capsules, specifically includes following steps：
1) by Tween 80, HPMC and K12Straight alcohol melt into adhesive is added, 100 mesh sieves are crossed, it is standby；
2) Rifapentine of recipe quantity is placed in granulating coated pot, when temperature of charge reaches 35 DEG C in granulating coated pot
Start top spray granulation, below 40 DEG C, until all having sprayed, material crosses 20 mesh sieves to control material temperature in whole pelletization
Net, rejects and is more than 20 mesh particles, and Rifapentine particle is obtained；
3) HPMC, BHA and vitamin C are added into straight alcohol melt into coating solution, crosses 100 mesh sieves, it is standby；
4) using step 3) obtained in coating solution to step 2) obtained in the Rifapentine particle carry out bottom spray and be coated, it is whole
Control material temperature is below 40 DEG C in individual coating process, until all having sprayed, material crosses 20 eye mesh screens, rejects and is more than 20 mesh
Grain, is obtained Rifapentine coated granule；
5) finally by step 4) be coated after Rifapentine coated granule admix pregelatinized starch and always mixed, refill
Product.
It is further preferred that in the preparation method of described Rifapentinum capsules, counting by weight, the sharp good fortune spray
Fourth particle is formulated by following components：
It is further preferred that in the preparation method of described Rifapentinum capsules, counting by weight, the sharp good fortune spray
Fourth particle is formulated by following components：
Further it is further preferable that in the preparation method of described Rifapentinum capsules, counting by weight, the profit
Good fortune spray fourth particle is formulated by following components：
It is further preferred that in the preparation method of described Rifapentinum capsules, counting by weight, the sharp good fortune spray
Fourth coated granule is formulated by following components：
Further more preferably, in the preparation method of described Rifapentinum capsules, count by weight, the profit
Good fortune spray fourth coated granule is formulated by following components：
Further it is further preferable that in the preparation method of described Rifapentinum capsules, counting by weight, the profit
Good fortune spray fourth coated granule is formulated by following components：
It is further preferred that in the preparation method of described Rifapentinum capsules, the step 2) in control material temperature
Spend is 30-40 DEG C.
Further more preferably, in the preparation method of described Rifapentinum capsules, the step 2) middle control thing
Material temperature degree is 32-35 DEG C.
It is further preferred that in the preparation method of described Rifapentinum capsules, the step 3) in control material temperature
Spend is 25-35 DEG C.
Further more preferably, in the preparation method of described Rifapentinum capsules, the step 3) middle control thing
Material temperature degree is 28-32 DEG C.
The second aspect of the invention is to provide Rifapentinum capsules prepared by a kind of use above method.
The present invention uses above-mentioned technical proposal, compared with prior art, have the following technical effect that：
The present invention is by Tween 80, HPMC and K12Add straight alcohol melt into adhesive to carry out spraying to Rifapentine raw material to be made
Particle, then HPMC, BHA and vitamin C addition straight alcohol melt into coating solution are carried out into hydrojet coating to Rifapentine particle, finally
Mix with pregelatinized starch always mix after refill, solve the problems, such as it is original prepare Rifapentinum capsules intermediate powder mobility,
Solve the problems, such as that pass material is exceeded and content uniformity is big with this, also had greatly improved simultaneously for dissolution rate.
Specific embodiment
The preparation method of Rifapentinum capsules provided by the present invention is to produce Rifapentine glue using fluidized bed granulation method
Capsule, by Tween 80, HPMC and K12Melt into adhesive in straight alcohol is added, Rifapentine raw material is sprayed using the adhesive
Rifapentine particle is obtained；Again by melt into coating solution in HPMC, BHA and vitamin C addition straight alcohol, and use the coating solution pair
The Rifapentine particle carries out hydrojet and is coated prepared Rifapentine coated granule；Finally the Rifapentine coated granule is mixed
It is filled after always being mixed with pregelatinized starch, Rifapentinum capsules is obtained.Solve the direct mixing granulation of original powder and
The big problem of the Rifapentinum capsules content uniformity of generation, simultaneously for dissolution rate, relevant material mass also has improvement.
Each supplementary material consumption that the embodiment of the present invention is used and its source are as shown in following table one：
Each supplementary material consumption of table one and its source
The present invention is described in more detail below by specific embodiment, for a better understanding of the present invention,
But following embodiments are not intended to limit the scope of the invention.
The preparation of the Rifapentinum capsules of embodiment 1
(1) supplementary material prescription (every 10000)
Count by weight, Rifapentine particle is formulated by following components：
Count by weight, Rifapentine coated granule is formulated by following components：
(2) specific preparation technology
1) Tween 80, HPMC and K12 are added into straight alcohol melt into adhesive, crosses 100 mesh sieves, it is standby；
2) Rifapentine of recipe quantity is placed in granulating coated pot, when temperature of charge reaches 35 DEG C in granulating coated pot
Start top spray granulation, at 40 DEG C, until all having sprayed, material crosses 20 eye mesh screens to control material temperature, picks in whole pelletization
Except more than 20 mesh particles, Rifapentine particle is obtained；
3) HPMC, BHA and vitamin C are added into straight alcohol melt into coating solution, crosses 100 mesh sieves, it is standby；
4) using step 3) obtained in coating solution to step 2) obtained in the Rifapentine particle carry out bottom spray and be coated, it is whole
Control material temperature is at 40 DEG C in individual coating process, until all having sprayed, material crosses 20 eye mesh screens, rejects and is more than 20 mesh particles,
Rifapentine coated granule is obtained；
5) finally by step 4) be coated after Rifapentine coated granule admix pregelatinized starch and always mixed, refilling system
Obtain Rifapentinum capsules X160301.
The preparation of the Rifapentinum capsules of embodiment 2
(1) supplementary material prescription (every 10000)
Count by weight, Rifapentine particle is formulated by following components：
Count by weight, Rifapentine coated granule is formulated by following components：
(2) specific preparation technology
1) Tween 80, HPMC and K12 are added into straight alcohol melt into adhesive, crosses 100 mesh sieves, it is standby；
2) Rifapentine of recipe quantity is placed in granulating coated pot, when temperature of charge reaches 35 DEG C in granulating coated pot
Start top spray granulation, at 30-35 DEG C, until all having sprayed, material crosses 20 eye mesh screens to control material temperature in whole pelletization,
Reject and be more than 20 mesh particles, Rifapentine particle is obtained；
3) HPMC, BHA and vitamin C are added into straight alcohol melt into coating solution, crosses 100 mesh sieves, it is standby；
4) using step 3) obtained in coating solution to step 2) obtained in the Rifapentine particle carry out bottom spray and be coated, it is whole
Control material temperature is at 30-35 DEG C in individual coating process, until all having sprayed, material crosses 20 eye mesh screens, rejects and is more than 20 mesh
Grain, is obtained Rifapentine coated granule；
5) finally by step 4) be coated after Rifapentine coated granule admix pregelatinized starch and always mixed, refilling system
Obtain Rifapentinum capsules X160302.
The preparation of the Rifapentinum capsules of embodiment 3
(1) supplementary material prescription (every 10000)
Count by weight, Rifapentine particle is formulated by following components：
Count by weight, Rifapentine coated granule is formulated by following components：
(2) specific preparation technology
1) Tween 80, HPMC and K12 are added into straight alcohol melt into adhesive, crosses 100 mesh sieves, it is standby；
2) Rifapentine of recipe quantity is placed in granulating coated pot, when temperature of charge reaches 35 DEG C in granulating coated pot
Start top spray granulation, at 35-40 DEG C, until all having sprayed, material crosses 20 eye mesh screens to control material temperature in whole pelletization,
Reject and be more than 20 mesh particles, Rifapentine particle is obtained；
3) HPMC, BHA and vitamin C are added into straight alcohol melt into coating solution, crosses 100 mesh sieves, it is standby；
4) using step 3) obtained in coating solution to step 2) obtained in the Rifapentine particle carry out bottom spray and be coated, it is whole
Control material temperature is at 25-30 DEG C in individual coating process, until all having sprayed, material crosses 20 eye mesh screens, rejects and is more than 20 mesh
Grain, is obtained Rifapentine coated granule；
5) finally by step 4) be coated after Rifapentine coated granule admix pregelatinized starch and always mixed, refilling system
Obtain Rifapentinum capsules X160303.
Performance：Rifapentinum capsules, and three batches for randomly selecting are prepared with traditional original technique powder direct mixing method
Sample 150501,150502 and 150503 is control sample；With three batches of Rifapentinum capsules obtained in embodiment of the present invention 1-3
X160301, X160302 and X160303 are test specimens, and accelerated test is carried out respectively, and test result is as shown in following table two：
Each detection test result of accelerated test of the control sample of table two and test specimens
Note:Criterion of acceptability：Content uniformity≤10%, content 90~110%, dissolution >=70%, singly miscellaneous≤1.0%, it is total miscellaneous
≤ 3.0%.
Such as the data display of table two, the more former technique of new technology product is greatly improved in terms of content uniformity, is fully solved
The unstable problem of the loading amount that is originally present；Meanwhile, it is no matter single miscellaneous or total miscellaneous after 6 months accelerate, all also allowed in pharmacopeia
In the range of, the more former technique of stability has very big lifting；Additionally, dissolution data display, the more former technique of new technology also has certain
Lifting.
Specific embodiment of the invention has been described in detail above, but it is intended only as example, and the present invention is not limited
It is formed on particular embodiments described above.To those skilled in the art, any equivalent modifications carried out to the present invention and
Replacement is also all among scope of the invention.Therefore, the impartial conversion made without departing from the spirit and scope of the invention and
Modification, all should be contained within the scope of the invention.
Claims (9)
1. a kind of preparation method of Rifapentinum capsules, it is characterised in that by Tween 80, HPMC and K12Add melt into straight alcohol
Adhesive, prepared Rifapentine particle of spraying is carried out using the adhesive to Rifapentine；HPMC, BHA and vitamin C are added again
Enter melt into coating solution in straight alcohol, and hydrojet is carried out to the Rifapentine particle using the coating solution and be coated prepared Rifapentine
Coated granule；Finally the Rifapentine coated granule is mixed and is filled after always being mixed with pregelatinized starch, profit good fortune is obtained
Spray fourth capsule.
2. the preparation method of Rifapentinum capsules according to claim 1, it is characterised in that specifically include following steps：
1) by Tween 80, HPMC and K12Straight alcohol melt into adhesive is added, 100 mesh sieves are crossed, it is standby；
2) Rifapentine of recipe quantity is placed in granulating coated pot, is started when temperature of charge reaches 35 DEG C in granulating coated pot
Top spray is pelletized, and below 40 DEG C, until all having sprayed, material crosses 20 eye mesh screens to control material temperature, picks in whole pelletization
Except more than 20 mesh particles, Rifapentine particle is obtained；
3) HPMC, BHA and vitamin C are added into straight alcohol melt into coating solution, crosses 100 mesh sieves, it is standby；
4) using step 3) obtained in coating solution to step 2) obtained in the Rifapentine particle carry out bottom spray and be coated, whole bag
Control material temperature is below 40 DEG C during clothing, until all having sprayed, material crosses 20 eye mesh screens, rejects and is more than 20 mesh particles,
Rifapentine coated granule is obtained；
5) finally by step 4) be coated after Rifapentine coated granule admix pregelatinized starch and always mixed, refilling to produce
Product.
3. the preparation method of Rifapentinum capsules according to claim 1 and 2, it is characterised in that count by weight, institute
Rifapentine particle is stated to be formulated by following components：
4. the preparation method of the Rifapentinum capsules stated according to claim 3, it is characterised in that count by weight, the profit
Good fortune spray fourth particle is formulated by following components：
5. the preparation method of Rifapentinum capsules according to claim 1 and 2, it is characterised in that count by weight, institute
Rifapentine coated granule is stated to be formulated by following components：
6. the preparation method of Rifapentinum capsules according to claim 5, it is characterised in that count by weight, it is described
Rifapentine coated granule is formulated by following components：
7. the preparation method of Rifapentinum capsules according to claim 2, it is characterised in that the step 2) in control thing
Material temperature degree is 30-40 DEG C.
8. the preparation method of Rifapentinum capsules according to claim 2, it is characterised in that the step 3) in control thing
Material temperature degree is 25-35 DEG C.
9. a kind of such as the Rifapentinum capsules of claim any one of 1-8 methods described preparation.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710269004.3A CN106913556B (en) | 2017-04-24 | 2017-04-24 | Rifapentine capsule and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710269004.3A CN106913556B (en) | 2017-04-24 | 2017-04-24 | Rifapentine capsule and preparation method thereof |
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| Publication Number | Publication Date |
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| CN106913556A true CN106913556A (en) | 2017-07-04 |
| CN106913556B CN106913556B (en) | 2021-03-02 |
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| CN201710269004.3A Active CN106913556B (en) | 2017-04-24 | 2017-04-24 | Rifapentine capsule and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112472702A (en) * | 2020-12-14 | 2021-03-12 | 卓和药业集团有限公司 | Pharmaceutical composition for treating pulmonary tuberculosis and preparation method thereof |
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| KR20100090138A (en) * | 2009-02-05 | 2010-08-13 | (주) 벡스코아 | Oral solid preparation for treatment and prevention of tuberculosis |
| CN102805740A (en) * | 2011-05-30 | 2012-12-05 | 浙江京新药业股份有限公司 | Rivastigmine capsules and preparation method thereof |
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2017
- 2017-04-24 CN CN201710269004.3A patent/CN106913556B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20100090138A (en) * | 2009-02-05 | 2010-08-13 | (주) 벡스코아 | Oral solid preparation for treatment and prevention of tuberculosis |
| CN102805740A (en) * | 2011-05-30 | 2012-12-05 | 浙江京新药业股份有限公司 | Rivastigmine capsules and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112472702A (en) * | 2020-12-14 | 2021-03-12 | 卓和药业集团有限公司 | Pharmaceutical composition for treating pulmonary tuberculosis and preparation method thereof |
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