CN107951859A - A kind of roxithromycin soft capsule and preparation method thereof - Google Patents
A kind of roxithromycin soft capsule and preparation method thereof Download PDFInfo
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- CN107951859A CN107951859A CN201711422155.4A CN201711422155A CN107951859A CN 107951859 A CN107951859 A CN 107951859A CN 201711422155 A CN201711422155 A CN 201711422155A CN 107951859 A CN107951859 A CN 107951859A
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- roxithromycin
- pomace
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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
- A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
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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
- A61K9/4875—Compounds of unknown constitution, e.g. material from plants or animals
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Abstract
The invention discloses a kind of roxithromycin soft capsule and preparation method thereof, which includes content and rubber, and the percentage by weight of each raw material of the content is：Roxithromycin 15%~70%, oleaginous base 15%~70%, compatilizer 1 10% and adsorbent 15 40%.Compatilizer and adsorbent are added in oleaginous base, the adsorbent used is pomace Ultramicro-powder that particle diameter is 8 20um, pomace thing after being squeezed the juice using fruit is the adsorbent and odor mask of natural polymer as pomace Ultramicro-powder made from raw material, roxithromycin is adsorbed on the sorbent, pomace Ultramicro-powder has masked the bad smell and taste of roxithromycin, reduces irritation of the medicine to stomach；Polymeric sorbent causes roxithromycin to be sustained, and extends the holdup time of medicine in vivo, and drug absorption rate significantly improves.
Description
Technical field
The invention belongs to pharmaceutical field, and in particular to a kind of roxithromycin soft capsule and preparation method thereof.
Background technology
Roxithromycin (Roxithromycin) antimicrobial spectrum and antibacterial activity are similar to erythromycin.Compared with erythromycin, this
Product blood concentration is high, serum half-life length, and bioavilability is significantly superior.The elderly is not required to adjustment dosage using this product.Yin Ben
Product influence from liver microsomes enzyme, therefore do not interact with other drugs.Oral absorption is good, and blood peak concentration of drug is high, into
Food can make declined bioavailability of oral administration half.Distribution is wide in vivo, tonsillotome, nasal sinus, middle ear, lung, phlegm, prostate and other uropoiesis
Drug concentration in reproductive tract tissue is up to effective treatment level.
In order to adapt to the needs of patient, many formulations, including capsule, soft capsule have been developed on roxithromycin
Agent, various tablets, particle etc..Due to the heavy bitter taste of roxithromycin, so the tablet of roxithromycin, granule are not easy to be connect by patient
By；And the capsule and soft capsule of roxithromycin, then it is suitable for the needs of many patients.
Sustained release preparation is a kind of new medicinal preparation technology developed in recent years, and medicine is made sustained release preparation can be with
Medicining times are reduced, increases patient compliance, medicine blood concentration can also be made gentle, fluctuation is small, reduces adverse reaction.Separately have
Studies have shown that roxithromycin belongs to time-dependent medicine, i.e., when drug concentration reaches more than a certain concentration, its bactericidal potency
Directly proportional to medicine and bacterium time of contact, i.e. time longer germicidal efficiency is higher.Therefore roxithromycin is made slow release formulation and has
Beneficial to higher bacteriocidal concentration is maintained, so as to improve bactericidal potency.
The content of the invention
It is an object of the invention to provide a kind of roxithromycin soft capsule and preparation method thereof, which simply has
Effect, obtained roxithromycin content is since specific surface area increases, and the contact area of medicine and agents area increases, in enteron aisle
Solubility substantially increase, so as to increase the bioavilability of medicine, higher bacteriocidal concentration is maintain, so as to improve Luo Hong
Mycin bactericidal potency.
The purpose of the present invention can be achieved through the following technical solutions：
A kind of roxithromycin soft capsule, including content and rubber, the percentage by weight of each raw material of the content are：
Roxithromycin 15%~70%, oleaginous base 15%~70%, compatilizer 1-10% and adsorbent 15-40%.
Further, the percentage by weight of each raw material of the content is：Roxithromycin 30%~55%, oleaginous base
23%~50%, compatilizer 2-5% and adsorbent 15-20%.
Further, the oleaginous base is physical squeezing oil, and physical squeezing oil is big for squeezing peanut oil, squeezing
One or more combination thing in soya-bean oil, squeezing rapeseed oil or pressed tea seed oil.
Further, the compatilizer is Dupont EEA2112AC compatilizers.
Further, the adsorbent is the pomace Ultramicro-powder that particle diameter is 8-20um.
Further, the pomace thing after the pomace is squeezed the juice for fruit；The preparation method of the pomace Ultramicro-powder is：Take
Pomace after squeezing juice is put into air dry oven, and dry 10-16h, takes out after dry and be put into ball mill at 60-70 DEG C
Crushed, cross 40 mesh sieve, obtain pomace coarse powder, pomace coarse powder is then sent into fluidized bed jet mill micronizer into one
The crushing of step, is collected by cyclone collector and obtains the pomace Ultramicro-powder of uniform particle diameter.
A kind of preparation method of roxithromycin soft capsule, specifically includes following steps：
(1) oleaginous base is added in mixer, adds adsorbent while stirring, be uniformly mixed；
(2) then toward compatilizer and roxithromycin is sequentially added in the mixed liquor of step (1), stirring is so that roxithromycin is filled
Divide absorption on the sorbent, and it is dispersed in oleaginous base, that is, obtain interior mixed liquid；
(3) interior mixed liquid is put into freeze drier, freeze-drying obtains interior batch mixing；
(4) the interior batch mixing after freeze-drying is put into homogenizer and emulsify up to content；
(5) content is injected in rubber, then through pelleting, sizing, wiping ball, drying to obtain roxithromycin soft capsule.
Beneficial effects of the present invention：
A kind of roxithromycin soft capsule of the offer of the present invention, adds compatilizer and adsorbent in oleaginous base, uses
Adsorbent be pomace Ultramicro-powder that particle diameter is 8-20um, the pomace thing after being squeezed the juice using fruit is pomace Ultramicro-powder made from raw material
It is the adsorbent and odor mask of natural polymer, roxithromycin is adsorbed on the sorbent, and it is mould that pomace Ultramicro-powder has masked Luo Hong
The bad smell and taste of element, reduce irritation of the medicine to stomach；Due to the particularity of technique, it can more completely retain sieve
The active ingredient of erythromycin, physical property are stablized, and are not easy to be influenced by high temperature and produce rotten, improve roxithromycin under one's belt
Activity, polymeric sorbent cause roxithromycin to be sustained, and extend the holdup time of medicine in vivo, and drug absorption rate is shown
Write and improve；Obtained roxithromycin content is since specific surface area increases, and the contact area of medicine and agents area increases, in intestines
Solubility in road substantially increases, so as to increase the bioavilability of medicine, higher bacteriocidal concentration is maintain, so as to improve
Roxithromycin bactericidal potency.
Embodiment
The technical solution in the embodiment of the present invention will be clearly and completely described below, it is clear that described implementation
Example is only part of the embodiment of the present invention, instead of all the embodiments.Based on the embodiments of the present invention, this area is common
All other embodiment that technical staff is obtained without creative efforts, belongs to the model that the present invention protects
Enclose.
Embodiment 1
Each raw material weight of roxithromycin soft capsule content is：Roxithromycin 30kg, squeezing peanut oil 50kg, Dupont
EEA2112AC compatilizers 2kg and pomace Ultramicro-powder 15kg；
S1：The preparation of pomace Ultramicro-powder
The pomace after squeezing juice is taken to be put into air dry oven, the dry 10h at 60 DEG C, takes out after dry and be put into ball milling
Crushed in machine, cross 40 mesh sieve, obtain pomace coarse powder, pomace coarse powder is then sent into fluidized bed jet mill micronizer
It is further to crush, collected by cyclone collector and obtain the pomace Ultramicro-powder that particle diameter is 8-20um；
S2：The preparation method of roxithromycin soft capsule, specifically includes following steps：
(1) oleaginous base is added in mixer, adds adsorbent pomace Ultramicro-powder while stirring, mixed at 35 DEG C
Uniformly；
(2) then toward sequentially adding Dupont EEA2112AC compatilizers and roxithromycin in the mixed liquor of step (1),
3h is stirred at 30 DEG C so that roxithromycin is fully adsorbed on adsorbent pomace Ultramicro-powder, and is uniformly divided in oleaginous base
Dissipate, that is, obtain interior mixed liquid；
(3) interior mixed liquid is put into freeze drier, 3h is freeze-dried at -40 DEG C and obtains interior batch mixing；
(4) the interior batch mixing after freeze-drying is put into homogenizer and emulsify up to content；
(5) content is injected in rubber, then through pelleting, sizing, wiping ball, drying to obtain roxithromycin soft capsule.
Embodiment 2
Each raw material weight of roxithromycin soft capsule content is：Roxithromycin 55kg, squeezing peanut oil 23kg, Dupont
EEA2112AC compatilizers 2kg and pomace Ultramicro-powder 20kg；
S1：The preparation of pomace Ultramicro-powder
The pomace after squeezing juice is taken to be put into air dry oven, the dry 16h at 70 DEG C, takes out after dry and be put into ball milling
Crushed in machine, cross 40 mesh sieve, obtain pomace coarse powder, pomace coarse powder is then sent into fluidized bed jet mill micronizer
It is further to crush, collected by cyclone collector and obtain the pomace Ultramicro-powder that particle diameter is 8-20um；
S2：The preparation method of roxithromycin soft capsule, specifically includes following steps：
(1) oleaginous base is added in mixer, adds adsorbent pomace Ultramicro-powder while stirring, mixed at 40 DEG C
Uniformly；
(2) then toward sequentially adding Dupont EEA2112AC compatilizers and roxithromycin in the mixed liquor of step (1),
35h is stirred at 35 DEG C so that roxithromycin is fully adsorbed on adsorbent pomace Ultramicro-powder, and is uniformly divided in oleaginous base
Dissipate, that is, obtain interior mixed liquid；
(3) interior mixed liquid is put into freeze drier, 5h is freeze-dried at -40 DEG C and obtains interior batch mixing；
(4) the interior batch mixing after freeze-drying is put into homogenizer and emulsify up to content；
(5) content is injected in rubber, then through pelleting, sizing, wiping ball, drying to obtain roxithromycin soft capsule.
Embodiment 3
Each raw material weight of roxithromycin soft capsule content is：Roxithromycin 45kg, squeezing peanut oil 34kg, Dupont
EEA2112AC compatilizers 5kg and pomace Ultramicro-powder 16kg；
S1：The preparation of pomace Ultramicro-powder
The pomace after squeezing juice is taken to be put into air dry oven, the dry 16h at 70 DEG C, takes out after dry and be put into ball milling
Crushed in machine, cross 40 mesh sieve, obtain pomace coarse powder, pomace coarse powder is then sent into fluidized bed jet mill micronizer
It is further to crush, collected by cyclone collector and obtain the pomace Ultramicro-powder that particle diameter is 8-20um；
S2：The preparation method of roxithromycin soft capsule, specifically includes following steps：
(1) oleaginous base is added in mixer, adds adsorbent pomace Ultramicro-powder while stirring, mixed at 40 DEG C
Uniformly；
(2) then toward sequentially adding Dupont EEA2112AC compatilizers and roxithromycin in the mixed liquor of step (1),
35h is stirred at 35 DEG C so that roxithromycin is fully adsorbed on adsorbent pomace Ultramicro-powder, and is uniformly divided in oleaginous base
Dissipate, that is, obtain interior mixed liquid；
(3) interior mixed liquid is put into freeze drier, 5h is freeze-dried at -40 DEG C and obtains interior batch mixing；
(4) the interior batch mixing after freeze-drying is put into homogenizer and emulsify up to content；
(5) content is injected in rubber, then through pelleting, sizing, wiping ball, drying to obtain roxithromycin soft capsule.
Above content is only to design example and explanation of the invention, affiliated those skilled in the art
Various modifications or additions are done to described specific embodiment or are substituted in a similar way, without departing from invention
Design or surmount scope defined in the claims, be within the scope of protection of the invention.
Claims (7)
1. a kind of roxithromycin soft capsule, including content and rubber, it is characterised in that：The weight of each raw material of the content
Percentage is：Roxithromycin 15%~70%, oleaginous base 15%~70%, compatilizer 1-10% and adsorbent 15-40%.
A kind of 2. roxithromycin soft capsule according to claim 1, it is characterised in that：The weight of each raw material of the content
Measuring percentage is：Roxithromycin 30%~55%, oleaginous base 23%~50%, compatilizer 2-5% and adsorbent 15-20%.
A kind of 3. roxithromycin soft capsule according to claim 1, it is characterised in that：The oleaginous base is physics pressure
Oil expression, physical squeezing oil are one kind in squeezing peanut oil, squeezing soyabean oil, squeezing rapeseed oil or pressed tea seed oil
Or several compositions.
A kind of 4. roxithromycin soft capsule according to claim 1, it is characterised in that：The compatilizer is Dupont
EEA2112AC compatilizers.
A kind of 5. roxithromycin soft capsule according to claim 1, it is characterised in that：The adsorbent is that particle diameter is 8-
The pomace Ultramicro-powder of 20um.
A kind of 6. roxithromycin soft capsule according to claim 5, it is characterised in that：After the pomace is squeezed the juice for fruit
Pomace thing；The preparation method of the pomace Ultramicro-powder is：The pomace after squeezing juice is taken to be put into air dry oven,
Dry 10-16h at 60-70 DEG C, taking-up, which is put into ball mill, after drying is crushed, and is crossed 40 mesh sieve, is obtained pomace coarse powder, connect
And further crush pomace coarse powder feeding fluidized bed jet mill micronizer, collected by cyclone collector and obtain grain
The homogeneous pomace Ultramicro-powder in footpath.
A kind of 7. preparation method of roxithromycin soft capsule, it is characterised in that：Specifically include following steps：
(1) oleaginous base is added in mixer, adds adsorbent while stirring, be uniformly mixed；
(2) then toward compatilizer and roxithromycin is sequentially added in the mixed liquor of step (1), stirring is so that roxithromycin is fully inhaled
It is attached on the sorbent, it is and dispersed in oleaginous base, that is, obtain interior mixed liquid；
(3) interior mixed liquid is put into freeze drier, freeze-drying obtains interior batch mixing；
(4) the interior batch mixing after freeze-drying is put into homogenizer and emulsify up to content；
(5) content is injected in rubber, then through pelleting, sizing, wiping ball, drying to obtain roxithromycin soft capsule.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711422155.4A CN107951859A (en) | 2017-12-25 | 2017-12-25 | A kind of roxithromycin soft capsule and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711422155.4A CN107951859A (en) | 2017-12-25 | 2017-12-25 | A kind of roxithromycin soft capsule and preparation method thereof |
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| Publication Number | Publication Date |
|---|---|
| CN107951859A true CN107951859A (en) | 2018-04-24 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201711422155.4A Pending CN107951859A (en) | 2017-12-25 | 2017-12-25 | A kind of roxithromycin soft capsule and preparation method thereof |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1709273A (en) * | 2004-06-18 | 2005-12-21 | 秦引林 | Roxhthromycin soft capsule and its preparing method |
| CN101077351A (en) * | 2007-05-21 | 2007-11-28 | 姚俊华 | Soft capsules containing roxithromycin |
| CN102697753A (en) * | 2012-06-08 | 2012-10-03 | 浙江维康药业有限公司 | Roxithromycin compound and soft capsule preparation thereof |
-
2017
- 2017-12-25 CN CN201711422155.4A patent/CN107951859A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1709273A (en) * | 2004-06-18 | 2005-12-21 | 秦引林 | Roxhthromycin soft capsule and its preparing method |
| CN101077351A (en) * | 2007-05-21 | 2007-11-28 | 姚俊华 | Soft capsules containing roxithromycin |
| CN100577178C (en) * | 2007-05-21 | 2010-01-06 | 姚俊华 | Soft capsules containing roxithromycin |
| CN102697753A (en) * | 2012-06-08 | 2012-10-03 | 浙江维康药业有限公司 | Roxithromycin compound and soft capsule preparation thereof |
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| PB01 | Publication | ||
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Application publication date: 20180424 |