CN104644608A - Improved preparation method of mecobalamine capsule - Google Patents
Improved preparation method of mecobalamine capsule Download PDFInfo
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- CN104644608A CN104644608A CN201510041768.8A CN201510041768A CN104644608A CN 104644608 A CN104644608 A CN 104644608A CN 201510041768 A CN201510041768 A CN 201510041768A CN 104644608 A CN104644608 A CN 104644608A
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Abstract
The invention discloses an improved preparation method of a mecobalamine capsule. The method comprises the steps of taking mecobalamine as a raw material, premixing, pelletizing, drying, granulating, and performing final mixing to form the mecobalamine capsule. According to the method, optimal dosage ratios of mecobalamine and auxiliary materials including mannitol, microcrystalline cellulose and povidone K30 are screened out through a large number of experiments; optimal steps of premixing, guniting and pelletizing, particularly the step of performing drying processing by adopting a fluid bed are screened out through a large number of experiments; equipment used in method adopts a totally-enclosed design, is good in sealability and high in preparation effect, can prevent light decomposition of mecobalamine, can avoid long-time drying, and overcome the defects of drying suspension, uneven drying and poor drying effect resulting from manual tray dumping; the method can greatly reduce the labor intensity of operating personnel, lower the production cost, improve the production yield, and is suitable for industrialized production.
Description
Technical field
The present invention relates to a kind of preparation method of medicine, be specifically related to a kind of preparation method of mecobalamin capsules of improvement.
Background technology
Mecobalamin capsules is a kind of preparation of Nanjing Hailing Pharmaceutical Co., Ltd. of Yangtze River Pharmaceutical Group's development, is used for the treatment of peripheral neuropathy.Its raw material mecobalamin is a kind of endogenic actimide, participates in one carbon unit circulation, plays an important role in the transmethylase course of reaction by homocysteine synthetic nitrogen propylhomoserin.Zoopery finds, this product is easy to enter neuronal cell device than cobalamin, participates in the synthesis of brain cell and spinal neuron thymidine, promotes utilization and the nucleic acid metabolism of folic acid, and comparatively cobalamin is strong to promote nucleic acid and protein synthesis; Axonal transport function and axon regeneration can be promoted, the conveying normalization of the diabetic sciatic nerve aixs cylinder skelemin that streptozotocin is induced,
This product Main Ingredients and Appearance is: mecobalamin.Its chemical name: Co α-[α-(5,6-dimethylbenzimidazole base)]-Co Beta-methyl cobalt amide.Molecular formula: C
63h
91coN
13o
14p molecular weight: 1344.38.
Of the prior artly prepare in the method for mecobalamin capsules granule, technological design is reasonable not, and because mecobalamin is shown in that photo-labile easily decomposes, the yield of gained intermediate is not high, and during mecobalamin dried, its thermal conversion efficiency is low, and energy consumption is high, and needs the operation that constantly turns between dry period, baking temperature is uneven, easily cause active component mecobalamin to store unstable, personnel labor intensity is large, and production cost is high.
In prior art, the production decision of mecobalamin, wet granulation, dry, it is low to there is production efficiency in granulate step, dry insufficient, the shortcomings such as drying time is long, and mecobalamin easily decomposes, poor stability, the present invention screens concrete granulation by great many of experiments, the technological parameter of drying and granulate method and optimum.Adopt optimum preparation process provided by the invention and technological parameter, long-time drying can be avoided, the drying that avoiding manually frequently turns over causes is interrupted, uneven drying prevents dust from flying in dry run, ensure the stability of active component mecobalamin, and greatly can reduce the labor intensity of operator, improve product yield, reduce production cost etc., compared to the prior art achieve extraordinary technological progress.
The preparation method of the mecobalamin capsules of improvement provided by the invention, described adjuvant is starch, magnesium stearate, sodium carboxymethyl cellulose.
Beneficial effect: the preparation method of the mecobalamin capsules of improvement provided by the invention compared with prior art has the following advantages:
The present invention filters out by great many of experiments the optimum amount proportioning that best mecobalamin and adjuvant comprise mannitol, microcrystalline Cellulose, PVP K30 etc., and filter out best premixing by great many of experiments, whitewashing, granulate, especially fluid bed is adopted to carry out dried step, and the optimal processing parameter of each step.Equipment used by the present invention designs for total enclosing, good airproof performance, can prevent raw material mecobalamin from seeing photolysis, preparation effect is high, can avoid long-time drying, the drying avoiding frequent Manual dumping tray to cause is interrupted, uneven drying, the shortcomings such as drying effect difference, and the present invention can reduce the labor intensity of operator greatly, reduce production cost, improve and produce yield.
Summary of the invention:
Goal of the invention: the deficiency that the object of the invention is the mecobalamin production method in order to solve prior art, provides a kind of technological design reasonable, rapidly dry, productive rate is high, energy consumption is low, and personnel labor intensity is low, the preparation method of the mecobalamin capsules of the improvement that production cost is low.The mecobalamin good stability that the present invention prepares, can ensure clinical drug effect.
Technical scheme: in order to realize above object, the technical scheme taked provided by the invention is:
A preparation method for the mecobalamin capsules of improvement, it comprises the following steps:
(1) preparation of binding agent: getting volumetric concentration is 95% ethanol, adding purified water, to be mixed with volumetric concentration be 50% ethanol, separately takes PVP K30 and slowly pour in 50% ethanol, stir, be prepared into 50% alcoholic solution of 10% PVP K30;
(2) wet granulation: under lucifuge condition, mecobalamin raw material is taken by recipe quantity, mix after adding microcrystalline Cellulose, in order the mixture of microcrystalline Cellulose, mecobalamin and microcrystalline Cellulose, mannitol are dropped into premixing in wet mixing pelletizer successively again, then in the granule after premixing, spray into PVP K30 50% alcoholic solution of step (1) 10%, stir, chopping, granulate;
(3) granulate: the wet granular wet method pelletizing machine made is crossed screen cloth and carries out granulate;
(4) dry: the granule after granulate to be placed in fluid bed dryer, after hot-air flow drying, to obtain dried granule;
(5) get the dried granule that step (4) obtains, after dry type pelletizing machine granulate, obtain dry granule;
(6) get the dry granule that step (5) obtains and add pharmaceutically acceptable adjuvant, after mixing, obtain mecobalamin capsules granule, in then encapsulated, obtain mecobalamin capsules.
Preferably, the preparation method of the mecobalamin capsules of above-described improvement, mecobalamin and microcrystalline Cellulose weight ratio are 1:160 ~ 200, and the weight ratio of mecobalamin and mannitol is 1:120 ~ 160.
Preferably, the preparation method of the mecobalamin capsules of above-described improvement, is characterized in that: the weight ratio of mecobalamin and PVP K30 is 1:15 ~ 20.
The features such as according to mecobalamin, the present invention is shown in that light easily decomposes, stability is bad, according to the granulation adjuvant such as preferred binding agent of experiment screening energetically, and filter out the preferable amount proportioning of each adjunct ingredient, the mecobalamin granule prepared, good stability, are evenly distributed.
Preferably, the preparation method of the mecobalamin capsules of above-described improvement, in step (2) during premixing, mixing speed is 120 ~ 150rpm, and chopping speed is 2500 ~ 3000rpm, and the premixing time is 100 ~ 300 seconds.
Preferably, the preparation method of the mecobalamin capsules of above-described improvement, it is characterized in that: in step (2), running parameter when spraying into 50% alcoholic solution of the PVP K30 of 10% in the granule after premixing is: peristaltic pump rotating speed is 50rpm ~ 70rpm, mixing speed is 75 ~ 100rpm, and chopping speed is 450 ~ 500rpm.
Preferably, the preparation method of the mecobalamin capsules of above-described improvement, in step (2) in pelletization, setting mixing speed is 160 ~ 180rpm, chopping speed 3000 ~ 4000rpm, Granulation time 60 ~ 120 seconds.
Preferably, the preparation method of the mecobalamin capsules of above-described improvement, granule after granulate is placed in fluid bed dryer in (4) by step, dry below 60 DEG C, control 1 ~ 2 hour drying time, to dry moisture≤3.0%, the parameter setting between dry period is as following table:
Fluid bed drying stage parameter setting:
Detailed description of the invention
The present invention is illustrated further below in conjunction with specific embodiment, these embodiments should be understood only be not used in for illustration of the present invention and limit the scope of the invention, after having read the present invention, the amendment of those skilled in the art to the various equivalent form of value of the present invention has all fallen within the application's claims limited range.
Embodiment 1
A kind of preparation method of mecobalamin capsules of improvement:
(1), prescription
(2), mecobalamin, mannitol, microcrystalline Cellulose (PH101) and ethanol has been weighed by recipe quantity.
(3), binding agent is prepared: in 95% ethanol, add purified water be mixed with 50% ethanol, separately take in the stainless steel cask that recipe quantity PVP K30 sterilizes in cleaning, slowly pour in 50% ethanol, limit edged stirs, and is prepared into 10% PVP K30 50% alcoholic solution.
(4), feed intake: get mecobalamin raw material; add microcrystalline Cellulose (PH101) and mix 30s afterwards, more in order the mixture of microcrystalline Cellulose (PH101), mecobalamin and microcrystalline Cellulose (PH101), mannitol are dropped in wet mixing pelletizer successively.
(5), premixing: setting premixing mixing speed 120rpm, chopping speed 2500rpm, 300 seconds premixing time.
(6), whitewashing: setting peristaltic pump rotating speed 50rpm ~ 70rpm, mixing speed 75rpm, chopping speed 450rpm, sprays into PVP K30 50% alcoholic solution of 10% in the granule after premixing.
(7), granulate: setting mixing speed 160rpm, chopping speed 3000rpm, Granulation time 120 seconds.
(8), granulate: the wet granular GSF180 wet method pelletizing machine made is crossed φ 3.0mm screen cloth and carries out granulate.
(9), dry: be placed in by the granule after granulate in GPCGPro60 fluid bed drying, drying below 60 DEG C, controls 1 hour ~ 2 hours drying time, terminates dry to moisture≤3.0%.Parameter setting between dry period refers to following table:
Fluid bed drying stage parameter setting:
(10) granulate: dried granule GS180 dry type pelletizing machine is crossed φ 0.8mm screen cloth and carries out granulate.
, eventually mixed: by dried granule eventually mixed machine mix 20 minutes, rotating speed 12rpm, add starch or cyclodextrin obtains mecobalamin capsules granule after mixing, in then encapsulated, obtain mecobalamin capsules.
Claims (8)
1. a preparation method for the mecobalamin capsules of improvement, is characterized in that comprising the following steps:
(1) preparation of binding agent: getting volumetric concentration is 95% ethanol, adding purified water, to be mixed with volumetric concentration be 50% ethanol, separately takes PVP K30 and slowly pour in 50% ethanol, stir, be prepared into 50% alcoholic solution of 10% PVP K30;
(2) wet granulation: under lucifuge condition, mecobalamin raw material is taken by recipe quantity, mix after adding microcrystalline Cellulose, in order the mixture of microcrystalline Cellulose, mecobalamin and microcrystalline Cellulose, mannitol are dropped into premixing in wet mixing pelletizer successively again, then in the granule after premixing, spray into PVP K30 50% alcoholic solution of step (1) 10%, stir, chopping, granulate;
(3) granulate: the wet granular wet method pelletizing machine made is crossed screen cloth and carries out granulate;
(4) dry: the granule after granulate to be placed in fluid bed dryer, after hot-air flow drying, to obtain dried granule;
(5) get the dried granule that step (4) obtains, after dry type pelletizing machine granulate, obtain dry granule;
(6) get the dry granule that step (5) obtains and add pharmaceutically acceptable adjuvant, after mixing, obtain mecobalamin capsules granule, in then encapsulated, obtain mecobalamin capsules.
2. the preparation method of the mecobalamin capsules of improvement according to claim 1, is characterized in that: mecobalamin and microcrystalline Cellulose weight ratio are 1:160 ~ 200, and the weight ratio of mecobalamin and mannitol is 1:120 ~ 160.
3. the preparation method of the mecobalamin capsules of improvement according to claim 1, is characterized in that: the weight ratio of mecobalamin and PVP K30 is 1:15 ~ 20.
4. the preparation method of the mecobalamin capsules of improvement according to claim 1, is characterized in that: in step (2) during premixing, mixing speed is 120 ~ 150rpm, and chopping speed is 2500 ~ 3000rpm, and the premixing time is 100 ~ 300 seconds.
5. the preparation method of the mecobalamin capsules of improvement according to claim 1, it is characterized in that: in step (2), running parameter when spraying into 50% alcoholic solution of the PVP K30 of 10% in the granule after premixing is: peristaltic pump rotating speed is 50rpm ~ 70rpm, mixing speed is 75 ~ 100rpm, and chopping speed is 450 ~ 500rpm.
6. the preparation method of the mecobalamin capsules of improvement according to claim 1, is characterized in that: in step (2) in pelletization, setting mixing speed is 160 ~ 180rpm, chopping speed 3000 ~ 4000rpm, Granulation time 60 ~ 120 seconds.
7. the preparation method of the mecobalamin capsules of improvement according to claim 1, it is characterized in that: the granule after granulate is placed in GPCGPro60 fluid bed dryer in (4) by step, dry below 60 DEG C, control 1 ~ 2 hour drying time, to dry moisture≤3.0%, the parameter setting between dry period is as following table:
Fluid bed drying stage parameter setting:
8. the preparation method of the mecobalamin capsules of improvement according to claim 1, is characterized in that: described adjuvant is starch, cyclodextrin, magnesium stearate or sodium carboxymethyl cellulose.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510041768.8A CN104644608A (en) | 2015-01-27 | 2015-01-27 | Improved preparation method of mecobalamine capsule |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510041768.8A CN104644608A (en) | 2015-01-27 | 2015-01-27 | Improved preparation method of mecobalamine capsule |
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| CN104644608A true CN104644608A (en) | 2015-05-27 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105997917A (en) * | 2016-05-12 | 2016-10-12 | 扬子江药业集团南京海陵药业有限公司 | Improved mecobalamine tablets and preparing method thereof |
| CN109481420A (en) * | 2018-12-03 | 2019-03-19 | 江苏四环生物制药有限公司 | A kind of mecobalamin sustained-release capsule |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101297798A (en) * | 2008-07-03 | 2008-11-05 | 南京海陵中药制药工艺技术研究有限公司 | Technique for producing mecobalamin capsules |
| CN102232939A (en) * | 2010-04-20 | 2011-11-09 | 广州艾格生物科技有限公司 | Novel mecobalamin sustained-release capsule and preparation method thereof |
-
2015
- 2015-01-27 CN CN201510041768.8A patent/CN104644608A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101297798A (en) * | 2008-07-03 | 2008-11-05 | 南京海陵中药制药工艺技术研究有限公司 | Technique for producing mecobalamin capsules |
| CN102232939A (en) * | 2010-04-20 | 2011-11-09 | 广州艾格生物科技有限公司 | Novel mecobalamin sustained-release capsule and preparation method thereof |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105997917A (en) * | 2016-05-12 | 2016-10-12 | 扬子江药业集团南京海陵药业有限公司 | Improved mecobalamine tablets and preparing method thereof |
| CN109481420A (en) * | 2018-12-03 | 2019-03-19 | 江苏四环生物制药有限公司 | A kind of mecobalamin sustained-release capsule |
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Application publication date: 20150527 |
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