CN104758180A - Secondary filling method for compound preparation capsules - Google Patents
Secondary filling method for compound preparation capsules Download PDFInfo
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- CN104758180A CN104758180A CN201410003173.9A CN201410003173A CN104758180A CN 104758180 A CN104758180 A CN 104758180A CN 201410003173 A CN201410003173 A CN 201410003173A CN 104758180 A CN104758180 A CN 104758180A
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Abstract
The invention discloses a secondary filling method for compound preparation capsules. The secondary filling method is accurate in metering and strong in feasibility and comprises the following steps: (1) material preparation: preparing any active ingredient in a compound preparation and corresponding auxiliary materials into flowing granules or micropills to obtain a first filling material, and preparing residual active ingredients and corresponding auxiliary materials into compressible granules or powder to obtain a secondary filling material; (2) first filling: filling an empty capsule with the first filling material obtained in the step (1), and keeping the capsule in a dead-lock or semi-dead-lock state after filling; and (3) secondary filling: opening the capsule filled at first, filling the opened capsule with the secondary filling material obtained in the step (1) for the second time, and locking the capsule after filling.
Description
Technical field
The present invention relates to a kind of secondary fill method, be specifically related to a kind of secondary fill method of compound preparation capsule.Belong to drug packaging technical field.
Background technology
Capsule is one of topmost pharmaceutical formulation, and production technology is simple, and its preparation output accounts for about 20% of oral solid formulation total output.Along with the developing rapidly of health products trade taking capsule as main dosage form, the fill method of capsule pharmaceutical is had higher requirement.
Especially the development of compound preparation, the secondary of capsule in the urgent need to address fills problem.The method that existing bibliographical information secondary (repeatedly) is filled, namely fills drug powder of different nature in same capsule, cannot the problem of mix homogeneously to solve several heterogeneity powder in granulation.But its special capsule secondary pad device involves great expense, and only has external a handful of countries to have, and there is no import at present.Thus cause large quantities of compound preparation cannot realize copying, and then cause the medicine of a large amount of determined curative effect, few side effects can only dependence on import, expensive price makes it widely apply in patients.
In addition, active component in compound preparation and between active component, or usually there is situation about cannot jointly granulate between arbitrary active component and other adjuvants, such as: there is incompatibility each other, require different activities composition different parts release, cannot cannot jointly the granulating of causing such as mix homogeneously.Require that different activities composition comprises in different parts release: require that wherein one or more active component discharge under one's belt, other active component discharges or discharges at other different parts in small intestinal.Cannot comprise by mix homogeneously: between the granule that specific gravity difference is large and granule, between granule and powder, between micropill and granule, between micropill and powder.Particularly between granule and powder or between micropill and powder.
For above-mentioned situation, even use special capsule secondary pad device also cannot obtain homogeneous, stable product.The capsule quality obtained is undesirable.
Summary of the invention
The object of the invention is, for overcoming above-mentioned the deficiencies in the prior art, to provide a kind of secondary fill method of compound preparation capsule.The method accurate measurement, feasibility is strong.
For achieving the above object, the present invention adopts following technical proposals:
A secondary fill method for compound preparation capsule, comprises the following steps:
(1) material prepares: its corresponding adjuvant of arbitrary active component in compound preparation is prepared into flowable particulates or micropill, is fill material first; Its corresponding adjuvant of another active component is prepared into compressibility granule or powder, is secondary fill material;
(2) fill first: the fill material first utilizing step (1) to obtain fills Capsules, makes it be locked or half locking state after filling;
(3) secondary is filled: open the capsule of filling first, and the secondary fill material utilizing step (1) to obtain carries out secondary filling, locked after filling.
In described step (1), prepare the adjuvant that fill material first uses and comprise: lactose, low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, glyceryl monostearate, hypromellose, weight ratio are the methacrylic acid-ethylacrylate copolymer of 1:1, magnesium stearate, polyoxyethylene sorbitan monoleate, sodium stearyl fumarate, cane sugar type medicinal fine pellet core, Pulvis Talci or triethyl citrate;
Prepare the adjuvant that secondary fill material uses to comprise: lactose, starch, pregelatinized Starch, microcrystalline Cellulose, hypromellose, sodium stearyl fumarate, magnesium stearate, Pulvis Talci or silicon dioxide.
In described step (1), the active component in compound preparation and between active component, or cannot jointly granulate between arbitrary active component and other adjuvants.
Described cannot jointly granulating comprises: there is incompatibility each other, require different activities composition different parts release, cannot cannot jointly granulating of causing of mix homogeneously.
Require that different activities composition comprises in different parts release: require that wherein one or more active component discharge under one's belt, other active component discharges or discharges at other different parts in small intestinal.
Described cannot comprise by mix homogeneously: between the granule of density ratio more than 0.8 and granule, between granule and powder, between micropill and granule, between micropill and powder.
Be preferably between micropill and granule or between micropill and powder.
More preferably between micropill and powder.
Described step (2) and step (3) all adopt conventional capsule pad device to fill.
Described conventional capsule pad device is routine encapsulation pad device or metering pin type capsule filling equipment.
Described conventional capsule pad device is one or two, preferably two.
Described fill material is first preferably micropill.
Described secondary fill material is preferably powder.
In described step (3), the capsule of filling first, through aligning, carries out secondary filling after cap body separating step.
Described cap body separating step, requires the separation completely realizing cap body.
Secondary fill material enters in the capsule after filling first after pressurization.
Beneficial effect of the present invention:
Fill material first of the present invention has good fluidity, and secondary fill material has better compressibility, and secondary fill material enters capsule body after pressurization, ensure that the accuracy of metering.The present invention does not rely on special capsule secondary pad device, the secondary that simple use conventional capsule pad device can realize compound preparation is filled, and cost is low, efficient imitated existing compound preparation, in content, stripping and stability, all obtain good effect, feasibility is strong.
Detailed description of the invention
Below in conjunction with embodiment, the present invention will be further elaborated, should be noted that following explanation is only to explain the present invention, not limiting its content.
Embodiment 1:
the capsule-filling method of esomeprazole magnesium/aspirin compound preparation
(1) material prepares:
By the esomeprazole magnesium (synthesis of esomeprazole magnesium, Song Weiguo, Chu Yafei, Song Chenggang, Zhang Xiao climbs, Xu Wenfang, " Chinese Journal of Pharmaceuticals ", 8th phase the 44th volume: 744-746 in 2013) by fluidized bed coating granulating technique, respectively through 0.25mm ~ 0.35mm sucrose ball core 30g, medicated layer (esomeprazole magnesium 40g, hypromellose 7g, polyoxyethylene sorbitan monoleate 1g, and purified water 210g), sealing coat (hyprolose 9g, Pulvis Talci 34g, magnesium stearate 2g, and purified water 310g), enteric layer (methacrylic acid-ethyl propylene acid esters 1:1(aqueous solution, mass concentration is 30%) 127g, triethyl citrate 3.8g, glyceryl monostearate 2g, polyoxyethylene sorbitan monoleate 0.2g, and purified water 50g, esomeprazole enteric capsules is prepared after coating, the preparation of aspirin 162g(aspirin, " Experiment of Organic Chemistry ", Cheng Qingfang edits, publishing house of Nanjing University, in JIUYUE, 2009) mix homogeneously with mobility and the good 491g low-substituted hydroxypropyl cellulose of compressibility.
(2) fill first:
Esomeprazole enteric capsules is placed in NJP-800 type capsule filling machine and fills Capsules 2000 (Suzhou Capsule Co., Ltd first, model: No. 0, lot number: 120506), loading amount is 83.5mg/ grain, and adjust lock catch part, make capsule be half locking state, obtain in half locking state and up-to-standard esomeprazole magnesium enteric coated capsule.
(3) secondary is filled:
By the esomeprazole magnesium enteric coated capsule in half locking state obtained after filling first, be reentered in the capsule hopper of capsule filling machine.Aspirin part and low-substituted hydroxypropyl cellulose mixture are placed in the silo of capsule filling machine, open capsule filling machine, making esomeprazole magnesium enteric coated capsule through aligning, cap body separating step carries out secondary filling.Due to the compressibility that aspirin part (loading amount is 326.5mg/ grain) is good, ensure that the accuracy of loading amount.Finally complete capsule filling process through locked step.
To adopting the obtained capsule of said method to carry out quality evaluation, mainly study from the Key Quality attribute of oral solid formulation, comprising: dissolution, content, the aspects such as stability, result is as table 1.
Table 1. esomeprazole magnesium/aspirin capsule qualitative attribute
Embodiment 2:
the capsule-filling method of omeprazole/aspirin compound preparation
(1) material prepares:
By the omeprazole (synthesis of omeprazole, Fu Jianwei, Tao Xingfa, Fu Zhaojuan, Wang Jingming, " Chinese Journal of Pharmaceuticals ", 2007, 38(2): 78-80) by fluidized bed coating granulating technique, respectively through 0.25 ~ 0.35mm sucrose ball core 30g, medicated layer (omeprazole 40g, hypromellose 6.7g, polyoxyethylene sorbitan monoleate 0.9g, and purified water 210g), sealing coat (hyprolose 9g, Pulvis Talci 34g, magnesium stearate 2.2g, and purified water 310g), enteric layer (methacrylic acid-ethyl propylene acid esters 1:1(aqueous solution, mass concentration is 30%) 127g, triethyl citrate 11.4g, glyceryl monostearate 1.9g, polyoxyethylene sorbitan monoleate 0.2g, and purified water 50g), omeprazole enteric-coated micro-pill is prepared after coating, 150g aspirin and mobility and the good low-substituted hydroxypropyl cellulose 150g of compressibility are mixed homogeneously.
(2) fill first:
Omeprazole enteric-coated micro-pill is placed in NJP-800 type capsule filling machine and fills Capsules 2000 (Suzhou Capsule Co., Ltd first, model: No. 2, lot number: 120506), loading amount is 87.2mg/ grain, and adjust lock catch part, make capsule be half locking state, obtain in half locking state and up-to-standard omeprazole enteric-coated capsules.
(3) secondary is filled:
By the omeprazole enteric-coated capsules in half locking state obtained after filling first, put into Z40F type capsule filling machine hopper, aspirin part and low-substituted hydroxypropyl cellulose mixture are placed in the silo of capsule filling machine, opening capsule filling machine, making omeprazole enteric-coated capsules through aligning, cap body separating step carries out secondary filling.Due to the compressibility that aspirin part (loading amount is 150mg/ grain) is good, ensure that the accuracy of loading amount.Finally complete capsule filling process through locked step.
To adopting the obtained capsule of said method to carry out quality evaluation, mainly study from the Key Quality attribute of oral solid formulation, comprising: dissolution, content, the aspects such as stability, result is as table 2.
The qualitative attribute of table 2. omeprazole/aspirin capsule
Conclusion
As can be seen from Table 1 and Table 2, the compound preparation capsule adopting secondary fill method of the present invention to prepare, all obtains good effect in content, stripping and stability, shows that the inventive method has good feasibility.
Although above-mentioned, the specific embodiment of the present invention is described; but not limiting the scope of the invention; on the basis of technical scheme of the present invention, those skilled in the art do not need to pay various amendment or distortion that creative work can make still within protection scope of the present invention.
1, a secondary fill method for compound preparation capsule, is characterized in that, comprise the following steps:
(1) material prepares: its corresponding adjuvant of active component arbitrary in compound preparation is prepared into flowable particulates or micropill, is fill material first; Its corresponding adjuvant of remaining active component is prepared into compressibility granule or powder, is secondary fill material;
(2) fill first: the fill material first utilizing step (1) to obtain fills Capsules, makes it be locked or half locking state after filling;
(3) secondary is filled: open the capsule of filling first, and the secondary fill material utilizing step (1) to obtain carries out secondary filling, locked after filling.
2, the secondary fill method of a kind of compound preparation capsule according to claim 1, it is characterized in that, in described step (1), prepare the adjuvant that fill material first uses and comprise: lactose, low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, glyceryl monostearate, hypromellose, weight ratio are the methacrylic acid-ethylacrylate copolymer of 1:1, magnesium stearate, polyoxyethylene sorbitan monoleate, sodium stearyl fumarate, cane sugar type medicinal fine pellet core, Pulvis Talci or triethyl citrate;
Prepare the adjuvant that secondary fill material uses to comprise: lactose, starch, pregelatinized Starch, microcrystalline Cellulose, hypromellose, sodium stearyl fumarate, magnesium stearate, Pulvis Talci or silicon dioxide.
3, the secondary fill method of a kind of compound preparation capsule according to claim 1, it is characterized in that, in described step (1), the active component in compound preparation and between active component, or cannot jointly granulate between arbitrary active component and other adjuvants.
4, the secondary fill method of a kind of compound preparation capsule according to claim 3, it is characterized in that, described cannot jointly granulating comprises: there is incompatibility each other, require different activities composition different parts release, cannot cannot jointly granulating of causing of mix homogeneously.
5, the secondary fill method of a kind of compound preparation capsule according to claim 4, it is characterized in that, require that different activities composition comprises in different parts release: require that wherein one or more active component discharge under one's belt, other active component discharges or discharges at other different parts in small intestinal.
6, the secondary fill method of a kind of compound preparation capsule according to claim 4, it is characterized in that, described cannot comprise by mix homogeneously: between the granule of density ratio more than 0.8 and granule, between granule and powder, between micropill and granule, between micropill and powder.
7, the secondary fill method of a kind of compound preparation capsule according to claim 1, is characterized in that, described step (2) and step (3) all adopt conventional capsule pad device to fill.
8, the secondary fill method of a kind of compound preparation capsule according to claim 1, is characterized in that, described conventional capsule pad device is one or two.
9, the secondary fill method of a kind of compound preparation capsule according to claim 1, is characterized in that, in described step (3), the capsule of filling first, through aligning, carries out secondary filling after cap body separating step.
10, the secondary fill method of a kind of compound preparation capsule according to claim 1, is characterized in that, secondary fill material enters in the capsule after filling first after pressurization.
The invention discloses a kind of secondary fill method of compound preparation capsule.The method accurate measurement, feasibility is strong.Comprise the following steps: (1) material prepares: its corresponding adjuvant of active component arbitrary in compound preparation is prepared into flowable particulates or micropill, is fill material first; Its corresponding adjuvant of remaining active component is prepared into compressibility granule or powder, is secondary fill material; (2) fill first: the fill material first utilizing step (1) to obtain fills Capsules, makes it be locked or half locking state after filling; (3) secondary is filled: open the capsule of filling first, and the secondary fill material utilizing step (1) to obtain carries out secondary filling, locked after filling.
Claims (10)
1. a secondary fill method for compound preparation capsule, is characterized in that, comprise the following steps:
(1) material prepares: its corresponding adjuvant of active component arbitrary in compound preparation is prepared into flowable particulates or micropill, is fill material first; Its corresponding adjuvant of remaining active component is prepared into compressibility granule or powder, is secondary fill material;
(2) fill first: the fill material first utilizing step (1) to obtain fills Capsules, makes it be locked or half locking state after filling;
(3) secondary is filled: open the capsule of filling first, and the secondary fill material utilizing step (1) to obtain carries out secondary filling, locked after filling.
2. the secondary fill method of a kind of compound preparation capsule according to claim 1, it is characterized in that, in described step (1), prepare the adjuvant that fill material first uses and comprise: lactose, low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, glyceryl monostearate, hypromellose, weight ratio are the methacrylic acid-ethylacrylate copolymer of 1:1, magnesium stearate, polyoxyethylene sorbitan monoleate, sodium stearyl fumarate, cane sugar type medicinal fine pellet core, Pulvis Talci or triethyl citrate;
Prepare the adjuvant that secondary fill material uses to comprise: lactose, starch, pregelatinized Starch, microcrystalline Cellulose, hypromellose, sodium stearyl fumarate, magnesium stearate, Pulvis Talci or silicon dioxide.
3. the secondary fill method of a kind of compound preparation capsule according to claim 1, it is characterized in that, in described step (1), the active component in compound preparation and between active component, or cannot jointly granulate between arbitrary active component and other adjuvants.
4. the secondary fill method of a kind of compound preparation capsule according to claim 3, it is characterized in that, described cannot jointly granulating comprises: there is incompatibility each other, require different activities composition different parts release, cannot cannot jointly granulating of causing of mix homogeneously.
5. the secondary fill method of a kind of compound preparation capsule according to claim 4, it is characterized in that, require that different activities composition comprises in different parts release: require that wherein one or more active component discharge under one's belt, other active component discharges or discharges at other different parts in small intestinal.
6. the secondary fill method of a kind of compound preparation capsule according to claim 4, it is characterized in that, described cannot comprise by mix homogeneously: between the granule of density ratio more than 0.8 and granule, between granule and powder, between micropill and granule, between micropill and powder.
7. the secondary fill method of a kind of compound preparation capsule according to claim 1, is characterized in that, described step (2) and step (3) all adopt conventional capsule pad device to fill.
8. the secondary fill method of a kind of compound preparation capsule according to claim 1, is characterized in that, described conventional capsule pad device is one or two.
9. the secondary fill method of a kind of compound preparation capsule according to claim 1, is characterized in that, in described step (3), the capsule of filling first, through aligning, carries out secondary filling after cap body separating step.
10. the secondary fill method of a kind of compound preparation capsule according to claim 1, is characterized in that, secondary fill material enters in the capsule after filling first after pressurization.
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| CN201410003173.9A CN104758180A (en) | 2014-01-06 | 2014-01-06 | Secondary filling method for compound preparation capsules |
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| CN201410003173.9A CN104758180A (en) | 2014-01-06 | 2014-01-06 | Secondary filling method for compound preparation capsules |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP3815681A1 (en) * | 2019-10-29 | 2021-05-05 | Shin-Etsu Chemical Co., Ltd. | Capsule filling composition, method of producing capsule formulation with the use of capsule filling composition, and capsule formulation |
| CN114053246A (en) * | 2021-11-18 | 2022-02-18 | 山东则正医药技术有限公司 | Drug isolation layer and application thereof, proton pump inhibitor enteric-coated pellet and preparation method thereof |
| CN114344159A (en) * | 2021-12-27 | 2022-04-15 | 康道生物（南通）有限公司 | Processing technology of reducing coenzyme Q10 capsule |
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| US4196564A (en) * | 1977-05-20 | 1980-04-08 | S.A. Capsugel A.G. | Method of manufacturing a joined capsule filled with viscous material |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| EP3815681A1 (en) * | 2019-10-29 | 2021-05-05 | Shin-Etsu Chemical Co., Ltd. | Capsule filling composition, method of producing capsule formulation with the use of capsule filling composition, and capsule formulation |
| CN114053246A (en) * | 2021-11-18 | 2022-02-18 | 山东则正医药技术有限公司 | Drug isolation layer and application thereof, proton pump inhibitor enteric-coated pellet and preparation method thereof |
| CN114344159A (en) * | 2021-12-27 | 2022-04-15 | 康道生物（南通）有限公司 | Processing technology of reducing coenzyme Q10 capsule |
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