CN104984355B - A kind of premixing auxiliary material and preparation method thereof - Google Patents
A kind of premixing auxiliary material and preparation method thereof Download PDFInfo
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- CN104984355B CN104984355B CN201510406690.5A CN201510406690A CN104984355B CN 104984355 B CN104984355 B CN 104984355B CN 201510406690 A CN201510406690 A CN 201510406690A CN 104984355 B CN104984355 B CN 104984355B
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Abstract
The invention discloses a kind of premixing auxiliary material and preparation method thereof, the premixing auxiliary material consists of the following composition：30 40 parts of hydroxypropul starch, 20 30 parts of starch, 15 parts of mannitol, 0.5 2 parts of hydroxypropyl methylcellulose, 0.5 5 parts of sorbierite, 14 parts of PVP.The premixing auxiliary material is only needed after adding suitable quantity of water formation solution, and the conventional method prepared using capsule can be made into capsule, and production process greatly reduces, and technological parameter requirement is simple, and the production time greatly shortens, product quality stabilization.
Description
Technical field
The present invention relates to a kind of premixing auxiliary material and preparation method thereof, belong to biomedicine field.
Background technology
Pharmaceutic adjuvant is part essential in pharmaceutical preparation, it is ensured that active constituents of medicine is with certain journey
Degree is optionally transported to tissue site, prevents active constituents of medicine from being inactivated before being discharged from main body, and can make medicine in vivo
Discharged according to certain kinetic factor, the performance for the practical application and curative effect of active constituents of medicine serves critical
Effect.
Premixing auxiliary material is the new auxiliary material of one kind developed in recent years, and it is not simple to several single pharmaceutic adjuvants
Be mutually mixed, but by largely testing, be formulated according to research, by two or more single pharmaceutic adjuvants according to certain
Allocation ratio and specific operating procedure, the auxiliary material that a kind of overall performance requires performance is fabricated to, only carries out changing for physical aspect
Become, mobility, compressibility, dispersiveness of auxiliary material etc. is improved.Existing disclosed premixing auxiliary material patent is more, such as Wujiang enlightening
Star Science and Technology Ltd. discloses the premixing auxiliary material of a kind of mannitol, lactose and PVPP（CN200910052769）, lake
The premixing auxiliary material of the mannitol of Nan Xiang medicines pharmaceutical Co. Ltd, sorbierite and microcrystalline cellulose（CN200910180030）, Shanghai
The premixing auxiliary material of the mannitol of Hua Mao pharmaceutcal corporation, Ltds, isobide and PVPP（CN201010184194）, Anhui
The premixing auxiliary material of the microcrystalline cellulose of mountains and rivers pharmaceutic adjuvant limited company, PVPP and silica
（CN201210097822）, the hydroxypropylcellulose of Tianjin Aileyi Medicine Materials Co., Ltd., the premixing auxiliary material of lactose
（CN201210332700）.
The content of the invention
The invention provides a kind of premixing auxiliary material and preparation method thereof, by hydroxypropul starch 30-40 parts, starch 20-30 parts,
Mannitol 1-5 parts, hydroxypropyl methylcellulose 0.5-2 parts, sorbierite 0.5-5 parts, PVP 1-4 parts composition.
A kind of preparation method of premixing auxiliary material has following steps：
A, hydroxypropul starch 30-40 parts are taken, starch 20-30 parts, are mixed after crossing 80 mesh sieves, add 80 DEG C of -100 DEG C of purifying
Water, the solution that mass concentration is 15-20% is configured to, is spray-dried using centrifugal spraying spray dryer, controls air intake
Temperature is 160 DEG C -210 DEG C, and leaving air temp is 90 DEG C -120 DEG C, obtains mixed-powder A；
B, mannitol 1-5 parts are taken, hydroxypropyl methylcellulose 0.5-2 parts, sorbierite 0.5-5 parts, PVP 1-4 parts, cross 80 mesh
Mixed after sieve, add 80 DEG C of -100 DEG C of purified waters, be configured to the solution that mass concentration is 5-10%, 50 DEG C -60 DEG C are dried in vacuo,
Obtain mixed powder B；
C, mixed-powder A, mixed powder B are mixed in proportion.
Further, described starch is one kind or several in the starch such as cassava, sweet potato starch, cornstarch, barley starch
Kind.
Further, described hydroxypropul starch is that cassava, sweet potato starch, cornstarch, barley starch obtain through hydroxypropylation
To starch in one or more.
Beneficial effect
（1）When preparing capsule or tablet, without being screened to the ratio of each auxiliary material in preparation, directly " step arrives
Preparation needed for the preparation of position ", enormously simplify the technological process of production, reduces research and development difficulty, reduce production cost, shorten work
Time, operating efficiency is improved, creates more social values.
（2）Acted on good figuration, thus obtained tablet surface is smooth, and transparency is high, and weight differential is small, medicine
Scattered homogeneity is good, no hygroscopicity.
（3）Chemical property is stable, good film-forming property, contributes to the shaping of capsule skin, can be directly used for preparing Capsules or soft
Capsule shells.Softgel shell outward appearance is preferable, and content of microorganisms is low, effectively moisture can be prevented to pass through, good water-retaining property.
Embodiment
Embodiment 1
Take cassava to take hydroxypropul starch 30kg, the kg of tapioca 20, mixed after crossing 80 mesh sieves, add 80 DEG C of purified waters, match somebody with somebody
The solution that mass concentration is 15% is set to, it is 160 DEG C to control EAT, and leaving air temp is 90 DEG C, is sprayed using centrifugal spraying
Drier is spray-dried, and obtains mixed-powder A；1 part of mannitol, the kg of hydroxypropyl methylcellulose 0.5, the kg of sorbierite 0.5, gather dimension
The kg of ketone 1, mixed after crossing 80 mesh sieves, add 80 DEG C of purified waters, be configured to the solution that mass concentration is 5%, 50 DEG C of vacuum drying, obtain
Mixed powder B；Mixed-powder A, mixed powder B are mixed in proportion.
Embodiment 2
The kg of corn hydroxy propyl starch 30, the kg of barley starch 20 are taken, is mixed after crossing 80 mesh sieves, 90 DEG C of purified waters is added, matches somebody with somebody
The solution that mass concentration is 17% is set to, it is 180 DEG C to control EAT, and leaving air temp is 100 DEG C, is sprayed using centrifugal spraying
Mist drier is spray-dried, and obtains mixed-powder A；2 parts of mannitol, the kg of hydroxypropyl methylcellulose 1, the kg of sorbierite 1.5, gather dimension
The kg of ketone 2, mixed after crossing 80 mesh sieves, add 90 DEG C of purified waters, be configured to the solution that mass concentration is 7%, 55 DEG C of vacuum drying, obtain
Mixed powder B；Mixed-powder A, mixed powder B are mixed in proportion.
Embodiment 3
The kg of cassava hydroxypropyl starch 35, the kg of sweet potato starch 25 are taken, is mixed after crossing 80 mesh sieves, 90 DEG C of purified waters is added, matches somebody with somebody
The solution that mass concentration is 20% is set to, it is 190 DEG C to control EAT, and leaving air temp is 110 DEG C, is sprayed using centrifugal spraying
Mist drier is spray-dried, and obtains mixed-powder A；The kg of mannitol 3, the kg of hydroxypropyl methylcellulose 1.5, the kg of sorbierite 2.5,
The kg of PVP 2, mixed after crossing 80 mesh sieves, add 100 DEG C of purified waters, be configured to the solution that mass concentration is 10%, 60 DEG C of vacuum
Dry, obtain mixed powder B；Mixed-powder A, mixed powder B are mixed in proportion.
Embodiment 4
The kg of rice hydroxypropul starch 40, the kg of tapioca 20 are taken, is mixed after crossing 80 mesh sieves, 100 DEG C of purified waters is added, matches somebody with somebody
The solution that mass concentration is 20% is set to, it is 210 DEG C to control EAT, and leaving air temp is 120 DEG C, is sprayed using centrifugal spraying
Mist drier is spray-dried, and obtains mixed-powder A；The kg of mannitol 4, the kg of hydroxypropyl methylcellulose 2, the kg of sorbierite 3.0, gather
The kg of ketone 2 is tieed up, is mixed after crossing 80 mesh sieves, adds 100 DEG C of purified waters, is configured to the solution that mass concentration is 10%, 60 DEG C of vacuum are done
It is dry, obtain mixed powder B；Mixed-powder A, mixed powder B are mixed in proportion.
Embodiment 5
The kg of cassava hydroxypropyl starch 40, the kg of cornstarch 30 are taken, is mixed after crossing 80 mesh sieves, 100 DEG C of purified waters is added, matches somebody with somebody
The solution that mass concentration is 20% is set to, it is 210 DEG C to control EAT, and leaving air temp is 120 DEG C, is sprayed using centrifugal spraying
Mist drier is spray-dried, and obtains mixed-powder A；The kg of mannitol 5, the kg of hydroxypropyl methylcellulose 2, the kg of sorbierite 5, gather dimension
The kg of ketone 4, mixed after crossing 80 mesh sieves, add 100 DEG C of purified waters, be configured to the solution that mass concentration is 10%, 60 DEG C are dried in vacuo,
Obtain mixed powder B；Mixed-powder A, mixed powder B are mixed in proportion.
Embodiment 6-10
The auxiliary material obtained by embodiment 1-5, Capsules is prepared using conventional method.
Embodiment 11-15
The auxiliary material obtained by embodiment 1-5, using glycerine as filler, soft capsule is prepared with conventional method.
Embodiment 16-20
The premixing auxiliary material obtained by embodiment 1-5 mixes with a certain proportion of Lovastatin, according to the routine of Lovastatin piece
The tablet that specification is 20mg is made in method.
Comparative example 1
Commercially available gelatin hollow capsule
Comparative example 2
Commercially available common starch Capsules
Comparative example 3
Commercially available gelatin soft capsule
Comparative example 4
Commercially available starch soft capsule
Comparative example 5
Commercially available Lovastatin piece
Comparative example 6
Obtained premixing auxiliary material after being removed with the PVP in embodiment 1 and sorbierite, then with the identical of embodiment 16
Method is prepared according to Lovastatin piece.
Above-described embodiment sample is taken to be detected.All samples testing result such as table 1, table 2.
Loss on drying, weight differential, microorganism detection are carried out using the detection method of relevant item in 2010 editions pharmacopeia
Detection.
Scattered homogeneity:Modified according to 2010 editions official methods, take test sample 6, put in 250ml beakers, add 15
~25 DEG C of water 100ml, shake 3 minutes, all disintegration after cross No. 3 sieve, all by when be judged as that homogeneity is fine, 85% with
It is upper by when think that homogeneity is good, 75%~85% by when think that homogeneity is preferable, 75% below by way of when think homogeneity
It is poor.
Tablet hygroscopicity detects：A certain amount of each test specimen is weighed in proportion, is placed in phosphorus pentoxide desiccator and is done
Dry 72h is to constant weight.The drier that bottom is filled to sodium chloride supersaturated solution is put in constant temperature 24h in 25 DEG C of constant incubators, this
When drier in relative humidity be 75%.Thickness about 2mm sample is put into the measuring cup bottom of constant weight, correct amount is rearmounted
In in drier（Weigh the cap is opened）In 25 DEG C of preservations, weighed after 0h, 12h, 24h, 36h, 48h, 60h, calculating 12h,
24h, 36h, 48h, change percentage of the example weight compared with 0h during 60h.
The Capsules of table 1 and the testing result of soft capsule property
The testing result of the tabletting properties of table 2
。
Above-described embodiment is only used for illustrating the inventive concept of the present invention, rather than the restriction to rights protection of the present invention,
All changes for carrying out unsubstantiality to the present invention using this design, all should fall into protection scope of the present invention.
Claims (8)
1. a kind of be used to prepare the premixing auxiliary material of soft capsule, Capsules, it is characterised in that by following weight proportion into packet
Into：
Hydroxypropul starch 30-40 parts, starch 20-30 parts, mannitol 1-5 parts, hydroxypropyl methylcellulose 0.5-2 parts, sorbierite 0.5-5
Part, PVP 1-4 parts；Described starch is the one or more in tapioca, sweet potato starch, cornstarch, barley starch；
Described hydroxypropul starch is the starch that tapioca obtains through hydroxypropylation；
It is made up of following steps：
A, take hydroxypropul starch, starch to be mixed after crossing 80 mesh sieves, add 80 DEG C of -100 DEG C of purified waters, stirring becomes viscous fluid
Body, it is incubated 2-4h；
B, take step a hydroxypropul starch-starch thick liquid body to be spray-dried with centrifugal spraying spray dryer, must mix
Powders A；
C, take mannitol, hydroxypropyl methylcellulose, sorbierite, PVP to be mixed after crossing 80 mesh sieves, add 80 DEG C of -100 DEG C of purified waters,
Stirring becomes thick liquid, is dried in vacuo, obtains mixed powder B；
D, mixed-powder A, mixed powder B are mixed in proportion and produced.
2. the preparation method of a kind of premixing auxiliary material according to claim 1, it is characterised in that it is comprised the steps of：
A, take hydroxypropul starch, starch to be mixed after crossing 80 mesh sieves, add 80 DEG C of -100 DEG C of purified waters, stirring becomes viscous fluid
Body, it is incubated 2-4h；
B, take step a hydroxypropul starch-starch thick liquid body to be spray-dried with centrifugal spraying spray dryer, must mix
Powders A；
C, take mannitol, hydroxypropyl methylcellulose, sorbierite, PVP to be mixed after crossing 80 mesh sieves, add 80 DEG C of -100 DEG C of purified waters,
Stirring becomes thick liquid, is dried in vacuo, obtains mixed powder B；
D, mixed-powder A, mixed powder B are mixed in proportion and produced.
3. according to the method for claim 2, it is characterised in that：Described starch is tapioca, sweet potato starch, corn shallow lake
One or more in powder, barley starch；Described hydroxypropul starch is the starch that tapioca obtains through hydroxypropylation.
4. the preparation method of a kind of premixing auxiliary material according to claim 2, it is characterised in that add purified water in step a
The solution that mass concentration is 15-20% is configured to afterwards.
A kind of 5. preparation method of premixing auxiliary material according to claim 2, it is characterised in that centrifugal spraying in step b
It is 160 DEG C -210 DEG C that spray dryer, which controls EAT, and leaving air temp is 90 DEG C -120 DEG C.
6. the preparation method of a kind of premixing auxiliary material according to claim 2, it is characterised in that match somebody with somebody after adding water in step c
The solution that mass concentration is 5-10% is made.
7. the preparation method of a kind of premixing auxiliary material according to claim 2, it is characterised in that temperature is dried in vacuo in step c
Spend for 50 DEG C -60 DEG C, drying time 2-4h.
8. a kind of premixing auxiliary material according to claim 1, it is characterised in that the premixing auxiliary material is used to prepare soft capsule, sky
Heart-soothing capsule or tablet.
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Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1687203A (en) * | 2005-04-07 | 2005-10-26 | 天津大学 | Vegetable capsule of starch composition and preparation method |
| CN103127517A (en) * | 2013-03-21 | 2013-06-05 | 北京英茂药业有限公司 | Method for preparing medicinal premixed ingredients |
| CN103893772A (en) * | 2014-04-21 | 2014-07-02 | 湖南同泰胶囊有限公司 | Hydroxypropyl starch empty capsules and preparation process thereof |
| CN103920157A (en) * | 2014-04-23 | 2014-07-16 | 湖南尔康制药股份有限公司 | Medicinal modified starch type blank pellet |
| CN104083768A (en) * | 2014-07-02 | 2014-10-08 | 湖南尔康制药股份有限公司 | Premix auxiliary and preparation method thereof |
-
2015
- 2015-07-13 CN CN201510406690.5A patent/CN104984355B/en active Active
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1687203A (en) * | 2005-04-07 | 2005-10-26 | 天津大学 | Vegetable capsule of starch composition and preparation method |
| CN103127517A (en) * | 2013-03-21 | 2013-06-05 | 北京英茂药业有限公司 | Method for preparing medicinal premixed ingredients |
| CN103893772A (en) * | 2014-04-21 | 2014-07-02 | 湖南同泰胶囊有限公司 | Hydroxypropyl starch empty capsules and preparation process thereof |
| CN103920157A (en) * | 2014-04-23 | 2014-07-16 | 湖南尔康制药股份有限公司 | Medicinal modified starch type blank pellet |
| CN104083768A (en) * | 2014-07-02 | 2014-10-08 | 湖南尔康制药股份有限公司 | Premix auxiliary and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| 软胶囊囊壳的研究概况;郑文杰等;《药学进展》;20071231;第31卷(第11期);第491-495页 * |
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