CN101596174B - Soft capsule and preparation method thereof - Google Patents
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- CN101596174B CN101596174B CN2009100882167A CN200910088216A CN101596174B CN 101596174 B CN101596174 B CN 101596174B CN 2009100882167 A CN2009100882167 A CN 2009100882167A CN 200910088216 A CN200910088216 A CN 200910088216A CN 101596174 B CN101596174 B CN 101596174B
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Abstract
A soft capsule comprises content and soft capsule skin as well as a layer of inner coating membrane which is located between the content and the soft capsule skin. The inner coating membrane comprises solute and solvent, the solute consists of liquid paraffin 25-50, polyvidone K30 5-15, polyacrylic acid resin II 10-20, polyving akohol 400 10-30 and citric acid 2.5-10 according to mass percentage;the solvent is salad oil, the content of which is 60-130% of the content of the solute. The invention aims at solving the problem of influence on the activity of effective constitutes in traditional Chinese medicine and soft capsule skin deterioration, leakage and partial deformation caused by reaction between the soft capsule skin and natural acid or natural aldehyde ketone in the traditional Chinese medicine after the soft capsule wraps the traditional Chinese medicine content in the prior art, thus providing the soft capsule capable of separating the soft capsule skin from the content and ensuring the activity of effective constitutes in traditional Chinese medicine and no soft capsule skin deterioration, or no leakage or no partial deformation.
Description
Technical field
The present invention relates to a kind of capsule.Particularly relate to a kind of soft capsule and preparation method thereof.
Background technology
At present, what soft capsule mainly adopted is the frame mode that the soft capsule suitcase is wrapped up in content, just with content as center material, the soft capsule skin is positioned at the outer coating that realizes content.Use common soft capsule suitcase to cover content, after entering human body by throat exactly, general its administering mode promptly carries out disintegrate, it can't realize the targeting control to soft capsule administration position to this kind mode on the one hand, has the influence of degree size for the therapeutic effect at the disease place that is not positioned at throat or stomach; On the other hand, most drug all has stimulation for the human stomach, and such administering mode stimulates stomach because of drug main will discharge in the disintegrate of throat or stomach easily, has influenced gastrointestinal function.
In order to address the above problem, the research staff has developed a kind of soft capsule with outer coatings film, for example in the prior art, Chinese patent CN101167765A discloses a kind of colon targeting drug delivery soft capsule, this soft capsule comprises oleum fructus bruceae soft capsule and macromolecule clothing film, wherein, described macromolecule clothing film is positioned at the skin of described oleum fructus bruceae soft capsule, it is a PH sensitivity enteric coating, includes acrylic resin III number or HPMCP, ethyl cellulose or cellulose acetate, diethyl phthalate, Oleum Ricini, dehydrated alcohol, acetone.This technology is provided with the dissolved macromolecule outer coatings of colon film, avoided effectively discharging medicine at stomach, duodenum, jejunum and ileum front end behind the Oleum Fructus Bruceae drug oral, reduced the stimulation of content, thereby discharged the therapeutical effect of medicine realization after having realized utilizing the outer coatings film that content is transported to ileocecum portion body local and whole body to the human stomach.
In above-mentioned existing soft capsule, it is to utilize the soft capsule skin to wrap up the oil-soluble product mostly, as unsaturated fatty acid, and vitamin, natural terpenoid.Along with popularizing of soft capsule technology, increasing Chinese medicine producer begins to attempt using soft capsule parcel Chinese medicine.But, because Chinese medicine complicated component, it more or less contains natural acid or natural aldehyde ketone, and natural acid or natural aldehyde ketone can and capsule shell in the main component gelatin between chemical reaction takes place, on the one hand, can be because chemical reaction make the interior effective ingredient of Chinese medicine change, thereby make the activity of Chinese medicine content effective ingredient reduce, on the other hand, the stability of capsule crust is declined to a great extent, problems such as rubber degeneration, seepage, local deformation occur.Thereby the stability in the large of soft capsule and the performance of drug effect have been reduced.
Summary of the invention
For this reason, to be solved by this invention is that soft capsule of the prior art is after coating the Chinese medicine content, the activity of pharmaceutically active ingredient in can influencing owing to the reaction between natural acid in the Chinese medicine or natural aldehyde ketone and the soft capsule skin, and the problem that causes the degeneration of soft capsule skin, seepage, local deformation, and then provide a kind of and can come content and soft capsule skin are isolated, guarantee the active and soft capsule skin invariance of Chinese medicine content effective ingredient, non-leakage, the soft capsule of local deformation not.
For solving the problems of the technologies described above, the invention provides a kind of soft capsule, comprise content and soft capsule skin, described soft capsule suitcase is overlying on described content outside, it is characterized in that, described soft capsule also comprises coating membrane in one deck, and described interior coating membrane is between described content and described soft capsule skin.
Coating membrane comprises solute and solvent in described, and by mass percentage, described solute is made up of liquid paraffin 25-50%, 30 POVIDONE K 30 BP/USP 305-15%, polyacrylic resin II 10-20%, polyvinyl alcohol 40010-30% and citric acid 2.5-10%; Described solvent is a salad oil, and the ratio of described salad oil content and described solutes content is 0.6-1.3.
Preferred described solute is made up of liquid paraffin 41%, 30 POVIDONE K 30 BP/USP 3013%, polyacrylic resin II 16%, polyvinyl alcohol 40025%, citric acid 5% by mass percentage, and the ratio of described salad oil content and described solutes content is 0.95.
The present invention also disclose above-mentioned have on the basis of soft capsule of coating membrane, a kind of method that is used to prepare above-mentioned soft capsule is further disclosed, it comprises the steps:
(1) take by weighing in the aforementioned soft capsule form in the raw material of coating membrane an amount of, above-mentioned raw materials is fully mixed in the coating solution storage tank, under 40～60 ℃ temperature, carry out emulsifying 0.5～3 hour, afterwards it is left standstill to room temperature standby;
(2) make capsule shell, raw material abundant melting mixing in the glue jar of producing capsule shell is standby;
(3) mixture in step (2) the glue jar is changed glue 0.6～4 hour under 55～75 ℃ temperature, obtain glue;
(4) flow into the glue box with changing the glue that obtains behind the glue through step (3) in the glue jar through sebific duct, glue flows out from glue box lower limb slit, forms the uniform rubber of thickness.Glue box below is the rubber wheel, and glue stream is on the rubber wheel, along with the rolling that rubber is taken turns, fully cooling;
(5) the coating solution storage tank port of export is connected with conduit one end, the conduit other end is a nozzle, and nozzle location is set in the top of described glue box, and when the capsule shell of making launched on the rubber wheel, nozzle was about to coating solution and evenly is sprayed on rubber one side;
(6) content is received the soft capsule compacting tool set by a conduit, spray into the soft capsule skin of being produced in the step (5) and be coated with in the side of interior coating membrane, get final product with interior coating membrane.
Raw material in described step (1) fully mixes in the coating solution storage tank, carries out emulsifying 40 minutes under 50 ℃ temperature.
In described step (3), under 64 ℃ temperature, change glue.
Technique scheme of the present invention has the following advantages compared to existing technology:
(1) soft capsule of the present invention, it is provided with coating membrane in one deck more between traditional structure content thing and soft capsule skin, coating membrane can be effectively isolated with Chinese medicine content and soft capsule skin in being somebody's turn to do, avoided between the main component gelatin of natural acid contained in the Chinese medicine or natural aldehyde ketone and soft capsule Intradermal chemical reaction taking place, thereby guaranteed the activity of Chinese medicine active component, also guarantee capsule shell can not take place owing to above-mentioned chemical reaction the soft capsule skin degeneration, seepage, local deformation, improved the stability of soft capsule on the whole.
(2) preparation of soft capsule method of the present invention, at first, its raw material to coating membrane in preparing carries out emulsifying, and the setting emulsifying temperature is 40～60 ℃, emulsification times is 0.5～3 hour, guaranteed the abundant mixing of above-mentioned raw materials and formed the emulsion of homogeneous, preferred described emulsifying temperature is 50 ℃ in this step, this temperature when guaranteeing the abundant mixing and emulsifying of above-mentioned raw materials, also guaranteed above-mentioned in coating mould raw material properties be not subjected to any Temperature Influence; Afterwards, make the step of capsule shell, raw material to the preparation capsule shell was being changed glue 0.6～4 hour under 55～75 ℃ temperature, obtain glue, set this change glue temperature and change the glue time and guaranteed above-mentioned raw materials glue on the one hand fully, evenly and make soft capsule have suitable toughness and pliability, also guaranteed to be unlikely to excessive and make the above-mentioned raw materials glue bond and influence the toughness and the pliability of capsule shell on the other hand because change the glue temperature and time; Above-mentioned glue to be made the soft capsule skin at last and further will be aforementioned prepare stand-by interior coating membrane raw material and the soft capsule skin be launched also evenly to be sprayed on the soft capsule skin along with the rolling of rubber wheel.Above-mentioned preparation method is carried out in the process of skin soft capsule skin raw material glue in realization, coating membrane raw material in the emulsifying fully evenly is sprayed at the one side (with the one side of this face) of soft capsule skin as the coating content, after it was pressed into ball, coating membrane was opened Chinese medicine content and soft capsule skin are isolated in can realizing effectively utilizing.
Description of drawings
For the easier quilt of content of the present invention is clearly understood, below according to a particular embodiment of the invention and in conjunction with the accompanying drawings, this utility model is described in further detail, wherein
Fig. 1 is for making soft capsule equipment sketch map.
Reference numeral is expressed as among the figure:
1-glue jar, 2-glue box, 3-rubber wheel, 4-coating solution storage tank, 5-conduit, 6-nozzle, 7-soft capsule compacting tool set, 8-content storage tank, 9-capsule shell.
The specific embodiment
Embodiment 1
(1) makes interior coating membrane, take by weighing liquid paraffin 41g, 30 POVIDONE K 30 BP/USP 3013g, polyacrylic resin II 16g, polyvinyl alcohol 400 25g, citric acid 5g and salad oil 95g.Above-mentioned raw materials is fully mixed in the coating solution storage tank, carry out emulsifying under 50 ℃ temperature, emulsifying was left standstill to room temperature standby to the feed liquid mix homogeneously in 40 minutes afterwards;
Wherein, liquid paraffin, 30 POVIDONE K 30 BP/USP 30, polyacrylic resin II, polyvinyl alcohol 400, citric acid are solute, and salad oil is a solvent.
(2) make capsule shell, will produce raw material abundant mixing for standby use in glue jar 1 of capsule shell;
(3) mixture in step (2) the glue jar 1 is changed glue 2 hours under 60 ℃ temperature, obtain glue;
(4) flow into glue box 2 with changing the glue that obtains behind the glue through step (3) in the glue jar 1 through sebific duct, glue flows out from glue box 2 lower limb slits, and glue box below is a rubber wheel 3, and glue stream is on rubber wheel 3, and the rolling along with rubber wheel 3 forms the uniform capsule shell 9 of thickness;
(5) coating solution storage tank 4 ports of export are connected with conduit 5 one ends, conduit 5 other ends are nozzle 6, nozzle 6 set positions are on the top that soft capsule is produced the glue box of machine, and when the capsule shell of making 9 launched on rubber wheel 3, nozzle 6 was about to coating solution and evenly is sprayed on capsule shell 9 one sides.This side has been preset as the soft capsule inboard that is about to compacting, promptly coats a side of content.
(6) with Chinese medicine be content, with the content in the content storage tank 8 by a conduit receive soft capsule compacting tool set 7 spray into the soft capsule skin of being produced in the step (5) with interior coating membrane be coated with in the side of coating membrane, get final product.
Coating membrane in the above-mentioned preparation soft capsule, comprise following component by weight percentage: described solute comprises liquid paraffin 41%, 30 POVIDONE K 30 BP/USP 3013%, polyacrylic resin II 16%, polyvinyl alcohol 40025% and citric acid 5%, and the ratio of described salad oil content and described solutes content is 0.95.
Embodiment 2
Prepare soft capsule of the present invention, comprise the steps:
(1) makes interior coating membrane, take by weighing liquid paraffin 25g, 30 POVIDONE K 30 BP/USP 3015g, polyacrylic resin II 20g, polyvinyl alcohol 40030g, citric acid 10g and salad oil 130g.Above-mentioned raw materials is fully mixed in the coating solution storage tank, carry out emulsifying under 40 ℃ temperature, emulsifying was left standstill to room temperature standby to the feed liquid mix homogeneously in 3 hours;
Wherein, liquid paraffin, 30 POVIDONE K 30 BP/USP 30, polyacrylic resin II, polyvinyl alcohol 400, citric acid are solute, and salad oil is a solvent.
(2) make capsule shell, will produce raw material abundant mixing for standby use in glue jar 1 of capsule shell;
(3) mixture in step (2) the glue jar 1 is changed glue 0.6 hour under 75 ℃ temperature, obtain glue;
(4) flow into glue box 2 with changing the glue that obtains behind the glue through step (3) in the glue jar 1 through sebific duct, glue flows out from glue box 2 lower limb slits, and glue box below is a rubber wheel 3, and glue stream is on rubber wheel 3, and the rolling along with rubber wheel 3 forms the uniform capsule shell 9 of thickness;
(5) coating solution storage tank 4 ports of export are connected with conduit 5 one ends, conduit 5 other ends are nozzle 6, nozzle 6 set positions are on the top that soft capsule is produced the glue box of machine, and when the capsule shell of making 9 launched on rubber wheel 3, nozzle 6 was about to coating solution and evenly is sprayed on capsule shell 9 one sides.This side has been preset as the soft capsule inboard that is about to compacting, promptly coats a side of content.
(6) with Chinese medicine be content, with the content in the content storage tank 8 by a conduit receive soft capsule compacting tool set 7 spray into the soft capsule skin of being produced in the step (5) with interior coating membrane be coated with in the side of coating membrane, get final product.
Coating membrane in the above-mentioned preparation soft capsule, comprise following component by weight percentage: described solute comprises liquid paraffin 25%, 30 POVIDONE K 30 BP/USP 3015%, polyacrylic resin II 20%, polyvinyl alcohol 400 30% and citric acid 10%, and the ratio of described salad oil content and described solutes content is 1.3.
Embodiment 3
Prepare soft capsule of the present invention, comprise the steps:
(1) makes interior coating membrane, take by weighing liquid paraffin 50g, 30 POVIDONE K 30 BP/USP 3010g, polyacrylic resin II 10g, polyvinyl alcohol 40020g, citric acid 10g and salad oil 60g.Above-mentioned raw materials is fully mixed in the coating solution storage tank, carry out emulsifying under 60 ℃ temperature, emulsifying was left standstill to room temperature standby to the feed liquid mix homogeneously in 30 minutes;
Wherein, liquid paraffin, 30 POVIDONE K 30 BP/USP 30, polyacrylic resin II, polyvinyl alcohol 400, citric acid are solute, and salad oil is a solvent.
(2) make capsule shell, will produce raw material abundant mixing for standby use in glue jar 1 of capsule shell;
(3) mixture in step (2) the glue jar 1 is changed glue 4 hours under 55 ℃ temperature, obtain glue;
(4) flow into glue box 2 with changing the glue that obtains behind the glue through step (3) in the glue jar 1 through sebific duct, glue flows out from glue box 2 lower limb slits, and glue box below is a rubber wheel 3, and glue stream is on rubber wheel 3, and the rolling along with rubber wheel 3 forms the uniform capsule shell 9 of thickness;
(5) coating solution storage tank 4 ports of export are connected with conduit 5 one ends, conduit 5 other ends are nozzle 6, nozzle 6 set positions are on the top that soft capsule is produced the glue box of machine, and when the capsule shell of making 9 launched on rubber wheel 3, nozzle 6 was about to coating solution and evenly is sprayed on capsule shell 9 one sides.This side has been preset as the soft capsule inboard that is about to compacting, promptly coats a side of content.
(6) with Chinese medicine be content, with the content in the content storage tank 8 by a conduit receive soft capsule compacting tool set 7 spray into the soft capsule skin of being produced in the step (5) with interior coating membrane be coated with in the side of coating membrane, get final product.
Coating membrane in the above-mentioned preparation soft capsule, comprise following component by weight percentage: described solute comprises liquid paraffin 50%, 30 POVIDONE K 30 BP/USP 3010%, polyacrylic resin II 10%, polyvinyl alcohol 400 20% and citric acid 10%, and the ratio of described salad oil content and described solutes content is 0.6.
Embodiment 4
Prepare soft capsule of the present invention, comprise the steps:
(1) makes interior coating membrane, take by weighing liquid paraffin 42.5g, 30 POVIDONE K 30 BP/USP 30 5g, polyacrylic resin II 20g, polyvinyl alcohol 400 30g, citric acid 2.5g and salad oil 100g.Above-mentioned raw materials is fully mixed in the coating solution storage tank, carry out emulsifying under 60 ℃ temperature, emulsifying was left standstill to room temperature standby to the feed liquid mix homogeneously in 30 minutes;
Wherein, liquid paraffin, 30 POVIDONE K 30 BP/USP 30, polyacrylic resin II, polyvinyl alcohol 400, citric acid are solute, and salad oil is a solvent.
(2)～(6) with the corresponding steps among the embodiment 1.
Coating membrane in the above-mentioned preparation soft capsule, comprise following component by weight percentage: described solute comprises liquid paraffin 42.5%, 30 POVIDONE K 30 BP/USP 30 5%, polyacrylic resin II 20%, polyvinyl alcohol 400 30% and citric acid 2.5%, and the ratio of described salad oil content and described solutes content is 1.
Embodiment 5
Prepare soft capsule of the present invention, comprise the steps:
(1) makes interior coating membrane, take by weighing liquid paraffin 50g, 30 POVIDONE K 30 BP/USP 30 15g, polyacrylic resin II 20g, polyvinyl alcohol 400 10g, citric acid 5g and salad oil 100g.Above-mentioned raw materials is fully mixed in the coating solution storage tank, carry out emulsifying under 60 ℃ temperature, emulsifying was left standstill to room temperature standby to the feed liquid mix homogeneously in 30 minutes;
Wherein, liquid paraffin, 30 POVIDONE K 30 BP/USP 30, polyacrylic resin II, polyvinyl alcohol 400, citric acid are solute, and salad oil is a solvent.
(2) with the step among the embodiment 1 (2);
(3) mixture in step (2) the glue jar 1 is changed glue 3 hours under 64 ℃ temperature, obtain glue;
(4)～(6) with the corresponding steps among the embodiment 1.
Coating membrane in the above-mentioned preparation soft capsule, comprise following component by weight percentage: described solute comprises liquid paraffin 50%, 30 POVIDONE K 30 BP/USP 30 15%, polyacrylic resin II 20%, polyvinyl alcohol 400 10% and citric acid 5%, and the ratio of described salad oil content and described solutes content is 1.
Obviously, the foregoing description only is for example clearly is described, and is not the qualification to embodiment.For those of ordinary skill in the field, can also make other changes in different forms on the basis of the above description.And conspicuous variation of being extended out thus or change still are within the protection domain of the invention.
Claims (5)
1. a soft capsule comprises content and soft capsule skin, and described soft capsule suitcase is overlying on described content outside, and described soft capsule also comprises coating membrane in one deck, and described interior coating membrane is between described content and described soft capsule skin;
It is characterized in that,
Coating membrane comprises solute and solvent in described, and by mass percentage, described solute is made up of liquid paraffin 25-50%, 30 POVIDONE K 30 BP/USP 305-15%, polyacrylic resin II 10-20%, polyvinyl alcohol 40010-30% and citric acid 2.5-10%; Described solvent is a salad oil, and the ratio of described salad oil content and described solutes content is 0.6-1.3.
2. according to the described soft capsule of claim 1, it is characterized in that, described solute is made up of liquid paraffin 41%, 30 POVIDONE K 30 BP/USP 3013%, polyacrylic resin II 16%, polyvinyl alcohol 40025%, citric acid 5% by mass percentage, and the ratio of described solvent salad oil content and described solutes content is 0.95.
3. method for preparing the described soft capsule of claim 1, it comprises the steps:
(1) takes by weighing as the raw material of claim 1 or 2 described in arbitrary in right amount, above-mentioned raw materials is fully mixed in the coating solution storage tank, under 40～60 ℃ temperature, carry out emulsifying 0.5～3 hour, afterwards it is left standstill to room temperature standby;
(2) make capsule shell, raw material abundant melting mixing in the glue jar of producing capsule shell is standby;
(3) mixture in step (2) the glue jar is changed glue 0.6～4 hour under 55～75 ℃ temperature, obtain glue;
(4) flow into the glue box with changing the glue that obtains behind the glue through step (3) in the glue jar through sebific duct, glue flows out from glue box lower limb slit, the uniform rubber of formation thickness, and glue box below is the rubber wheel, glue stream is on the rubber wheel, along with the rolling that rubber is taken turns, fully cooling;
(5) the coating solution storage tank port of export is connected with conduit one end, the conduit other end is a nozzle, and nozzle location is set in the top of described glue box, and when the capsule shell of making launched on the rubber wheel, nozzle was about to coating solution and evenly is sprayed on rubber one side;
(6) content is received the soft capsule compacting tool set by a conduit, spray into the soft capsule skin of being produced in the step (5) and be coated with in the side of interior coating membrane, get final product with interior coating membrane.
4. the method for preparing soft capsule according to claim 3 is characterized in that, the raw material in described step (1) fully mixes in the coating solution storage tank, carries out emulsifying 40 minutes under 50 ℃ temperature.
5. the method for preparing soft capsule according to claim 3 is characterized in that, changes glue in described step (3) under 64 ℃ temperature.
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| Application Number | Priority Date | Filing Date | Title |
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| CN2009100882167A CN101596174B (en) | 2009-07-13 | 2009-07-13 | Soft capsule and preparation method thereof |
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| CN2009100882167A CN101596174B (en) | 2009-07-13 | 2009-07-13 | Soft capsule and preparation method thereof |
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| CN101596174A CN101596174A (en) | 2009-12-09 |
| CN101596174B true CN101596174B (en) | 2011-04-06 |
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Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105748994A (en) * | 2016-03-30 | 2016-07-13 | 青岛百瑞吉生物工程有限公司 | Anti-fatigue soft capsule and preparation method thereof |
| CN110150703B (en) * | 2019-05-13 | 2021-08-31 | 广州普正生物科技有限公司 | Anti-adhesion chewing soft capsule shell and preparation method thereof |
| CN112451501B (en) * | 2020-12-25 | 2022-07-26 | 北京达因高科儿童药物研究院有限公司 | A soft capsule containing chloral hydrate and its preparation method |
| CN113384462A (en) * | 2021-05-20 | 2021-09-14 | 神威药业集团有限公司 | Soft capsule manufacturing equipment |
| CN115721627B (en) * | 2022-11-10 | 2024-08-30 | 南通华山药业有限公司 | A herba Leonuri soft capsule and its preparation method |
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| CN1186429A (en) * | 1995-06-07 | 1998-07-01 | R·P·谢勒公司 | Methods and compositions for preparing soft gelatin capsules having shells resistant to permeation by fill materials |
| CN1331580A (en) * | 1998-12-17 | 2002-01-16 | 阿尔扎有限公司 | Conversion of liquid filled gelatin capsules into controlled release systems by multiple coatings |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1186429A (en) * | 1995-06-07 | 1998-07-01 | R·P·谢勒公司 | Methods and compositions for preparing soft gelatin capsules having shells resistant to permeation by fill materials |
| CN1331580A (en) * | 1998-12-17 | 2002-01-16 | 阿尔扎有限公司 | Conversion of liquid filled gelatin capsules into controlled release systems by multiple coatings |
Non-Patent Citations (1)
| Title |
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| 齐惠敏等.软胶囊剂的工艺研究现状.《软胶囊剂的工艺研究现状》.1997,第9卷(第4期),第32-34页. * |
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Address after: 100176, No. three, No. 21, Hai Zhen industrial town, Daxing District, Beijing, Yizhuang Patentee after: HANGYANG HEALTH Co.,Ltd. Address before: 100176 Beijing City, Daxing District economic and Technological Development Zone East Street Branch Patentee before: BEIJING HANGYANG CAPSULE TECHNOLOGY Co.,Ltd. |
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Address after: 1st Floor, Building 1, No. 21 Jinghai Third Road, Beijing Economic and Technological Development Zone, 100176 (Yizhuang Cluster, High end Industrial Zone, Beijing Pilot Free Trade Zone) Patentee after: HANGYANG HEALTH Co.,Ltd. Address before: 100176 21 Jinghai 3rd road, East Industrial Zone, Yizhuang Town, Daxing District, Beijing Patentee before: HANGYANG HEALTH Co.,Ltd. |