CN104083339A - Naproxen sodium soft capsule and preparation method thereof - Google Patents
Naproxen sodium soft capsule and preparation method thereof Download PDFInfo
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- CN104083339A CN104083339A CN201410378699.5A CN201410378699A CN104083339A CN 104083339 A CN104083339 A CN 104083339A CN 201410378699 A CN201410378699 A CN 201410378699A CN 104083339 A CN104083339 A CN 104083339A
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Abstract
The invention discloses a naproxen sodium soft capsule and a preparation method thereof. The method comprises the following steps: (1) mixing polyethylene glycol, povidone K30, propylene glycol, lactic acid and naproxen sodium to obtain a content material of the soft capsule; (2) mixing glycerinum, sorbitol, water and gelatin to obtain a shell material of the soft capsule; (3) pelleting the content material and the shell material of the soft capsule on an encapsulating machine to obtain the naproxen sodium soft capsule. The method is simple in process and can be used for remarkably reducing equipment investment, and the content is stable in preparation and has a safe treatment effect.
Description
Technical field
The invention belongs to biological medicine technology field, particularly, the present invention relates to a kind of naproxen sodium soft capsule and preparation method thereof.
Background technology
Naproxen sodium (naproxen sodium), chemical name: S-(-) 2-(6-methoxyl group-2-naphthyl) sodium propionate, molecular formula: C
14h
13o
3na; Molecular weight: 252.24; Chemical structural formula is as follows:
This product is white or off-white color crystalline powder, odorless, micro-have draw moist.Naproxen sodium is a kind of nonsteroidal anti-inflammatory analgetic of more easily accepting for people, belongs to phenylpropionic acid compound, brings into play anti-inflammatory and analgesic effect by suppressing the synthetic of prostaglandin, and oral rear absorption is rapid, in 2～4 hours, and the blood plasma concentration that peaks.Food is little on absorption rate impact, and naproxen is combined (99%) with plasma protein height, between plasma concentration 23～40mcg/ml.Metabolism is that demethyl is combined with glucosiduronic acid again, eliminates 12～15 hours half-life, is mainly discharged by urine.Clinically be applicable to alleviate the various slight pain to medium degree, as exodontia and other postoperative pain, primary dysmenorrhea and headache etc.Also be applicable to rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, juvenile form rheumatic arthritis (Juvenile arthritis), tendinitis, bursitis and acute gouty arthritis, all have the effect of relief of symptoms for arthritic pain, swelling and limitation of activity.Psoriasis arthropathica and Reiter Cotard also can be used this product treatment instead.With ibuprofen, fenoprofen, aspirin, sulindac and indomethacin comparison, the effect of remission is similar, but the incidence rate of gastrointestinal tract and neural untoward reaction and the order of severity are all lower.This product also can suppress platelet aggregation as aspirin in addition, extends the bleeding time, but is reversibility, after drug withdrawal, can recover.
The at present naproxen sodium soft capsule of listing, content is by naproxen sodium, lactic acid, 30 POVIDONE K 30 BP/USP 17, Polyethylene Glycol, propylene glycol and water composition; Softgel shell is by gelatin, glycerol, sorbitol, water and pigment composition.Content passes through naproxen sodium, lactic acid and water, and mixing granulation, dry, then by the granule obtaining and Polyethylene Glycol, propylene glycol, after polyvidone mixed dissolution, fill becomes soft capsule.But; in the method, content need to be by naproxen sodium; organic acid; water mixing granulation is also dry; complex operation and granulator and drying equipment that need to be special; be unfavorable for production operation; and dry moisture is wayward; the naproxen generating after part naproxen and organic acid reaction is insoluble in water; produce and the middle-grade moisture of storage process exceedes marginal value or local moisture is too high, naproxen can crystallize out, after crystallization; the absorption in dissolution rate and the body of product be can slow down, therapeutic effect and safety affected.
Separately there is patent report, naproxen sodium and naproxen are mixed, be dissolved in Polyethylene Glycol, propylene glycol and 30 POVIDONE K 30 BP/USP 12, the solution that formation pH is 5.8～8, then fill becomes soft capsule.But this patent relates to two kinds of crude drug, not only make folk prescription become compound recipe, also increase buying, inspection and management cost, and in content, added water, and in production and storage process, easily naproxen crystallization.
Therefore, existing naproxen sodium soft capsule preparation method is further improved.
Summary of the invention
The present invention is intended to solve at least to a certain extent one of technical problem in correlation technique.For this reason, one object of the present invention is to propose a kind of naproxen sodium soft capsule and preparation method thereof, and the method technique is simple, can significantly reduce equipment investment, and gained content dosage form is stable and therapeutic effect safety.
In one aspect of the invention, the present invention proposes a kind of method of preparing naproxen sodium soft capsule, comprising:
(1) by Polyethylene Glycol, PVP K30, propylene glycol, lactic acid and naproxen sodium mixed processing, to obtain soft capsule content material;
(2) glycerol, sorbitol, water and gelatin are mixed, to obtain soft capsule shell material; And
(3) described soft capsule content material and described soft capsule shell material are carried out to pelleting processing on encapsulating machine, to obtain described naproxen sodium soft capsule.
According to the preparation easy operating of content in the method for preparing naproxen sodium soft capsule of the embodiment of the present invention, by naproxen sodium, lactic acid, PVP K30, Polyethylene Glycol and propylene glycol are mixed in proportion, and do not add water in preparation content process, can prepare equally the naproxen sodium soft capsule of the stable and therapeutic effect safety of dosage form, and then save and granulate and drying process, thereby simplify preparation technology and reduced equipment investment.
In addition, the method for preparing naproxen sodium soft capsule according to the above embodiment of the present invention can also have following additional technical characterictic:
In some embodiments of the invention, the mass ratio of described naproxen sodium, described lactic acid, described PVP K30, described Polyethylene Glycol and described propylene glycol is 100:20～30:8～12:250～450:8～10.Thus, can effectively avoid naproxen crystallization, thereby obtain the naproxen sodium soft capsule of the stable and therapeutic effect safety of dosage form.
In some embodiments of the invention, the mass ratio of described naproxen sodium, described lactic acid, described PVP K30, described Polyethylene Glycol and described propylene glycol is 100:23～27:9～11:280～320:8～10.Thus, can further improve naproxen sodium soft capsule preparation stability and clinical therapeutic efficacy.Thus, can further avoid naproxen crystallization, thereby obtain the naproxen sodium soft capsule of the stable and therapeutic effect safety of dosage form.
In some embodiments of the invention, the mass ratio of described naproxen sodium, described lactic acid, described PVP K30, described Polyethylene Glycol and described propylene glycol is 100:25:10:300:9.Thus, can further avoid naproxen crystallization, thereby obtain the naproxen sodium soft capsule of the stable and therapeutic effect safety of dosage form.
In some embodiments of the invention, described Polyethylene Glycol is PEG400 or Macrogol 600.
In some embodiments of the invention, described mixed processing is carried out according to the following step: (1-1) described Polyethylene Glycol is heated to 50～80 degrees Celsius; (1-2) in the described Polyethylene Glycol of heating, add described PVP K30, described propylene glycol, described lactic acid and described naproxen sodium, to obtain mixture; And (1-3) described in high-speed stirred mixture to described naproxen sodium dissolve, to obtain soft capsule content material.Thus, can simplify preparation technology and reduce equipment investment.
In some embodiments of the invention, the rotating speed of described high-speed stirred is higher than 800 revs/min.Thus, can accelerate the dissolving of naproxen sodium.
In some embodiments of the invention, the rotating speed of described high-speed stirred is 1500-3000 rev/min.Thus, can further accelerate the dissolving of naproxen sodium.
In another aspect of the present invention, the present invention proposes a kind of naproxen sodium soft capsule, described naproxen sodium soft capsule is prepared by method described above.Thus, can reduce equipment cost investment.
In addition, naproxen sodium soft capsule according to the above embodiment of the present invention can also have following additional technical characterictic:
In some embodiments of the invention, the water content in the content of described naproxen sodium soft capsule is no more than 15 volume %.Thus, can ensure the stable and therapeutic effect safety of naproxen sodium soft capsule dosage form.
Brief description of the drawings
Fig. 1 is the method flow schematic diagram of preparing according to an embodiment of the invention naproxen sodium soft capsule.
Detailed description of the invention
Be exemplary below by the embodiment being described with reference to the drawings, be intended to for explaining the present invention, and can not be interpreted as limitation of the present invention.
Naproxen sodium soft capsule Chinese medicine composition exists with naproxen sodium and two kinds of forms of naproxen, and the difficult water-soluble medicine of naproxen, naproxen will crystallization when the moisture of content too high (higher than 15 volume %), and in process of production, content can absorb softgel shell moisture, makes the too high and crystallization of the local moisture of content.In prior art, for naproxen sodium being dissolved in formula completely and crystallization not, by naproxen sodium, lactic acid and water mixing granulation, and dry remove most of moisture, then obtained granule materials is dissolved in to the solution system of Polyethylene Glycol, propylene glycol and PVP K30.But special granulation device and the drying device of this process need be unfavorable for producing, and dry moisture is wayward.
For this reason, the present invention proposes a kind of method of preparing naproxen sodium soft capsule, below with reference to Fig. 1, the method for preparing naproxen sodium soft capsule of the embodiment of the present invention is described in detail.According to embodiments of the invention, the method comprises:
S100: prepare soft capsule content material
According to embodiments of the invention, Polyethylene Glycol, PVP K30, propylene glycol, lactic acid and naproxen sodium are mixed, thereby can obtain soft capsule content material.According to concrete example of the present invention, Polyethylene Glycol is heated to 50～80 degrees Celsius, then in the Polyethylene Glycol of heating, add PVP K30, propylene glycol, lactic acid and naproxen sodium, obtain mixture; Last high-speed stirred mixture to naproxen sodium dissolves, thereby obtains soft capsule content material.Inventor surprisingly finds by great many of experiments, can make medicine dissolution in formula by the mode of high-speed stirred, thereby by Polyethylene Glycol, PVP K30, propylene glycol, lactic acid and naproxen sodium mix can prepare soft capsule content material, compared with prior art, although the present invention has saved composition water in naproxen sodium soft capsule content formula, but can prepare equally, dosage form is stablized and the naproxen sodium soft capsule of therapeutic effect safety, and granulation and drying process are saved compared with prior art, thereby can improve preparation efficiency and reduce equipment investment.
According to embodiments of the invention, the particular type of Polyethylene Glycol is also not particularly limited, and according to a particular embodiment of the invention, Polyethylene Glycol can be PEG400 or Macrogol 600.Inventor finds, compared with the solvent using water as granulation in prior art, after granulation, remove most of moisture, then be dissolved in Polyethylene Glycol and propylene glycol, and the present invention is using Polyethylene Glycol and propylene glycol as solvent, can make equally medicine dissolution in formula, thus the investment of having saved granulation and drying equipment.
According to embodiments of the invention, the rotating speed of high-speed stirred is also not particularly limited, and according to a particular embodiment of the invention, the rotating speed of high-speed stirred can be higher than 800 revs/min, preferably 2000～3000 revs/min.Inventor surprisingly finds by great many of experiments, can make medicine dissolution in formula, thereby avoid naproxen crystallization, and within speed of agitator scope of the present invention, medicine dissolution rate is the highest by the mode of high-speed stirred.
According to embodiments of the invention, the proportioning of naproxen sodium, lactic acid, PVP K30, Polyethylene Glycol and propylene glycol is also not particularly limited, according to a particular embodiment of the invention, the mass ratio of naproxen sodium, lactic acid, PVP K30, Polyethylene Glycol and propylene glycol can be 100:20～30:8～12:250～450:8～10, preferably 100:23～27:9～11:280～320:8～10, more preferably 100:25:10:300:9.Inventor finds, in content preparation process of the present invention, using Polyethylene Glycol and propylene glycol as solvent, if measure very fewly, medicine cannot dissolve; Lactic acid is very few, makes content pH higher than 7.5, causes softgel shell destroyed, and lactic acid is too much, produce too much naproxen, have crystallization, thus, according to ratio range of the present invention, can ensure in production process, the content Chinese medicine of preparation dissolves completely, and is being pressed into after soft capsule, content is stable, does not have crystallization.
The present inventor surprisingly finds by great many of experiments; adopt content preparing process of the present invention; can save special granulator and drying equipment; simultaneously in the content material of this formula; the naproxen that part naproxen sodium and lactic acid generate can be dissolved in content matrix system completely; and clear after dissolving, places room temperature without crystallization, thereby can ensure the stable and therapeutic effect safety of naproxen sodium soft capsule dosage form.
S200: prepare soft capsule shell material
According to embodiments of the invention, glycerol, sorbitol, water and gelatin are mixed, thereby can obtain soft capsule shell material.In this step, concrete, glycerol, Pyrusussuriensis alcohol and water, 60～80 degrees Celsius of lower Hybrid Heating, are then added to gelatin, and stir degassedly, obtain soft capsule shell material solution.
S300: prepare naproxen sodium soft capsule
According to embodiments of the invention, soft capsule content material obtained above and soft capsule shell material are carried out to pelleting processing on encapsulating machine, thereby can obtain naproxen sodium soft capsule.Inventor finds, in pelleting processing procedure, moisture in shell material can move to content, moisture in content is raise, but according to formula of the present invention, in content, moisture is lower than 15 volume %, and now medicine is dissolved in content matrix system completely, therefore can not make naproxen crystallization, thereby can not affect naproxen sodium soft capsule preparation stability and clinical therapeutic efficacy.
According to the preparation easy operating of content in the method for preparing naproxen sodium soft capsule of the embodiment of the present invention, by naproxen sodium, lactic acid, PVP K30, Polyethylene Glycol and propylene glycol are mixed in proportion, and do not add water in preparation content process, can prepare equally the naproxen sodium soft capsule of the stable and therapeutic effect safety of dosage form, and then save and granulate and drying process, thereby simplify preparation technology and reduced equipment investment.
In another aspect of the present invention, the present invention proposes a kind of naproxen sodium soft capsule.According to embodiments of the invention, this naproxen sodium soft capsule adopts said method to prepare.Water content in the content of the naproxen sodium soft capsule obtaining according to said method is no more than 15 volume %, thereby avoid naproxen sodium crystallization, thus, ensured the stable and therapeutic effect safety of naproxen sodium soft capsule dosage form in equipment investment cost reducing.
Below with reference to specific embodiment, present invention is described, it should be noted that, these embodiment are only descriptive, and do not limit the present invention in any way.
Embodiment 1
1) content formula composition: naproxen sodium 22g, lactic acid 6.5g, PVP K30 1.8g, PEG400 97.5g and propylene glycol 2.2g;
2) preparation method
The preparation of a, soft capsule content material: PEG400 is heated to 60～80 DEG C, then add PVP K30, lactic acid, propylene glycol, after stirring dissolving completely, add naproxen sodium, after dissolving completely with 2000～3000 revs/min of high-speed stirred to naproxen sodium, carry out degassed and be cooled to room temperature, obtaining soft capsule content material;
The preparation of b, soft capsule shell material: glycerol, sorbitol, water are mixed and heated to 70 DEG C, then add gelatin, agitating solution, degassed, 60 DEG C of insulations, obtain soft capsule shell material;
C, prepare naproxen sodium soft capsule: soft capsule content material obtained above and soft capsule shell material are pressed into soft capsule on encapsulating machine, dry, polishing, packaging, thus obtain naproxen sodium soft capsule.
Embodiment 2
1) content formula composition: naproxen sodium 22g, lactic acid 4.4g, PVP K30 2.6g, PEG400 64.2g and propylene glycol 1.8g;
2) preparation method: with embodiment 1.
Embodiment 3
1) content formula composition: naproxen sodium 22g, lactic acid 5.3g, PVP K30 2.0g, Macrogol 600 68.7g and propylene glycol 2.0g;
2) preparation method: with embodiment 1.
Embodiment 4
1) content formula composition: naproxen sodium 22g, lactic acid 5.5g, PVP K30 2.2g, Macrogol 600 68.3g and propylene glycol 2.0g;
2) preparation method: with embodiment 1.
Comparative example
1) content formula composition: naproxen sodium 22.0g, lactic acid 4.4g, 30 POVIDONE K 30 BP/USP 12 3.6g, PEG400 g, propylene glycol 1.6g and water 11.0g;
2) preparation method
The preparation of a, soft capsule content material: naproxen sodium, lactic acid and water are mixed, obtain mixed material, then utilize granulator to carry out pelletization treatment to obtained mixed material, obtain compound particles, then utilize drying equipment to carry out dried to obtained compound particles, then by dissolving, obtain soft capsule content material after the compound particles of super-dry mixes with Polyethylene Glycol, propylene glycol and PVP K30;
The preparation of b, soft capsule shell material: glycerol, sorbitol, water are mixed and heated to 70 DEG C, then add gelatin, agitating solution, degassed, 60 DEG C of insulations, obtain soft capsule shell material;
C, prepare naproxen sodium soft capsule: soft capsule content material obtained above and soft capsule shell material are pressed into soft capsule on encapsulating machine, dry, polishing, packaging, thus obtain naproxen sodium soft capsule.
Evaluate:
The naproxen sodium soft capsule that embodiment 1～4 and comparative example are obtained, put into the stability test case of 40 DEG C/75%RH, 0,1,2, sampling in 3 months, observe naproxen sodium soft capsule physical stability, in oar method, pH is 7.4 dissolution mediums, 75 revs/min are detected dissolution and utilize high performance liquid chromatograph test content and impurity, and result is as shown in table 1:
Table 1
Conclusion: as seen from the results in Table 1, along with the prolongation of time, in the naproxen sodium soft capsule that embodiment 1～4 obtains, there is no crystallization, and the naproxen sodium soft capsule that medicament contg and stripping and comparative example obtain approaches, show that the naproxen sodium soft capsule that naproxen sodium soft capsule that embodiment 1～4 obtains obtains with comparative example has identical stability, thus, employing the present invention prepares the method for naproxen sodium soft capsule in the situation that ensureing that naproxen sodium soft capsule dosage form is stablized with therapeutic effect safety, compared with comparative example, can save and granulate and drying process, thereby simplify preparation technology and reduced equipment investment.
In the description of this description, the description of reference term " embodiment ", " some embodiment ", " example ", " concrete example " or " some examples " etc. means to be contained at least one embodiment of the present invention or example in conjunction with specific features, structure, material or the feature of this embodiment or example description.In this manual, to the schematic statement of above-mentioned term not must for be identical embodiment or example.And, specific features, structure, material or the feature of description can one or more embodiment in office or example in suitable mode combination.In addition,, not conflicting in the situation that, those skilled in the art can carry out combination and combination by the feature of the different embodiment that describe in this description or example and different embodiment or example.
Although illustrated and described embodiments of the invention above, be understandable that, above-described embodiment is exemplary, can not be interpreted as limitation of the present invention, and those of ordinary skill in the art can change above-described embodiment within the scope of the invention, amendment, replacement and modification.
Claims (10)
1. a method of preparing naproxen sodium soft capsule, is characterized in that, comprising:
(1) by Polyethylene Glycol, PVP K30, propylene glycol, lactic acid and naproxen sodium mixed processing, to obtain soft capsule content material;
(2) glycerol, sorbitol, water and gelatin are mixed, to obtain soft capsule shell material; And
(3) described soft capsule content material and described soft capsule shell material are carried out to pelleting processing on encapsulating machine, to obtain described naproxen sodium soft capsule.
2. method according to claim 1, is characterized in that, the mass ratio of described naproxen sodium, described lactic acid, described PVP K30, described Polyethylene Glycol and described propylene glycol is 100:20～30:8～12:250～450:8～10.
3. method according to claim 2, is characterized in that, the mass ratio of described naproxen sodium, described lactic acid, described PVP K30, described Polyethylene Glycol and described propylene glycol is 100:23～27:9～11:280～320:8～10.
4. method according to claim 3, is characterized in that, the mass ratio of described naproxen sodium, described lactic acid, described PVP K30, described Polyethylene Glycol and described propylene glycol is 100:25:10:300:9.
5. method according to claim 1, is characterized in that, described Polyethylene Glycol is PEG400 or Macrogol 600.
6. method according to claim 1, is characterized in that, described mixed processing is carried out according to the following step:
(1-1) described Polyethylene Glycol is heated to 50～80 degrees Celsius;
(1-2) in the described Polyethylene Glycol of heating, add described PVP K30, described propylene glycol, described lactic acid and described naproxen sodium, to obtain mixture; And
(1-3) described in high-speed stirred, mixture to described naproxen sodium dissolves, to obtain soft capsule content material.
7. method according to claim 6, is characterized in that, the rotating speed of described high-speed stirred is higher than 800 revs/min.
8. method according to claim 7, is characterized in that, the rotating speed of described high-speed stirred is 1500-3000 rev/min.
9. a naproxen sodium soft capsule, is characterized in that, described naproxen sodium soft capsule is prepared by the method described in claim 1-8 any one.
10. naproxen sodium soft capsule according to claim 9, is characterized in that, the water content in the content of described naproxen sodium soft capsule is no more than 15 volume %.
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|---|---|---|---|---|
| WO2002017855A2 (en) * | 2000-08-29 | 2002-03-07 | R.P. Scherer Technologies, Inc. | Process for preparing pharmaceutical compositions for use with soft gelatin formulations |
| US20040157928A1 (en) * | 2003-02-12 | 2004-08-12 | Jae-Hwan Kim | Solvent system of hardly soluble drug with improved dissolution rate |
| CN102225055A (en) * | 2011-06-14 | 2011-10-26 | 贵州地道药业有限公司 | Formula of soft capsule shell |
| US20130011470A1 (en) * | 2010-01-19 | 2013-01-10 | Accucaps Industries Limited | Pharmaceutical formulations of naproxen for soft gel encapsulation and combinations thereof |
| CN102940887A (en) * | 2005-03-08 | 2013-02-27 | 班纳制药公司 | Solvent system for enhancing the solubility of pharmaceutical agents |
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2014
- 2014-08-04 CN CN201410378699.5A patent/CN104083339A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2002017855A2 (en) * | 2000-08-29 | 2002-03-07 | R.P. Scherer Technologies, Inc. | Process for preparing pharmaceutical compositions for use with soft gelatin formulations |
| US20040157928A1 (en) * | 2003-02-12 | 2004-08-12 | Jae-Hwan Kim | Solvent system of hardly soluble drug with improved dissolution rate |
| CN102940887A (en) * | 2005-03-08 | 2013-02-27 | 班纳制药公司 | Solvent system for enhancing the solubility of pharmaceutical agents |
| US20130011470A1 (en) * | 2010-01-19 | 2013-01-10 | Accucaps Industries Limited | Pharmaceutical formulations of naproxen for soft gel encapsulation and combinations thereof |
| CN102225055A (en) * | 2011-06-14 | 2011-10-26 | 贵州地道药业有限公司 | Formula of soft capsule shell |
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Application publication date: 20141008 |