CN101933910A - Mecobalamin soft capsule and preparation method thereof - Google Patents
Mecobalamin soft capsule and preparation method thereof Download PDFInfo
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- CN101933910A CN101933910A CN2009100748172A CN200910074817A CN101933910A CN 101933910 A CN101933910 A CN 101933910A CN 2009100748172 A CN2009100748172 A CN 2009100748172A CN 200910074817 A CN200910074817 A CN 200910074817A CN 101933910 A CN101933910 A CN 101933910A
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Abstract
The invention discloses a mecobalamin soft capsule and a preparation method thereof, the mecobalamin soft capsule contains the following raw materials in the following based on a ratio: mecobalamin which accounts for 0.05-1 percent of the total weight of the contents, and the residual is auxiliary materials; components of gelatin, glycerin and water are used to make a shell of the soft capsule; the raw medicine of the mecobalamin and the auxiliary materials make the contents of the soft capsule; the gelatin is put into water to be soaked and expanded, and after the gelatin is dissolved, other materials are added together, then the materials are stirred and well mixed to make the capsule shell material of the soft capsule; and the capsule shell material is used to press or drop the contents into the soft capsule. Compared with the ordinary mecobalamin tablet and the ordinary mecobalamin capsule, the mecobalamin capsule has rapid dissolution rate and complete dissolution and high degree of uniformity, the content of related substances is reduced obviously, and the relative bioavailability is enhanced obviously.
Description
Technical field:
The present invention relates to the preparation method of medicine, a kind of specifically mecobalamin soft capsule and preparation method.
Background technology:
Mecobalamin is a kind of endogenic actimide, and its chemical name is: Go α-[α-(5,6)-dimethylbenzimidazole base]-Co β-first cobalt amide.The circulation of participation one carbon unit plays an important role in the transmethylase course of reaction by the homocysteine synthetic methionine.Clinical indication is a peripheral neuropathy.At present, the clinical middle mecobalamin oral formulations that uses is mecobalamin tablet and mecobalamin capsules agent.Because the consumption of mecobalamin crude drug in tablet or capsule very little (existing oral formulations specification is 500 μ g/ sheets or grain), so its uniformity is extremely wayward, blood concentration fluctuation is bigger, and also needs heating in the preparation process, therefore stability of drug is had certain influence; Moreover the mecobalamin crude drug sees that auroral poles easily decomposes, and tablet or capsule itself is not very desirable for the effect that keeps in Dark Place, and easily makes the composition degeneration of mecobalamin, thus the curative effect of losing; Problems such as also there is disintegrate in tablet or capsule itself, moltenly looses, dissolution velocity is slower, and bioavailability is low.
Summary of the invention
Purpose of the present invention will provide a kind of mecobalamin soft capsule exactly, to overcome the weak point of existing mecobalamin oral formulations.A kind of mecobalamin preparation of soft capsule method is provided simultaneously.
The object of the present invention is achieved like this:
Mecobalamin soft capsule provided by the present invention, soft capsule content includes mecobalamin crude drug and adjuvant; Wherein the mecobalamin crude drug accounts for the 0.01-1% of content gross weight, and its surplus is an adjuvant; Its soft capsule housing is made by the component of following weight part ratio: gelatin 20-50 part, glycerol accounts for 10-30 part, water 20-50 part, liquid polyethylene glycol 0-10 part (as PEG400, Macrogol 600 etc.), inorganic salt 0-5% part, organic acid 0-5 part, opacifier 0-2 part, pigment 0-2 part, antiseptic 0-2 part.
Because mecobalamin is seen auroral poles and is easily decomposed, so the application of opacifier is comparatively crucial in the capsule casing material, preferred titanium dioxide, its consumption is few, and good shading effect does not have interaction with other compositions, and it is stable to help medicine.
Mecobalamin preparation of soft capsule method provided by the present invention may further comprise the steps:
(a) raw material and consumption proportion thereof:
Soft capsule content includes mecobalamin crude drug and adjuvant; Wherein the mecobalamin crude drug accounts for the 0.01-1% of content gross weight, and all the other are adjuvant; The soft capsule housing is made by the component of following weight part ratio: gelatin 20-50 part, glycerol 10-30 part, water 20-50 part, liquid polyethylene glycol 0-10 part, inorganic salt 0-5% part, organic acid 0-5 part, opacifier 0-2 part, pigment 0-2 part, antiseptic 0-2 part;
(b) take by weighing the mecobalamin crude drug, add in the adjuvant, make even medicinal liquid, as soft capsule content;
(c) take by weighing each component for preparing the soft capsule housing by described weight part ratio of (a) step, gelatin is put into the water immersion make its expansion, heating is treated after gelatin dissolves unclassified stores to be added in the lump, mixes; Be mixed and made into the softgel shell of soft capsule;
(d) with above-mentioned softgel shell with content compacting or drip and be made as soft capsule.
The preferable amount of mecobalamin described in the inventive method is the 0.1-0.5% that accounts for the content gross weight, and its surplus is an adjuvant;
At least comprise diluent in the described soft capsule content adjuvant of the inventive method;
Soft capsule content described in the inventive method preferably comprises water, and its consumption is less than 10% of the content gross weight.Can improve capsular disintegrative thus.
Content adjuvant of the present invention preferably contains emulsifying agent, and its addition is the 0.5-45% of content weight; Preferably contain suspending agent in the adjuvant, its addition is the 0.1-10% of content gross weight.Can improve the stability of capsule 's content thus.
Diluent of the present invention can be selected any one in vegetable oil (as Oleum Arachidis hypogaeae semen, corn wet goods), polyoxyethylene castor oil, polyoxyethylene hydrogenated Oleum Ricini, PEG400, Macrogol 600, glycerol, the propylene glycol for use, also can be wherein any two kinds combination or two or more mixed liquors.
Wherein a kind of in preferably vegetable oil, PEG400, the glycerol or wherein two or more mixed liquor arbitrarily.
In the optional span of emulsifying agent of the present invention, tween, polyoxyethylene castor oil, polyoxyethylene hydrogen China Oleum Ricini, the granulesten a kind of any one, or wherein any two kinds combination or two or more mixed liquors.
A kind of or its mixed liquor in wherein preferred polyoxyethylene hydrogenated Oleum Ricini, the granulesten.
Suspending agent of the present invention can be selected a kind of in Cera Flava, solid polyethylene glycol (as Macrogol 4000, polyethylene glycol 6000), aerosil, lanoline, mono stearate glyceryl ester, high fatty alcohol, lecithin, the sucrose ester or two or more mixture arbitrarily wherein for use.
Its preferred Cera Flava, Macrogol 4000 is a kind of or its mixture.
Mecobalamin soft capsule provided by the present invention is compared with mecobalamin capsules with common mecobalamin tablet, and its dissolution rate is fast and fully, uniformity height, its related substances obviously descend, and relative bioavailability is improved significantly.
Beneficial effect of the present invention has obtained confirmation by following contrast test.Assay method all adopts 2005 editions Chinese Pharmacopoeia related assays methods.Comparing result sees table 1. for details
Table 1
Preferred ingredient among the present invention and preferred consumption proportion can further improve the product quality of made mecobalamin soft capsule.It is at the uniformity, dissolution, related substance, and aspects such as bioavailability all have more significant beneficial effect.
Below the present invention is described in further detail by specific embodiment.But it does not limit the present invention in any form.
Specific embodiment
Embodiment 1
(a) raw material and consumption proportion thereof:
Soft capsule content: mecobalamin 0.5g, PEG400 499.5g.
Soft capsule shell: gelatin 500g, glycerol 200g, water 500g, carmine pigment 0.1g, titanium dioxide 2g, ethyl hydroxybenzoate 1.2g.
(b) take by weighing the mecobalamin crude drug, add the PEG400 dissolving, make soft capsule content;
(c) go on foot described weight ratio by (a), take by weighing each component of preparation soft capsule housing, gelatin is put into the water immersion make its expansion, add glycerol, the heating for dissolving gelatin, vacuum is extracted excessive moisture out, adds carmine pigment, titanium dioxide, mixes stand-by;
(d), on the soft capsule pellet press, make 1000 soft capsules with above-mentioned capsule casing material and content.Every intragranular contains mecobalamin 500 μ g.
Embodiment 2
(a) raw material and consumption proportion thereof:
Soft capsule content: mecobalamin 2.5g, Semen Maydis oil 497.5g.
Soft capsule shell: gelatin 300g, glycerol 300g, water 300g.
(b) take by weighing the mecobalamin crude drug, add Semen Maydis oil, make soft capsule content through grinding;
(c) go on foot described weight ratio by (a), take by weighing each component of preparation soft capsule housing, gelatin is put into the water immersion make its expansion, add glycerol, the heating for dissolving gelatin, vacuum is extracted excessive moisture out, mixes stand-by;
(d), on the soft capsule pellet press, make 1000 soft capsules with above-mentioned capsule casing material and content.Every intragranular contains mecobalamin 2500 μ g.
Embodiment 3
(a) raw material and consumption proportion thereof:
Soft capsule content: mecobalamin 1.25g, water 40g, propylene glycol 200g, glycerol 258.75g.
Soft capsule shell: gelatin 400g, glycerol 200g, water 500g, Macrogol 600 50g, carmine pigment 0.1g, titanium dioxide 2g.
(b) take by weighing the mecobalamin crude drug,, add mecobalamin crude drug stirring and dissolving, make soft capsule content water, propylene glycol, glycerol mix homogeneously;
(c) go on foot described weight ratio by (a), take by weighing each component of preparation soft capsule housing, gelatin is put into the water immersion make its expansion, add glycerol, Macrogol 600, the heating for dissolving gelatin, vacuum is extracted excessive moisture out, add carmine pigment, titanium dioxide, mix stand-by;
(d), on the soft capsule pellet press, make 2500 soft capsules with above-mentioned capsule casing material and content.Every intragranular contains mecobalamin 500 μ g.
Embodiment 4
(a) raw material and consumption proportion thereof:
Soft capsule content: mecobalamin 1g, polyoxyethylene hydrogenated Oleum Ricini 220g, Oleum Arachidis hypogaeae semen 279g.
Soft capsule shell: gelatin 400g, glycerol 200g, water 500g, Macrogol 600 50g, carmine pigment 0.1g, titanium dioxide 2g.
(b) take by weighing the mecobalamin crude drug,, the mecobalamin crude drug is added in the mixed liquor, make soft capsule content according to the equivalent method of progressively increasing with polyoxyethylene hydrogenated Oleum Ricini, Oleum Arachidis hypogaeae semen mix homogeneously;
(c) make the capsule casing material of soft capsule according to embodiment 1 mode;
(d) with above-mentioned capsule casing material with content, on the soft capsule pellet press, make 2000 of soft capsules.Every intragranular contains mecobalamin 500 μ g.
Embodiment 5
(a) raw material and consumption proportion thereof:
Soft capsule content: mecobalamin 1g, soybean phospholipid 2.5g, Semen Maydis oil 491.5, Cera Flava 5g.
Soft capsule shell: gelatin 400g, glycerol 200g, water 400g, sodium chloride 2g.
(b) take by weighing the mecobalamin crude drug, with soybean phospholipid, Semen Maydis oil, Cera Flava mix homogeneously.According to the equivalent method of progressively increasing the mecobalamin crude drug is added in the mixed liquor, make soft capsule content through grinding;
(c) go on foot described weight ratio by (a), take by weighing each component of preparation soft capsule housing, gelatin is put into the water immersion make its expansion, add glycerol, sodium chloride, the heating for dissolving gelatin, vacuum is extracted excessive moisture out, mixes stand-by;
(d), on the soft capsule pellet press, make 2000 soft capsules with above-mentioned capsule casing material and content.Every intragranular contains mecobalamin 500 μ g.
Embodiment 6
Soft capsule content: mecobalamin 1g, Semen Maydis oil 300g, polyoxyethylene hydrogenated Oleum Ricini 149g, PEG400 50g.
Soft capsule shell: gelatin 500g, glycerol 200g, water 500g, PEG400 50g, carmine pigment 0.1g, titanium dioxide 2g.
Make the soft capsule that every intragranular contains mecobalamin 500 μ g with reference to preceding method.
Embodiment 7
Soft capsule content:: mecobalamin 1g, Semen Maydis oil 499g.
Soft capsule shell: gelatin 500g, glycerol 200g, water 500g, PEG400 50g, carmine pigment 0.1g.
Make the soft capsule that every intragranular contains mecobalamin 500 μ g with reference to preceding method.
Embodiment 8
Soft capsule content: mecobalamin 1g, Semen Maydis oil 494g, Cera Flava 5g.
Soft capsule shell: gelatin 500g, glycerol 200g, water 500g, PEG400 50g, carmine pigment 0.1g, titanium dioxide 2g.
Make the soft capsule that every intragranular contains mecobalamin 500 μ g with reference to preceding method.
The made soft capsule of the foregoing description, sample was preserved 3 months under 40 degree temperature, relative humidity 50% environment, and testing result is as follows:
Annotate: the disintegrate of pharmacopeia regulation soft capsule is less than 60min, and dissolution is greater than 70%, and the uniformity is less than 15%.Related substance is less than 3.0%.
Claims (10)
1. a mecobalamin soft capsule is characterized in that soft capsule content includes mecobalamin crude drug and adjuvant, and wherein the mecobalamin crude drug accounts for the 0.01-1% of content gross weight, and its surplus is an adjuvant; The soft capsule housing is made by the component of following weight part ratio: gelatin 20-50 part, glycerol accounts for 10-30 part, water 20-50 part, liquid polyethylene glycol 0-10 part, inorganic salt 0-5% part, organic acid 0-5 part, opacifier 0-2 part, pigment 0-2 part, antiseptic 0-2 part.
2. mecobalamin soft capsule according to claim 1 is characterized in that described opacifier is a titanium dioxide.
3. mecobalamin preparation of soft capsule method is characterized in that it may further comprise the steps:
(a) raw material and consumption proportion thereof:
Soft capsule content: mecobalamin accounts for the 0.05-1% of content gross weight, and its surplus is an adjuvant; The soft capsule housing is made by the component of following weight part ratio: gelatin 20-50 part, glycerol 10-30 part, water 20-50 part, liquid polyethylene glycol 0-10 part, inorganic salt 0-5% part, organic acid 0-5 part, opacifier 0-2 part, pigment 0-2 part;
(b) take by weighing the mecobalamin crude drug, add adjuvant and make even medicinal liquid, as soft capsule content;
(c) go on foot described weight ratio by (a), take by weighing each component of preparation soft capsule housing, gelatin is put into the water immersion make its expansion, heating is treated after gelatin dissolves unclassified stores to be added in the lump, mixes; Be mixed and made into the capsule casing material of soft capsule;
(d) with above-mentioned capsule casing material with content compacting or drip and be made as soft capsule.
4. mecobalamin preparation of soft capsule method according to claim 3 is characterized in that said mecobalamin accounts for the 0.1-0.5% of content gross weight.
5. mecobalamin preparation of soft capsule method according to claim 3 is characterized in that said soft capsule content includes water, and its consumption is less than 10% of the content gross weight.
6. mecobalamin preparation of soft capsule method according to claim 4 is characterized in that containing emulsifying agent in the said adjuvant, and its addition is the 0.5-45% of content weight.
7. mecobalamin preparation of soft capsule method according to claim 5 is characterized in that containing suspending agent in the said adjuvant, and its addition is the 0.1-10% of content weight.
8. mecobalamin preparation of soft capsule method according to claim 3 is characterized in that said diluent is a kind of in vegetable oil, PEG400, the glycerol or two or more mixed liquor arbitrarily wherein.
9. mecobalamin preparation of soft capsule method according to claim 6 is characterized in that a kind of or its mixed liquor in said emulsifier polyoxyethylene castor oil hydrogenated, the granulesten.
10. mecobalamin preparation of soft capsule method according to claim 7 is characterized in that said suspending agent is a kind of or its mixture in Cera Flava, solid polyethylene glycol, the span.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2009100748172A CN101933910A (en) | 2009-07-03 | 2009-07-03 | Mecobalamin soft capsule and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN2009100748172A CN101933910A (en) | 2009-07-03 | 2009-07-03 | Mecobalamin soft capsule and preparation method thereof |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102225055A (en) * | 2011-06-14 | 2011-10-26 | 贵州地道药业有限公司 | Formula of soft capsule shell |
| CN102716102A (en) * | 2012-05-30 | 2012-10-10 | 杭州康恩贝制药有限公司 | Mecobalamin tablet and preparation method thereof |
| CN104473882A (en) * | 2014-12-25 | 2015-04-01 | 北京华禧联合科技发展有限公司 | Mecobalamin granules |
| CN109481420A (en) * | 2018-12-03 | 2019-03-19 | 江苏四环生物制药有限公司 | A kind of mecobalamin sustained-release capsule |
| CN109527556A (en) * | 2018-12-29 | 2019-03-29 | 厦门金达威生物科技有限公司 | A kind of Co-Q10 adds selenium soft capsule and content and preparation method thereof |
-
2009
- 2009-07-03 CN CN2009100748172A patent/CN101933910A/en active Pending
Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102225055A (en) * | 2011-06-14 | 2011-10-26 | 贵州地道药业有限公司 | Formula of soft capsule shell |
| CN102225055B (en) * | 2011-06-14 | 2012-05-23 | 贵州地道药业有限公司 | Formula of soft capsule shell |
| CN102716102A (en) * | 2012-05-30 | 2012-10-10 | 杭州康恩贝制药有限公司 | Mecobalamin tablet and preparation method thereof |
| CN102716102B (en) * | 2012-05-30 | 2014-02-05 | 杭州康恩贝制药有限公司 | Mecobalamin tablet and preparation method thereof |
| CN104473882A (en) * | 2014-12-25 | 2015-04-01 | 北京华禧联合科技发展有限公司 | Mecobalamin granules |
| CN104473882B (en) * | 2014-12-25 | 2018-10-02 | 北京华禧联合科技发展有限公司 | A kind of Mecobalamin particle |
| CN109481420A (en) * | 2018-12-03 | 2019-03-19 | 江苏四环生物制药有限公司 | A kind of mecobalamin sustained-release capsule |
| CN109527556A (en) * | 2018-12-29 | 2019-03-29 | 厦门金达威生物科技有限公司 | A kind of Co-Q10 adds selenium soft capsule and content and preparation method thereof |
| CN109527556B (en) * | 2018-12-29 | 2022-04-22 | 厦门金达威生物科技有限公司 | Coenzyme Q10 selenium-added soft capsule and content and preparation method thereof |
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Application publication date: 20110105 |