CN1875949A - Soft gastrodine capsule and preparation method thereof - Google Patents
Soft gastrodine capsule and preparation method thereof Download PDFInfo
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- CN1875949A CN1875949A CNA2006100452771A CN200610045277A CN1875949A CN 1875949 A CN1875949 A CN 1875949A CN A2006100452771 A CNA2006100452771 A CN A2006100452771A CN 200610045277 A CN200610045277 A CN 200610045277A CN 1875949 A CN1875949 A CN 1875949A
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- gastrodine
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Abstract
The invention relates to soft capsules containing active ingredient of gastrodine and process for preparation, wherein the capsules are prepared from gastrodine as the main ingredient, the soft capsules have the advantages of high dissolving speed, quick effect, high biological availability, convenience in administration and carrying.
Description
One, technical field
The present invention relates to a kind of soft capsule that contains the gastrodine effective ingredient and preparation method thereof, belong to oral solid formulation class medicine, medical technical field.
Two, background technology:
The chemical name of gastrodine is 4-methylol benzene-β-D-pyranglucoside semihydrate; it is the effective ingredient of Chinese medicine Rhizoma Gastrodiae; have calmness, convulsion, epilepsy, analgesia, cerebral blood flow increasing amount, effects such as neuroprotective cell, promotion myocardial cell energy metabolism.Clinically, gastrodine has been widely used in treatment neurasthenia and combined external head injuries, vertigo, neuralgia, headache etc., determined curative effect, safe and reliable.
Dosage forms such as tablet, hard capsule and small-volume injection are arranged in clinical practice, and as the tablet of peroral dosage form, its molten diffusing speed is lower, onset is slow, bioavailability is low, and hard capsule is taken very inconvenient for the patient of old people, bed patient and dysphagia.Though the molten diffusing speed of injection is fast, the bioavailability height, it uses and carries inconvenience, is not suitable for the employee on business trip, takes personnel for a long time.
Three, summary of the invention
The present invention provides a kind of soft gastrodine capsule in order to overcome the deficiency of above technology, has the dissolution height, good looking appearance, advantage easy to carry.
Another object of the present invention is to provide the preparation method of above-mentioned soft gastrodine capsule, it is simple that this preparation method has technology, is suitable for suitability for industrialized production.
Technical scheme of the present invention is as follows:
Soft gastrodine capsule of the present invention is to be the soft capsule that principal agent is made by gastrodine.
Soft gastrodine capsule of the present invention, its pharmaceutic adjuvant are diluent, cosolvent, suspending agent, and the percentage by weight of principal agent and pharmaceutic adjuvant is respectively:
Gastrodine: 10-30%
Diluent: 65-85%
Cosolvent: 0-5.7%
Suspending agent: 0-4%.
Preferably, described diluent is one or more of ethanol, propylene glycol, glycerol, PEG400, soybean oil, Semen Maydis oil, Oleum Gossypii semen and olive oil; Described cosolvent is one or more in beta-schardinger dextrin-, polyoxyethylene sorbitan monoleate, sodium lauryl sulphate, alginic acid, polyvinylpolypyrrolidone and the general methylamine; Described suspending agent is one or more in Cera Flava, glyceryl monostearate, calcium stearate, carmethose, dextrin and the oleic acid.
Preferably, every soft capsule contains gastrodine 5～300mg.
Preferably, its softgel shell is made by glycerol, gelatin, opacifier, antiseptic.
The preparation method of the described soft gastrodine capsule of the invention described above may further comprise the steps:
(1) gets diluent and add the suspending agent heating for dissolving, naturally cool to room temperature under the stirring;
(2) gastrodine is joined in (1), fully stir and make dissolving;
(3) cosolvent is joined in (2), stir and promptly get the content medicinal liquid;
(4) content medicinal liquid and softgel shell glue are inserted in the pellet processing machine simultaneously, be pressed into ball, typing is put the hothouse drying, promptly.
Soft gastrodine capsule of the present invention, promptly increased the peroral dosage form of gastrodine, realized that again gastrodine directly enters in the body molten diffusing speed height with the form of liquid state, the purpose that onset is rapid, bioavailability is high is compared with injection and have been overcome the shortcoming that injection used and carried inconvenience.Soft capsule good looking appearance in addition, patient's compliance is good, and the patient who is particularly suitable for old people, bed patient and dysphagia takes, and this is that other peroral dosage forms can't be than U.S..
Preparation method of the present invention, it is simple to have technology, is suitable for suitability for industrialized production.
Four, the specific embodiment
Below in conjunction with embodiment the present invention is described further, but protection scope of the present invention is not limited to this.Below component content among each embodiment be example all to process 1000.
Embodiment 1:
Soft gastrodine capsule, the content medicinal liquid comprises principal agent and pharmaceutic adjuvant, and principal agent is a gastrodine, and diluent is a soybean oil in the pharmaceutic adjuvant, and suspending agent is a dextrin, and cosolvent is a polyoxyethylene sorbitan monoleate, and the components by weight of its herb liquid is as follows:
Gastrodine 5.0g (10.0%)
Soybean oil 42.0g (84.0%)
Dextrin 1.0g (2%)
Polyoxyethylene sorbitan monoleate 2.0g (4%)
The heavy 50mg of every ball content contains gastrodine 5mg.
Preparation method:
(1) gets soybean oil, add the dextrin heating in water bath and make dissolving, stir, naturally cool to room temperature;
(2) adding gastrodine stirs;
(3) polyoxyethylene sorbitan monoleate is joined in (2), stir, promptly get the content medicinal liquid.
Content medicinal liquid and softgel shell glue are inserted in the pellet processing machine simultaneously, be pressed into ball, typing is put the hothouse drying, promptly.
Embodiment 2:
As described in embodiment 1, the components by weight of different is content medicinal liquid in the soft gastrodine capsule is as follows:
Gastrodine 10.0g (14.0%)
Semen Maydis oil 54.0g (77.0%)
Glyceryl monostearate 4.0g (5.7%)
Beta-schardinger dextrin-2.0g (2.8%)
The heavy 70mg of every ball content contains gastrodine 10mg
Preparation method:
(1) gets Semen Maydis oil, add the glyceryl monostearate heating in water bath and make dissolving, stir, naturally cool to room temperature;
(2) adding gastrodine stirs;
(3) beta-schardinger dextrin-is joined in (2), stir, promptly get the content medicinal liquid.
Content medicinal liquid and softgel shell glue are inserted in the pellet processing machine simultaneously, be pressed into ball, typing is put the hothouse drying, promptly.
Embodiment 3:
As described in embodiment 1, the components by weight of different is content medicinal liquid in the soft gastrodine capsule is as follows:
Gastrodine 20.0g (20%)
PEG400 60.0g (60%)
Glycerol 17.0g (16%)
Alginic acid 3.0g (4%)
The heavy 100mg of every ball content contains gastrodine 20mg.
Preparation method:
(1) taking polyethylene glycol 400, add glycerol and stir;
(2) add gastrodine and stir, heating in water bath makes dissolving, naturally cools to room temperature;
(3) alginic acid joins in (2), stirs, and promptly gets the content medicinal liquid.
Content medicinal liquid and softgel shell glue are inserted in the pellet processing machine simultaneously, be pressed into ball, typing is put the hothouse drying, promptly.
Embodiment 4:
As described in embodiment 1, the components by weight of different is content medicinal liquid in the soft gastrodine capsule is as follows:
Gastrodine 25.0g (20%)
PEG400 75.0g (60%)
Propylene glycol 25.0g (20%)
The heavy 125mg of every ball content contains gastrodine 25mg.
Preparation method:
(1) taking polyethylene glycol 400, add propylene glycol and stir;
(2) add gastrodine and stir, heating in water bath makes dissolving, naturally cools to room temperature;
Content medicinal liquid and softgel shell glue are inserted in the pellet processing machine simultaneously, be pressed into ball, typing is put the hothouse drying, promptly.
Embodiment 5:
As described in embodiment 1, the components by weight of different is content medicinal liquid in the soft gastrodine capsule is as follows:
Gastrodine 50.0g (20%)
PEG400 150.0g (60%)
Ethanol 40.0g (16%)
Polyvinylpolypyrrolidone 10.0g (4%)
The heavy 250mg of every ball content contains gastrodine 50mg.
Preparation method:
(1) taking polyethylene glycol 400, add ethanol and stir;
(2) add gastrodine and stir, heating in water bath makes dissolving, naturally cools to room temperature;
(3) polyvinylpolypyrrolidone joins in (2), stirs, and promptly gets the content medicinal liquid.
Content medicinal liquid and softgel shell glue are inserted in the pellet processing machine simultaneously, be pressed into ball, typing is put the hothouse drying, promptly.
Embodiment 6:
As described in embodiment 1, the components by weight of different is soft gastrodine capsule herb liquid is as follows:
Gastrodine 100.0g (20%)
Oleum Gossypii semen 275.0g (75%)
Cera Flava 10.0g (2%)
Calcium stearate 5.0g (1%)
Sodium lauryl sulphate 10.0g (2%)
The heavy 400mg of every ball content contains gastrodine 100mg.
Preparation method:
(1) get Oleum Gossypii semen, adding Cera Flava, calcium stearate heating in water bath make dissolving, stir, and naturally cool to room temperature;
(2) adding gastrodine stirs;
(3) sodium lauryl sulphate is joined in (2), stir, promptly get the content medicinal liquid.
Content medicinal liquid and softgel shell glue are inserted in the pellet processing machine simultaneously, be pressed into ball, typing is put the hothouse drying, promptly.
Embodiment 7:
As described in embodiment 1, the components by weight of different is soft gastrodine capsule herb liquid is as follows:
Gastrodine 200.0g (28.57%)
Olive oil 470.0g (67.14%)
General methylamine 20.0g (2.56%)
Polyoxyethylene sorbitan monoleate 10.0g (1.43%)
The heavy 700mg of every ball content contains gastrodine 200mg.
Preparation method:
(1) gets olive oil, add general methylamine heating in water bath and make dissolving, stir, naturally cool to room temperature;
(2) adding gastrodine stirs;
(3) polyoxyethylene sorbitan monoleate is joined in (2), stir, promptly get the content medicinal liquid.
Content medicinal liquid and softgel shell glue are inserted in the pellet processing machine simultaneously, be pressed into ball, typing is put the hothouse drying, promptly.
Embodiment 8:
As described in embodiment 1, the components by weight of different is soft gastrodine capsule herb liquid is as follows:
Gastrodine 300.0g (30%)
Soybean oil 650.0g (65%)
Carmethose 30.0g (3%)
General methylamine 10.0g (1%)
Polyoxyethylene sorbitan monoleate 10.0 (1%)
The heavy 1g of every ball content contains gastrodine 300mg.
Preparation method:
(1) get soybean oil, adding carmethose, glyceryl monostearate heating in water bath make dissolving, stir, and naturally cool to room temperature;
(2) adding gastrodine stirs;
(3) polyoxyethylene sorbitan monoleate is joined in (2), stir, promptly get the content medicinal liquid.
Content medicinal liquid and softgel shell glue are inserted in the pellet processing machine simultaneously, be pressed into ball, typing is put the hothouse drying, promptly.
Test case:
Commercially available gastrodine tablet and embodiment of the invention dissolution rate comparative test result
Test method: sample thief, according to dissolution method (two appendix XC of Chinese Pharmacopoeia version in 2005), be solvent with 900ml water, rotating speed is that per minute 75 changes, operation in accordance with the law, respectively at 5 ', 15 ', 25 ', 35 ', 45 ' sampling, filter, get subsequent filtrate, according to high performance liquid chromatography (two appendix VD of Chinese Pharmacopoeia version in 2005), the detection wavelength is 220nm, with calculated by peak area, the results are shown in following table by external standard method:
| Sample source | Sample time (minute) | |||||
| 5′ | 15′ | 25′ | 35′ | 45′ | ||
| Dissolution (%) | Marketed tablet | 5.12 | 28.23 | 45.44 | 63.21 | 78.88 |
| Embodiment 1 | 6.04 | 27.44 | 55.36 | 92.02 | 101.33 | |
| Embodiment 2 | 5.44 | 26.33 | 58.42 | 88.63 | 100.66 | |
| Embodiment 3 | 5.36 | 25.63 | 54.23 | 86.47 | 101.21 | |
| Embodiment 4 | 5.25 | 25.36 | 57.42 | 90.25 | 100.37 | |
| Embodiment 5 | 5.64 | 26.12 | 60.05 | 92.44 | 101.12 | |
| Embodiment 6 | 4.66 | 24.33 | 51.14 | 82.46 | 97.45 | |
| Embodiment 7 | 4.87 | 25.12 | 53.28 | 86.45 | 96.68 | |
| Embodiment 8 | 4.69 | 25.47 | 55.44 | 85.88 | 95.46 | |
Claims (6)
1, a kind of soft gastrodine capsule is characterized in that: be to be the soft capsule that principal agent is made by gastrodine.
2, soft gastrodine capsule as claimed in claim 1 is characterized in that: its pharmaceutic adjuvant is diluent, cosolvent, suspending agent, and the percentage by weight of principal agent and pharmaceutic adjuvant is respectively:
Gastrodine: 10-30%
Diluent: 65-85%
Cosolvent: 0-5.7%
Suspending agent: 0-4%.
3, soft gastrodine capsule as claimed in claim 1 or 2 is characterized in that: described diluent is one or more of ethanol, propylene glycol, glycerol, PEG400, soybean oil, Semen Maydis oil, Oleum Gossypii semen and olive oil; Described cosolvent is one or more in beta-schardinger dextrin-, polyoxyethylene sorbitan monoleate, sodium lauryl sulphate, alginic acid, polyvinylpolypyrrolidone and the general methylamine; Described suspending agent is one or more in Cera Flava, glyceryl monostearate, calcium stearate, carmethose, dextrin and the oleic acid.
4. soft gastrodine capsule as claimed in claim 1 or 2 is characterized in that: every soft capsule contains gastrodine 5～300mg.
5, soft gastrodine capsule as claimed in claim 1 or 2 is characterized in that: its softgel shell is made by glycerol, gelatin, opacifier, antiseptic.
6, the preparation method of the described soft gastrodine capsule of a kind of claim 2 is characterized in that: may further comprise the steps:
(1) gets diluent and add the suspending agent heating for dissolving, naturally cool to room temperature under the stirring;
(2) gastrodine is joined in (1), fully stir and make dissolving;
(3) cosolvent is joined in (2), stir and promptly get the content medicinal liquid;
(4) content medicinal liquid and softgel shell glue are inserted in the pellet processing machine simultaneously, be pressed into ball, typing is put the hothouse drying, promptly.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2006100452771A CN1875949A (en) | 2006-07-04 | 2006-07-04 | Soft gastrodine capsule and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2006100452771A CN1875949A (en) | 2006-07-04 | 2006-07-04 | Soft gastrodine capsule and preparation method thereof |
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| Publication Number | Publication Date |
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| CN1875949A true CN1875949A (en) | 2006-12-13 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA2006100452771A Pending CN1875949A (en) | 2006-07-04 | 2006-07-04 | Soft gastrodine capsule and preparation method thereof |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101317971B (en) * | 2008-07-02 | 2011-07-20 | 贵州益康制药有限公司 | Complete-gastrodia tuber soft capsule and preparation method thereof |
| CN107349186A (en) * | 2017-06-28 | 2017-11-17 | 新疆金骏阳光生物科技有限公司 | Dogbane flower leaf volatile oil soft capsule and preparation method thereof |
| CN108703955A (en) * | 2018-07-31 | 2018-10-26 | 荆楚理工学院 | A kind of minerals soft capsule and preparation method thereof |
-
2006
- 2006-07-04 CN CNA2006100452771A patent/CN1875949A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101317971B (en) * | 2008-07-02 | 2011-07-20 | 贵州益康制药有限公司 | Complete-gastrodia tuber soft capsule and preparation method thereof |
| CN107349186A (en) * | 2017-06-28 | 2017-11-17 | 新疆金骏阳光生物科技有限公司 | Dogbane flower leaf volatile oil soft capsule and preparation method thereof |
| CN108703955A (en) * | 2018-07-31 | 2018-10-26 | 荆楚理工学院 | A kind of minerals soft capsule and preparation method thereof |
| CN108703955B (en) * | 2018-07-31 | 2020-02-21 | 荆楚理工学院 | Mineral soft capsule and preparation method thereof |
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