CN1628674A - Ligustrazine phosphate soft capsule and its preparation method - Google Patents
Ligustrazine phosphate soft capsule and its preparation method Download PDFInfo
- Publication number
- CN1628674A CN1628674A CN 200410073664 CN200410073664A CN1628674A CN 1628674 A CN1628674 A CN 1628674A CN 200410073664 CN200410073664 CN 200410073664 CN 200410073664 A CN200410073664 A CN 200410073664A CN 1628674 A CN1628674 A CN 1628674A
- Authority
- CN
- China
- Prior art keywords
- soft capsule
- gram
- phosphate
- lingustrazine
- vegetable oil
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 239000007901 soft capsule Substances 0.000 title claims abstract description 42
- KWWLGXNRLABSMP-UHFFFAOYSA-N phosphoric acid;2,3,5,6-tetramethylpyrazine Chemical compound OP(O)(O)=O.CC1=NC(C)=C(C)N=C1C KWWLGXNRLABSMP-UHFFFAOYSA-N 0.000 title claims abstract description 22
- 238000002360 preparation method Methods 0.000 title claims abstract description 17
- 239000000203 mixture Substances 0.000 claims abstract description 28
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims abstract description 21
- 235000015112 vegetable and seed oil Nutrition 0.000 claims abstract description 21
- 239000008158 vegetable oil Substances 0.000 claims abstract description 21
- 108010010803 Gelatin Proteins 0.000 claims abstract description 18
- 229920000159 gelatin Polymers 0.000 claims abstract description 18
- 239000008273 gelatin Substances 0.000 claims abstract description 18
- 235000019322 gelatine Nutrition 0.000 claims abstract description 18
- 235000011852 gelatine desserts Nutrition 0.000 claims abstract description 18
- 239000011257 shell material Substances 0.000 claims abstract description 15
- 239000002775 capsule Substances 0.000 claims abstract description 14
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 10
- 238000001035 drying Methods 0.000 claims abstract description 6
- 239000007788 liquid Substances 0.000 claims abstract description 4
- 239000000463 material Substances 0.000 claims abstract description 3
- 229910019142 PO4 Inorganic materials 0.000 claims description 26
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims description 23
- 239000010452 phosphate Substances 0.000 claims description 23
- FINHMKGKINIASC-UHFFFAOYSA-N Tetramethylpyrazine Chemical compound CC1=NC(C)=C(C)N=C1C FINHMKGKINIASC-UHFFFAOYSA-N 0.000 claims description 19
- 239000007766 cera flava Substances 0.000 claims description 18
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 claims description 16
- 235000010469 Glycine max Nutrition 0.000 claims description 10
- 244000068988 Glycine max Species 0.000 claims description 10
- 239000003921 oil Substances 0.000 claims description 10
- 235000019198 oils Nutrition 0.000 claims description 10
- 229910000147 aluminium phosphate Inorganic materials 0.000 claims description 8
- 239000011344 liquid material Substances 0.000 claims description 7
- 239000000084 colloidal system Substances 0.000 claims description 6
- -1 G & W in proportion Substances 0.000 claims description 5
- 238000010438 heat treatment Methods 0.000 claims description 3
- 238000005213 imbibition Methods 0.000 claims description 3
- 239000004615 ingredient Substances 0.000 claims description 3
- 239000003292 glue Substances 0.000 claims description 2
- 235000013871 bee wax Nutrition 0.000 abstract 3
- 239000012166 beeswax Substances 0.000 abstract 3
- 239000000306 component Substances 0.000 abstract 1
- 239000008173 hydrogenated soybean oil Substances 0.000 abstract 1
- 235000021317 phosphate Nutrition 0.000 description 15
- 239000002552 dosage form Substances 0.000 description 8
- 238000005303 weighing Methods 0.000 description 7
- 238000009413 insulation Methods 0.000 description 4
- 239000004480 active ingredient Substances 0.000 description 3
- 239000003814 drug Substances 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 238000000034 method Methods 0.000 description 3
- 238000010298 pulverizing process Methods 0.000 description 3
- 235000012424 soybean oil Nutrition 0.000 description 3
- 239000003549 soybean oil Substances 0.000 description 3
- 230000002950 deficient Effects 0.000 description 2
- 239000007902 hard capsule Substances 0.000 description 2
- 238000002347 injection Methods 0.000 description 2
- 239000007924 injection Substances 0.000 description 2
- 239000007787 solid Substances 0.000 description 2
- 239000003826 tablet Substances 0.000 description 2
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 230000008595 infiltration Effects 0.000 description 1
- 238000001764 infiltration Methods 0.000 description 1
- 230000000968 intestinal effect Effects 0.000 description 1
- 230000000302 ischemic effect Effects 0.000 description 1
- 239000012669 liquid formulation Substances 0.000 description 1
- 230000010534 mechanism of action Effects 0.000 description 1
- 229940126701 oral medication Drugs 0.000 description 1
- 229940096978 oral tablet Drugs 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 239000000375 suspending agent Substances 0.000 description 1
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses a ligustrazine phosphate soft capsule, which is a soft capsule prepared by taking gelatin, glycerol and water as capsule shell materials, ligustrazine phosphate as an effective component and vegetable oil, beeswax or a mixture of hydrogenated soybean oil and beeswax as dressing. Each soft capsule contains 0.05-0.1 g of ligustrazine phosphate; vegetable oil 0.3-0.4 g; beeswax 0.03-0.05 g. The materials are prepared into soft capsules through capsule shell preparation, capsule liquid preparation and a soft capsule machine, and the finished products are obtained after drying.
Description
Technical field
The dosage form that the present invention relates to a kind of ligustrazine phosphate improves particularly a kind of Lingustrazine Phosphate soft capsule; The invention still further relates to above-mentioned preparation of soft capsule method simultaneously.
Background technology
Ligustrazine phosphate is as a kind of sophisticated medicine, and its mechanism of action is familiar with by people, and has definite curative effect in diseases such as treatment ischemic cerebrovascular.But the dosage form of existing ligustrazine phosphate has only injection to be used for injection or instils; Tablet, hard capsule are used for oral.Cause dosage form more single, as oral drugs, tablet and hard capsule are solid preparation, have infiltration rate unavoidably and wait the dosage form defective slowly when orally using.And soft capsule has overcome the defective of solid formulation basically as oral novel liquid formulation.But on the dosage form of ligustrazine phosphate, also there is not soft capsule to occur.
Summary of the invention
The object of the present invention is to provide a kind of Lingustrazine Phosphate soft capsule, a kind of dosage form blank that it has remedied the ligustrazine phosphate preparation has the unrivaled effect of other dosage form.
Lingustrazine Phosphate soft capsule of the present invention is to be the softgel shell material with gelatin, G ﹠ W, is effective ingredient with the ligustrazine phosphate, is the soft capsule that dressing is made with vegetable oil, Cera Flava or oil with hydrogenated soybean and mellisic mixture.
The used material's proportion of above-mentioned described capsule shells is a gelatin: glycerol: water=1: 0.32: 1.15.
Above-mentioned every phosphoric acid ligustrazine of described Lingustrazine Phosphate soft capsule 0.05-0.1 gram; Vegetable oil 0.3-0.4 gram; Cera Flava 0.03-0.05 gram; Preferably every phosphoric acid ligustrazine 0.05 restrains; Vegetable oil 0.318 gram; Cera Flava 0.032 gram.
Every phosphoric acid ligustrazine of above-mentioned described Lingustrazine Phosphate soft capsule 0.05-0.1 gram; Vegetable oil 0.3-0.4 gram; Each a mixture 0.03-0.05 gram of forming of oil with hydrogenated soybean and Cera Flava; Preferably every phosphoric acid ligustrazine 0.05 restrains; Vegetable oil 0.3 18 grams; Each a mixture of forming 0.032 gram of oil with hydrogenated soybean and Cera Flava.
The preparation method of above-mentioned described Lingustrazine Phosphate soft capsule comprises the following steps:
A: softgel shell preparation: get gelatin, G ﹠ W in proportion, mix with gelatin with wherein part water, make the gelatin imbibition, remaining water and glycerol Hybrid Heating, add expansible gelatin again, continue to mix, temperature remains between 50-70 degree centigrade, make to be melt into till the uniform glue, be incubated standby;
B: capsule liquid preparation: get vegetable oil, Cera Flava or oil with hydrogenated soybean and mellisic mixture in proportion, mix homogeneously also is heated to 50-70 degree centigrade, gets exsiccant ligustrazine phosphate more in proportion and is ground into micropowder, and above-mentioned micropowder is added mix homogeneously in the vegetable oil, grind with colloid mill, standby;
C: above-mentioned softgel shell material that makes and capsule liquid material are made soft capsule with encapsulating machine, obtain finished product after the drying.
The present invention is ground into differential with ligustrazine phosphate, use vegetable oil as liquid medium, and the mixture that uses Cera Flava or soybean oil and Cera Flava is as suspending agent, medicine and dressing all grind with colloid mill, can keep medicine stability for a long time, possess all features of soft capsule.Remedy the dosage form blank of ligustrazine phosphate, improved the effect that absorbs when oral greatly.
The specific embodiment
Lingustrazine Phosphate soft capsule of the present invention is to be the softgel shell material with gelatin, G ﹠ W, is effective ingredient with the ligustrazine phosphate, is that dressing is made with vegetable oil, Cera Flava or oil with hydrogenated soybean and mellisic mixture.Following embodiment is an example with the soft capsule of making 1000 different contents respectively.During preparation softgel shell material, not by 1000 calculating.
Embodiment 1:
Take by weighing gelatin 1000 gram, glycerol 320 grams, water 1150 grams mix suitable quantity of water wherein with gelatin, treat after the gelatin imbibition standby.With remaining water and all glycerol mix homogeneously, and be heated to 50-70 degree centigrade, follow the mixture of the gelatin of suction all being put into G ﹠ W, continue 50-70 degree centigrade of heating and insulation, wait to enter complete molten condition and be incubated standby.
Take by weighing vegetable oil (as soybean oil) 300 gram, Cera Flava 30 grams, with above-mentioned dressing mix homogeneously and be heated to 50-70 degree centigrade, insulation; Then take by weighing 70 gram ligustrazine phosphates and be ground into micropowder, in the ligustrazine phosphate micropowder adding dressing mixed liquor with this pulverizing, mix homogeneously grinds with colloid mill, and is standby.
The above-mentioned softgel shell material that makes 400 grams and all capsule liquid materials are made 1000 soft capsules through encapsulating machine, obtain finished product after drying.Every of this Lingustrazine Phosphate soft capsule contains active ingredient ligustrazine phosphate 0.07 gram.
Embodiment 2:
The method of producing the softgel shell material is identical with embodiment 1.
When preparation capsule liquid material, take by weighing vegetable oil (as Oleum Sesami) 400 grams, Cera Flava 50 grams, with above-mentioned dressing mix homogeneously and be heated to 50-70 degree centigrade, insulation; Then take by weighing 100 gram ligustrazine phosphates and be ground into micropowder, in the ligustrazine phosphate micropowder adding dressing mixed liquor with this pulverizing, mix homogeneously grinds with colloid mill, and is standby.
Softgel shell material 500 grams and all capsule liquid materials that make are made 1000 soft capsules through encapsulating machine, obtain finished product after drying.Every of this Lingustrazine Phosphate soft capsule contains active ingredient ligustrazine phosphate 0.1 gram.
Embodiment 3:
The method of producing the softgel shell material is identical with embodiment 1.
When preparation capsule liquid material, take by weighing each a mixture of forming 32 gram of vegetable oil (as soybean oil) 318 grams, Cera Flava and oil with hydrogenated soybean, with above-mentioned dressing mix homogeneously and be heated to 50-70 degree centigrade, insulation; Then take by weighing 50 gram ligustrazine phosphates and be ground into micropowder, in the ligustrazine phosphate micropowder adding dressing mixed liquor with this pulverizing, mix homogeneously grinds with colloid mill, and is standby.
Softgel shell material 400 grams and all capsule liquid materials that make are made 1000 soft capsules through encapsulating machine, obtain finished product after drying.Every of this Lingustrazine Phosphate soft capsule contains active ingredient ligustrazine phosphate 0.05 gram.
Lingustrazine Phosphate soft capsule disintegration time of the present invention generally between 20-40 minute, is absorbed in intestinal (or stomach) preferably.
Prove that through stability test soft capsule preparation room temperature preservation of the present invention is after 2 years, quality still meets the demands.
Claims (7)
1. Lingustrazine Phosphate soft capsule is characterized in that: it is to be the softgel shell material with gelatin, G ﹠ W, is effective ingredient with the ligustrazine phosphate, is the soft capsule that dressing is made with vegetable oil and Cera Flava or oil with hydrogenated soybean and mellisic mixture.
2. Lingustrazine Phosphate soft capsule according to claim 1 is characterized in that: the used material's proportion of described capsule shells is a gelatin: glycerol: water=1: 0.32: 1.15.
3. Lingustrazine Phosphate soft capsule according to claim 1 and 2 is characterized in that: every phosphoric acid ligustrazine of described Lingustrazine Phosphate soft capsule 0.05-0.1 gram; Vegetable oil 0.3-0.4 gram; Cera Flava 0.03-0.05 gram.
4. Lingustrazine Phosphate soft capsule according to claim 3 is characterized in that: every phosphoric acid ligustrazine of described Lingustrazine Phosphate soft capsule 0.05 gram; Vegetable oil 0.318 gram; Cera Flava 0.032 gram.
5. Lingustrazine Phosphate soft capsule according to claim 1 and 2 is characterized in that: every phosphoric acid ligustrazine of described Lingustrazine Phosphate soft capsule 0.05-0.1 gram; Vegetable oil 0.3-0.4 gram; Each a mixture 0.03-0.05 gram of forming of oil with hydrogenated soybean and Cera Flava.
6. Lingustrazine Phosphate soft capsule according to claim 5 is characterized in that: every phosphoric acid ligustrazine of described Lingustrazine Phosphate soft capsule 0.05 gram; Vegetable oil 0.318 gram; Each a mixture of forming 0.032 gram of oil with hydrogenated soybean and Cera Flava.
7. the preparation method of a Lingustrazine Phosphate soft capsule as claimed in claim 1 is characterized in that comprising the following steps:
A: softgel shell preparation: get gelatin, G ﹠ W in proportion, mix with gelatin with wherein part water, make the gelatin imbibition, remaining water and glycerol Hybrid Heating, add expansible gelatin again, continue to mix, temperature remains between 50-70 degree centigrade, make to be melt into till the uniform glue, be incubated standby;
B: capsule liquid preparation: get vegetable oil, Cera Flava or oil with hydrogenated soybean and mellisic mixture in proportion, mix homogeneously also is heated to 50-70 degree centigrade, gets exsiccant ligustrazine phosphate more in proportion and is ground into micropowder, and above-mentioned micropowder is added mix homogeneously in the vegetable oil, grind with colloid mill, standby;
C: above-mentioned softgel shell material that makes and capsule liquid material are made soft capsule with encapsulating machine, obtain finished product after the drying.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410073664 CN1628674A (en) | 2004-08-31 | 2004-08-31 | Ligustrazine phosphate soft capsule and its preparation method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410073664 CN1628674A (en) | 2004-08-31 | 2004-08-31 | Ligustrazine phosphate soft capsule and its preparation method |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1628674A true CN1628674A (en) | 2005-06-22 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200410073664 Pending CN1628674A (en) | 2004-08-31 | 2004-08-31 | Ligustrazine phosphate soft capsule and its preparation method |
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| Country | Link |
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| CN (1) | CN1628674A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110403913A (en) * | 2018-04-25 | 2019-11-05 | 人福普克药业（武汉）有限公司 | Amantadine hydrochloride soft capsule and preparation method thereof |
-
2004
- 2004-08-31 CN CN 200410073664 patent/CN1628674A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110403913A (en) * | 2018-04-25 | 2019-11-05 | 人福普克药业（武汉）有限公司 | Amantadine hydrochloride soft capsule and preparation method thereof |
| CN110403913B (en) * | 2018-04-25 | 2022-02-01 | 人福普克药业（武汉）有限公司 | Amantadine hydrochloride soft capsule and preparation method thereof |
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| C12 | Rejection of a patent application after its publication | ||
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