CN103054861A - Compound solid preparation containing tranexamic acid - Google Patents
Compound solid preparation containing tranexamic acid Download PDFInfo
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- CN103054861A CN103054861A CN2012105926106A CN201210592610A CN103054861A CN 103054861 A CN103054861 A CN 103054861A CN 2012105926106 A CN2012105926106 A CN 2012105926106A CN 201210592610 A CN201210592610 A CN 201210592610A CN 103054861 A CN103054861 A CN 103054861A
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- tranexamic acid
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Abstract
The invention relates to a compound solid preparation containing tranexamic acid. The compound oral solid preparation containing the tranexamic acid is prepared from the tranexamic acid serving as a main active ingredient, other active ingredients and pharmaceutically acceptable auxiliary materials by a preparation technology. The compound solid preparation containing the tranexamic acid is stable and controllable in quality, safe and effective.
Description
Technical field
The present invention relates to a kind of compound oral solid preparation that contains tranexamic acid.It is oral clad sheet, ordinary tablet, freeze-dried instant sheet, Film coated tablets, enteric coatel tablets, hard capsule and the granule that tranexamic acid and other active component and pharmaceutically acceptable adjuvant are made by preparation technique.The compound solid preparation of tranexamic acid of the present invention and application quality thereof are stable, controlled, safe and effective, belong to medical technical field.
Background technology
Chloasma is commonly called as " butterfly spot ", " chloasma hepaticum " or " cyasma ".Mainly occur in face, take cheekbone section, buccal, nose, forehead, chin section as main.For the brown of obscure boundary Chu or the patch of black, mostly be symmetry.The appearance of chloasma is most relevant with endocrine, especially relevant with women's estrogen level, menoxenia, gestation, takes contraceptive or liver function is bad and chronic nephropathy all chloasma may occur.Exposure to Sunlight and Nervous and Mental Factors also can increase the weight of primary disease in addition.The anemia of pregnant woman usually occurred later on chloasma in 3 months in gestation, and majority are disappeared when minute the puerperium, menstruation recovery was normal gradually.If do not move back for a long time, need to treat.
The combination of inner and outside is wanted in the treatment of chloasma, at first will dispel the cause of disease, and strictly sun-proof.There are on the market some whitening cosmetics to contain the whitening compositions such as arbutin, vitamin C/E and derivant thereof, some Flavonoids and Polyphenols extract, nicotiamide, external also has certain effect, can be used in conjunction with, the melanin that tretinoin can affect melanocyte generates, its effect is multidigit point, the three type catalyzing enzyme activity such as tyrosine hydroxylase, dopase and dihydroxy indole oxidase there is inhibitory action, forms, alleviate cutaneous pigmentation thereby reduce melanin.No matter be skin-lightening cosmetic or medicine, will just can see effect more than two months service time at least, need to adhere to.Fruit acid changes skin in addition.With treatments such as vitamin C iontophoresis reasonable therapeutic effect is arranged also.These medicines need long-term taking, can not take effect in a short time.
Summary of the invention
The purpose of this invention is to provide a kind of disintegrate fast, absorb rapidly, bioavailability and blood drug level that can the Effective Raise medicine improve the tranexamic acid compound solid preparation of taste, taking convenience, few side effects simultaneously.
The compound solid preparation of tranexamic acid provided by the invention, contain tranexamic acid and vitamin C, vitamin B6, Cys, calcium pantothenate and be fit to make the excipient substance of solid preparation, wherein said oral solid formulation is oral ordinary tablet, clad sheet, freeze-dried instant sheet, Film coated tablets, enteric coatel tablets, hard capsule, granule, oral cavity disintegration tablet, the effervescent tablet that tranexamic acid, vitamin C, vitamin B6, Cys, calcium pantothenate and pharmaceutically acceptable adjuvant are made by preparation technique, preferred clad sheet.
The specification of tranexamic acid is per unit dosage 100-500mg;
Ascorbic specification is per unit dosage 10-100mg;
The specification of vitamin B6 is per unit dosage 0.5-5mg;
The specification of Cys is per unit dosage 10-50mg;
The specification of calcium pantothenate is per unit dosage 1-10mg;
Pharmaceutically acceptable adjuvant can be filler, binding agent, disintegrating agent, lubricant, correctives (necessity) and coating materials.Wherein filler includes but not limited to lactose, sucrose, glucose, mannitol, sorbitol, calcium sulfate, calcium gluconate, calcium hydrogen phosphate, calcium phosphate, calcium carbonate, calcium bicarbonate, starch, carboxymethyl starch, pregelatinized Starch or microcrystalline Cellulose;
Pharmaceutically acceptable adjuvant can be filler, binding agent, disintegrating agent, lubricant, correctives (necessity) and coating materials.Binding agent includes but not limited to starch, gelatin dextrin, maltodextrin, sucrose, arabic gum, polyvinylpyrrolidone, various viscosity methylcellulose, low viscosity carboxymethyl cellulose, various viscosity ethyl cellulose, various viscosity polyvinyl alcohol, polyethylene glycol 6000 or the following hyprolose of 50mpaS;
Pharmaceutically acceptable adjuvant can be filler, binding agent, disintegrating agent, lubricant, correctives (necessity) and coating materials.Disintegrating agent includes but not limited to pregelatinized Starch, microcrystalline Cellulose, alginic acid, pure wood fiber element, carboxymethyl starch sodium, guar gum, crospolyvinylpyrrolidone, methylcellulose or cross-linking sodium carboxymethyl cellulose;
Pharmaceutically acceptable adjuvant can be filler, binding agent, disintegrating agent, lubricant, correctives (necessity) and coating materials.Lubricant includes but not limited to magnesium stearate, calcium stearate, Pulvis Talci, glyceryl monostearate, Macrogol 4000, polyethylene glycol 6000, PEG 8000, sodium benzoate, adipic acid, fumaric acid, boric acid, sodium chloride, sodium laurylsulfate or magnesium laurylsulfate;
Pharmaceutically acceptable adjuvant can be filler, binding agent, disintegrating agent, lubricant, correctives (necessity) and coating materials.Correctives includes but not limited to steviosin, sorbitol, maltose alcohol, glycyrrhizin, stem tea element, Sodium Cyclamate, flavoring banana essence, flavoring pineapple essence, Mint Essence, Fructus Foeniculi, vanillin, Fructus Citri Limoniae essence, cherry essence or rose essence.
Pharmaceutical preparation of the present invention also comprises wetting agent, for purified water, ethanol or purified water alcohol mixture etc.The used coating material of the present invention includes but not limited to cellulose and derivant thereof, crylic acid resin, ethene polymers etc.
The present invention also comprises the application of compound solid preparation in preparation treatment chloasma medicine of tranexamic acid.
The specific embodiment:
Following case study on implementation is used for explaining the present invention, but is not limited to this.
Embodiment 1
| The label composition | The mg/ sheet | The g/1000 sheet |
| Vitamin C | 55.00 | 55.00 |
| Cys | 42.00 | 42.00 |
| Calcium lactate | 10.00 | 10.00 |
| CCNa | 3.00 | 3.00 |
| Starch1500 | 12.00 | 12.00 |
| MS | 1.00 | 1.00 |
| 50% ethanol water | In right amount | In right amount |
| Outer composition of layer | The mg/ sheet | 1000 |
| Tranexamic acid | 125.00 | 125.00 |
| Vitamin B6 | 1.05 | 1.05 |
| Calcium pantothenate | 4.00 | 4.00 |
| MCC?PH102 | 147.00 | 147.00 |
| Starch1500 | 110.00 | 110.00 |
| CCNa | 10.00 | 10.00 |
| MS | 3.00 | 3.00 |
Preparation technology:
Label
1. vitamin C, calcium lactate are crossed the pulverizing of 120 mesh sieves, and Cys is crossed 80 mesh sieves and pulverized, and is for subsequent use;
2. vitamin C, calcium lactate, Cys, CCNa, starch1500 are crossed 60 mesh sieves, fully mixing;
3. with 50% ethanol water soft material processed, 24 mesh sieves are granulated, 50 ℃ of dryings, 40 mesh sieve granulate;
4 add the abundant mix homogeneously of magnesium stearate, tabletting, and get final product.
Outer
1. outer all the components is crossed 60 eye mesh screens, fully mixing;
2. above-mentioned mixing powder and label are pressed clad sheet, and get final product.
Embodiment 2
| The label composition | The mg/ sheet | The g/1000 sheet |
| Vitamin C | 55.00 | 55.00 |
| Cys | 42.00 | 42.00 |
| Calcium lactate | 10.00 | 10.00 |
| CCNa | 3.00 | 3.00 |
| Starch1500 | 12.00 | 12.00 |
| MS | 1.00 | 1.00 |
| 50% ethanol water | In right amount | In right amount |
| Outer composition of layer | The mg/ sheet | 1000 |
| Tranexamic acid | 125.00 | 125.00 |
| Vitamin B6 | 1.05 | 1.05 |
| Calcium pantothenate | 4.00 | 4.00 |
| MCC?PH102 | 147.00 | 147.00 |
| Starch1500 | 110.00 | 110.00 |
| Add in the CCNa() | 10.00（5.00+5.00） | 10.00（5.00+5.00） |
| MS | 3.00 | 3.00 |
Preparation technology:
Label
1. vitamin C, calcium lactate are crossed the pulverizing of 120 mesh sieves, and Cys is crossed 80 mesh sieves and pulverized, and is for subsequent use;
2. vitamin C, calcium lactate, Cys, CCNa, starch1500 are crossed 60 mesh sieves, fully mixing;
3. with 50% ethanol water soft material processed, 24 mesh sieves are granulated, 50 ℃ of dryings, 40 mesh sieve granulate;
4 add the abundant mix homogeneously of magnesium stearate, tabletting, and get final product.
Outer
1. tranexamic acid, vitamin B6, calcium pantothenate are crossed the pulverizing of 80 mesh sieves, and be for subsequent use;
2. tranexamic acid, vitamin B6, calcium pantothenate, MCC PH102, starch1500 and Nei Jia part CCNa cross 60 mesh sieves, fully mixing;
3. with 50% ethanol water soft material processed, 24 mesh sieves are granulated, 60 ℃ of dryings, 40 mesh sieve granulate;
4 add Extra Section CCNa, the abundant mix homogeneously of fatty acid magnesium, and label is pressed into clad sheet, and get final product.
Embodiment 3
| The label composition | The mg/ sheet | The g/1000 sheet |
| Vitamin C | 55.00 | 55.00 |
| Cys | 42.00 | 42.00 |
| Calcium lactate | 10.00 | 10.00 |
| Add in the CCNa() | 14.00（7.00+7.00） | 14.00（7.00+7.00） |
| Starch1500 | 12.00 | 12.00 |
| MS | 1.00 | 1.00 |
| 50% ethanol water | In right amount | In right amount |
| Outer composition of layer | The mg/ sheet | 1000 |
| Tranexamic acid | 125.00 | 125.00 |
| Vitamin B6 | 1.05 | 1.05 |
| Calcium pantothenate | 4.00 | 4.00 |
| MCC?PH102 | 147.00 | 147.00 |
| Starch1500 | 110.00 | 110.00 |
| Add in the CCNa() | 10.00（5.00+5.00） | 10.00（5.00+5.00） |
| MS | 3.00 | 3.00 |
Preparation technology:
Label
1. vitamin C, calcium lactate are crossed the pulverizing of 120 mesh sieves, and Cys is crossed 80 mesh sieves and pulverized, and is for subsequent use;
2. vitamin C, calcium lactate, Cys, CCNa, starch1500 are crossed 60 mesh sieves, fully mixing;
3. with 50% ethanol water soft material processed, 24 mesh sieves are granulated, 50 ℃ of dryings, 40 mesh sieve granulate;
4 add Extra Section CCNa and the abundant mix homogeneously of magnesium stearate, tabletting, and get final product.
Outer
1. tranexamic acid, vitamin B6, calcium pantothenate are crossed the pulverizing of 80 mesh sieves, and be for subsequent use;
2. tranexamic acid, vitamin B6, calcium pantothenate, MCC PH102, starch1500 and Nei Jia part CCNa cross 60 mesh sieves, fully mixing;
3. with 50% ethanol water soft material processed, 24 mesh sieves are granulated, 60 ℃ of dryings, 40 mesh sieve granulate;
4 add Extra Section CCNa, the abundant mix homogeneously of fatty acid magnesium, and label is pressed into clad sheet, and get final product.
Embodiment 4
| The label composition | The mg/ sheet | The g/1000 sheet |
| Vitamin C | 55.00 | 55.00 |
| Cys | 42.00 | 42.00 |
| Calcium lactate | 10.00 | 10.00 |
| CCNa | 2.00 | 2.00 |
| Starch1500 | 12.00 | 12.00 |
| MS | 1.00 | 1.00 |
| 50% ethanol water | In right amount | In right amount |
| Outer composition of layer | The mg/ sheet | 1000 |
| Tranexamic acid | 125.00 | 125.00 |
| Vitamin B6 | 1.05 | 1.05 |
| Calcium pantothenate | 4.00 | 4.00 |
| MCC?PH102 | 147.00 | 147.00 |
| Starch1500 | 110.00 | 110.00 |
| Add in the CCNa() | 10.00（5.00+5.00） | 10.00（5.00+5.00） |
| MS | 3.00 | 3.00 |
Preparation technology:
Label
1. vitamin C, calcium lactate are crossed the pulverizing of 120 mesh sieves, and Cys is crossed 80 mesh sieves and pulverized, and is for subsequent use;
2. vitamin C, calcium lactate, Cys, CCNa, starch1500 are crossed 60 mesh sieves, fully mixing;
3. with 50% ethanol water soft material processed, 24 mesh sieves are granulated, 50 ℃ of dryings, 40 mesh sieve granulate;
4 add the abundant mix homogeneously of magnesium stearate, tabletting, and get final product.
Outer
1. tranexamic acid, vitamin B6, calcium pantothenate are crossed the pulverizing of 80 mesh sieves, and be for subsequent use;
2. tranexamic acid, vitamin B6, calcium pantothenate, MCC PH102, starch1500 and Nei Jia part CCNa cross 60 mesh sieves, fully mixing;
3. with 50% ethanol water soft material processed, 24 mesh sieves are granulated, 60 ℃ of dryings, 40 mesh sieve granulate;
4 add Extra Section CCNa, the abundant mix homogeneously of fatty acid magnesium, and label is pressed into clad sheet, and get final product.
The effect experiment of embodiment 5 compound recipe tranexamic acids treatment chloasma
Kunming kind regular grade KM female mice, 3 monthly ages, body weight 18～20g, advanced action thing screening before the modeling, the labelling of weighing.The qualified mice of screening is divided into 4 groups at random: be respectively blank group, model control group (O), tretinoin external group (A), compound recipe tranexamic acid oral administration group (B: embodiment 1 sample), 10 every group.
Modeling: above each group exposes 1 of skin all with the depilation of 8%Na2S aqueous solution mouse back, and area is 2cm * lcm approximately.Lose hair or feathers weekly 1 time, clean with warm clear water after the depilation.Except the blank group, all the other each groups all ultraviolet B radiation take wavelength as 320nm (UVB) are shone mice 1 time every day, irradiation time 60min, 4 weeks of Continuous irradiation and the situation of change of observing mice depilation position skin.
Administration: the mice of modeling success is normally fed the O group every day: not medication, observe its change of skin situation.The A group: be coated with tretinoin in the affected part every day, 3 times on the one.The B group: gavage gives the compound recipe tranexamic acid, 3 times on the one.Blank group: normally feed every day, gives sufficient moisture and food.Be 1 month every group of observing time.
Index determining: the dislocation of mice cervical vertebra is put to death, get 1 of mice skin of unhairing, 10% formalin is fixed.The melanin labelling adopts immunohistochemistry technology, selects streptocin-biotin method.The melanin Positive Objects is by the graphical analysis of computer pathology.
The result: model group epidermal melanin Positive Objects average area (melanin dyeing area) surface density, target number, number density, all apparently higher than normal group animal and positive administration group, wherein the melanin Positive Objects of compound recipe tranexamic acid significantly is lower than the topical administration group to cell nuclei.Illustrate that the compound recipe tranexamic acid is remarkable to the chloasma therapeutical effect.
Table 1 mouse skin melanin pigmentation area, number change
Claims (9)
1. compound solid preparation take tranexamic acid as main active, it is characterized in that, contain tranexamic acid and vitamin C, vitamin B6, Cys, calcium pantothenate and be fit to make the excipient substance of solid preparation, the compound solid preparation of making by preparation technique.
2. compound solid preparation as claimed in claim 1 is characterized in that, the specification of tranexamic acid is per unit dosage 100-500mg; Ascorbic specification is per unit dosage 10-100mg; The specification of vitamin B6 is per unit dosage 0.5-5mg; The specification of Cys is per unit dosage 10-50mg; The specification of calcium pantothenate is per unit dosage 1-10mg.
3. compound solid preparation as claimed in claim 1 is characterized in that, can be made into following dosage form clad sheet, ordinary tablet, freeze-dried instant sheet, Film coated tablets, enteric coatel tablets, effervescent tablet, oral cavity disintegration tablet, hard capsule, granule, preferred clad sheet.
4. tranexamic acid compound solid preparation as claimed in claim 1 is characterized in that, adjuvant comprises filler, binding agent, disintegrating agent, lubricant, correctives (necessary words) and coating materials.
5. tranexamic acid compound solid preparation as claimed in claim 3, it is characterized in that, filler includes but not limited to lactose, sucrose, glucose, mannitol, sorbitol, calcium sulfate, calcium gluconate, calcium hydrogen phosphate, calcium phosphate, calcium carbonate, calcium bicarbonate, starch, carboxymethyl starch, pregelatinized Starch, microcrystalline Cellulose, hydroxypropyl cellulose.
6. the compound solid preparation of tranexamic acid as claimed in claim 3, it is characterized in that, binding agent includes but not limited to hyprolose, gelatin, dextrin, maltodextrin, sucrose, arabic gum, polyvinylpyrrolidone, methylcellulose, carboxymethyl cellulose, ethyl cellulose, polyvinyl alcohol, polyethylene glycols or starch.
7. the compound solid preparation of tranexamic acid as claimed in claim 3, it is characterized in that, disintegrating agent includes but not limited to pregelatinized Starch, microcrystalline Cellulose, alginic acid, pure wood fiber element, carboxymethyl starch sodium, guar gum, crospolyvinylpyrrolidone, methylcellulose, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose or gas-producing disintegrant.
8. the compound solid preparation of tranexamic acid as claimed in claim 3, it is characterized in that, lubricant includes but not limited to magnesium stearate, calcium stearate, zinc stearate, colloidal silica, sodium stearyl fumarate, Pulvis Talci, glyceryl monostearate, Macrogol 4000, polyethylene glycol 6000, PEG 8000, sodium benzoate, adipic acid, fumaric acid, boric acid, leucine, sodium chloride, sodium laurylsulfate or magnesium laurylsulfate.
9. the described arbitrary solid preparation of claim 1-8 is preparing the application for the treatment of in the chloasma medicine.
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| CN2012105926106A CN103054861A (en) | 2012-12-29 | 2012-12-29 | Compound solid preparation containing tranexamic acid |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104414991A (en) * | 2013-09-05 | 2015-03-18 | 杭州赛利药物研究所有限公司 | Tranexamic acid solid sustained-release tablets and preparation method thereof |
| US9314442B2 (en) * | 2014-03-25 | 2016-04-19 | Leading BioSciences, Inc. | Compositions for the treatment of autodigestion |
| US9504736B2 (en) | 2010-09-23 | 2016-11-29 | The Regents Of The University Of California | Administration of serine protease inhibitors to the stomach |
| CN113663118A (en) * | 2021-10-22 | 2021-11-19 | 中国人民解放军军事科学院军事医学研究院 | Application of esterified modified starch hemostatic material |
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| CN102137663A (en) * | 2008-09-12 | 2011-07-27 | 第一三共健康事业株式会社 | Stable pharmaceutical formulation with limited discoloration |
| CN102228415A (en) * | 2011-05-12 | 2011-11-02 | 康美药业股份有限公司 | Composition containing tranexamic acid, and preparation method and uses thereof |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102137664A (en) * | 2008-09-05 | 2011-07-27 | 第一三共健康事业株式会社 | Pharmaceutical solid preparation having active ingredients separated by boundary therein |
| CN102137663A (en) * | 2008-09-12 | 2011-07-27 | 第一三共健康事业株式会社 | Stable pharmaceutical formulation with limited discoloration |
| CN102228415A (en) * | 2011-05-12 | 2011-11-02 | 康美药业股份有限公司 | Composition containing tranexamic acid, and preparation method and uses thereof |
Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9504736B2 (en) | 2010-09-23 | 2016-11-29 | The Regents Of The University Of California | Administration of serine protease inhibitors to the stomach |
| US10137100B2 (en) | 2010-09-23 | 2018-11-27 | The Regents Of The University Of California | Administration of serine protease inhibitors to the stomach |
| US10772861B2 (en) | 2010-09-23 | 2020-09-15 | Leading Biosciences, LLC | Administration of serine protease inhibitors to the stomach |
| US11439611B2 (en) | 2010-09-23 | 2022-09-13 | Leading BioSciences, Inc. | Administration of serine protease inhibitors to the stomach |
| CN104414991A (en) * | 2013-09-05 | 2015-03-18 | 杭州赛利药物研究所有限公司 | Tranexamic acid solid sustained-release tablets and preparation method thereof |
| US9314442B2 (en) * | 2014-03-25 | 2016-04-19 | Leading BioSciences, Inc. | Compositions for the treatment of autodigestion |
| US9775821B2 (en) | 2014-03-25 | 2017-10-03 | Leading BioSciences, Inc. | Compositions for the treatment of autodigestion |
| US11123317B2 (en) | 2014-03-25 | 2021-09-21 | Leading BioSciences, Inc. | Compositions for the treatment of autodigestion |
| CN113663118A (en) * | 2021-10-22 | 2021-11-19 | 中国人民解放军军事科学院军事医学研究院 | Application of esterified modified starch hemostatic material |
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