CN105796513A - Calcium dobesilate pharmaceutical composition - Google Patents
Calcium dobesilate pharmaceutical composition Download PDFInfo
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- CN105796513A CN105796513A CN201410844894.2A CN201410844894A CN105796513A CN 105796513 A CN105796513 A CN 105796513A CN 201410844894 A CN201410844894 A CN 201410844894A CN 105796513 A CN105796513 A CN 105796513A
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- calcium
- phenolsulfonic acid
- medicine compound
- acid calcium
- adjusting agent
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Abstract
Belonging to the field of pharmaceutical preparations, the invention relates to calcium dobesilate pharmaceutical compositions, in particular to the field of calcium dobesilate dispersible tablets. Directed at the problems of poor stability and easy color change after dispersion in water in existing calcium dobesilate dispersible tablets, the invention discloses an optimized calcium dobesilate pharmaceutical composition, which is added with a pH regulator. The technical scheme disclosed by the invention not only solves the long-term placement stability and water solution discoloration problems of calcium dobesilate dispersible tablets, but also provides a stability improving idea for drugs with similar properties.
Description
Technical field
The present invention relates to phenolsulfonic acid calcium medicine compound, relate in particular to Calcium Dobsilate field, belong to field of medicine preparations.
Background technology
Calcium dobesilate (CalciumDobesilate) is a kind of microcirculation regulating drug, it can pass through to suppress vaso-active substance, such as histamine, 5-hydroxy tryptamine, Kallidin I, hyaluronidase, prostaglandin, the high penetration effect caused, thus improving the biosynthesis of basement membrane collagen.In American-European countries; calcium dobesilate has been acknowledged as prevention and treatment microcirculation dysfunction; particularly unique matured product of diabetic retinopathy; it is widely used to endocrine, ophthalmology and Urology Department at present; to protect blood capillary, preventing and treating diabetic retinopathy and all kinds of ophthalmic diseasess caused by microcirculation disturbance, and proteinuria of renal disease, the nephrotic syndrome and renal failure etc..
The common formulations of calcium dobesilate mostly is conventional capsule and tablet clinically at present, but owing to the disintegrate of capsule and tablet is slow, affect drug-eluting so that it is can not be fully absorbed by body, and have to need escalated dose first, this brings difficulty to the patient of old man, child and dysphagia.For the patient of microcirculation disturbance, its medicine is it is generally required to rapid-action, and drug release can stably continue.And this capsule and what tablet can not possess just.
Therefore, our tablet formulation of calcium dobesilate medicine disclosed in CN201210565167.3 applies for.Dispersible tablet can in 19 DEG C ~ 21 DEG C water in 3 minutes complete disintegrate become little granule and form homogenous suspension, compared with conventional tablet, dispersity is good, and disintegration time is short.Dispersible tablet both can be swallowed as conventional tablet is the same with capsule, it is also possible under clothes soluble in water, is particularly suited for old man, child and swallows the patient of difficulty.
Along with going deep into further of research, it has been found that this dispersible tablet exists following defect:
(1), after being dispersed in water by this dispersible tablet, through after a while, solution becomes rufous.
(2) this dispersible tablet is placed in form of tablets for a long time, and color can be become off-white color by white.
(3) calcium dobesilate has stronger bitterness, and palatability is poor.
Therefore, optimize the prescription of Calcium Dobsilate further, overcome Problems existing in research at present to become inventor's problem demanding prompt solution.
Summary of the invention
For current Calcium Dobsilate poor stability, and it is susceptible to the problem of variable color after being dispersed in water, discloses the phenolsulfonic acid calcium medicine compound of a kind of optimization, described phenolsulfonic acid calcium medicine compound is added with pH adjusting agent.
Preferably, described pH adjusting agent is one or more in citric acid, lactic acid, tartaric acid, malic acid, sodium citrate, potassium citrate.Wherein it is preferably citric acid.
Further, we also disclosed described pH adjusting agent and account for 0.01% ~ 40%(w/w of medicine total amount).
Further, we also disclosed described phenolsulfonic acid calcium medicine compound to be made up of calcium dobesilate, polyvinylpolypyrrolidone, microcrystalline Cellulose, lactose, magnesium stearate and pH adjusting agent.
Wherein, described polyvinylpolypyrrolidone accounts for 1% ~ 70%(w/w of medicine total amount).Described magnesium stearate accounts for 0.01% ~ 15%(w/w of medicine total amount).Described microcrystalline Cellulose accounts for 0.5% ~ 60%(w/w of medicine total amount).Described lactose accounts for 2% ~ 90%(w/w of medicine total amount).
In use, pH adjusting agent directly can be mixed with calcium dobesilate and acceptable excipient substance thereof.And prepare Calcium Dobsilate by pressed disc method further.
In the present invention, the preparation method we disclosing a kind of preferred phenolsulfonic acid calcium medicine compound, comprise the following steps:
(1) pH adjusting agent is crossed 80 mesh sieves, calcium dobesilate and other pharmaceutic adjuvants and all crosses 40 mesh sieves；
(2) by the polyvinylpolypyrrolidone of recipe quantity, microcrystalline Cellulose, lactose, magnesium stearate with equivalent progressively increase method mixing, obtain mixture A；
(3) by the pH adjusting agent of recipe quantity and mixture A mixing, mixture B is obtained；
(4) the phenolsulfonic acid calcium raw material drug of recipe quantity is progressively increased method and mixture B mixing with equivalent, obtain mixture C；
(5) magnesium stearate is added in mixture C, mixing, obtain phenolsulfonic acid calcium medicine compound.
Wherein, pH adjusting agent is one or more in citric acid, lactic acid, tartaric acid, malic acid, sodium citrate, potassium citrate.PH adjusting agent accounts for 0.01% ~ 40%(w/w of medicine total amount).Polyvinylpolypyrrolidone accounts for 1% ~ 70%(w/w of medicine total amount).Magnesium stearate accounts for 0.01% ~ 15%(w/w of medicine total amount).Microcrystalline Cellulose accounts for 0.5% ~ 60%(w/w of medicine total amount).Lactose accounts for 2% ~ 90%(w/w of medicine total amount).
Further, after we also disclosed prepared phenolsulfonic acid calcium medicine compound, also include step (5) and phenolsulfonic acid calcium medicine compound is adopted direct powder compression tabletting, obtain Calcium Dobsilate.
Adopt the pharmaceutical composition good stability of gained of the present invention.Pharmaceutical composition is adopted direct powder compression tabletting, prepared dispersible tablet stable in properties, be dispersed in the aqueous solution in water long-time (48 hours) place will not variable color, dispersible tablet is placed for a long time in form of tablets and color will not be occurred to change.Dispersible tablet good palatability disclosed in this invention, tablet surface are more smooth simultaneously, and dispersibility is higher simultaneously, in 2 minutes can disintegrate completely, when dilute hydrochloric acid solution, 5 minutes dissolutions reach more than 95%.
Technical scheme disclosed in this invention not only efficiently solves stability and the aqueous solution discoloration problem thereof that Calcium Dobsilate is placed for a long time, is also that the medicine with similarity provides a kind of stability raising thinking simultaneously.
Detailed description of the invention
For being further appreciated by the present invention, below in conjunction with implementing technical scheme disclosed in this invention is described in detail, protection scope of the present invention is not limited by the following examples.
Experimental technique described in following example, if no special instructions, is conventional method, involved reagent and material, if no special instructions, is the commercially available prod of commercial sources.
Embodiment 1
Prescription: calcium dobesilate 25g
Polyvinylpolypyrrolidone 9g
Microcrystalline Cellulose 2.25g
Lactose 7.325g
PH adjusting agent 1.2g
Magnesium stearate 0.225g
Make 100
Preparation technology: pH adjusting agent is crossed 80 mesh sieves, calcium dobesilate and other pharmaceutic adjuvants and all crosses 40 mesh sieves, by the polyvinylpolypyrrolidone of recipe quantity, microcrystalline Cellulose and lactose with equivalent progressively increase method mixing, the pH adjusting agent of recipe quantity is mixed with it, again calcium dobesilate and the above-mentioned powder mixed are progressively increased method mixing with equivalent, it is eventually adding magnesium stearate mixing, obtains phenolsulfonic acid calcium medicine compound.Determine tablet weight and hardness, adopt direct powder compression tabletting with this phenolsulfonic acid calcium medicine compound, obtain Calcium Dobsilate.
Discoloration is investigated: be dissolved in 100ml solution by gained phenolsulfonic acid calcium medicine compound 450mg, places 48h, has no color change.
Outward appearance: adopt Calcium Dobsilate prepared by direct powder compression to be white with the phenolsulfonic acid calcium medicine compound of this law gained, smooth surface morphology.
Dispersing uniformity: take prepared Calcium Dobsilate 6, be placed in jolting in 100ml pure water, in the pure water of 20 ± 1 DEG C, 1 point of whole disintegrate in 20 seconds also passes through No. 2 sieves.
Dissolution: taking this Calcium Dobsilate 6 with dilute hydrochloric acid for dissolution medium (Chinese Pharmacopoeia two annex Ⅹ C the second methods of version in 2010), the dissolution of 5 minutes is 96.4%.
Palatability: good.
Dispersible tablet tablet stability is investigated: at 40 ± 2 ° of C of temperature, when relative humidity 75 ± 5%, investigating 3 months, color does not change.
Embodiment 2
Prescription: calcium dobesilate 25g
Polyvinylpolypyrrolidone 9g
Microcrystalline Cellulose 2.25g
Lactose 7.525g
PH adjusting agent 1.0g
Magnesium stearate 0.225g
Make 100
Preparation technology: pH adjusting agent is crossed 80 mesh sieves, calcium dobesilate and other pharmaceutic adjuvants and all crosses 40 mesh sieves, by the polyvinylpolypyrrolidone of recipe quantity, microcrystalline Cellulose and lactose with equivalent progressively increase method mixing, the PH regulator of recipe quantity is mixed with it, again calcium dobesilate and the above-mentioned powder mixed are progressively increased method mixing with equivalent, it is eventually adding magnesium stearate mixing, obtains phenolsulfonic acid calcium medicine compound.Determine tablet weight and hardness, adopt direct powder compression tabletting with this phenolsulfonic acid calcium medicine compound, obtain Calcium Dobsilate.
Discoloration is investigated: be dissolved in 100ml solution by gained phenolsulfonic acid calcium medicine compound 450mg, places 48h, has no color change.
Outward appearance: adopt Calcium Dobsilate prepared by direct powder compression to be white with the phenolsulfonic acid calcium medicine compound of this law gained, smooth surface morphology.
Dispersing uniformity: take prepared Calcium Dobsilate 6, be placed in jolting in 100ml pure water, in the pure water of 20 ± 1 DEG C, 1 point of whole disintegrate in 30 seconds also passes through No. 2 sieves.
Dissolution: taking this Calcium Dobsilate 6 with dilute hydrochloric acid for dissolution medium (Chinese Pharmacopoeia two annex Ⅹ C the second methods of version in 2010), the dissolution of 5 minutes is 95.7%.
Palatability: good.
Dispersible tablet tablet stability is investigated: at 40 ± 2 ° of C of temperature, when relative humidity 75 ± 5%, investigating 3 months, color does not change.
Embodiment 3
Prescription: calcium dobesilate 25g
Polyvinylpolypyrrolidone 9g
Microcrystalline Cellulose 2.25g
Lactose 7.725g
PH adjusting agent 0.8g
Magnesium stearate 0.225g
Make 100
Preparation technology: pH adjusting agent is crossed 80 mesh sieves, calcium dobesilate and other pharmaceutic adjuvants and all crosses 40 mesh sieves, by the polyvinylpolypyrrolidone of recipe quantity, microcrystalline Cellulose and lactose with equivalent progressively increase method mixing, the pH adjusting agent of recipe quantity is mixed with it, again calcium dobesilate and the above-mentioned powder mixed are progressively increased method mixing with equivalent, it is eventually adding magnesium stearate mixing, obtains phenolsulfonic acid calcium medicine compound.Determine tablet weight and hardness, adopt direct powder compression with this phenolsulfonic acid calcium medicine compound, obtain Calcium Dobsilate.
Discoloration is investigated: be dissolved in 100ml solution by gained phenolsulfonic acid calcium medicine compound 450mg, places 48h, has no color change.
Outward appearance: adopt Calcium Dobsilate prepared by direct powder compression to be white with the phenolsulfonic acid calcium medicine compound of this law gained, smooth surface morphology.
Dispersing uniformity: take prepared Calcium Dobsilate 6, be placed in jolting in 100ml pure water, in the pure water of 20 ± 1 DEG C, 1 point of whole disintegrate in 20 seconds also passes through No. 2 sieves.
Dissolution: taking this Calcium Dobsilate 6 with dilute hydrochloric acid for dissolution medium (Chinese Pharmacopoeia two annex Ⅹ C the second methods of version in 2010), the dissolution of 5 minutes is 97.0%.
Palatability: good.
Dispersible tablet tablet stability is investigated: at 40 ± 2 ° of C of temperature, when relative humidity 75 ± 5%, investigating 3 months, color does not change.
Embodiment 4
Prescription: calcium dobesilate 25g
Polyvinylpolypyrrolidone 9g
Microcrystalline Cellulose 2.25g
Lactose 7.925g
PH adjusting agent 0.6g
Magnesium stearate 0.225g
Make 100
Preparation technology: pH adjusting agent is crossed 80 mesh sieves, calcium dobesilate and other pharmaceutic adjuvants and all crosses 40 mesh sieves, by the polyvinylpolypyrrolidone of recipe quantity, microcrystalline Cellulose and lactose with equivalent progressively increase method mixing, the pH adjusting agent of recipe quantity is mixed with it, again calcium dobesilate and the above-mentioned powder mixed are being progressively increased method mixing with equivalent, it is eventually adding magnesium stearate mixing, obtains phenolsulfonic acid calcium medicine compound.Determine tablet weight and hardness, adopt direct powder compression with this phenolsulfonic acid calcium medicine compound, obtain Calcium Dobsilate.
Discoloration is investigated: be dissolved in 100ml solution by gained phenolsulfonic acid calcium medicine compound 450mg, places 48h, has no color change.
Outward appearance: adopt Calcium Dobsilate prepared by direct powder compression to be white with the phenolsulfonic acid calcium medicine compound of this law gained, smooth surface morphology.
Dispersing uniformity: take prepared Calcium Dobsilate 6, be placed in jolting in 100ml pure water, in the pure water of 20 ± 1 DEG C, 1 point of whole disintegrate in 35 seconds also passes through No. 2 sieves.
Dissolution: taking this Calcium Dobsilate 6 with dilute hydrochloric acid for dissolution medium (Chinese Pharmacopoeia two annex Ⅹ C the second methods of version in 2010), the dissolution of 5 minutes is 96.2%.
Palatability: good.
Dispersible tablet tablet stability is investigated: at 40 ± 2 ° of C of temperature, when relative humidity 75 ± 5%, investigating 3 months, color does not change.
Embodiment 5
Prescription: calcium dobesilate 25g
Polyvinylpolypyrrolidone 9g
Microcrystalline Cellulose 2.25g
Lactose 8.125g
PH adjusting agent 0.4g
Magnesium stearate 0.225g
Make 100
Preparation technology: pH adjusting agent is crossed 80 mesh sieves, calcium dobesilate and other pharmaceutic adjuvants and all crosses 40 mesh sieves, by the polyvinylpolypyrrolidone of recipe quantity, microcrystalline Cellulose and lactose with equivalent progressively increase method mixing, the pH adjusting agent of recipe quantity is mixed with it, again calcium dobesilate and the above-mentioned powder mixed are being progressively increased method mixing with equivalent, it is eventually adding magnesium stearate mixing, obtains phenolsulfonic acid calcium medicine compound.Determine tablet weight and hardness, adopt direct powder compression with this phenolsulfonic acid calcium medicine compound, obtain Calcium Dobsilate.
Discoloration is investigated: be dissolved in 100ml solution by gained phenolsulfonic acid calcium medicine compound 450mg, places 48h, has no color change.
Outward appearance: adopt Calcium Dobsilate prepared by direct powder compression to be white with the phenolsulfonic acid calcium medicine compound of this law gained, smooth surface morphology.
Dispersing uniformity: take prepared Calcium Dobsilate 6, be placed in jolting in 100ml pure water, in the pure water of 20 ± 1 DEG C, 1 point of whole disintegrate in 25 seconds also passes through No. 2 sieves.
Dissolution: taking this Calcium Dobsilate 6 with dilute hydrochloric acid for dissolution medium (Chinese Pharmacopoeia two annex Ⅹ C the second methods of version in 2010), the dissolution of 5 minutes is 96.7%.
Palatability: good.
Dispersible tablet tablet stability is investigated: at 40 ± 2 ° of C of temperature, when relative humidity 75 ± 5%, investigating 3 months, color does not change.
Embodiment 6
According to the preparation method in embodiment 1, choose one or more mixture in citric acid, lactic acid, tartaric acid, malic acid, sodium citrate, potassium citrate respectively as pH adjusting agent, prepare Calcium Dobsilate, and it is carried out tablet stability investigation.
Method:
Study on the stability is carried out according to " chemicals stability study technological guidance's principle ", test sample is respectively at 60 DEG C, RH95 ± 5%, place 10 days when 4500 ± 500Lx, in 0,5,10 days taking sample determinations, detecting by stability high spot reviews project (character, content and have related substance), result is in Table 1.
Table 1 Calcium Dobsilate study on the stability result
Comparative example 1
Existing phenolsulfonic acid dispersible tablet is prepared according to the method disclosed in patent CN201210565167.3.Tablet surface is relatively smooth but tablet mealiness is bigger.
Approach is bought, it is thus achieved that calcium dobesilate tablet and capsule by market.
Modified model Calcium Dobsilate is obtained according to the mode in the embodiment of the present invention 1.Tablet surface unusual light, tablet mealiness is little.
Respectively the existing Calcium Dobsilate of 450mg, modified model Calcium Dobsilate are dissolved in 100mL water, observe solution changes color situation, variable color is there is when finding existing Calcium Dobsilate 30 minutes, solution becomes rufous, and modified model Calcium Dobsilate disclosed in this invention discoloration did not occur in 48 hours.
Respectively by existing Calcium Dobsilate, modified model Calcium Dobsilate and calcium dobesilate tablet when room temperature, normal pressure, traditional humidity, carry out study on the stability, find that existing Calcium Dobsilate and calcium dobesilate tablet all have discoloration, modified model Calcium Dobsilate stability is high, it does not have discoloration.
According to the mode in embodiment 1 ~ 5, investigate existing Calcium Dobsilate, modified model Calcium Dobsilate and commercially available calcium dobesilate tablet and capsule disintegrative in water respectively, the whole disintegrate of modified model benzenesulfonic acid calcium dispersible tablet needs 2 minutes, the whole disintegrate of existing Calcium Dobsilate needs 2 points 45 seconds, and existing tablet and the whole disintegrate of capsule need 15 minutes.
According to the mode in embodiment 1 ~ 5, investigate the dissolution having Calcium Dobsilate, modified model Calcium Dobsilate and commercially available calcium dobesilate tablet and capsule respectively, with dilute hydrochloric acid solution for dissolution medium, investigate dissolution when its 5 minutes, the dissolution of modified model Calcium Dobsilate is more than 95%, the dissolution of existing Calcium Dobsilate is about 90%, existing tablet and capsule dissolution are non-normally low, continue to extend dissolution time, when dissolution time is 15 minutes, dissolution is only about 80%.
Claims (10)
1. a phenolsulfonic acid calcium medicine compound, is characterized in that, is added with pH adjusting agent in described phenolsulfonic acid calcium medicine compound.
2. phenolsulfonic acid calcium medicine compound according to claim 1, is characterized in that, described pH adjusting agent is one or more in citric acid, lactic acid, tartaric acid, malic acid, sodium citrate, potassium citrate.
3. phenolsulfonic acid calcium medicine compound according to claim 1, is characterized in that, described pH adjusting agent accounts for 0.01% ~ 40%(w/w of medicine total amount).
4. the phenolsulfonic acid calcium medicine compound according to any one in claim 1 ~ 3, is characterized in that, described phenolsulfonic acid calcium medicine compound is made up of calcium dobesilate, polyvinylpolypyrrolidone, microcrystalline Cellulose, lactose, magnesium stearate and pH adjusting agent.
5. phenolsulfonic acid calcium medicine compound according to claim 4, is characterized in that, described polyvinylpolypyrrolidone accounts for 1% ~ 70%(w/w of medicine total amount).
6. phenolsulfonic acid calcium medicine compound according to claim 4, is characterized in that, described magnesium stearate accounts for 0.01% ~ 15%(w/w of medicine total amount).
7. phenolsulfonic acid calcium medicine compound according to claim 4, is characterized in that, described microcrystalline Cellulose accounts for 0.5% ~ 60%(w/w of medicine total amount).
8. phenolsulfonic acid calcium medicine compound according to claim 4, is characterized in that, described lactose accounts for 2% ~ 90%(w/w of medicine total amount).
9. a preparation method for phenolsulfonic acid calcium medicine compound described in any one in claim 1 ~ 8, is characterized in that, comprise the following steps:
(1) pH adjusting agent is crossed 80 mesh sieves, calcium dobesilate and other pharmaceutic adjuvants and all crosses 40 mesh sieves；
(2) by the polyvinylpolypyrrolidone of recipe quantity, microcrystalline Cellulose, lactose, magnesium stearate with equivalent progressively increase method mixing, obtain mixture A；
(3) by the pH adjusting agent of recipe quantity and mixture A mixing, mixture B is obtained；
(4) the phenolsulfonic acid calcium raw material drug of recipe quantity is progressively increased method and mixture B mixing with equivalent, obtain mixture C；
(5) magnesium stearate is added in mixture C, mixing, obtain phenolsulfonic acid calcium medicine compound.
10. the preparation method of phenolsulfonic acid calcium medicine compound according to claim 9, is characterized in that, also includes step (5) and phenolsulfonic acid calcium medicine compound is adopted direct powder compression tabletting, obtain Calcium Dobsilate.
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| CN201410844894.2A CN105796513A (en) | 2014-12-31 | 2014-12-31 | Calcium dobesilate pharmaceutical composition |
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| CN201410844894.2A CN105796513A (en) | 2014-12-31 | 2014-12-31 | Calcium dobesilate pharmaceutical composition |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101062011A (en) * | 2006-04-30 | 2007-10-31 | 沈阳市兴齐制药有限责任公司 | Calcium dobesilate injection |
| CN102219715A (en) * | 2011-04-26 | 2011-10-19 | 北京振东光明药物研究院有限公司 | Method for preparing medicinal high-purity calcium dobesilate |
| CN103877038A (en) * | 2012-12-24 | 2014-06-25 | 江苏万邦生化医药股份有限公司 | Calcium dobesilate dispersible tablet and preparation method thereof |
-
2014
- 2014-12-31 CN CN201410844894.2A patent/CN105796513A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101062011A (en) * | 2006-04-30 | 2007-10-31 | 沈阳市兴齐制药有限责任公司 | Calcium dobesilate injection |
| CN102219715A (en) * | 2011-04-26 | 2011-10-19 | 北京振东光明药物研究院有限公司 | Method for preparing medicinal high-purity calcium dobesilate |
| CN103877038A (en) * | 2012-12-24 | 2014-06-25 | 江苏万邦生化医药股份有限公司 | Calcium dobesilate dispersible tablet and preparation method thereof |
Non-Patent Citations (2)
| Title |
|---|
| 国家药典委员会: "《中华人民共和国药典 2010年版 二部》", 31 January 2010, 中国医药科技出版社 * |
| 陈冠荣等: "《化工百科全书 第1卷》", 31 December 1990, 化学工业出版社 * |
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Application publication date: 20160727 |