CN102579396A - Calcium dobesilate capsule composition - Google Patents
Calcium dobesilate capsule composition Download PDFInfo
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- CN102579396A CN102579396A CN2012100934746A CN201210093474A CN102579396A CN 102579396 A CN102579396 A CN 102579396A CN 2012100934746 A CN2012100934746 A CN 2012100934746A CN 201210093474 A CN201210093474 A CN 201210093474A CN 102579396 A CN102579396 A CN 102579396A
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Abstract
The invention relates to a calcium dobesilate capsule composition, which comprises calcium dobesilate serving as an active ingredient, a filling agent and a lubricating agent, wherein the filling agent is microcrystalline cellulose preferably, the lubricating agent is a mixture of silicon dioxide and atoleine, and a weight ratio of the silicon dioxide to the atoleine is (1:1)-(1:3). According to the calcium dobesilate capsule composition, by optimizing a formula and a process, the problem of poor stability during long-term storage is solved well to ensure the quality of medicines.
Description
Technical field
The present invention relates to a kind of compositions of calcium hydrophenyl sulfonate capsule, the pharmaceutical preparation, the prescription that are specifically related to calcium dobesilate are formed and method for preparing.
Background technology
Calcium dobesilate (calcium dobesilate) chemistry is called 2, and 5-dihydroxy benzenes sulfonic acid calcium monohydrate is a kind of blood capillary protection medicine of chemosynthesis, draws Rand Corporation to develop by the Switzerland Supreme Being.This medicine was written into " European Pharmacopoeia " in 1997, be written into " British Pharmacopoeia " in 1998, and introduce to the market June calendar year 2001 at home.Abroad from the seventies in last century calcium dobesilate just be used to treat diabetes and because varicosis, hemorrhoid, myocardial infarction and the pruritic dermatitis that microcirculation disturbance causes.In the higher area of living standard, aged people take for microcirculation improvement for a long time, are acknowledged as unique matured product of prevention and treatment microcirculation dysfunction, particularly diabetic renal papillary necrosis.
Research shows that calcium dobesilate can reduce the wall of micrangium permeability, builds up one's resistance to disease; Improve lymph fluid and reflux, reduce edema; Blood viscosity lowering is corrected albumins/globulins ratio, reduces hematoblastic high aggregation, thus the thrombosis of preventing, and improve the erythrocyte pliability.Also can suppress the high penetration effect that vaso-active substance causes blood capillary, reduce the tunica intima damage, improve the biosynthesis of basement membrane collagen.In addition, calcium dobesilate has tangible improvement effect to the microcirculation disturbance function.Can strengthen the activity of trunk and CMEC nitric oxide synthetase, the capillary permeability of antagonistic activity oxygen clusters changes, thus the protection blood vessel; Can suppress macrophage activating factor, obviously reduce the macrophage adhesion thereby have antiinflammatory action.
The present market orientation of calcium dobesilate is main with diabetic renal papillary necrosis mainly; But it is as a kind of novel vascular protective agent, can also prevent and treat the multiple disease that caused by blood capillary circulatory disturbance like the heart that (1) microcirculation disturbance causes, brain, kidney disease (myocardial infarction, angina pectoris, thrombus sequela, atherosclerosis of renal glomerulus etc.); (2) blood viscosity lowering; (3) prevention microthrombusis; (4) numb limbs and tense tendons, ice-cold, the pain of trick, diseases such as skin pruritus; (5) varicosis syndrome etc.Along with to the deepening continuously of diabetes and chronic complicating diseases thereof and the ischemic heart, cerebrovascular disease study on prevention, this medicine has wide application prospect.
Calcium dobesilate is widely used clinically at present, and a large amount of clinical practices show that calcium dobesilate is long-acting, effective and safe drug, has special pharmacological action and therapeutic effect clinically.But in the existing calcium hydrophenyl sulfonate capsule method for preparing of existing market, all use a certain amount of disintegrating agent to reach the complete stripping of calcium dobesilate, and the disintegrating agent majority has and draw moistly, be unfavorable for the long-term storage of calcium hydrophenyl sulfonate capsule.Owing to there is above problem, make the long-time stability of calcium hydrophenyl sulfonate capsule can not get bigger improvement, be unfavorable for the storage and the use of product.
Summary of the invention
Be prone to the shortcoming of moisture absorption when overcoming calcium hydrophenyl sulfonate capsule long-time stability poor stability and long term store, the invention provides a kind of prescription and method for preparing of calcium hydrophenyl sulfonate capsule.
Contain 2 phenolic hydroxyl groups in the molecular structure of calcium hydrophenyl sulfonate capsule; Determine it to have and drawn chemical property such as moist, photo-labile property and easy oxidation; The present invention is through the optimization to prescription and technology; Well solved the problem of its poor stability when long term store, guaranteed the quality of medicine with this.In the present invention, we are with the disintegrating agent of widespread usage in the alternative present calcium hydrophenyl sulfonate capsule of the microcrystalline Cellulose that is difficult for moisture absorption, and it is moist to reduce drawing of calcium hydrophenyl sulfonate capsule; In lubricant; Through screening to lubricant; We have selected with silicon dioxide and liquid paraffin, with a certain proportion of proportioning, can obviously improve the flowability of medicine; And because liquid paraffin itself possesses the effect of isolated medicine moisture absorption, so silicon dioxide and liquid paraffin are used the stability that can obviously improve medicine.
Calcium hydrophenyl sulfonate capsule provided by the invention, its technology is simple, easy to operate, good reproducibility, and sample quality is stable, is applicable to the big production of industrialization.
The present invention provides a kind of calcium hydrophenyl sulfonate capsule compositions, and said composition comprises: with composition weight meter, 60%～90% calcium dobesilate is as active component, 5%～40% filler, 0.2%～10% lubricant.
The present invention provides a kind of compositions of calcium hydrophenyl sulfonate capsule, and wherein with composition weight meter, said active component phenolsulfonic acid calcium content is 65%～85%.
The present invention provides a kind of compositions of calcium hydrophenyl sulfonate capsule; Said filler is a kind of, two or more the compositions in microcrystalline Cellulose, lactose, pregelatinized Starch, starch, dextrin or the mannitol; Preferably microcrystalline cellulose wherein; With composition weight meter, the content of said filler is 5%～30%.
The present invention provides a kind of compositions of calcium hydrophenyl sulfonate capsule; Said lubricant is a kind of, two or more the compositions in Pulvis Talci, silicon dioxide, magnesium stearate, liquid paraffin or the hard alcohol fumaric acid sodium; Wherein preferred silicon dioxide and liquid paraffin; The more preferably weight ratio 1: 1～1: 3 of silicon dioxide and liquid paraffin, with composition weight meter, the content of said lubricant is 0.2%～5%.
The present invention provides a kind of preparation of compositions method of calcium hydrophenyl sulfonate capsule, comprises the steps:
1) calcium dobesilate was pulverized 80 mesh sieves, microcrystalline Cellulose is crossed 80 mesh sieves;
2) take by weighing recipe quantity calcium dobesilate and filler, mixing;
3) be wetting agent system soft material with 45% ethanol, cross 28 mesh sieves and granulate that wet granular is dry under 80 ℃ of conditions, takes out dried particles;
4) add the recipe quantity lubricant, mix homogeneously is crossed 28 mesh sieve granulate, adorns capsule No. 0.
Calcium hydrophenyl sulfonate capsule compositions of the present invention, it is characterized in that being applicable to diabetic microangiopathy, non-diabetic microangiopathies, varicosis syndrome, with microcirculation disturbance occur together impaired function of vein, vein is peeled off and the treatment of venosclerosis and auxiliary treatment.
The invention optimized technical scheme is:
A kind of calcium hydrophenyl sulfonate capsule compositions; Said composition comprises: with composition weight meter; 60%～90% calcium dobesilate is as active component; 5%～40% microcrystalline Cellulose, 0.2%～10% silicon dioxide and liquid paraffin, the wherein weight ratio 1: 1～1: 3 of silicon dioxide and liquid paraffin.
A kind of calcium hydrophenyl sulfonate capsule compositions provided by the invention, it is characterized in that being applicable to diabetic microangiopathy, non-diabetic microangiopathies, varicosis syndrome, with microcirculation disturbance occur together impaired function of vein, vein is peeled off and the treatment of venosclerosis and auxiliary treatment.
The present composition through the screening to adjuvant in the prescription, is selected the proper supplementary material composition in prescription is formed, make medicine can not cause degraded because of moisture absorption.In at present general calcium hydrophenyl sulfonate capsule prescription is formed, used disintegrating agent, in conjunction with the patent prescription, we have carried out the hygroscopicity experiment to disintegrating agent commonly used and filler more, and experimental result is seen table 1.
Table 1 hygroscopicity comparing result
At granted patent " calcium hydrophenyl sulfonate capsule and preparation technology " (publication number: CN100377705C); Do not use filler in the optimizing prescriptions; And select with carboxymethyl starch sodium as disintegrating agent, and lubricant has been selected the wych-elm acid glyceride in the prescription, in granted patent, has mentioned the wych-elm acid glyceride to be beneficial to capsular compressibility; But the wych-elm acid glyceride does not have remarkable improvement to product moisture absorption aspect, product stability is not had significantly improve.
(publication number: CN102091055), used disintegrating agent cross-linking sodium carboxymethyl cellulose and magnesium stearate lubricant in the optimizing prescriptions, cross-linking sodium carboxymethyl cellulose can cause the moisture absorption in the product long term store process in publication " a kind of calcium hydrophenyl sulfonate capsule and preparation method thereof "; It is inhomogeneous that magnesium stearate can cause product to mix; (see granted patent " calcium hydrophenyl sulfonate capsule and preparation technology " (publication number: CN100377705C)) for details, optimizing prescriptions does not have the stability of calcium hydrophenyl sulfonate capsule and significantly improves, and the production technology aspect has adopted fluidization to influence dissolution of product etc.; Need just can obtain stable prod through preparation repeatedly; Be unfavorable for industrialized great production, be prone to produce waste in the production process, and; This publication is in order better to solve the dissolution of calcium hydrophenyl sulfonate capsule; But be prone to soluble drug because calcium dobesilate is a water, on prescription and technology, select the adjuvant and the equipment of complicacy, costliness in a large number for use, be unfavorable for the popularization on a large scale of product.
And the present invention finds when selecting specific filler and lubricant through a large amount of experiments and screening, can obviously improve the stability of medicine, and result of extraction is good.
Description of drawings
Fig. 1 embodiment one and the stripping curve of Comparative Examples one sample in the 900ml0.1mol/L hydrochloric acid solution
Comparative Examples
Embodiment one
Through embodiment the present invention is described further below.
Embodiment one
Prescription:
Technology:
1, calcium dobesilate was pulverized 80 mesh sieves, microcrystalline Cellulose is crossed 80 mesh sieves;
2, take by weighing recipe quantity calcium dobesilate and microcrystalline Cellulose, mixing;
3, be wetting agent system soft material with 45% ethanol, cross 28 mesh sieves and granulate that wet granular is dry under 80 ℃ of conditions, takes out dried particles;
4, add recipe quantity liquid paraffin and silicon dioxide, mix homogeneously is crossed 28 mesh sieve granulate, adorns capsule No. 0.
Embodiment two
Technology:
1, calcium dobesilate was pulverized 80 mesh sieves, microcrystalline Cellulose is crossed 80 mesh sieves;
2, take by weighing recipe quantity calcium dobesilate and microcrystalline Cellulose, mixing;
3, be wetting agent system soft material with 45% ethanol, cross 28 mesh sieves and granulate that wet granular is dry under 80 ℃ of conditions, takes out dried particles;
4, add recipe quantity liquid paraffin and silicon dioxide, mix homogeneously is crossed 28 mesh sieve granulate, adorns capsule No. 0.
Embodiment three
Preparation technology:
1) calcium dobesilate was pulverized 80 mesh sieves, filler is crossed 80 mesh sieves;
2) take by weighing recipe quantity calcium dobesilate and microcrystalline Cellulose, lactose, mixing;
3) be wetting agent system soft material with 45% ethanol, cross 28 mesh sieves and granulate that wet granular is dry under 80 ℃ of conditions, takes out dried particles;
4) add recipe quantity silicon dioxide and liquid paraffin, mix homogeneously is crossed 28 mesh sieve granulate, adorns capsule No. 0.
Embodiment four
Preparation technology:
1) calcium dobesilate was pulverized 80 mesh sieves, filler is crossed 80 mesh sieves;
2) take by weighing recipe quantity calcium dobesilate and microcrystalline Cellulose, lactose mixing;
3) be wetting agent system soft material with 45% ethanol, cross 28 mesh sieves and granulate that wet granular is dry under 80 ℃ of conditions, takes out dried particles;
4) add recipe quantity silicon dioxide, mix homogeneously is crossed 28 mesh sieve granulate, adorns capsule No. 0.
Embodiment five
A kind of calcium hydrophenyl sulfonate capsule compositions, said composition comprises: with composition weight meter,
Preparation technology:
1) calcium dobesilate was pulverized 80 mesh sieves, filler is crossed 80 mesh sieves;
2) take by weighing recipe quantity calcium dobesilate and microcrystalline Cellulose, lactose mixing;
3) be wetting agent system soft material with 45% ethanol, cross 28 mesh sieves and granulate that wet granular is dry under 80 ℃ of conditions, takes out dried particles;
4) add the recipe quantity magnesium stearate, mix homogeneously is crossed 28 mesh sieve granulate, adorns capsule No. 0.
Comparative Examples one (prior art publication number: the technical scheme of putting down in writing among the CN100377705C)
Prescription:
Technology:
1, former, adjuvant were pulverized 100 mesh sieves, subsequent use;
2, the phenolsulfonic acid calcium raw material drug is dropped into the high speed wet granulator and open stirring at low speed 1min, 120 rev/mins, add 95% alcohol granulation, stirring at low speed 3min, 120 rev/mins;
3,60～65 ℃ of aeration-dryings, 16 mesh sieve granulate;
4, add recipe quantity carboxymethyl starch sodium, wych-elm acid glyceride, mix 50 and changeed sampling and measuring intermediate content and moisture 15 minutes.
5, capsule is filled.
Select for use embodiment one sample and Comparative Examples one sample to carry out stability test and dissolution investigation, can aspect stable, describe product.Test method is following:
(1) get embodiment one sample and Comparative Examples one sample, in 60 ℃ of high temperature, 40 ℃, RH75%, RH92.5% and intensity of illumination 4500Lx ± 500Lx condition held, respectively at sampling in 5 days, 10 days, detect, and compared with 0 day, result of the test is seen table 2-table 7.
(2) get embodiment one sample and Comparative Examples one sample and carry out the dissolution investigation according to the calcium hydrophenyl sulfonate capsule national drug standards; Respectively at 5min, 10min, 20min, 30min, 45min, the 60min 5ml that takes a sample; Replenish synthermal dissolution medium simultaneously with volume; Filter, get subsequent filtrate as need testing solution.Measure according to method under the dissolution determination item, and draw stripping curve, see Fig. 1 with time and dissolution.
Table 2 embodiment one self-control calcium hydrophenyl sulfonate capsule influence factor result of the test
Table 3 embodiment two self-control calcium hydrophenyl sulfonate capsule influence factor result of the tests
Table 4 embodiment three self-control calcium hydrophenyl sulfonate capsule influence factor result of the tests
Table 5 embodiment four selfs system calcium hydrophenyl sulfonate capsule influence factor result of the test
Table 6 embodiment five self-control calcium hydrophenyl sulfonate capsule influence factor result of the tests
Table 7 Comparative Examples one self-control calcium hydrophenyl sulfonate capsule influence factor result of the test
The dissolution in 0.1mol/L hydrochloric acid of comparison as a result through embodiment 1-5 and Comparative Examples 1 does not have significant difference.
Study on the stability through above embodiment 1-5 and Comparative Examples 1 can be known: 1, embodiment 1～5 sample has good stability under high temperature, high humidity, illumination condition, compares with Comparative Examples 1, and its related substance and moisture absorption weightening finish all are better than Comparative Examples; 2,, when not adopting the higher disintegrating agent of hygroscopicity, can better solve the moisture absorption under the product long term store condition, and obviously improve stability through the prescription proportioning among the embodiment; 3, in an embodiment, when using silicon dioxide and liquid paraffin mixture as lubricant, when using silicon dioxide or other lubricants more separately, stability is better.
Claims (7)
1. calcium hydrophenyl sulfonate capsule compositions, said composition comprises: with composition weight meter, 60%～90% calcium dobesilate is as active component, 5%～40% filler, 0.2%～10% lubricant.
2. compositions according to claim 1, wherein with composition weight meter, said active component phenolsulfonic acid calcium content is 65%～85%.
3. compositions according to claim 1; Said filler is a kind of, two or more the compositions in microcrystalline Cellulose, lactose, pregelatinized Starch, starch, dextrin or the mannitol; Preferably microcrystalline cellulose wherein; With composition weight meter, the content of said filler is 5%～30%.
4. compositions according to claim 1; Said lubricant is a kind of, two or more the compositions in Pulvis Talci, silicon dioxide, magnesium stearate, liquid paraffin or the hard alcohol fumaric acid sodium; Wherein preferred silicon dioxide and liquid paraffin; The more preferably weight ratio 1: 1～1: 3 of silicon dioxide and liquid paraffin, with composition weight meter, the content of said lubricant is 0.2%～5%.
5. compositions according to claim 1; Said composition comprises: with composition weight meter; 60%～90% calcium dobesilate is as active component; 5%～40% microcrystalline Cellulose, 0.2%～10% silicon dioxide and liquid paraffin, the wherein weight ratio 1: 1～1: 3 of silicon dioxide and liquid paraffin.
6. one kind prepares the said method for compositions of claim 1, comprises the steps:
1) calcium dobesilate was pulverized 80 mesh sieves, microcrystalline Cellulose is crossed 80 mesh sieves;
2) take by weighing recipe quantity calcium dobesilate and filler, mixing;
3) be wetting agent system soft material with 45% ethanol, cross 28 mesh sieves and granulate that wet granular is dry under 80 ℃ of conditions, takes out dried particles;
4) add the recipe quantity lubricant, mix homogeneously is crossed 28 mesh sieve granulate, adorns capsule No. 0.
7. calcium hydrophenyl sulfonate capsule compositions according to claim 1, it is characterized in that being applicable to diabetic microangiopathy, non-diabetic microangiopathies, varicosis syndrome, with microcirculation disturbance occur together impaired function of vein, vein is peeled off and the treatment of venosclerosis and auxiliary treatment.
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| CN 201210093474 CN102579396B (en) | 2012-04-01 | 2012-04-01 | Calcium dobesilate capsule composition |
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| CN 201210093474 CN102579396B (en) | 2012-04-01 | 2012-04-01 | Calcium dobesilate capsule composition |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103230383A (en) * | 2013-03-31 | 2013-08-07 | 北京万全阳光医学技术有限公司 | Calcium dobesilate capsule composition and preparation method thereof |
| CN106619564A (en) * | 2016-12-23 | 2017-05-10 | 北京满格医药科技有限公司 | Calcium dobesilate capsule and preparation method |
| CN110123776A (en) * | 2019-05-17 | 2019-08-16 | 贵州天安药业股份有限公司 | A kind of calcium hydrophenyl sulfonate capsule that efficient microcirculation improves |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1771927A (en) * | 2005-11-03 | 2006-05-17 | 上海复星朝晖药业有限公司 | Calcium hydrophenyl sulfonate capsule and its prepn process |
| CN1939291A (en) * | 2006-09-29 | 2007-04-04 | 何岩 | Hydroxyphenyl sulfonated calcium slow-releasing preparation |
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2012
- 2012-04-01 CN CN 201210093474 patent/CN102579396B/en not_active Expired - Fee Related
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1771927A (en) * | 2005-11-03 | 2006-05-17 | 上海复星朝晖药业有限公司 | Calcium hydrophenyl sulfonate capsule and its prepn process |
| CN1939291A (en) * | 2006-09-29 | 2007-04-04 | 何岩 | Hydroxyphenyl sulfonated calcium slow-releasing preparation |
Non-Patent Citations (1)
| Title |
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| 刘辉等: "预胶化淀粉对羟苯磺酸钙胶囊溶出度的影响", 《中国药房》 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103230383A (en) * | 2013-03-31 | 2013-08-07 | 北京万全阳光医学技术有限公司 | Calcium dobesilate capsule composition and preparation method thereof |
| CN106619564A (en) * | 2016-12-23 | 2017-05-10 | 北京满格医药科技有限公司 | Calcium dobesilate capsule and preparation method |
| CN110123776A (en) * | 2019-05-17 | 2019-08-16 | 贵州天安药业股份有限公司 | A kind of calcium hydrophenyl sulfonate capsule that efficient microcirculation improves |
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| CN102579396B (en) | 2013-12-25 |
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Address after: 750002 the Ningxia Hui Autonomous Region street, Jinfeng District, Yinchuan City Fu Ning Lane No. 57 Patentee after: Ningxia Kang Ya pharmaceutical Limited by Share Ltd Address before: 750002 No. 6 road, hi tech Industrial Development Zone, the Ningxia Hui Autonomous Region, Yinchuan Patentee before: Kangya Pharmaceutical Industry Co., Ltd., Ningxia |
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