CN101176724A - Oxymatrine or matrine sustained-release pellet and preparation method thereof - Google Patents
Oxymatrine or matrine sustained-release pellet and preparation method thereof Download PDFInfo
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- CN101176724A CN101176724A CNA2007101586693A CN200710158669A CN101176724A CN 101176724 A CN101176724 A CN 101176724A CN A2007101586693 A CNA2007101586693 A CN A2007101586693A CN 200710158669 A CN200710158669 A CN 200710158669A CN 101176724 A CN101176724 A CN 101176724A
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Abstract
The invention discloses an oxymatrine sustained-release pellet, a matrine sustained-release pellet and a preparation method of the sustained-release pellets, belonging to the medicine technical field. The invention is characterized in that: the sustained-release preparation mainly comprises a oxymatrine or a matrine, a blank pill core, a coating material, a surface-active material, a hydroxypropyl methylcellulose, an antisticking agent and a plasticizing agent; the weight ratios are 10 to 70 percent for the oxymatrine or the matrine, 20 to 85 percent for the blank pill core, 2 to 20 percent for the coating material, 0.01 to 1 percent for the surface-active material, 1 to 3 percent for the adhesive, 1 to 5 percent for the antisticking agent and 0 to 1.5 percent for the plasticizing agent. The invention is reposefully released in different medium from the experiment results in vitro, and has the advantages of smooth blood concentration of drug in vivo, small side effect, few medication time and long duration of drug effect.
Description
Technical field
The invention belongs to medical technical field, relate to kurarinone or matrine sustained-release pellet and preparation technology thereof.
Background technology
Kurarinone (oxymatrine) is the effective ingredient that extracts by in Chinese medicine Herba Sophorae alopecuroidis (Sophora alopecuroides L) or the Radix Sophorae Flavescentis (Sophora flavescens Ait), wherein oxymatrine (Oxymatrine) content is more than 98%, pharmacology and clinical research show that it has antitumor, antibiotic, antiviral, improves liver function and prevent effects such as hepatic fibrosis, transaminase lowering, human body immunity improving power.At present, kurarinone has been confirmed as treating the viral hepatitis emphasis and has promoted the engineering medicine, it can obviously suppress hepatitis B virus infection, detect through gene quantification, use after the kurarinone, the hepatitis B virus duplication level obviously descends in the infected cell, and this shows that this medical instrument has the effect that suppresses the viral growth breeding.This medicine has promotional value widely under China's applied economics level, market prospect is very good.At present the preparation of kurarinone mainly contains injection, transfusion, quick-release capsules and tablet, and prior dosage form can not be fit to needs clinically far away, exploitation once-a-day or twice slow releasing preparation meet the needs of medical market.
Matrine (matrine) is to separate the alkaloid that obtains from cassia leguminous plant Herba Sophorae alopecuroidis radix sophorae, has effects such as antitumor, arrhythmia, antiinflammatory, obtains good efficacy in the treatment of viral myocarditis.At present the preparation of matrine mainly contains injection, transfusion, quick-release capsules and suppository, and prior dosage form can not be fit to needs clinically far away, exploitation once-a-day or twice slow releasing preparation meet the needs of medical market.
Kurarinone and matrine water dissolubility are fabulous, are not easy to control rate of releasing drug, and long-time steadily release of control medicine is its main difficulty, are that the difference between product is criticized and criticized is big on the other hand, are difficult for carrying out industrialized great production.
Summary of the invention
The object of the present invention is to provide two kinds of micropills with slow-release function, slow-release micro-pill can effectively be kept more than 12 hours in vitro tests, compare with prior dosage form, can better control the rate of release of medicament, can prolong this medicine keeping in blood in human body in medicine valid density, reduce the peak valley phenomenon of blood drug level, alleviated the toxicity of medicine, improved the therapeutic effect of this medicine.
Kurarinone of the present invention or matrine sustained-release pellet, contain following component (following all be weight percentage):
Kurarinone or matrine 10%-75%
Celphere 20%-85%
Surfactant 0.01%-1%
Antiplastering aid 1%-5%
Plasticizer 0-1.5%
Above-mentioned each component consists of celphere, medicated layer, confining bed, sustained-release coating layer from inside to outside.
Wherein medicated layer is made up of following component
Kurarinone or matrine 95%-99%
Wherein confining bed is made up of hydroxypropyl emthylcellulose.
Wherein sustained-release coating layer is made up of following component:
Coating material 60%-95%
Surfactant 0.1%-1%
Antiplastering aid 4%-35%
Plasticizer 0-20%
Wherein celphere is made by microcrystalline Cellulose, is perhaps mixed by 20%-80% starch and 20%-80% sucrose.Surfactant is a sodium lauryl sulphate, hydroxypropyl emthylcellulose, polyvinylpyrrolidone, hexadecanol, monovalence ammonium soaps or their mixture.Binding agent is a water, and/or hydroxypropyl emthylcellulose.Antiplastering aid is Pulvis Talci or Kaolin, and plasticizer is Polyethylene Glycol, triethyl citrate, dibutyl sebacate, diethyl phthalate, acetic acid monoglyceride, tributyl citrate, Oleum Ricini, triacetyl glycerine, cochin oil, oleic acid or their mixture.Coating material is acrylic resin aqueous dispersion or Aquacoat.The acrylic resin aqueous dispersion is selected from Eudragit NE 30D, Eudragit RL 30D and/or Eudragit RS 30D; Aquacoat is selected from Aquacoat and/or Surelease.Mainly select Eudragit NE 30D for use, it is the aqueous dispersion of solids content 30%, is the neutral copolymer of ethyl acrylate and methyl methacrylate (2: 1) composition, and plasticity is good, and easily film forming can not added plasticizer.Eudragit RS 30D and Eudragit RL 30D are the water-insoluble filmogens, and swellable in water is the cationic polymer that ethyl acrylate, methyl methacrylate and methacrylic acid chlorination trimethylamine groups ethyl ester are formed.
The preparation method of kurarinone of the present invention or matrine sustained-release pellet, form by following steps successively:
(1) water is adopted in the preparation of binding agent, or hydroxypropyl emthylcellulose is dissolved in the distilled water fully, and filters.
(2) preparation of sustained release coating liquid adds surfactant, antiplastering aid, plasticizer in the entry, forms even suspension, pours in the coating material aqueous dispersion, stirs evenly, and filters.
(3) preparation of medicated layer is spraying under the atomized adhesive, evenly slowly is sprinkled into kurarinone or matrine to the dry celphere of crossing, drying.
(4) preparation of confining bed continues spray coating with binding agent, drying.
(5) preparation of sustained-release coating layer is got and is contained pill core sustained release coating liquid continuation spray coating, drying.
Following be kurarinone of the present invention or matrine sustained-release pellet preparation method preferred version it
(1) preparation of binding agent restrains hydroxypropyl emthylcellulose in 100ml room temperature distilled water magnetic agitation 2-8 hour with 1-3, and after treating to dissolve fully, 100 mesh sieves filter.
(2) preparation of sustained release coating liquid adds surfactant, antiplastering aid, plasticizer in the entry, stirs 2 hours, makes evenly, and above-mentioned suspension is slowly poured in the coating material aqueous dispersion, stirs evenly.Filter through 80 mesh sieves.In the coating process, continue to stir.
(3) the exsiccant celphere 300-400 gram of the preparation of medicated layer is spraying under the atomized adhesive, evenly slowly is sprinkled into kurarinone or matrine 100-300 gram, drying.
(4) preparation of confining bed continues spray coating, drying with the binding agent of 50ml.
(5) preparation of the sustained-release coating layer pill core that contains of getting certain order number continues spray coating, drying with sustained release coating liquid.
Wherein spray coating carries out in centrifugal coating pelletizing machine.The working condition of centrifugal coating pelletizing machine is: engine speed 120-200r/min, and air blast flux 10-15L/min, whiff pressure 0.025～0.1Mpa, jet flow 10-20L/min, spray pump rotating speed are 5-25r/min, baking temperature 20-40 ℃.
Experiment shows, rapid release after the conventional capsule of kurarinone is taken medicine, and blood drug level raises suddenly, a tangible peak value occurs; And slow-release micro-pill of the present invention slowly steadily discharges in dissolution medium, and medicine continues release time and reaches 12 hours.Different preparation release in vitro degree situations see Table 1, table 2, table 3.
The dissolution of table 1 kurarinone conventional capsule in distilled water
| Time (min) | 5 | 10 | 20 | 30 | 45 | 60 |
| Dissolution (%) | 82.05 | 98.7 | 99.6 | 99.8 | 100.1 | 100.2 |
The dissolution of table 2 slow-releasing micro-pills of sophocarpidine in different medium
The dissolution of table 3 matrine conventional capsule in distilled water
| 0.1mol/L hydrochloric acid solution | 22.58 | 42.46 | 65.10 | 73.41 | 81.27 | 87.48 | 93.41 |
| The pH6.8 phosphate buffer | 22.74 | 41.56 | 64.49 | 75.15 | 82.04 | 86.78 | 94.72 |
Above-mentioned experimental result shows that slow-release micro-pill all can discharge in 12 hours more stably in three kinds of media of phosphate buffer of water, 0.1mol/L hydrochloric acid solution, pH6.8; Conventional capsule is stripping in water, and stripping fast reached complete stripping substantially in 20 minutes in 5 minutes, has the significantly prominent phenomenon of releasing.The two is compared, and slow-release micro-pill has remarkable advantages.
The present invention can prolong this medicine the keeping of blood in human body in medicine valid density, and has reduced the peak valley phenomenon of blood drug level, has alleviated the toxicity of medicine, improves the therapeutic effect of this medicine.
Description of drawings
Fig. 1 is the average blood drug level-time graph of oxymatrine in 6 oral slow-releasing micro-pills of sophocarpidine of health volunteer and the commercially available kurarinone capsule body.
◆ self-made sustrained release pellets (self-control slow-releasing micro-pills of sophocarpidine)
■ commercial capsules (commercially available kurarinone glue)
Fig. 2 is the average blood drug level-time graph of matrine in 6 oral slow-releasing micro-pills of sophocarpidine of health volunteer and the commercially available kurarinone capsule body
◆ self-made sustrained release pellets (self-control slow-releasing micro-pills of sophocarpidine)
■ commercial capsules (commercially available kurarinone glue)
The specific embodiment
(1) preparation of binding agent was with 24 gram hydroxypropyl emthylcelluloses in 800ml room temperature distilled water magnetic agitation 2-8 hour, and after treating to dissolve fully, 100 mesh sieves filter.
(2) preparation of sustained release coating liquid adds 0.2 gram sodium lauryl sulphate, 9.24 gram Pulvis Talci in the 100mL water, stirs 2 hours, makes evenly, and above-mentioned suspension is slowly poured among the 70 gram Eudragit NE 30D, adds water to 250mL, stirs evenly.Filter through 80 mesh sieves.In the coating process, continue to stir.
(3) exsiccant celphere 300 grams of the preparation of medicated layer are spraying under the atomized adhesive, evenly slowly are sprinkled into kurarinone 300 grams, and room temperature is dried.
(4) preparation of confining bed continues spray coating with the binding agent of 50ml, and room temperature is dried.
(5) preparation of sustained-release coating layer is got 24-20 purpose 300 gram and is contained pill core, continues spray coating with sustained release coating liquid, 40 ℃ of dryings 24 hours.Promptly get white spherical piller, be slow-releasing micro-pills of sophocarpidine of the present invention.
(1) preparation of binding agent is binding agent with water
(2) preparation of sustained release coating liquid adds 0.21 gram sodium lauryl sulphate, 9.95 gram Pulvis Talci, 4.2 gram triethyl citrates in the 100mL water, stirred 2 hours, make evenly, above-mentioned suspension is slowly poured among the 50 gram Eudragit RS30D, add water to 250mL and stir evenly.Filter through 80 orders.In the coating process, continue to stir.
(3) exsiccant celphere 400 grams of the preparation of medicated layer are spraying under the atomized adhesive, evenly slowly are sprinkled into kurarinone 280 grams, and room temperature is dried.
(4) 3% of the preparation of confining bed usefulness 50ml hydroxypropyl emthylcellulose aqueous solution continues spray coating, and room temperature is dried.
(5) preparation of sustained-release coating layer is got 28-24 purpose 300 gram and is contained pill core, continues spray coating with sustained release coating liquid, 40 ℃ of dryings 24 hours.Promptly get white spherical piller, be slow-releasing micro-pills of sophocarpidine of the present invention.
(1) preparation of binding agent was with 16 gram hydroxypropyl emthylcelluloses in 800ml room temperature distilled water magnetic agitation 2-8 hour, and after treating to dissolve fully, 100 mesh sieves filter.
(2) preparation of sustained release coating liquid is dissolved in (heating hydrotropy) adding 0.22 gram sodium lauryl sulphate, 10.5 gram Pulvis Talci in the 100mL water with 1.35 gram polyethylene glycol 6000s, stirs 2 hours, makes evenly.Above-mentioned suspension is slowly poured among 60 gram Eudragit RS 30D and the Eudragit RL30D (10: 1), added water to 250mL and stir evenly.Filter through 80 orders.In the coating process, continue to stir.
(3) exsiccant celphere 400 grams of the preparation of medicated layer are spraying under the atomized adhesive, evenly slowly are sprinkled into kurarinone 280 grams, and room temperature is dried.
(4) preparation of confining bed continues spray coating with the binding agent of 50ml, and room temperature is dried.
(5) preparation of sustained-release coating layer is got 24-20 purpose 300 gram and is contained pill core, continues spray coating with controlled release coat liquid, 40 ℃ of dryings 24 hours.。Promptly get white spherical piller, be slow-releasing micro-pills of sophocarpidine of the present invention.
(1) preparation of binding agent was with 16 gram hydroxypropyl emthylcelluloses in 800ml room temperature distilled water magnetic agitation 2-8 hour, and after treating to dissolve fully, 100 mesh sieves filter.
(2) preparation of sustained release coating liquid adds 0.2 gram sodium lauryl sulphate, 9.24 gram Pulvis Talci in the 100mL water, stirs 2 hours, makes evenly, and above-mentioned suspension is slowly poured among the 100 gram Eudragit NE 30D, adds water to 250mL, stirs evenly.Filter through 80 mesh sieves.In the coating process, continue to stir.
(3) exsiccant celphere 300 grams of the preparation of medicated layer are spraying under the atomized adhesive, evenly slowly are sprinkled into kurarinone 300 grams, and room temperature is dried.
(4) preparation of confining bed continues spray coating with the binding agent of 50ml, and room temperature is dried.
(5) preparation of sustained-release coating layer is got 24-20 purpose 300 gram and is contained pill core, continues spray coating with sustained release coating liquid, 40 ℃ of dryings 24 hours.Promptly get white spherical piller, be slow-releasing micro-pills of sophocarpidine of the present invention.
Embodiment 5
(1) preparation of binding agent is binding agent with water
(2) preparation of sustained release coating liquid adds 0.21 gram sodium lauryl sulphate, 9.95 gram Pulvis Talci, 4.2 gram triethyl citrates in the 100mL water, stirred 2 hours, make evenly, above-mentioned suspension is slowly poured among the 70 gram Eudragit RS 30D, add water to 250mL and stir evenly.Filter through 80 orders.In the coating process, continue to stir.
(3) exsiccant celphere 400 grams of the preparation of medicated layer are spraying under the atomized adhesive, evenly slowly are sprinkled into kurarinone 280 grams, and room temperature is dried.
(4) 2% of the preparation of confining bed usefulness 50ml hydroxypropyl emthylcellulose aqueous solution continues spray coating, and room temperature is dried.
(5) preparation of sustained-release coating layer is got 28-24 purpose 300 gram and is contained pill core, continues spray coating with sustained release coating liquid, 40 ℃ of dryings 24 hours.Promptly get white spherical piller, be slow-releasing micro-pills of sophocarpidine of the present invention.
(1) preparation of binding agent was with 16 gram hydroxypropyl emthylcelluloses in 800ml room temperature distilled water magnetic agitation 2-8 hour, and after treating to dissolve fully, 100 mesh sieves filter.
(2) preparation of sustained release coating liquid is dissolved in (heating hydrotropy) adding 0.22 gram sodium lauryl sulphate, 10.5 gram Pulvis Talci in the 100mL water with 1.35 gram polyethylene glycol 6000s, stirs 2 hours, makes evenly.Above-mentioned suspension is slowly poured among 80 gram Eudragit RS 30D and the Eudragit RL30D (19: 1), added water to 250mL and stir evenly.Filter through 80 orders.In the coating process, continue to stir.
(3) exsiccant celphere 400 grams of the preparation of medicated layer are spraying under the atomized adhesive, evenly slowly are sprinkled into kurarinone 280 grams, and room temperature is dried.
(4) preparation of confining bed continues spray coating with the binding agent of 50ml, and room temperature is dried.
(5) preparation of sustained-release coating layer is got 24-20 purpose 300 gram and is contained pill core, continues spray coating with controlled release coat liquid, 40 ℃ of dryings 24 hours.Promptly get white spherical piller, be slow-releasing micro-pills of sophocarpidine of the present invention.
Kurarinone among the embodiment also can replace with matrine.
Embodiment 7
The kurarinone capsule of producing with commercially available Ningxia Boertaili Pharmaceutical Co., Ltd (100mg/ grain) is contrast, carries out slow-releasing micro-pills of sophocarpidine relative bioavailability and pharmacokinetic.Because oxymatrine concentration is greater than 98.0% in the kurarinone, offer report in a separate paper, oxymatrine is converted into matrine with the equimolecular form in vivo, and conversion ratio higher (about 90%), the two pharmacologically active and unit effect intensity suitable.Therefore bioavailability is calculated, and with the concentration total of the two, the result shows that with respect to commercially available kurarinone capsule, the relative bioavailability of slow-releasing micro-pills of sophocarpidine is 106.7%.Plasma concentration curve shows that the peak concentration of slow-releasing micro-pills of sophocarpidine reduces, and moves behind the peak time, has played the good slow release effect, sees accompanying drawing 1,2.
Claims (10)
1. kurarinone or matrine sustained-release pellet, it is characterized in that: contain following component, its percentage by weight is as follows:
Kurarinone or matrine 10%-75%
Celphere 20%-85%
Coating material 2%-20%
Surfactant 0.01%-1%
Binding agent 1%-3%
Antiplastering aid 1%-5%
Plasticizer 0-1.5%.
2. kurarinone according to claim 1 or matrine sustained-release pellet, it is characterized in that: celphere is made by microcrystalline Cellulose, is perhaps mixed by 20%-80% starch and 20%-80% sucrose; Coating material is acrylic resin or ethyl cellulose; Surfactant is a sodium lauryl sulphate, hydroxypropyl emthylcellulose, polyvinylpyrrolidone, hexadecanol, monovalence ammonium soaps or their mixture; Binding agent is a water, and/or hydroxypropyl emthylcellulose; Antiplastering aid is Pulvis Talci or Kaolin; Plasticizer is Polyethylene Glycol, triethyl citrate, dibutyl sebacate, diethyl phthalate, acetic acid monoglyceride, tributyl citrate, Oleum Ricini, triacetyl glycerine, cochin oil, oleic acid or their mixture.
3. kurarinone according to claim 2 or matrine sustained-release pellet is characterized in that coating material is acrylic resin aqueous dispersion or Aquacoat.
4. kurarinone according to claim 3 or matrine sustained-release pellet is characterized in that the acrylic resin aqueous dispersion is selected from Eudragit NE 30D, Eudragit RL 30D and/or Eudragit RS 30D; Base cellulose aqueous dispersion is selected from Aquacoat and/or Surelease.
5. kurarinone according to claim 1 or matrine sustained-release pellet is characterized in that: each component consists of celphere, medicated layer, confining bed, sustained-release coating layer from inside to outside.
6. kurarinone according to claim 5 or matrine sustained-release pellet is characterized in that: medicated layer is made up of following component:
Kurarinone or matrine 95%-99% weight
Hydroxypropyl emthylcellulose 0%-5% weight;
Sustained-release coating layer comprises:
Coating material 60%-95%
Surfactant 0.1%-1%
Antiplastering aid 4%-35%
Plasticizer 0-20%.
7. kurarinone according to claim 5 or matrine sustained-release pellet, it is characterized in that: confining bed comprises hydroxypropyl emthylcellulose.
8. the preparation method of kurarinone as claimed in claim 1 or matrine sustained-release pellet is characterized in that: be made up of following steps successively:
(1) water is adopted in the preparation of binding agent, or hydroxypropyl emthylcellulose is dissolved in the distilled water fully, and filters;
(2) preparation of sustained release coating liquid adds surfactant, antiplastering aid, plasticizer in the entry, forms even suspension, pours in the coating material aqueous dispersion, stirs evenly, and filters;
(3) preparation of medicated layer is spraying under the atomized adhesive, evenly slowly is sprinkled into kurarinone or matrine to the dry celphere of crossing, drying;
(4) preparation of confining bed continues spray coating with binding agent, drying;
(5) preparation of sustained-release coating layer is got and is contained pill core sustained release coating liquid continuation spray coating, drying.
9. the preparation method of kurarinone as claimed in claim 1 or matrine sustained-release pellet, it is characterized in that: its preferred version is:
(1) preparation of binding agent restrains hydroxypropyl emthylcellulose in 100ml room temperature distilled water magnetic agitation 2-8 hour with 1-3, and after treating to dissolve fully, 100 mesh sieves filter;
(2) preparation of sustained release coating liquid adds surfactant, antiplastering aid, plasticizer in the entry, stirs 2 hours, makes evenly, and above-mentioned suspension is slowly poured in the coating material aqueous dispersion, stirs evenly.Filter through 80 mesh sieves; In the coating process, continue to stir;
(3) the exsiccant celphere 300-400 gram of the preparation of medicated layer is spraying under the atomized adhesive, evenly slowly is sprinkled into kurarinone or matrine 100-300 gram, drying;
(4) preparation of confining bed continues spray coating, drying with the binding agent of 50ml;
(5) preparation of the sustained-release coating layer pill core that contains of getting certain order number continues spray coating, drying with sustained release coating liquid.
10. according to the preparation method of claim 9 or 10 described kurarinones or matrine sustained-release pellet, it is characterized in that: coating carries out in centrifugal coating pelletizing machine; Its working condition is engine speed 120-200r/min, air blast flux 15L/min, and whiff pressure 0.025～0.1MPa, jet flow 10-20L/min, spray pump rotating speed are 5-25r/min, baking temperature 20-40 ℃.
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| Application Number | Priority Date | Filing Date | Title |
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| CNA2007101586693A CN101176724A (en) | 2007-12-03 | 2007-12-03 | Oxymatrine or matrine sustained-release pellet and preparation method thereof |
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| CNA2007101586693A CN101176724A (en) | 2007-12-03 | 2007-12-03 | Oxymatrine or matrine sustained-release pellet and preparation method thereof |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101869556A (en) * | 2010-07-23 | 2010-10-27 | 贵州百花医药股份有限公司 | Uncaria slow release capsule preparation and preparation method thereof |
| CN102525951A (en) * | 2012-02-22 | 2012-07-04 | 张永胜 | Method for producing oxymatrine and oxysophocarpine pellets |
| CN103565779A (en) * | 2013-09-11 | 2014-02-12 | 中国药科大学 | Oxymatrine biological adhering sustained release preparation and preparation method thereof |
| CN104958473A (en) * | 2015-06-29 | 2015-10-07 | 济南正骐生物科技有限公司 | Anti-neoplastic drug composition and preparation method thereof |
-
2007
- 2007-12-03 CN CNA2007101586693A patent/CN101176724A/en active Pending
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101869556A (en) * | 2010-07-23 | 2010-10-27 | 贵州百花医药股份有限公司 | Uncaria slow release capsule preparation and preparation method thereof |
| CN101869556B (en) * | 2010-07-23 | 2015-11-25 | 贵州百花医药股份有限公司 | Uncaria slow release capsule preparation and preparation method thereof |
| CN102525951A (en) * | 2012-02-22 | 2012-07-04 | 张永胜 | Method for producing oxymatrine and oxysophocarpine pellets |
| CN103565779A (en) * | 2013-09-11 | 2014-02-12 | 中国药科大学 | Oxymatrine biological adhering sustained release preparation and preparation method thereof |
| CN104958473A (en) * | 2015-06-29 | 2015-10-07 | 济南正骐生物科技有限公司 | Anti-neoplastic drug composition and preparation method thereof |
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Open date: 20080514 |