CN1235584C - Sustained release tablet of matrine and its preparing method - Google Patents
Sustained release tablet of matrine and its preparing method Download PDFInfo
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Abstract
The present invention relates to a sustained release tablet of matrine and a preparing method thereof. The sustained release tablet of matrine basically contains matrine and sustained release framework materials in the ratio of 1: 0.12 to 3.3. The preparing method of the sustained release tablet of matrine is simple. Various materials are proportionally compounded and prepared by a tablet preparation method. The release rate of the sustained release tablet of matrine prepared according to the method achieves the requirements of medicinal sustained release preparation. Compared with the existing dosage form, the sustained release tablet of matrine has a sustained release function and can maintain long release and absorption time after the administration of patients, avoid the 'peak valley 'phenomenon of blood concentration, maintain required blood concentration and time for treating diseases. The sustained release tablet of matrine is taken 1 to 2 times every day. Therefore, the present invention can reduce side effect and guarantee therapeutic effect. Moreover, because of a small number of times of administration, the present invention has the advantage of convenient use and is suitable for patients who need long-term medication.
Description
Technical field
The present invention relates to a kind of matrine slow-release tablet and preparation method thereof.
Background technology
Matrine be the Chinese crude drug Radix Sophorae Flavescentis mainly contain one of effective constituent, mainly in the leguminous plant Herba Sophorae alopecuroidis, extracted afterwards.Matrine is used for diseases such as gynecological inflammation, leukopenia, asthma at first clinically, and main dosage form is injection and suppository.The matrine treatment that is used for hepatitis B has clinically afterwards obtained good curative effect, clinical studies show matrine hepatitis B patient HBsAg, HBeAg are had higher negative conversion rate and effect of reducing enzyme levels preferably, pharmaceutical research has shown the hepatitis model animal effective.
Matrine is used for the treatment of the existing injection product of hepatitis B, and the application clinically of oral ordinary preparation has document announcement.Because hepatitis B patient needs long-time medication treatment, the injection life-time service can be made troubles and misery to the patient, and oral ordinary preparation " peak valley " phenomenon can occur at the back blood drug level of taking medicine, and side effect is increased, and curative effect reduces, and need take medicine every day three times.
Summary of the invention
The object of the present invention is to provide a kind of medicine that is used for the treatment of hepatitis B---matrine slow-release tablet.
Another object of the present invention is to provide a kind of preparation method that is applicable to the matrine slow-release tablet of suitability for industrialized production.
The object of the present invention is achieved like this: a kind of matrine slow-release tablet is characterized in that: it contains matrine and slow release framework material, wherein matrine substantially: sustained-release matrix material=1: 0.12-3.3.
Above-mentioned sustained-release matrix material is one or more a combination in any of hydrophilic gel sustained-release matrix material, erodible sustained-release matrix material, water-insoluble sustained-release matrix material.
Above-mentioned hydrophilic gel sustained-release matrix material is one or more a combination in any of hydroxypropyl emthylcellulose, sodium carboxymethyl cellulose, carbomer (Carbomer), and its addition be the Radix Sophorae Flavescentis alkali number 0.25-3 doubly; Above-mentioned erodible sustained-release matrix material is one or more the combination in any in stearic acid, hexadecanol, octadecanol, the Polyethylene Glycol, and its addition be the Radix Sophorae Flavescentis alkali number 0.01-0.3 doubly; Above-mentioned water-insoluble sustained-release matrix material is an ethyl cellulose or/and zein, and its addition be the Radix Sophorae Flavescentis alkali number 0.01-1.5 doubly.
Be added with lubricant or/and additives in the described matrine slow-release tablet; Described lubricant is one or more the combination in any in magnesium stearate, silicon dioxide, the Pulvis Talci, and its addition is the 0.5%-5% of described matrine slow-release tablet total amount; Described additives are one or more the combination in any in lactose, polyvinylpyrrolidone, the microcrystalline Cellulose, and its addition be the Radix Sophorae Flavescentis alkali number 0.05-0.3 doubly.
Hydroxypropyl emthylcellulose among the present invention plays main slow releasing function in matrine slow-release tablet, result of study is, selecting methoxyl content for use is 19.0-24.0, propoxyl content is the hydroxypropyl emthylcellulose of 4.0-12.0, viscosity changes little to the influence of slow release effect in a big way, its range of viscosities all can reach practical requirement between 4000-15000mPas (milli pascal second), under the suitable situation of selecting prescription for use, viscosity reaches as high as 100000mPas; The molecular weight of Polyethylene Glycol can be selected between 1000-10000.
The prescription of the best of the present invention is: it by matrine, hydroxypropyl emthylcellulose, ethyl cellulose or/and zein, polyvinylpyrrolidone and lubricant form, matrine wherein: hydroxypropyl emthylcellulose: ethyl cellulose is or/and zein: the ratio of polyvinylpyrrolidone is 1: 0.5-1: 0.01-0.07: 0.06-0.2, lubricant are an amount of.
Another object of the present invention is achieved in that a kind of preparation method of matrine slow-release tablet, it is characterized in that: above-mentioned various materials are prepared burden in proportion, make slow releasing tablet by the sheet agent method.
Specifically, be with matrine, erodible sustained-release matrix material, additives and the hydrophilic gel sustained-release matrix material mix homogeneously of milling, add the lubricant tabletting behind the adding lubricant behind direct compression or the dry granulation or add typical binders granulation, drying earlier, tabletting behind the adding lubricant.
Or earlier matrine, erodible sustained-release matrix material and additives are milled earlier jointly mix homogeneously, even with hydrophilic gel sustained-release matrix material mixing again, add the lubricant tabletting behind the adding lubricant behind direct compression or the dry granulation or add typical binders granulation, drying earlier, tabletting behind the adding lubricant.Why these are difficult for dispersive composition to this preparation method with stearic acid, hexadecanol, octadecanol, Polyethylene Glycol, earlier with matrine and additives mill jointly mix after, again with hydrophilic gel sustained-release matrix material mixing, add the lubricant tabletting, material is mixed easily, reduce the consumption of used slow-release material, improve release profiles, thereby eliminated the sticking phenomenon that above-mentioned substance occurs when the tabletting by force because of viscosity.
Or with the alcoholic solution mix homogeneously of the water-soluble components in matrine, the described additives such as polyvinylpyrrolidone, lactose and water-insoluble sustained-release matrix material, adding hydrophilic gel sustained-release matrix material mixing granulates, drying adds the lubricant tabletting and gets finished product.
Or with the alcoholic solution mix homogeneously or the dissolving of the water-soluble components in matrine, the described additives such as polyvinylpyrrolidone, lactose and water-insoluble sustained-release matrix material, vacuum drying, pulverize, add hydrophilic gel sustained-release matrix material mixing, add the lubricant tabletting again behind adding lubricant direct compression or the first dry granulation.Adopt this preparation method, can reduce the consumption of water-insoluble sustained-release matrix material, make that release profiles is level and smooth, color and luster evenly, invariant color.
Or matrine, water-insoluble sustained-release matrix material and additives and mix lubricant are even, tabletting gets finished product.
Certainly the product of gained of the present invention, or adopt coating material coating or coating not.
The present invention research draws: if ethyl cellulose is mixed with matrine after with dissolve with ethanol, a small amount of ethyl cellulose just can produce stronger slow releasing function, under the identical situation of consumption, the viscosity increase can make slow releasing function that certain increase is arranged, and uses jointly and can improve release profiles and matrine is discharged fully with water-soluble components in the listed additives such as polyvinylpyrrolidone, lactose.It is the ethyl cellulose of 30-150mPas that the present invention has adopted viscosity.The present invention also studies and thinks that zein has identical phenomenon.
The present invention research draws: if with matrine and hydrophilic gel slow-release material mixed together, tabletting just can obtain the slow releasing tablet of tool slow releasing function, is that slow-release time is shorter; When being added with erodible sustained-release matrix material again or/and can obviously improve slow release effect behind the water-insoluble sustained-release matrix material; If be added with the process conditions that to improve release profiles better behind the additives and more be applicable to suitability for industrialized production again.
The present invention has adopted direct compression, dry granulation tabletting and wet granule compression tablet respectively.Certainly the product color that adopts direct compression and dry granulation tabletting to prepare is even, bright and clean, invariant color, and the product that wet granule compression tablet obtains has jaundice, the uneven phenomenon of color and luster, but still can reach slow release effect of the present invention.
The drug release rate test shows, the rate of release of matrine slow-release tablet of the present invention reaches medicinal slow releasing preparation requirement, it is compared with prior dosage form, has slow releasing function, keep long release and soak time after patient is taken, can avoid " peak valley " phenomenon of blood drug level, can keep treatment disease due blood drug level of institute and time again, taking medicine every day gets final product for 1-2 time, thereby can reduce side effect and guarantee curative effect.And because of its medicining times is few, easy to use, be fit to the patient of needs long-term prescription.
Pharmacodynamics test shows, in carbon tetrachloride and the inductive acute liver damage model of D-Gal, slow releasing tablet of the present invention can obviously reduce glutamate pyruvate transaminase and glutamic oxaloacetic transaminase, GOT activity, alleviates the pathologic damage of liver, and its drug effect is longer than the persistent period of matrine ordinary preparation.And in the sheldrake model that dhbv dna infects, slow releasing tablet of the present invention can significantly reduce the HBV-DNA content in the sheldrake serum, shows that the hepatic injury that described slow releasing tablet causes hepatitis B virus has the good curing effect.
The preparation method of product of the present invention is easy, and the adjuvant of use is easy to get, and economy has multiple formulations and technology available within the specific limits, is applicable to suitability for industrialized production.
Description of drawings
The common matrine capsule of Fig. 1 release profiles
The release profiles of Fig. 2 embodiment 1 products obtained therefrom
The release profiles of Fig. 3 embodiment 2 products obtained therefroms
The release profiles of Fig. 4 embodiment 3 products obtained therefroms
The release profiles of Fig. 5 embodiment 4 products obtained therefroms
The release profiles of Fig. 6 embodiment 5 products obtained therefroms
The release profiles of Fig. 7 embodiment 6 products obtained therefroms
The release profiles of Fig. 8 embodiment 7 products obtained therefroms
The release profiles of Fig. 9-1 embodiment 8 products obtained therefroms
The release profiles of Fig. 9-2 embodiment 8 products obtained therefroms
The release profiles of Fig. 9-3 embodiment 8 products obtained therefroms
The release profiles of Figure 10 embodiment 9 products obtained therefroms
The release profiles of Figure 11-1 embodiment 10 products obtained therefroms
The release profiles of Figure 11-2 embodiment 10 products obtained therefroms
The specific embodiment
The present invention is further elaborated below in conjunction with specific embodiments and the drawings.
The drug release determination of this experiment is measured according to 2000 editions two appendix XD first methods of Pharmacopoeia of People's Republic of China.
Embodiment 1:
Prescription: matrine 30g,
Hydroxypropyl emthylcellulose 23g,
Magnesium stearate 0.5g
Method for making: above material mixed together is even, and directly compacting in flakes.Wherein to adopt viscosity respectively be 4000mPa.s, 15000mPa.s, 100000mPa.s to hydroxypropyl emthylcellulose, prepares 3 batches altogether, each 100.Through drug release determination, its result shows that the hydroxypropyl emthylcellulose of different viscosities is little to the release profiles influence.Release profiles is seen Fig. 2.
Embodiment 2:
Prescription: matrine 30g
Ethyl cellulose 3.5g
Polyvinylpyrrolidone 5g
Magnesium stearate 0.4g
Method for making: with the ethyl cellulose dissolve with ethanol, add matrine, polyvinylpyrrolidone mixed dissolution, vacuum drying is pulverized, and adds magnesium stearate and is pressed into sheet.Wherein to adopt viscosity respectively be 30mpa.s, 60mPa.s, 100mPa.s, 150mPa.s to ethyl cellulose, prepares 4 batches altogether, each 100.Through drug release determination, its result shows that the ethyl cellulose of different viscosities is little to the release profiles influence.Release profiles is seen Fig. 3.
Example 3:
Prescription: matrine 30g
Hydroxypropyl emthylcellulose 20g
Polyvinylpyrrolidone 2g
Ethyl cellulose 1.2g
Magnesium stearate 0.5g
Method for making: with the ethyl cellulose dissolve with ethanol, mix with matrine, polyvinylpyrrolidone, vacuum drying is pulverized, and adds the hydroxypropyl emthylcellulose mix homogeneously, adds magnesium stearate and mixes, and tabletting gets finished product.Wherein to adopt viscosity respectively be 30mpa.s, 60mPa.s, 100mPa.s, 150mPa.s to ethyl cellulose, prepares 4 batches altogether, each 100.Through drug release determination, the result shows that ethyl cellulose has stronger slow releasing function, and the ethyl cellulose of different viscosities is less to the release profiles influence, and release profiles is seen Fig. 4.
Example 4:
Prescription: matrine 30g
Hydroxypropyl emthylcellulose 20g
Stearic acid 1.5g
Lactose 4g
Magnesium stearate 0.55g
Method for making: with matrine, hydroxypropyl emthylcellulose, stearic acid, the lactose mix homogeneously of milling jointly, add after the magnesium stearate direct compression or dry granulation and add tabletting after the magnesium stearate, make 100 altogether.Release profiles is seen Fig. 5.
Example 5:
Prescription: matrine 30g
Hydroxypropyl emthylcellulose 20g
Stearic acid 1.5g
Lactose 4g
Magnesium stearate 0.55g
Method for making: with matrine, stearic acid, the lactose mix homogeneously of milling earlier, add the hydroxypropyl emthylcellulose mix homogeneously again, add behind the lubricant direct compression or dry granulation and add behind the lubricant tabletting or use 85% alcohol granulation, drying adds tabletting behind the lubricant.Prepare 3 batches altogether, each 100.Result of the test shows, with the mixing of milling earlier of matrine, stearic acid, lactose, makes mixing more even, and stearic consumption is few; Adopt direct compression or dry granulation tabletting or basic identical, but wet granulation there is metachromatism with the release profiles of 85% alcohol granulation tabletting.Release profiles is seen Fig. 6.
Example 6:
Prescription: matrine 30g
Hydroxypropyl emthylcellulose 20g
Polyvinylpyrrolidone 2g
Ethyl cellulose 0.9g
Magnesium stearate 0.5g
Method for making 1: with the ethyl cellulose dissolve with ethanol, with matrine, polyvinylpyrrolidone mix homogeneously, vacuum drying, pulverize,, add the magnesium stearate tabletting behind direct compression or the dry granulation after the adding magnesium stearate with the hydroxypropyl emthylcellulose mix homogeneously, make 2 batches altogether, each 100.
Method for making 2: with the ethyl cellulose dissolve with ethanol,, granulate with matrine, polyvinylpyrrolidone, hydroxypropyl emthylcellulose mix homogeneously, drying, tabletting after the adding magnesium stearate is made 100.
Test shows that the elution profiles of above method preparation is basic identical, but adopts the slow releasing tablet of wet granulation jaundice to be arranged, the uneven phenomenon of color and luster.Release profiles is seen Fig. 7.
Example 7:
Prescription: matrine 30g
Ethyl cellulose 26g
Polyethylene Glycol 5g
Magnesium stearate 0.4g
Method for making: above mixing of materials is even, be pressed into 100.Release profiles is seen Fig. 8.
Example 8:
Prescription sees Table: (unit: gram)
| Join | Radix Sophorae Flavescentis | HPMC | EC | Corn | PVP | Lactose | Crystallite | Stearic | Remarks |
| 8-a | 30 | 10 | 2 | - | 6 | - | 3 | 0.51 | Release profiles is seen Fig. 9-1 |
| 8- | 30 | 19 | 0.9 | - | 3 | - | - | 0.5 | |
| 8- | 30 | 19.5 | 0.6 | - | 3 | - | - | 0.5 | |
| 8- | 30 | 18 | - | 1.2 | 3 | - | - | 0.5 | |
| 8- | 30 | 14 | 0.3 | - | 9 | - | 0.5 | Release profiles is seen Fig. 9-2 | |
| 8- | 30 | 18 | 0.9 | - | 3 | 5 | - | 0.55 | |
| 8- | 30 | 18 | - | 0.9 | 3 | - | 5 | 0.55 | |
| 8-h | 15 | 12.8 | 0.45 | - | 1.5 | - | - | 0.30 | Release profiles is seen Fig. 9-3 |
| 8-i | 15 | 12.9 | 0.3 | - | 1.5 | - | - | 0.30 | |
| 8-j | 15 | 12.7 | - | 0.6 | 1.5 | - | - | 0.30 |
Annotate: HPMC is a hydroxypropyl emthylcellulose; EC is an ethyl cellulose; PVP is a polyvinylpyrrolidone.
Method for making: with ethyl cellulose or zein dissolve with ethanol, with matrine, polyvinylpyrrolidone (or lactose) mix homogeneously, vacuum drying, pulverize, with other additives mix homogeneously, add the magnesium stearate tabletting behind adding magnesium stearate direct compression or the dry granulation, make 100.
Example 9:
Prescription sees Table: (unit: gram)
| Prescription | Matrine | HPMC | Stearic acid | Octadecanol | PEG | PVP | Lactose | Microcrystalline Cellulose | Magnesium stearate | Silicon oxide | Remarks |
| 9- a | 30 | 20 | 1.5 | - | 1 | - | - | - | - | - | Release profiles is seen Figure 10 |
| 9- | 30 | 17.5 | 1.5 | - | 2 | - | 4 | - | - | 2.5 | |
| 9- | 30 | 20 | 1.5 | - | - | 1 | - | - | 0.5 | - | |
| 9- | 30 | 16 | 1.5 | - | - | 1 | - | 4 | 0.5 | 1 | |
| 9- | 30 | 19.5 | - | 2 | - | 1 | - | - | 0.5 | - | |
| 9- f | 15 | 25 | 0.8 | - | - | - | 4 | - | - | 1 | |
| 9- g | 15 | 30 | - | 0.7 | 0.2 | - | 5 | - | 0.5 | - | |
| 9- h | 15 | 40 | 0.8 | - | - | - | 3 | 2 | - | 1.5 |
Annotate: PEG is a Polyethylene Glycol
Method for making: the mix homogeneously of will the material except that magnesium stearate fully milling, add magnesium stearate and mix the back direct compression, or dry granulation, add the magnesium stearate tabletting.Be pressed into 100.
Example 10:
Prescription sees Table: (unit: gram)
| Prescription | Matrine | EC | HPMC | CMC-Na | Carbomer | PVP | Lactose | Microcrystalline Cellulose | Magnesium stearate | Remarks |
| 10-a | 30 | 0.9 | 12.6 | 10 | - | 1 | - | - | 0.5 | Release profiles is seen Figure 11-1 |
| 10- | 30 | 0.9 | 10.6 | 8 | - | - | 4 | - | 0.5 | |
| 10- | 30 | 0.9 | 10.6 | 7 | - | 1 | - | 4 | 0.5 | |
| 10- | 30 | 0.9 | 8 | 10 | - | 1 | - | - | 0.4 | |
| 10-e | 15 | 0.3 | 15 | 16 | - | 3 | - | - | 0.6 | |
| 10- | 30 | 0.9 | 17.6 | - | 5 | 1 | - | - | 0.5 | Release profiles is seen Figure 11-2 |
| 6- | 30 | 0.9 | 14.6 | - | 4 | - | 4 | - | 0.5 | |
| 10- | 30 | 0.9 | 17.6 | - | 4 | 1 | - | 4 | 0.5 | |
| 10- | 30 | 0.9 | 8 | - | 4 | 1 | 4 | - | 0.4 | |
| 10-j | 15 | 0.3 | 15 | - | 8 | 4 | - | - | 0.6 |
Annotate: CMC-Na is a sodium carboxymethyl cellulose
Method for making: with the ethyl cellulose dissolve with ethanol,, pulverize with matrine, polyvinylpyrrolidone (or lactose) mix homogeneously, vacuum drying, even with other mixing of materials, be pressed into 100.
Claims (10)
1, a kind of matrine slow-release tablet is characterized in that: it contains matrine and slow release framework material, wherein matrine substantially: sustained-release matrix material=1: 0.12-3.3; Described sustained-release matrix material is one or more a combination in any of hydrophilic gel sustained-release matrix material, erodible sustained-release matrix material, water-insoluble sustained-release matrix material; Described hydrophilic gel sustained-release matrix material is one or more a combination in any of hydroxypropyl emthylcellulose, sodium carboxymethyl cellulose, carbomer, and its addition be the Radix Sophorae Flavescentis alkali number 0.25-3 doubly; Described erodible sustained-release matrix material is one or more the combination in any in stearic acid, hexadecanol, octadecanol, the Polyethylene Glycol, and its addition be the Radix Sophorae Flavescentis alkali number 0.01-0.3 doubly; Described water-insoluble sustained-release matrix material is an ethyl cellulose or/and zein, and its addition be the Radix Sophorae Flavescentis alkali number 0.01-1.5 doubly.
2, matrine slow-release tablet as claimed in claim 1 is characterized in that: be added with lubricant or/and additives in the described matrine slow-release tablet; Described lubricant is one or more the combination in any in magnesium stearate, silicon dioxide, the Pulvis Talci, and its addition is the 0.5%-5% of described matrine slow-release tablet total amount; Described additives are one or more the combination in any in lactose, polyvinylpyrrolidone, the microcrystalline Cellulose, and its addition be the Radix Sophorae Flavescentis alkali number 0.05-0.3 doubly.
3, matrine slow-release tablet as claimed in claim 2, it is characterized in that: it by matrine, hydroxypropyl emthylcellulose, ethyl cellulose or/and zein, polyvinylpyrrolidone and lubricant form, matrine wherein: hydroxypropyl emthylcellulose: ethyl cellulose is or/and zein: the ratio of polyvinylpyrrolidone is 1: 0.5-1: 0.01-0.07: 0.06-0.2, lubricant are an amount of.
4, matrine slow-release tablet as claimed in claim 1 is characterized in that: the methoxyl content of described hydroxypropyl emthylcellulose is 19.0-24.0, and propoxyl content is 4.0-12.0, and range of viscosities is at 4000-15000 milli pascal second; The molecular weight of Polyethylene Glycol is selected between 1000-10000.
5, as the preparation method of the described any matrine slow-release tablet of claim 1-4, it is characterized in that: described various materials are prepared burden in proportion, make slow releasing tablet by method for preparing tablet thereof.
6, the preparation method of a kind of matrine slow-release tablet as claimed in claim 5, it is characterized in that: with matrine, erodible sustained-release matrix material, additives and the hydrophilic gel sustained-release matrix material mix homogeneously of milling, direct compression or dry granulation behind the adding lubricant, tabletting or elder generation add typical binders granulation, drying behind the adding lubricant, add the lubricant tabletting again.
7, the preparation method of a kind of matrine slow-release tablet as claimed in claim 5, it is characterized in that: after the mixing of earlier matrine, erodible sustained-release matrix material and additives being milled jointly, again with hydrophilic gel sustained-release matrix material mixing, direct compression or dry granulation behind the adding lubricant, tabletting or elder generation add typical binders granulation, drying behind the adding lubricant, add the lubricant tabletting again.
8, the preparation method of a kind of matrine slow-release tablet as claimed in claim 5, it is characterized in that:, add hydrophilic gel sustained-release matrix material mixing and granulate drying the alcoholic solution mix homogeneously of matrine, additives and water-insoluble sustained-release matrix material, add lubricant, tabletting gets finished product.
9, the preparation method of a kind of matrine slow-release tablet as claimed in claim 5, it is characterized in that: with the alcoholic solution mix homogeneously or the dissolving of water-soluble components in matrine, the described additives and water-insoluble sustained-release matrix material, vacuum drying, pulverize, add hydrophilic gel sustained-release matrix material mixing, add the lubricant tabletting again behind adding lubricant direct compression or the dry granulation and get finished product.
10, the preparation method of a kind of matrine slow-release tablet as claimed in claim 5 is characterized in that: matrine, water-insoluble sustained-release matrix material and additives and mix lubricant are even, and tabletting gets finished product.
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