CN111067877A - Diammonium glycyrrhizinate enteric-coated tablet and preparation method thereof - Google Patents
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Abstract
The invention relates to the technical field of medicinal preparations, and particularly discloses a diammonium glycyrrhizinate enteric-coated tablet and a preparation method thereof, wherein the diammonium glycyrrhizinate enteric-coated tablet sequentially comprises a tablet core, an isolation coating and an enteric coating from inside to outside, and the tablet core consists of the following components in parts by weight: 40-60 parts of diammonium glycyrrhizinate, 10-30 parts of lactose, 5-20 parts of low-substituted hydroxypropyl cellulose, 1-5 parts of povidone and 1-5 parts of magnesium stearate, wherein the isolation coating comprises the following components in parts by weight: 20-40 parts of ethyl cellulose, 520-40 parts of HPMCE and 5-10 parts of triethyl citrate, wherein the enteric coating comprises the following components in parts by weight: 30-30D-55100 parts of Eudragit L, 10-30 parts of talcum powder, 6-12 parts of glyceryl behenate, 2-4 parts of triethyl citrate and 4-6 parts of hydroxypropyl methyl cellulose. The invention overcomes the defects of the prior art, and the isolation coating and the enteric coating are coated outside the medicament, so that the absorption concentration of the medicament in the intestinal tract is improved, the absorption of the medicament is facilitated, and the invention has better effect.
Description
Technical Field
The invention relates to the technical field of medicinal preparations, and particularly belongs to diammonium glycyrrhizinate enteric-coated tablets and a preparation method thereof.
Background
Diammonium glycyrrhizinate is an extract of effective components of liquorice in traditional Chinese medicines, and has certain effects of resisting inflammation, protecting liver cells and improving liver functions. The traditional Chinese medicine composition is clinically used for treating acute and chronic viral hepatitis, particularly for treating viral hepatitis B, chronic active phase, active phase of hepatitis C and liver function damage, and can obviously improve clinical symptoms and liver functions of patients.
The existing diammonium glycyrrhizinate is a capsule medicament, but the capsule medicament is unstable in gastric juice and has the possibility of disintegration, so most of the medicament is lost, and the efficacy of the medicament is reduced.
Disclosure of Invention
The invention aims to provide diammonium glycyrrhizinate enteric-coated tablets and a preparation method thereof, overcomes the defects of the prior art, improves the absorption concentration of a medicament in an intestinal tract by coating an isolation coating and an enteric coating on the outer side of the medicament, is beneficial to the absorption of the medicament, and has better effect.
In order to solve the problems, the technical scheme adopted by the invention is as follows:
the diammonium glycyrrhizinate enteric-coated tablet comprises a tablet core, an isolation coating and an enteric coating from inside to outside in sequence, wherein the tablet core comprises the following components in parts by weight: 40-60 parts of diammonium glycyrrhizinate, 10-30 parts of lactose, 5-20 parts of low-substituted hydroxypropyl cellulose, 1-5 parts of povidone and 1-5 parts of magnesium stearate, wherein the isolation coating comprises the following components in parts by weight: 20-40 parts of ethyl cellulose, 520-40 parts of HPMCE and 5-10 parts of triethyl citrate, wherein the enteric coating comprises the following components in parts by weight: 30-30D-55100 parts of Eudragit L, 10-30 parts of talcum powder, 6-12 parts of glyceryl behenate, 2-4 parts of triethyl citrate and 4-6 parts of hydroxypropyl methyl cellulose.
Further, the tablet core consists of the following components in parts by weight: 50 parts of diammonium glycyrrhizinate, 20 parts of lactose, 12.5 parts of low-substituted hydroxypropyl cellulose, 3 parts of povidone and 3 parts of magnesium stearate, wherein the isolation coating comprises the following components in parts by weight: 30 parts of ethyl cellulose, 530 parts of HPMCE and 7.5 parts of triethyl citrate, wherein the enteric coating comprises the following components in parts by weight: 30-30D-55100 parts of Eudragit L, 20 parts of talcum powder, 9 parts of glyceryl behenate, 3 parts of triethyl citrate and 5 parts of hydroxypropyl methyl cellulose.
Further, the content of the isolating coating is 5-10 mg/tablet, the content of the enteric coating is 30-50 mg/tablet, and the content of diammonium glycyrrhizinate in the tablet core is not lower than 48%.
A preparation method of diammonium glycyrrhizinate enteric-coated tablets comprises the following steps:
s1: preparing a tablet core, weighing diammonium glycyrrhizinate, lactose, low-substituted hydroxypropyl cellulose, povidone and magnesium stearate according to the formula amount, sequentially mixing diammonium glycyrrhizinate, lactose and low-substituted hydroxypropyl cellulose by an equivalent incremental method, adding povidone during the mixing process, uniformly mixing, performing wet granulation on a swing granulator, drying, performing total mixing with magnesium stearate, and performing tabletting by using a rotary tablet press to obtain the tablet core;
s2: dissolving ethyl cellulose with deionized water, adding HPMCE5 and triethyl citrate, stirring, and filtering to obtain an isolation coating solution;
s3: preparing an enteric coating solution: diluting the Eudragit L30D-55 with deionized water, adding dissolved triethyl citrate, slowly adding glyceryl behenate and hydroxypropyl methylcellulose under stirring, adding pulvis Talci under stirring, and filtering to obtain enteric coating solution;
s4: coating: and placing the tablet cores in a coating machine, starting the coating machine, and spraying the isolation coating solution and the enteric coating solution on the surfaces of the tablet cores in sequence to obtain the diammonium glycyrrhizinate enteric-coated tablets.
Further, in the step S1, the drying is carried out for 3 to 5 hours by adopting a thermal cycle oven, the drying temperature is controlled to be 70 to 80 ℃, and then a stainless steel screen mesh with 18 meshes is used for finishing the particles.
Further, in S4, the rotating speed of a roller of the coating machine is set to be 6-10 r/min, the air inlet temperature is controlled to be 40-60 ℃, the air outlet temperature is controlled to be 35-45 ℃, and the air inlet flow rate is as follows: 300m3And h, opening a peristaltic pump and a compressed air valve to spray coating.
Compared with the prior art, the invention has the following implementation effects:
according to the diammonium glycyrrhizinate enteric-coated tablet and the preparation method thereof, the medicament can not disintegrate in gastric juice, but can be released in the intestinal tract in a positioning manner, so that the medicament effect is improved, the stimulation to the stomach is reduced, and the diammonium glycyrrhizinate enteric-coated tablet is safer and more reliable; the preparation process is simple in flow, convenient to operate, convenient for batch production and high in economic benefit.
Drawings
FIG. 1 is a graph showing the cumulative release profile at 100 revolutions in phosphate buffer pH 6.8.
FIG. 2 is a graph showing the cumulative release profile at 50 revolutions in phosphate buffer pH 6.8.
Detailed Description
The present invention will be further described with reference to the following examples, but the present invention is not limited to these examples, and any modification is within the scope of the present invention without departing from the spirit of the present invention.
Example 1
The embodiment provides a preparation method of diammonium glycyrrhizinate enteric-coated tablets, which comprises the following steps:
s1: preparing a tablet core, weighing 40 parts of diammonium glycyrrhizinate, 10 parts of lactose, 5 parts of low-substituted hydroxypropyl cellulose, 1 part of povidone and 1 part of magnesium stearate according to the formula amount, sequentially mixing diammonium glycyrrhizinate, lactose and low-substituted hydroxypropyl cellulose by an equivalent incremental method, adding povidone in the mixing process, uniformly mixing, performing wet granulation on a swing granulator, drying for 3-5 hours by a thermal circulation oven, controlling the drying temperature to be 70-80 ℃, granulating by using a 18-mesh stainless steel screen, performing total mixing with magnesium stearate, and performing tabletting by using a rotary tablet press to obtain the tablet core;
wherein, the content of the isolating coating is 5-10 mg/tablet, the content of the enteric coating is 30-50 mg/tablet, and the content of diammonium glycyrrhizinate in the tablet core is not lower than 48%;
s2: preparing an isolation coating solution, namely dissolving 20 parts of ethyl cellulose by using deionized water, adding 20 parts of HPMCE5 and 5 parts of triethyl citrate, uniformly stirring, and filtering to obtain the isolation coating solution for later use;
s3: preparing an enteric coating solution: diluting 100 parts of Uygizi L30D-55 with deionized water, adding dissolved 2 parts of triethyl citrate, slowly adding 6 parts of glyceryl behenate and 4 parts of hydroxypropyl methyl cellulose under stirring, adding 10 parts of talcum powder under stirring, stirring uniformly, and filtering to obtain enteric coating solution for later use;
s4: coating: placing the tablet core in a coating machine, setting the rotating speed of a roller of the coating machine to be 6-10 r/min, controlling the air inlet temperature to be 40-60 ℃, the air outlet temperature to be 35-45 ℃, and the air inlet flow rate: 300m3And opening the peristaltic pump and the compressed air valve to perform guniting coating, and spraying the isolation coating solution and the enteric coating solution on the surface of the tablet core in sequence to obtain the diammonium glycyrrhizinate enteric-coated tablet.
Example 2
The embodiment provides a preparation method of diammonium glycyrrhizinate enteric-coated tablets, which comprises the following steps:
s1: preparing a tablet core, weighing 50 parts of diammonium glycyrrhizinate, 20 parts of lactose, 12 parts of low-substituted hydroxypropyl cellulose, 3 parts of povidone and 3 parts of magnesium stearate according to the formula amount, sequentially mixing diammonium glycyrrhizinate, lactose and low-substituted hydroxypropyl cellulose by an equivalent incremental method, adding povidone in the mixing process, uniformly mixing, performing wet granulation on a swing granulator, drying for 3-5 hours by a thermal circulation oven, controlling the drying temperature to be 70-80 ℃, granulating by using a 18-mesh stainless steel screen, performing total mixing with magnesium stearate, and performing tabletting by using a rotary tablet press to obtain the tablet core;
wherein, the content of the isolating coating is 5-10 mg/tablet, the content of the enteric coating is 30-50 mg/tablet, and the content of diammonium glycyrrhizinate in the tablet core is not lower than 48%;
s2: preparing an isolation coating solution, namely dissolving 30 parts of ethyl cellulose by using deionized water, adding 30 parts of HPMCE5 and 7.5 parts of triethyl citrate, uniformly stirring, and filtering to obtain the isolation coating solution for later use;
s3: preparing an enteric coating solution: diluting 100 parts of Uygizi L30D-55 with deionized water, adding dissolved 3 parts of triethyl citrate, slowly adding 9 parts of glyceryl behenate and 5 parts of hydroxypropyl methyl cellulose under stirring, adding 20 parts of talcum powder under stirring, stirring uniformly, and filtering to obtain enteric coating solution for later use;
s4: coating: placing the tablet core in a coating machine, setting the rotating speed of a roller of the coating machine to be 6-10 r/min, controlling the air inlet temperature to be 40-60 ℃, the air outlet temperature to be 35-45 ℃, and the air inlet flow rate: 300m3And opening the peristaltic pump and the compressed air valve to perform guniting coating, and spraying the isolation coating solution and the enteric coating solution on the surface of the tablet core in sequence to obtain the diammonium glycyrrhizinate enteric-coated tablet.
Example 3
The embodiment provides a preparation method of diammonium glycyrrhizinate enteric-coated tablets, which comprises the following steps:
s1: preparing a tablet core, weighing 60 parts of diammonium glycyrrhizinate, 30 parts of lactose, 20 parts of low-substituted hydroxypropyl cellulose, 5 parts of povidone and 5 parts of magnesium stearate according to the formula amount, sequentially mixing diammonium glycyrrhizinate, lactose and low-substituted hydroxypropyl cellulose by an equivalent incremental method, adding povidone in the mixing process, uniformly mixing, performing wet granulation on a swing granulator, drying for 3-5 hours by a thermal circulation oven, controlling the drying temperature to be 70-80 ℃, granulating by using a 18-mesh stainless steel screen, performing total mixing with magnesium stearate, and performing tabletting by using a rotary tablet press to obtain the tablet core;
wherein, the content of the isolating coating is 5-10 mg/tablet, the content of the enteric coating is 30-50 mg/tablet, and the content of diammonium glycyrrhizinate in the tablet core is not lower than 48%;
s2: preparing an isolation coating solution, namely dissolving 40 parts of ethyl cellulose by using deionized water, adding 40 parts of HPMCE5 and 10 parts of triethyl citrate, uniformly stirring, and filtering to prepare the isolation coating solution for later use;
s3: preparing an enteric coating solution: diluting 100 parts of Uygizi L30D-55 with deionized water, adding dissolved 4 parts of triethyl citrate, slowly adding 12 parts of glyceryl behenate and 6 parts of hydroxypropyl methyl cellulose under stirring, adding 30 parts of talcum powder under stirring, stirring uniformly, and filtering to obtain enteric coating solution for later use;
s4: coating: placing the tablet core in a coating machine, setting the rotating speed of a roller of the coating machine to be 6-10 r/min, controlling the air inlet temperature to be 40-60 ℃, the air outlet temperature to be 35-45 ℃, and the air inlet flow rate: 300m3And opening the peristaltic pump and the compressed air valve to perform guniting coating, and spraying the isolation coating solution and the enteric coating solution on the surface of the tablet core in sequence to obtain the diammonium glycyrrhizinate enteric-coated tablet.
Quality detection
1. Quality study
Study sample information: three batches of samples were produced for quality testing according to the production method provided in example 3:
the impurity and release behavior studies were performed on three self-developed samples.
1.1 Standard conditions
Three self-made samples (lot numbers: 150501, 150502 and 150503) are taken, and are measured according to the dissolution rate and release rate (first method of 0931 of the general rules of the national pharmacopoeia 2015), 1000ml of 0.1mol/L hydrochloric acid solution is used as a solvent, the rotating speed is 100 r/min, the temperature is 37 +/-0.5 ℃, the operation is carried out according to the method, 10ml of the solution is taken and filtered after 120 minutes, and the solution is used as a test solution (1). The acid solution in the container was discarded, and 1000ml of phosphate buffer (pH 6.8) at 37. + -. 0.5 ℃ was immediately added thereto at a rotation speed of 100 rpm, and 10ml of each of the solutions was filtered at 10 minutes, 15 minutes, 20 minutes, 30 minutes and 45 minutes to obtain a sample solution (2). Separately, the nicotinamide control solution dried at 105 ℃ to constant weight is precisely weighed, and 0.1mol/L hydrochloric acid solution and phosphate buffer solution (pH 6.8) are respectively added to dissolve and quantitatively dilute to prepare solutions containing about 20 μ g per 1ml, which are respectively used as the control solution (1) and the control solution (2). Taking a reference substance solution (1) and a test substance solution (1), measuring the absorbance AS1 of the reference substance solution (1) AT the wavelength of 261nm by taking a 0.1mol/L hydrochloric acid solution AS a blank, measuring the absorbance AT1 of the test substance solution (1) AT the wavelength of 252nm, and multiplying the absorbance AT1 by 1.898 to calculate the release amount in acid; taking the reference solution (2) and the test solution (2), measuring the absorbance AS2 of the reference solution (2) AT the wavelength of 261nm by taking a phosphate buffer solution (pH 6.8) AS a blank, measuring the absorbance AT2 of the test solution (2) AT the wavelength of 252nm, and multiplying the absorbance AT2 by 1.898 to calculate the release amount in the buffer. The results are shown in tables 1 to 5 (n: 12).
The results show that: the release amount of the same batch of samples in 0.1mol/L hydrochloric acid is within 3 percent and not more than 10 percent, and the acid resistance meets the requirement; the release uniformity was shown to be good when the release rate in the phosphate buffer solution at pH6.8 was < 20% at 10min and < 10% at each of the other time points.
TABLE 10.1 mol/L hydrochloric acid solution release (%)
| |
150501 | 150502 | 150503 |
| 100 turns | 0.58 | 0.77 | 0.82 |
TABLE 2 cumulative release from tablets in phosphate buffer at pH6.8 (batch No. 150501)
TABLE 3 cumulative release from tablets in phosphate buffer at pH6.8 (batch No. 150502)
TABLE 4 cumulative release from tablets in phosphate buffer at pH6.8 (batch No. 150503)
TABLE 5 comparison of the results of 100-turn cumulative release in phosphate buffer at pH6.8
1.2 investigation of different rotational speeds
Taking a self-made sample (batch number: 150501), and according to a dissolution and release determination method (the first method of 0931 in the four parts of the 2015 edition of Chinese pharmacopoeia), taking 1000ml of 0.1mol/L hydrochloric acid solution as a solvent, rotating at the speed of 50 r/min and at the temperature of 37 +/-0.5 ℃, operating according to the method, and taking 10ml of the solution and filtering the solution after 120 minutes to be used as a test solution (1). The acid solution in the container was discarded, and 1000ml of phosphate buffer (pH 6.8) at 37. + -. 0.5 ℃ was immediately added thereto at a rotation speed of 100 rpm, and 10ml of each of the solutions was filtered at 10 minutes, 15 minutes, 20 minutes, 30 minutes and 45 minutes to obtain a sample solution (2). Separately, the nicotinamide control solution dried at 105 ℃ to constant weight is precisely weighed, and 0.1mol/L hydrochloric acid solution and phosphate buffer solution (pH 6.8) are respectively added to dissolve and quantitatively dilute to prepare solutions containing about 20 μ g per 1ml, which are respectively used as the control solution (1) and the control solution (2). Taking a reference substance solution (1) and a test substance solution (1), measuring the absorbance AS1 of the reference substance solution (1) AT the wavelength of 261nm by taking a 0.1mol/L hydrochloric acid solution AS a blank, measuring the absorbance AT1 of the test substance solution (1) AT the wavelength of 252nm, and multiplying the absorbance AT1 by 1.898 to calculate the release amount in acid; taking the reference solution (2) and the test solution (2), measuring the absorbance AS2 of the reference solution (2) AT the wavelength of 261nm by taking a phosphate buffer solution (pH 6.8) AS a blank, measuring the absorbance AT2 of the test solution (2) AT the wavelength of 252nm, and multiplying the absorbance AT2 by 1.898 to calculate the release amount in the buffer. The results are shown in tables 6 to 8 (n: 12).
TABLE 60.1 mol/L hydrochloric acid solution Release amount (%)
| Rotational speed | 20141001 | 150501 | 150723202 |
| 50 turn | 0.51 | 0.46 | 0.46 |
TABLE 7 cumulative release from tablets in phosphate buffer at pH6.8 (50 rpm, lot number: 150501)
TABLE 8 comparison of the results of 50-turn cumulative release in phosphate buffer at pH6.8
The results show that: at 100 revolutions and 50 revolutions, the accumulated release amount RSD% of the same batch at the first time point is less than 20%, the accumulated release amount RSD% of the rest time points is less than 10%, the release of the self-researched samples in phosphate buffer medium with pH6.8 for 45 minutes is more than 85%, and the batch-to-batch reproducibility is good (n is 12).
1.3 related substance Studies
The self-made samples were subjected to impurity profile analysis and the results are shown in Table 9.
As can be seen from the following table, the maximum content of the glycyrrhizic acid impurity 18- α in the product is 0.83% and is far less than the limit (less than or equal to 10%) required by the drug standard, the maximum content of the glycyrrhizic acid impurity A in the product is 3.59% and is also less than or equal to 5% required by the drug standard, the maximum content of other single-seed products is 0.95% and 2% respectively, the maximum content of all other impurities (excluding glycyrrhizic acid impurity A and glycyrrhizic acid peaks 18- α) is 3.93% and 7% respectively.
Table 9 sample impurity results from self-study
Injecting 1, 18- β glycyrrhizic acid peak relative retention time of 1.00, 2, impurity A glycyrrhizic acid peak and 3, 18- α glycyrrhizic acid peak.
The foregoing is merely exemplary and illustrative of the present inventive concept and various modifications, additions and substitutions of similar embodiments may be made to the specific embodiments described by those skilled in the art without departing from the inventive concept or exceeding the scope of the claims as defined in the accompanying claims.
Claims (6)
1. A diammonium glycyrrhizinate enteric-coated tablet is characterized in that: the diammonium glycyrrhizinate enteric-coated tablet comprises a tablet core, an isolation coating and an enteric coating from inside to outside in sequence, wherein the tablet core consists of the following components in parts by weight: 40-60 parts of diammonium glycyrrhizinate, 10-30 parts of lactose, 5-20 parts of low-substituted hydroxypropyl cellulose, 1-5 parts of povidone and 1-5 parts of magnesium stearate, wherein the isolation coating comprises the following components in parts by weight: 20-40 parts of ethyl cellulose, 520-40 parts of HPMCE and 5-10 parts of triethyl citrate, wherein the enteric coating comprises the following components in parts by weight: 30-30D-55100 parts of Eudragit L, 10-30 parts of talcum powder, 6-12 parts of glyceryl behenate, 2-4 parts of triethyl citrate and 4-6 parts of hydroxypropyl methyl cellulose.
2. The diammonium glycyrrhizinate enteric-coated tablet according to claim 1, characterized in that: the tablet core consists of the following components in parts by weight: 50 parts of diammonium glycyrrhizinate, 20 parts of lactose, 12.5 parts of low-substituted hydroxypropyl cellulose, 3 parts of povidone and 3 parts of magnesium stearate, wherein the isolation coating comprises the following components in parts by weight: 30 parts of ethyl cellulose, 530 parts of HPMCE and 7.5 parts of triethyl citrate, wherein the enteric coating comprises the following components in parts by weight: 30-30D-55100 parts of Eudragit L, 20 parts of talcum powder, 9 parts of glyceryl behenate, 3 parts of triethyl citrate and 5 parts of hydroxypropyl methyl cellulose.
3. The diammonium glycyrrhizinate enteric-coated tablet according to claim 1, characterized in that: the content of the isolating coating is 5-10 mg/tablet, the content of the enteric coating is 30-50 mg/tablet, and the content of diammonium glycyrrhizinate in the tablet core is not lower than 48%.
4. The preparation method of diammonium glycyrrhizinate enteric-coated tablets according to any one of claims 1 to 3, characterized in that: the method comprises the following steps:
s1: preparing a tablet core, weighing diammonium glycyrrhizinate, lactose, low-substituted hydroxypropyl cellulose, povidone and magnesium stearate according to the formula amount, sequentially mixing diammonium glycyrrhizinate, lactose and low-substituted hydroxypropyl cellulose by an equivalent incremental method, adding povidone during the mixing process, uniformly mixing, performing wet granulation on a swing granulator, drying, performing total mixing with magnesium stearate, and performing tabletting by using a rotary tablet press to obtain the tablet core;
s2: dissolving ethyl cellulose with deionized water, adding HPMCE5 and triethyl citrate, stirring, and filtering to obtain an isolation coating solution;
s3: preparing an enteric coating solution: diluting the Eudragit L30D-55 with deionized water, adding dissolved triethyl citrate, slowly adding glyceryl behenate and hydroxypropyl methylcellulose under stirring, adding pulvis Talci under stirring, and filtering to obtain enteric coating solution;
s4: coating: and placing the tablet cores in a coating machine, starting the coating machine, and spraying the isolation coating solution and the enteric coating solution on the surfaces of the tablet cores in sequence to obtain the diammonium glycyrrhizinate enteric-coated tablets.
5. The preparation method of diammonium glycyrrhizinate enteric-coated tablets according to claim 4, characterized in that: and S1, drying for 3-5 hours by adopting a thermal cycle oven, controlling the drying temperature to be 70-80 ℃, and then finishing the particles by using a stainless steel screen mesh with 18 meshes.
6. The preparation method of diammonium glycyrrhizinate enteric-coated tablets according to claim 4, characterized in that: s4, setting the rotating speed of a roller of the coating machine to be 6-10 r/min, controlling the air inlet temperature to be 40-60 ℃, the air outlet temperature to be 35-45 ℃, and the air inlet flow rate: 300m3And h, opening a peristaltic pump and a compressed air valve to spray coating.
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Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101081227A (en) * | 2006-05-31 | 2007-12-05 | 江苏正大天晴药业股份有限公司 | Composition of diammonium glycyrrhizinate |
| CN102008492A (en) * | 2006-12-29 | 2011-04-13 | 江苏正大天晴药业股份有限公司 | Oral medicinal composition of glycyrrhizic acid or glycyrrhetate and preparation method thereof |
| JP2012012325A (en) * | 2010-06-30 | 2012-01-19 | St Marianna Univ School Of Medicine | Nanoparticle of anti-inflammatory compound and method for producing the same |
| CN104288108A (en) * | 2014-10-18 | 2015-01-21 | 山东世博金都药业有限公司 | Diammonium glycyrrhizinate enteric-coated sustained-release pellet and preparation method thereof |
| CN105582546A (en) * | 2016-02-26 | 2016-05-18 | 正大天晴药业集团股份有限公司 | Compound enteric-coated tablets of entecavir phospholipid complex and diammonium glycyrrhizinate |
| CN105663063A (en) * | 2016-02-26 | 2016-06-15 | 正大天晴药业集团股份有限公司 | Compound pellet of diammonium glycyrrhizinate and entecavir and preparation method of compound pellet |
-
2020
- 2020-01-19 CN CN202010059962.XA patent/CN111067877A/en active Pending
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101081227A (en) * | 2006-05-31 | 2007-12-05 | 江苏正大天晴药业股份有限公司 | Composition of diammonium glycyrrhizinate |
| CN102008492A (en) * | 2006-12-29 | 2011-04-13 | 江苏正大天晴药业股份有限公司 | Oral medicinal composition of glycyrrhizic acid or glycyrrhetate and preparation method thereof |
| JP2012012325A (en) * | 2010-06-30 | 2012-01-19 | St Marianna Univ School Of Medicine | Nanoparticle of anti-inflammatory compound and method for producing the same |
| CN104288108A (en) * | 2014-10-18 | 2015-01-21 | 山东世博金都药业有限公司 | Diammonium glycyrrhizinate enteric-coated sustained-release pellet and preparation method thereof |
| CN105582546A (en) * | 2016-02-26 | 2016-05-18 | 正大天晴药业集团股份有限公司 | Compound enteric-coated tablets of entecavir phospholipid complex and diammonium glycyrrhizinate |
| CN105663063A (en) * | 2016-02-26 | 2016-06-15 | 正大天晴药业集团股份有限公司 | Compound pellet of diammonium glycyrrhizinate and entecavir and preparation method of compound pellet |
Non-Patent Citations (1)
| Title |
|---|
| 谢云根: "甘草酸二铵肠溶片的处方设计及工艺的研究", 《江西中医学院学报》 * |
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