CN104983707A - Composite phosphoesterase and chitin compound sustained release tablet and preparation method thereof - Google Patents
Composite phosphoesterase and chitin compound sustained release tablet and preparation method thereof Download PDFInfo
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- CN104983707A CN104983707A CN201510420962.7A CN201510420962A CN104983707A CN 104983707 A CN104983707 A CN 104983707A CN 201510420962 A CN201510420962 A CN 201510420962A CN 104983707 A CN104983707 A CN 104983707A
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- chitin
- slow
- release tablet
- phosphoesterases complex
- release
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Abstract
The invention discloses a composite phosphoesterase and chitin compound sustained release tablet and a preparation method thereof. The compound sustained release tablet is composed of a composite phosphoesterase slow release part and a chitin rapid release part, wherein the composite phosphoesterase slow release part comprises composite phosphoesterase, a slow release material, a diluent, a surfactant and a lubricant, and the chitin rapid release part comprises chitin, the diluent, the surfactant, a disintegrating agent and the lubricant. The preparation method comprises the following steps: preparing materials, granulating, finishing and tabletting. The compound sustained release tablet organically combining composite phosphoesterase and chitin, maximally reduces the amount of pharmaceutic adjuvants, can effectively prevent and treat hepatopathy, has high effective proportions of medicines, has mutually promoted medicine effects, is convenient to take, and is in favor of reducing the medicine price and realizing industrial production.
Description
Technical field
The present invention relates to a kind of compound slow-release tablet of prevention and therapy hepatopathy, is a kind of phosphoesterases complex chitin compound slow-release tablet and preparation method specifically.
Background technology
In recent years, along with the change of people life style and diet structure, the sickness rate of the hyperlipemia-fatty liver (non-alcoholic fatty liver disease) caused by the factors such as obesity increases day by day, and likely develops into fat hepatitis, fatty cirrhosis, there is no definite therapeutic scheme at present.Barley malt sprouts is the by-product of Beer Production, phosphoesterases complex is then have bioactive compound enzymic preparation from wherein extraction and isolation, mainly comprise phosphodiesterase, phosphate, ribonuclease, deoxyribonuclease, nucleotidase, proteolytic enzyme, arginine esterase and amylase etc. more than ten and plant enzyme, for isabelline fine powder, water content, below 10%, is dissolved better in micro alkaline solution.There is promotion appetite, health invigorating, improve organism metabolism, improve the functions such as the regeneration capacity of wounded hepatocytes, for the auxiliary therapeutical agent of chronic persistent hepatitis, chronic hepatitis, early stage liver cirrhosis etc.
Chitin, as functional health food, is described as the 6th vital principle after protein, fat, saccharide, vitamin and inorganic salt by American-European academia in 1991.It is different from general nutrient and healthcare products completely, has reduction cholesterol and fat, prevents fatty liver and hepatitis, promotion to produce the effect of hepatitis virus antibody.Containing amino (-NH2) in chitin molecule, there is alkalescence, can ammonium salt be generated under the reaction of gastric acid, intestinal pH can be made to shift to alkaline side, improve acidic physique.Generate positively charged cation group in reaction, this is the positively charged edibility dietary fiber that occurring in nature uniquely exists.Because single medicine often can not obtain desirable curative effect, clinically usually by two kinds or two or more Drug combinations, good curative effect can be obtained; But two kinds or two or more folk prescription Drug combinations, take inconvenience, independent tableting aid consumption is relatively many, packing cost is high, therefore not only medication is facilitated after two kinds or two or more depressor being made compound preparation, and reduce adjuvant and packing cost, be conducive to large production.
Summary of the invention
The object of the invention is exactly to overcome the defect of the folk prescription Drug combination of two kinds or two or more prevention and therapy hepatopathys, proposing one can prevention and therapy hepatopathy, two kinds of medicines are combined, the effective ratio of medicine is high, the phosphoesterases complex chitin compound slow-release tablet of taking convenience.
The present invention seeks to be realized by following technical scheme:
A kind of phosphoesterases complex chitin compound slow-release tablet, this compound slow-release tablet is made up of phosphoesterases complex slow-released part and chitin immediate release section;
Wherein the weight proportion of each component of phosphoesterases complex slow-released part and compound slow-release tablet is:
The weight proportion of each component of chitin immediate release section and compound slow-release tablet is:
Further, the object of the invention can also be realized by following technical scheme:
A kind of phosphoesterases complex chitin compound slow-release tablet, slow-release material is: at least one in hypromellose, polyvidone, alginate, chitosan.
A kind of phosphoesterases complex chitin compound slow-release tablet, diluent is: at least one in starch, Icing Sugar, lactose, microcrystalline Cellulose.
A kind of phosphoesterases complex chitin compound slow-release tablet, surfactant is: fatty glyceride, sucrose ester, fatty acid Pyrusussuriensis are smooth, at least one in Polysorbate.
A kind of phosphoesterases complex chitin compound slow-release tablet, disintegrating agent is: dried starch, carboxymethyl starch are received, at least one in crospolyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose.
A kind of phosphoesterases complex chitin compound slow-release tablet, lubricant is: at least one in magnesium stearate, micropowder silica gel, Pulvis Talci.
Present invention also offers a kind of preparation method of phosphoesterases complex chitin compound slow-release tablet, comprise the following steps:
1. get the raw materials ready, get the raw materials ready according to a kind of each composition weight proportioning of phosphoesterases complex chitin compound slow-release tablet, pharmaceutic adjuvant pulverized 80 ~ 100 mesh sieves respectively, and phosphoesterases complex, chitin pulverized 100 mesh sieves respectively;
2. granulate, granulate respectively after phosphoesterases complex slow-released part is mixed homogeneously respectively with chitin immediate release section, 16 ~ 24 mesh sieve granulate;
3. tabletting, by step, 2. gained granule is by bi-layer tablet press secondary tabletting, and first pressure phosphoesterases complex slow release layer, presses chitin release layer again after slow release synusia coincidence lattice; The specification of compound slow-release tablet is: every sheet is containing phosphoesterases complex 50 ~ 200mg, chitin 100 ~ 300mg.
In order to verify the drug effect of compound slow-release tablet of the present invention, pharmacodynamic analysis is as follows:
To CCl
4the preventive effect of induced mice hepatic injury
Mice 30, is divided into 3 groups at random, and first group is negative control group, not medicine feed, second group is positive controls, and the 3rd group is test group, second group of folk prescription oral administration phosphoesterases complex quick releasing formulation 30mg/kg/d, every day 3 times, chitin 50mg/kg/d, every day 2 times; 3rd group of compound oral administration phosphoesterases complex 25mg/kg/d, chitin 40mg/kg/d, wherein phosphoesterases complex is slow-released part, every day 2 times.Test the 3rd day, each group all gives 0.2%CCl
4oleum sesami 10ml/kg, after 18h, whole mouse orbit gets blood, 1500r/min centrifugalize serum, measures SGPT (U/L) value, and gets liver, fix, make PATHOMORPHOLOGICAL OBSERVATION OF PULLORUM with 10% formalin with reitman-frankel method.
Administration group mice can resist CCl
4sGPT value caused by hepatic injury raises, but from angle of statistics, compound medicine group drug effect is better; From liver injury degree, administration group to a certain degree can prevent mouse liver injury, and matched group is hepatic injury seriously, but from angle of statistics, compound medicine group drug effect is better.
SGPT (U/L) result:
| 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | |
| First group | 200.02 | 180.21 | 195.23 | 179.34 | 186.56 | 177.21 | 184.35 | 191.28 | 187.54 | 168.15 |
| Second group | 123.02 | 115.34 | 102.26 | 128.25 | 116.35 | 120.79 | 134.71 | 129.21 | 119.65 | 108.97 |
| 3rd group | 98.32 | 81.25 | 105.32 | 116.59 | 92.75 | 102.57 | 87.54 | 95.26 | 124.51 | 114.89 |
Conclusion: compound slow-release tablet active drug consumption of the present invention every day is phosphoesterases complex 25mg/kg, chitin 40mg/kg, being less than positive controls active drug consumption every day is phosphoesterases complex 30mg/kg, chitin 50mg/kg.Therapeutic effect aspect, the preventive effect of compound slow-release tablet hepatic injury of the present invention is better, is better than matched group.Illustrate that phosphoesterases complex chitin compound slow-release tablet of the present invention has good slow release effect and drug effect.
To CCl
4the therapeutical effect of induced mice hepatic injury
Mice 30, is divided into 3 groups at random, and first group is negative control group, and second group is positive controls, and the 3rd group is test group, experiment first day respectively organize all to 0.2%CCl
4oleum sesami 10ml/kg, after 8h, first group of group not medicine feed; Second group of folk prescription oral administration phosphoesterases complex quick releasing formulation 30mg/kg/d, every day 3 times, chitin 50mg/kg/d, every day 2 times; 3rd group of compound oral administration phosphoesterases complex 25mg/kg/d, chitin 40mg/kg/d, wherein phosphoesterases complex is slow-released part, every day 2 times.Within 4th day, eye socket gets blood, and survey SGPT, hepatic tissue makes PATHOMORPHOLOGICAL OBSERVATION OF PULLORUM.
Administration group can make impaired hepatic tissue recover to accelerate, and SGPT value reduces to be accelerated, and the reduction of compound medicine group SGPT value is accelerated faster.Hepatic lesions degree aspect compound medicine group has 3 mice pathological changes comparatively light, and folk prescription medicine group has 2 mice pathological changes lighter.
SGPT (U/L) result:
| 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | |
| First group | 204.56 | 184.21 | 199.87 | 179.34 | 189.58 | 174.28 | 188.37 | 196.28 | 213.84 | 210.56 |
| Second group | 152.23 | 148.51 | 141.28 | 139.57 | 154.67 | 120.51 | 135.09 | 124.50 | 116.35 | 128.91 |
| 3rd group | 129.26 | 130.54 | 102.30 | 97.20 | 143.54 | 119.54 | 96.58 | 125.93 | 109.40 | 116.42 |
Conclusion: compound slow-release tablet active drug consumption of the present invention every day is phosphoesterases complex 25mg/kg, chitin 40mg/kg, being less than positive controls active drug consumption every day is phosphoesterases complex 30mg/kg, chitin 50mg/kg.Therapeutic effect aspect, compound slow-release tablet of the present invention is better to the therapeutical effect of hepatic injury, is better than matched group.Illustrate that phosphoesterases complex chitin compound slow-release tablet of the present invention has good slow release effect and drug effect.
Beneficial effect of the present invention:
Two kinds of medicine phosphoesterases complexs, chitins combine by the present invention, decrease pharmaceutic adjuvant consumption to greatest extent, can be used for prevention and therapy hepatopathy.Phosphoesterases complex dissolves better in micro alkaline solution, and containing amino (-NH2) in chitin molecule, has alkalescence, can generate ammonium salt under the reaction of gastric acid, intestinal pH can be made to shift to alkaline side; Therefore two kinds of medicines complement each other, and combine, drug effect increases greatly than folk prescription medicine.This compound slow-release tablet enables phosphoesterases complex realize in vivo discharging medicine lastingly, slowly, and blood drug level is steady, fluctuates little, thus reduces administration frequency, improves patient compliance.By controlling active drug composition concentration in blood to maintain drug effect, reducing drug release and reaching peak number of times, certain protection is also had to the internal organs of patient.Present invention process is simple, and favorable reproducibility, is easy to suitability for industrialized production; Cost is low, is conducive to reducing product price.
Detailed description of the invention
According to following embodiment, the present invention may be better understood.But those skilled in the art will readily understand, concrete material proportion, process conditions and result thereof described by embodiment only should can not limit the present invention described in detail in claims yet for illustration of the present invention.
Embodiment 1
Slow releasing tablet of the present invention is formulated by the supplementary material of following weight proportioning:
Phosphoesterases complex slow-released part:
Chitin immediate release section:
A preparation method for phosphoesterases complex chitin compound slow-release tablet, comprises the following steps:
1. get the raw materials ready, get the raw materials ready according to the described each composition weight proportioning of a kind of phosphoesterases complex chitin compound slow-release tablet, pharmaceutic adjuvant pulverized 80 mesh sieves, and phosphoesterases complex, chitin were pulverized 100 mesh sieves;
2. granulate, granulate respectively after phosphoesterases complex slow-released part is mixed homogeneously respectively with chitin normal part, 20 mesh sieve granulate;
3. tabletting, by step, 2. gained granule is by bi-layer tablet press secondary tabletting, and first pressure phosphoesterases complex slow release layer, presses the common layer of chitin again after slow release synusia coincidence lattice; The specification of compound slow-release tablet is: every sheet is containing phosphoesterases complex 50mg, chitin 100mg.
Using method: every day 2 times, each 1 ~ 4, or follow the doctor's advice according to state of an illness weight situation.
Storage: cool place, shading, sealing are preserved.
Embodiment 2
Slow releasing tablet of the present invention is formulated by the supplementary material of following weight proportioning:
Phosphoesterases complex slow-released part:
Chitin immediate release section:
A preparation method for phosphoesterases complex chitin compound slow-release tablet, comprises the following steps:
1. get the raw materials ready, get the raw materials ready according to the described each composition weight proportioning of a kind of phosphoesterases complex chitin compound slow-release tablet, pharmaceutic adjuvant pulverized 100 mesh sieves, and phosphoesterases complex, chitin were pulverized 100 mesh sieves;
2. granulate, granulate respectively after phosphoesterases complex slow-released part is mixed homogeneously respectively with chitin normal part, 24 mesh sieve granulate;
3. tabletting, by step, 2. gained granule is by bi-layer tablet press secondary tabletting, and first pressure phosphoesterases complex slow release layer, presses the common layer of chitin again after slow release synusia coincidence lattice; The specification of compound slow-release tablet is: every sheet is containing phosphoesterases complex 100mg, chitin 150mg.
Using method: every day 2 times, each 1 ~ 4, or follow the doctor's advice according to state of an illness weight situation.
Storage: cool place, shading, sealing are preserved.
Embodiment 3
Slow releasing tablet of the present invention is formulated by the supplementary material of following weight proportioning:
Phosphoesterases complex slow-released part:
Chitin immediate release section:
A preparation method for phosphoesterases complex chitin compound slow-release tablet, comprises the following steps:
1. get the raw materials ready, get the raw materials ready according to the described each composition weight proportioning of a kind of phosphoesterases complex chitin compound slow-release tablet, pharmaceutic adjuvant pulverized 80 mesh sieves, and phosphoesterases complex, chitin were pulverized 100 mesh sieves;
2. granulate, granulate respectively after phosphoesterases complex slow-released part is mixed homogeneously respectively with chitin normal part, 16 mesh sieve granulate;
3. tabletting, by step, 2. gained granule is by bi-layer tablet press secondary tabletting, and first pressure phosphoesterases complex slow release layer, presses the common layer of chitin again after slow release synusia coincidence lattice; The specification of compound slow-release tablet is: every sheet is containing phosphoesterases complex 200mg, chitin 300mg.
Using method: every day 2 times, each 1 ~ 2, or follow the doctor's advice according to state of an illness weight situation.
Storage: cool place, shading, sealing are preserved.
Embodiment 4
Slow releasing tablet of the present invention is formulated by the supplementary material of following weight proportioning:
Phosphoesterases complex slow-released part:
Chitin immediate release section:
A preparation method for phosphoesterases complex chitin compound slow-release tablet, comprises the following steps:
1. get the raw materials ready, get the raw materials ready according to the described each composition weight proportioning of a kind of phosphoesterases complex chitin compound slow-release tablet, pharmaceutic adjuvant pulverized 100 mesh sieves, and phosphoesterases complex, chitin were pulverized 100 mesh sieves;
2. granulate, granulate respectively after phosphoesterases complex slow-released part is mixed homogeneously respectively with chitin normal part, 20 mesh sieve granulate;
3. tabletting, by step, 2. gained granule is by bi-layer tablet press secondary tabletting, and first pressure phosphoesterases complex slow release layer, presses the common layer of chitin again after slow release synusia coincidence lattice; The specification of compound slow-release tablet is: every sheet is containing phosphoesterases complex 50mg, chitin 150mg.
Using method: every day 2 times, each 1 ~ 4, or follow the doctor's advice according to state of an illness weight situation.
Storage: cool place, shading, sealing are preserved.
Embodiment 5
Slow releasing tablet of the present invention is formulated by the supplementary material of following weight proportioning:
Phosphoesterases complex slow-released part:
Chitin immediate release section:
A preparation method for phosphoesterases complex chitin compound slow-release tablet, comprises the following steps:
1. get the raw materials ready, get the raw materials ready according to the described each composition weight proportioning of a kind of phosphoesterases complex chitin compound slow-release tablet, pharmaceutic adjuvant pulverized 80 mesh sieves, and phosphoesterases complex, chitin were pulverized 100 mesh sieves;
2. granulate, granulate respectively after phosphoesterases complex slow-released part is mixed homogeneously respectively with chitin normal part, 24 mesh sieve granulate;
3. tabletting, by step, 2. gained granule is by bi-layer tablet press secondary tabletting, and first pressure phosphoesterases complex slow release layer, presses the common layer of chitin again after slow release synusia coincidence lattice; The specification of compound slow-release tablet is: every sheet is containing phosphoesterases complex 150mg, chitin 250mg.
Using method: every day 2 times, each 1 ~ 2, or follow the doctor's advice according to state of an illness weight situation.
Storage: cool place, shading, sealing are preserved.
Embodiment 6
Friability inspection of the present invention
Check according to " Chinese Pharmacopoeia " 2010 editions (two) annex X G tablet friability inspection technique.
Instrument: friability tester.
Method: inspection technique sheet heavily gets some for 0.65g or following person, makes its gross weight be about 6.5g; Sheet is great gets 10 in 0.65g person.Blow away the powder come off with hair-dryer, precise weighing, put in cylinder, rotate 100 times.Take out, with method removing powder, precise weighing, less loss weight must not cross 1%, and the sheet that must not detect fracture, be full of cracks and pulverize.This test is general only to be done 1 time.As less loss weight more than 1% time, should recheck 2 times, the average less loss weight of 3 times must not cross 1%, and must not detect fracture, be full of cracks and pulverize sheet.
Result: embodiments of the invention 1-5 gained sample all conforms with the regulations through friability test inspection.
Embodiment 7
Release inspection of the present invention
According to Chinese Pharmacopoeia 2010 editions two annex XD drug release determination method first methods, adopting the device of dissolution method, take water as release medium, measures the release of sample obtained by embodiment 1-5 respectively.Each sample is all in 1h, 2h, 8h, 12h sampling, and detected by HPLC, phosphoesterases complex release (%) the results are shown in Table 1.
Table 1
Conclusion: a kind of phosphoesterases complex chitin compound slow-release tablet vitro release result of the present invention shows that this compound slow-release tablet has slow releasing medicine, drug level is steady, and fluctuate little feature.
Above embodiment is only for illustrating technical conceive of the present invention and feature; its object is to allow person skilled in the art understand content of the present invention and to be implemented; can not limit the scope of the invention with this; all equivalences done according to spirit of the present invention change or modify, and all should be encompassed in protection scope of the present invention.
Claims (7)
1. a phosphoesterases complex chitin compound slow-release tablet, is characterized in that, this compound slow-release tablet is made up of phosphoesterases complex slow-released part and chitin immediate release section;
Wherein the weight proportion of each component of phosphoesterases complex slow-released part and compound slow-release tablet is:
The weight proportion of each component of chitin immediate release section and compound slow-release tablet is:
。
2. a kind of phosphoesterases complex chitin compound slow-release tablet according to claim 1, it is characterized in that, slow-release material is: at least one in hypromellose, polyvidone, alginate, chitosan.
3. a kind of phosphoesterases complex chitin compound slow-release tablet according to claim 1, it is characterized in that, diluent is: at least one in starch, Icing Sugar, lactose, microcrystalline Cellulose.
4. a kind of phosphoesterases complex chitin compound slow-release tablet according to claim 1, it is characterized in that, surfactant is: fatty glyceride, sucrose ester, fatty acid Pyrusussuriensis are smooth, at least one in Polysorbate.
5. a kind of phosphoesterases complex chitin compound slow-release tablet according to claim 1, it is characterized in that, disintegrating agent is: dried starch, carboxymethyl starch are received, at least one in crospolyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose.
6. a kind of phosphoesterases complex chitin compound slow-release tablet according to claim 1, it is characterized in that, lubricant is: at least one in magnesium stearate, micropowder silica gel, Pulvis Talci.
7. a preparation method for phosphoesterases complex chitin compound slow-release tablet, is characterized in that, comprises the following steps:
1. get the raw materials ready, get the raw materials ready according to each composition weight proportioning of a kind of phosphoesterases complex chitin compound slow-release tablet described in any one of claim 1-6, pharmaceutic adjuvant pulverized 80 ~ 100 mesh sieves respectively, and phosphoesterases complex, chitin pulverized 100 mesh sieves respectively;
2. granulate, granulate respectively after phosphoesterases complex slow-released part is mixed homogeneously respectively with chitin immediate release section, 16 ~ 24 mesh sieve granulate;
3. tabletting, by step, 2. gained granule is by bi-layer tablet press secondary tabletting, and first pressure phosphoesterases complex slow release layer, presses chitin release layer again after slow release synusia coincidence lattice; The specification of compound slow-release tablet is: every sheet is containing phosphoesterases complex 50 ~ 200mg, chitin 100 ~ 300mg.
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN201524268U (en) * | 2009-11-04 | 2010-07-14 | 青岛汉河药业有限公司 | Extended release pills in micro-capsules |
| CN101869552A (en) * | 2009-04-25 | 2010-10-27 | 青岛科技大学 | Preparation method of chitin tablet |
| WO2014150074A1 (en) * | 2013-03-15 | 2014-09-25 | Massachusetts Institute Of Technology | Compositions and methods for nucleic acid delivery |
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2015
- 2015-07-17 CN CN201510420962.7A patent/CN104983707A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101869552A (en) * | 2009-04-25 | 2010-10-27 | 青岛科技大学 | Preparation method of chitin tablet |
| CN201524268U (en) * | 2009-11-04 | 2010-07-14 | 青岛汉河药业有限公司 | Extended release pills in micro-capsules |
| WO2014150074A1 (en) * | 2013-03-15 | 2014-09-25 | Massachusetts Institute Of Technology | Compositions and methods for nucleic acid delivery |
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Application publication date: 20151021 |