CN103315971B - Acarbose tablets and preparation method thereof - Google Patents
Acarbose tablets and preparation method thereof Download PDFInfo
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- CN103315971B CN103315971B CN201310232803.5A CN201310232803A CN103315971B CN 103315971 B CN103315971 B CN 103315971B CN 201310232803 A CN201310232803 A CN 201310232803A CN 103315971 B CN103315971 B CN 103315971B
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Abstract
The invention discloses acarbose tablets and a preparation method thereof. The preparation method comprises the following steps of: uniformly mixing acarbose, microcrystalline cellulose, starch and 2/3 of carboxymethyl starch sodium to form a premix; pelletizing and granulating the premix through a dry process to obtain particles; and uniformly mixing the particles, 1/3 of carboxymethyl starch sodium, magnesium stearate and silicon dioxide, tabletting the mixture by a tablet press to obtain the acarbose tablets. According to the tablets prepared by dry-process palletizing and tabletting methods, the hardness and stability of the tablets are effectively improved and the problems of unaccepted disintegration time and unaccepted microorganisms are solved; as a result, the quality of the tablets is improved; and besides, the preparation method is simple in process flow, capable of saving energy source and cost, and suitable for industrial production.
Description
Technical field
The present invention relates to a kind of field of pharmaceutical preparations, be specifically related to a kind of acarbose tablet and preparation method thereof.
Background technology
Diabetes (Diabetes Mellitus, DM) are one group and increase the metabolic disease for feature with chronic blood glucose (abbreviation blood glucose) level, are caused by insulin secretion and (or) effect defect.Long-term carbohydrate and fat, protein metabolism disorder can cause Multisystem damage, cause the chronic progressive external pathological changes of the histoorgans such as eye, kidney, nerve, heart, blood vessel, hypofunction and exhaustion.Be in a bad way or stress time can there is serious metabolic disorder, as diabetic ketoacidosis (DKA), Hyperglycemic hyperosmolar status etc.Primary disease makes patients ' life quality reduce, the lost of life, and case fatality rate increases, and has become the third-largest noninfectious of the serious harm human health after developed country's relaying cardiovascular and cerebrovascular disease, cancer.Expect the year two thousand thirty, the prevalence of diabetes by by 2000 1.73 hundred million rise to 3.66 hundred million.Accordingly, diabetes will feed through to 5% of whole world total population.The diabetics of China constantly increases, and has become the second diabetes big country after India.Diabetes are a kind of chronic diseases, need Long-term taking medicine, Scientific Treatment.In diabetics, patients with NIDDM accounts for more than 90%, and in the remedy measures of patients with NIDDM, oral antidiabetic drug is main treatment means.
Acarbose (Acarbose) is a kind of medicine being used for the treatment of type Ⅱdiabetes mellitus that Bayer A.G's the mid-1970s is developed, it is now the number one brand medicine of oral antidiabetic drug, its chemical name is O-4, two deoxidation-the 4-[(1S of 6-, 4R, 5S, 6S)-4, 5, 6-trihydroxy-3-(hydroxymethyl)-2-cyclohexenyl-1-amino]-a-D-glucopyranosyl-(1 → 4)-O-a-D-glucopyranosyl-(1 → 4)-D-Glucopyranose., nineteen ninety takes the lead in going on the market in Germany, within 1996, obtain FDA approval to go on the market in the U.S., within 1998, acarbose enters China, commodity are called " acarbose ".
Acarbose structural formula is:
Acarbose is a kind of oral antidiabetic drug being different from sulphanylureas and biguanides utilizing biosynthetic method to make, and is a-glucosidase inhibitor, has powerful affinity to the amylase of enterocyte upper limb and a-glucosidase.Take acarbose at table, the hydrolysis of food polysaccharide class in digestive tract can be disturbed, and the absorption of delay glucose and fructose, the peak value that therefore post-prandial glycemia raises obviously reduces.Because this suppression is reversible, so acarbose only deferrable complex carbohydrates digestion, instead of block the absorption of glucose completely.Show health adult's clinical trial, acarbose can reduce post-prandial hyperglycemia and plasma insulin concentrations, and delay glucose enters the concentration of blood, has evened up blood glucose peak after the meal, can slow down again the decline after sugared peak value.Blood glucose is tended to be steady round the clock.The patient of commute generation Nocturnal hypoglycemia, application acarbose is more useful.Show through zoopery, acarbose reduces the effect of blood triglyceride, cholesterolemia and FFA concentrations in addition.
Publication number is disclose Acarbose medicine composition and preparation method thereof in the Chinese patent application of CN101019874A, and it adopts the mix lubricant by acarbose and fluidizer effect, adds filler, then adds mix lubricant, tabletting, to obtain final product after mixing.The shortcoming that the method exists: acarbose mobility is very poor, although added lubricant can not well to take on a new look its mobility, and tabletting after principal agent and auxiliary materials and mixing, acarbose raw material ratio is lighter, adjuvant is directly mixed rear, then tabletting, occurs that in sheet, difference is large, even there is underproof phenomenon and there will be in tableting processes dusting, the heavy qualification of sheet cannot be ensured.
The prescription that the present inventor adopts CN102688252A to invent and method carry out tabletting, and find that the mobility of powder and compressibility are not very desirable, and occur phenomenon of dusting, tablet weight variation is large.
In the preparation process of tablet, the preparation of granule is a crucial step, and the quality of grain graininess, directly affects the effect of tabletting.Adopt wet granulation and High Shear Mixer Granulator effect all not good, easily cause the tablet quality after tabletting defective, and the phenomenon of sieve series grain of being sorry.
Summary of the invention
The invention provides a kind of acarbose tablet and preparation method thereof, when adopting this preparation method to prepare acarbose tablet, avoid poor fluidity that acarbose tablet prepared by existing preparation method exists, poor compressibility, disintegration difference and the high phenomenon of cost, substantially increase the qualification rate of product.
A kind of acarbose tablet, with parts by weight, be made up by dry granulation tabletting of following raw material:
In the present invention, found through experiments and add appropriate carboxymethylstach sodium in the prescription of acarbose tablet, not only can improve the disintegration of acarbose tablet, the mobility in acarbose tablet preparation process and compressibility can also be improved, decrease the phenomenon of dusting in preparation process, substantially increase the qualification rate of product.
As preferably, described acarbose tablet, with parts by weight, be made up by dry granulation tabletting of following raw material:
Or, as preferably, described acarbose tablet, with parts by weight, be made up by dry granulation tabletting of following raw material:
Or, as preferably, described acarbose tablet, with parts by weight, be made up by dry granulation tabletting of following raw material:
The acarbose tablet adopting these proportionings to obtain has good disintegration, mobility and compressibility simultaneously, and the method easily through dry granulation obtains.
The preparation method of described acarbose tablet, comprises the following steps:
(1) by acarbose, microcrystalline Cellulose and starch, 2/3 carboxymethylstach sodium mix homogeneously, pre-composition is obtained;
(2) pre-composition step (1) obtained, by dry granulation, granulate, obtains particulate matter;
(3) particulate matter, 1/3 carboxymethylstach sodium, magnesium stearate and the silicon dioxide mix homogeneously that step (2) are obtained, through tabletting, obtain described acarbose tablet.
In preparation method of the present invention, in advance by acarbose, microcrystalline Cellulose and carboxymethylstach sodium mix homogeneously, be because the mobility of acarbose, compressibility are poor, be mixed together can improve liquidity with microcrystalline Cellulose, carboxymethylstach sodium in advance, be convenient to Homogeneous phase mixing; Again through dry granulation, granulate, then add remaining carboxymethylstach sodium, magnesium stearate and silicon dioxide mix homogeneously, through tabletting, obtain acarbose tablet.Make to produce adhesion between each raw molecule by compression stress during such tabletting, improve hardness and the stability of tablet, and tablet weight variation is qualified in tableting processes, avoids the phenomenon of dusting.
As preferably, the order number of described acarbose, microcrystalline Cellulose, starch, carboxymethylstach sodium, silicon dioxide, magnesium stearate is at least 100 orders.The raw material selecting granularity less is more conducive to the Homogeneous phase mixing of material, can obtain uniformity better particulate matter during dry granulation, improves stability and the compressibility of the mixture of particulate matter and magnesium stearate and silicon dioxide.
As preferably, in step (2), described dry granulation adopts dry granulating machine; Described dry granulating machine nip pressure be Stress control at 20 ~ 50N, pressure roller rotating speed is 17 revs/min ~ 22 revs/min, and mixture transfer rate is 45 revs/min ~ 80 revs/min.This granulation conditions is convenient to obtain evenly, the particulate matter of good fluidity, and after ensureing tabletting, tablet is qualified for disintegration, and hardness meets the requirements.Described dry granulating machine can adopt GZL series dry method rolling granulator.
As further preferred, in step (2), described dry granulating machine nip pressure is 40Pa, and pressure roller rotating speed is 20 revs/min, and mixture transfer rate is 60 revs/min.
As preferably, in step (2), described pre-composition by after dry granulation through 10 order ~ 30 mesh sieve granulate, obtain particulate matter.Homogeneous particulate matter can be obtained like this, the uniformity of subsequent mixtures material can be improved, thus improve the hardness of compression tablet.
As further preferably, in step (2), described pre-composition by after dry granulation through 20 mesh sieve granulate, obtain particulate matter.
The usage and dosage of acarbose tablet of the present invention: with before the meal at once full wafer swallow or chew together with former mouthfuls of foods and take, dosage varies with each individual.
General recommended dose is: initial dose is a 50mg, 3 times on the one.Be increased to a 0.1g gradually, 3 times on the one later.Under individual cases, a 0.2g can be increased to, 3 times on the one.Or follow the doctor's advice.
If patient's curative effect after taking medicine 4 ~ 8 weeks is not obvious, dosage can be increased.If it is not in good time that patient adheres to that strict diabetic diet still has, just can not increase dosage again, sometimes also need suitably to reduce dosage, mean dose is a 0.1g, 3 times on the one.
The present invention adopts dry granulation tabletting, is the water of crystallization utilizing material itself, directly compresses → a kind of granulating process of molding → fragmentation → pelletize to material powder by mechanical presses.Be characterized in: material powder is straight forming, pelletize continuously, eliminate humidification and drying process, saved a large amount of electric energy; The granulating process of environment protection-type, without the need to adding binding agent, not only energy-conservation but also pollution-free.
The present invention adopts dry granulation method tabletting to compare with existing wet granulation, has following feature: (1) dry granulation is few compared with wet granulation used device, maintenance cost is low, floor space is few, therefore its production cost is low; (2) dry granulation is simpler than wet granulation technology, and intermediate link is few, not only controlled dust from flying processed but also can reduce powder waste; Meanwhile, non-exhaust emission, minimizing environmental pollution; (3) dry granulation is dry again without the need to humidification, low energy consumption; (4) epigranular of finished product after dry granulation, bulk density increases, mobility is improved, and can control disintegration and microbial limit, is convenient to postorder processing, storage and transport simultaneously.In actual applications, dry granulation method tabletting is more suitable for suitability for industrialized production.
The quality index such as acarbose tablet of the present invention disintegration, microorganism, stability, friability all meet the requirements, constant product quality is controlled, even if defective phenomenon does not appear in storage a period of time yet, solve the shortcoming that xeraphium hygroscopicity is strong, supplementary product consumption is large.
Acarbose tablet of the present invention is when taking, and energy disintegrate rapidly, melts dispersion, absorb fast, can reach drug effect very soon, this is because the present invention adopts powder dry granulation tabletting, be the water of crystallization relying on material self, utilize the direct pelletize of mechanical presses, smashing principle, do not need to add binding agent, therefore when having an effect with water, energy imbibition rapidly, rapid disintegrate dispersion, reaches the effect playing rapidly drug effect.
Detailed description of the invention
Explain further by the following examples or content of the present invention is described, but the embodiment provided should not be understood to be construed as limiting scope.
Embodiment 1
Acarbose 50.0g microcrystalline Cellulose 13.0 starch 63.0g
Carboxymethylstach sodium 4.2g silicon dioxide 7.0g magnesium stearate 0.7g
Acarbose, microcrystalline Cellulose, starch, carboxymethylstach sodium, silicon dioxide, magnesium stearate were pulverized 100 mesh sieves respectively, for subsequent use.
Be placed in mixer by acarbose, microcrystalline Cellulose, starch and 2/3 carboxymethylstach sodium, mix homogeneously of machining, obtains pre-composition; Above-mentioned pre-composition is put into GZL series dry method rolling granulator, nip pressure is 40Pa, and pressure roller rotating speed is 20 revs/min, and mixture transfer rate is 60 revs/min, machines, and crosses 20 mesh sieve dischargings, obtain particulate matter after granulate; Above-mentioned particulate matter is added multidirectional mixer with magnesium stearate, silicon dioxide, remaining carboxymethylstach sodium and mixes 30 minutes, gained mixed material tablet machine carries out tabletting, obtains acarbose tablet 2700.
Embodiment 2
Acarbose 80.0g microcrystalline Cellulose 18.0g starch 94.0g
Carboxymethylstach sodium 6.3g silica 1 0.5g magnesium stearate 1.05g
Acarbose, microcrystalline Cellulose, starch, carboxymethylstach sodium, silicon dioxide, magnesium stearate were pulverized 100 mesh sieves respectively, for subsequent use.
Be placed in mixer by acarbose, microcrystalline Cellulose, starch and 2/3 carboxymethylstach sodium, mix homogeneously of machining, obtains pre-composition; Above-mentioned pre-composition is put into GZL series dry method rolling granulator, nip pressure is 20Pa, and pressure roller rotating speed is 17 revs/min, and mixture transfer rate is 45 revs/min, machines, and crosses 20 mesh sieve dischargings, obtain particulate matter after granulate; Above-mentioned particulate matter is added multidirectional mixer with magnesium stearate, silicon dioxide, remaining carboxymethylstach sodium and mixes 30 minutes, gained mixed material tablet machine carries out tabletting, obtains acarbose tablet 4000.
Embodiment 3
Acarbose 100.0g microcrystalline Cellulose 26.0g starch 126.0g
Carboxymethylstach sodium 8.4g silica 1 4g magnesium stearate 1.4g
Acarbose, microcrystalline Cellulose, starch, carboxymethylstach sodium, silicon dioxide, magnesium stearate were pulverized 100 mesh sieves respectively, for subsequent use.
Be placed in mixer by acarbose, microcrystalline Cellulose, starch and 2/3 carboxymethylstach sodium, mix homogeneously of machining, obtains pre-composition; Above-mentioned pre-composition is put into GZL series dry method rolling granulator, nip pressure is 50Pa, and pressure roller rotating speed is 22 revs/min, and mixture transfer rate is 80 revs/min, machines, and crosses 20 mesh sieve dischargings, obtain particulate matter after granulate; Above-mentioned particulate matter is added multidirectional mixer with magnesium stearate, silicon dioxide, remaining carboxymethylstach sodium and mixes 30 minutes, gained mixed material tablet machine carries out tabletting, obtains acarbose tablet 5400.
Comparative example 1
Prescription
Acarbose 100g microcrystalline Cellulose 40g starch 50g
Amylum pregelatinisatum 60g magnesium stearate 0.1g silicon dioxide 0.1g
First the acarbose of recipe quantity and silicon dioxide are added blender and mix 3 minutes, add microcrystalline Cellulose and mix 5 minutes, the starch and the amylum pregelatinisatum that add recipe quantity again mix 5 minutes, and the magnesium stearate finally adding recipe quantity mixes 1 minute, is pressed into 2000.
Comparative example 2
Prescription
Acarbose 100g microcrystalline Cellulose 40g starch 50g
Amylum pregelatinisatum 60g magnesium stearate 0.1g silicon dioxide 0.1g
First the acarbose of recipe quantity and microcrystalline Cellulose are mixed 5 minutes, the starch and the amylum pregelatinisatum that add recipe quantity mix 5 minutes, mix 1 minute the magnesium stearate of recipe quantity and silicon dioxide are added blender, are pressed into 2000.
Comparative example 3
Prescription
Acarbose 100g microcrystalline Cellulose 40g starch 50g
Amylum pregelatinisatum 60g magnesium stearate 0.1g silicon dioxide 0.1g
First the acarbose of recipe quantity and silicon dioxide are added blender 3 minutes, the starch and the amylum pregelatinisatum that add recipe quantity mix 5 minutes, then add microcrystalline Cellulose and mix 5 minutes, and the magnesium stearate finally adding recipe quantity mixes 1 minute, is pressed into 2000.
Comparative example 4
Acarbose 80.0g microcrystalline Cellulose 18.0g starch 94.0g
Polyvinylpolypyrrolidone 6.3g silica 1 0.5g magnesium stearate 1.05g
Acarbose, microcrystalline Cellulose, starch, polyvinylpolypyrrolidone, silicon dioxide, magnesium stearate were pulverized 100 mesh sieves respectively, for subsequent use.
Be placed in mixer by acarbose, microcrystalline Cellulose, starch and 2/3 polyvinylpolypyrrolidone, mix homogeneously of machining, obtains pre-composition; Above-mentioned pre-composition is put into GZL series dry method rolling granulator, nip pressure is 20Pa, and pressure roller rotating speed is 17 revs/min, and mixture transfer rate is 45 revs/min, machines, and crosses 20 mesh sieve dischargings, obtain particulate matter after granulate; Above-mentioned particulate matter is added multidirectional mixer with magnesium stearate, silicon dioxide, remaining polyvinylpolypyrrolidone and mixes 30 minutes, gained mixed material tablet machine carries out tabletting, obtains acarbose tablet 4000.
According to version " Chinese Pharmacopoeia " two annex I A methods in 2010, acarbose tablet prepared by the acarbose tablet prepare embodiment 1 ~ 3 and comparative example 1 ~ 3 carried out quality inspection, detected the testing result of projects as table 1.
The related check data of table 1 acarbose tablet
From the testing result in table 1, tablet mobility of the present invention, friability, hardness, disintegration and be all better than comparative example 1 ~ 3(and publication number is the Chinese patent application of CN101019874A) tablet prepared.
After acarbose tablet prepared by the acarbose tablet prepare embodiment 1 ~ 3 and comparative example 1 ~ 3 stores 6 months, carry out the comparison of outward appearance, mobility, disintegration, sliver, moisture absorption weightening finish, the detection method in disintegration of tablet time limit detects according to version " Chinese Pharmacopoeia " two annex I A methods in 2005 respectively, and result is as table 2.
From comparative example 4, when adopting another kind of conventional disintegrating agent polyvinylpolypyrrolidone to replace carboxymethylstach sodium, the acarbose tablet obtained has good disintegration, but mobility and compressibility bad.
Table 2
As shown in Table 2, outward appearance after 6 months stored by tablet of the present invention, underproof phenomenon does not all appear in mobility, disintegration, sliver, moisture absorption weightening finish, therefore the present invention is better than prior art.
Claims (7)
1. an acarbose tablet, is characterized in that, with parts by weight, is made up by dry granulation tabletting of following raw material:
The preparation method of described acarbose tablet, comprises the following steps:
(1) by acarbose, microcrystalline Cellulose and starch, 2/3 carboxymethylstach sodium mix homogeneously, pre-composition is obtained;
(2) pre-composition step (1) obtained, by dry granulation, granulate, obtains particulate matter;
(3) particulate matter, 1/3 carboxymethylstach sodium, magnesium stearate and the silicon dioxide mix homogeneously that step (2) are obtained, through tabletting, obtain described acarbose tablet;
In step (2), described dry granulation adopts dry granulating machine; Described dry granulating machine nip pressure be Stress control at 20 ~ 50N, pressure roller rotating speed is 17 revs/min ~ 22 revs/min, and mixture transfer rate is 45 revs/min ~ 80 revs/min.
2. acarbose tablet according to claim 1, is characterized in that, with parts by weight, is made up by dry granulation tabletting of following raw material:
3. acarbose tablet according to claim 1, is characterized in that, with parts by weight, is made up by dry granulation tabletting of following raw material:
4. acarbose tablet according to claim 1, is characterized in that, with parts by weight, is made up by dry granulation tabletting of following raw material:
5. acarbose tablet according to claim 1, is characterized in that, the order number of described acarbose, microcrystalline Cellulose, starch, carboxymethylstach sodium, silicon dioxide and magnesium stearate is at least 100 orders.
6. acarbose tablet according to claim 1, is characterized in that, in step (2), described pre-composition by after dry granulation through 10 order ~ 30 mesh sieve granulate, obtain particulate matter.
7. acarbose tablet according to claim 6, is characterized in that, in step (2), described pre-composition by after dry granulation through 20 mesh sieve granulate, obtain particulate matter.
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101019874A (en) * | 2007-03-12 | 2007-08-22 | 杭州中美华东制药有限公司 | Acarbose medicine composition and its prepn |
| CN101336904A (en) * | 2008-08-08 | 2009-01-07 | 杭州华东医药集团生物工程研究所有限公司 | Acarbose chewable tablets and preparation method thereof |
| CN101411715A (en) * | 2007-10-19 | 2009-04-22 | 杭州华东医药集团生物工程研究所有限公司 | Pharmaceutical composition containing acarbose |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101019874A (en) * | 2007-03-12 | 2007-08-22 | 杭州中美华东制药有限公司 | Acarbose medicine composition and its prepn |
| CN101411715A (en) * | 2007-10-19 | 2009-04-22 | 杭州华东医药集团生物工程研究所有限公司 | Pharmaceutical composition containing acarbose |
| CN101336904A (en) * | 2008-08-08 | 2009-01-07 | 杭州华东医药集团生物工程研究所有限公司 | Acarbose chewable tablets and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| 阿卡波糖分散片的制备及溶出度测定;刘祖雄等;《中国药师》;20111231;第14卷(第11期);第1612-1614页 * |
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Address after: 570216, East B District, No. 6, Haikou Free Trade Zone, No. 168 Nanhai Road, Hainan, Haikou Patentee after: HAINAN HULUWA PHARMACEUTICAL GROUP CO., LTD. Address before: 570216, East B District, No. 6, Haikou Free Trade Zone, No. 168 Nanhai Road, Hainan, Haikou Patentee before: Hainan Gourd Doll Pharmaceutical Co., Ltd. |