CN104940164B - A kind of Acarbose capsules agent medicine compositions and preparation method thereof - Google Patents
A kind of Acarbose capsules agent medicine compositions and preparation method thereof Download PDFInfo
- Publication number
- CN104940164B CN104940164B CN201510388308.2A CN201510388308A CN104940164B CN 104940164 B CN104940164 B CN 104940164B CN 201510388308 A CN201510388308 A CN 201510388308A CN 104940164 B CN104940164 B CN 104940164B
- Authority
- CN
- China
- Prior art keywords
- mixed powder
- mesh sieves
- microcrystalline cellulose
- acarbose
- starch
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
Landscapes
- Medicinal Preparation (AREA)
Abstract
The invention discloses Acarbose medicine composition and preparation method thereof, be specially a kind of Acarbose capsules agent medicine compositions and preparation method thereof.The Acarbose capsules agent medicine compositions prepared by specific preparation method, has better quality stability and faster dissolution rate.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition treating diabetes and preparation method thereof, be specifically related to a kind of acarbose
Capsule medicine compositions and preparation method thereof.
Background technology
Diabetes (Diabetes Mellitus, DM) be one group with chronic blood glucose (abbreviation blood glucose) level increase for
The metabolic disease of feature, is caused by insulin secretion and (or) effect defect.Long-term carbohydrate and fat,
Protein metabolism disorder can cause Multisystem damage, causes the chronic progressive external of the histoorgans such as eye, kidney, nerve, heart, blood vessel
Pathological changes, hypofunction and exhaustion, be in a bad way or stress time serious metabolic can be occurred disorderly, such as diabetic ketoacidosis
(DKA), Hyperglycemic hyperosmolar status etc..Primary disease makes patients ' life quality reduce, the lost of life, and case fatality rate increases, it has also become flourishing
The third-largest noninfectious of the serious harm human health after country relaying cardiovascular and cerebrovascular disease, cancer.In diabetes
In patient, patients with NIDDM accounts for more than 90%.
Acarbose (Acarbose) is a kind of alpha-glucosidase inhibitor, is used for treating type Ⅱdiabetes mellitus, by unwrapping wire
Bacterium is fermented and obtains.Its pharmacological action is the alpha-glucosidase of suppression small intestinal, many sugar decomposition of suppression food, makes the absorption phase of sugar
Should slow down, thus reduce postprandial hyperglycemia, coordinate Diet Therapy diabetes.Acarbose must be several with the most at once taking
Without intestinal absorption, so systemic adverse reactions is rare, it is showed only as mild to moderate local gastrointestinal uncomfortable, was treating
As long as journey is held the principle of " starting in a small amount, be slowly increased ", it is possible to improve compliance and the toleration of patient for treatment.Cause
This, acarbose is wide because of its purposes, and side effect is little, gets more and more and is paid attention to by clinician and use.
Acarbose hygroscopicity is relatively strong, therefore usually selects tablet rather than capsule when preparing preparation, though existing skill
Art has and acarbose is prepared as capsule there is also some technical problems.As CN104546795A discloses a kind of Ah Ka
Ripple carbohydrate gum wafer and preparation method thereof, particularly as follows: active substance is acarbose in described Acarbose capsules agent；Described diluent can
With selected from starch, microcrystalline Cellulose, modified pregelatinized Starch and combinations thereof；Described lubricant is selected from: magnesium stearate, stearic acid,
The Polyethylene Glycol of molecular weight 4000-8000, calcium stearate, zinc stearate, sodium stearyl fumarate etc. and combinations thereof；And/or
Described fluidizer is selected from: Pulvis Talci, silicon dioxide, micropowder silica gel etc. and combinations thereof.The concrete preparation method of this capsule is: (1) makes
Size-reduced became the acarbose of 80 mesh sieves and recipe quantity mix lubricant uniform；(2) incite somebody to action the most size-reduced and cross 80 mesh sieves
Diluent mix homogeneously with step (1) gained mixed powder；(3) by fluidizer and step (2) gained mixed powder in three-dimensional hybrid
Machine mixes 5-10 minute, obtains homogeneous total mixture, as the implant of capsule；(4) gained implant is filled to glue
In softgel shell, capsule is sealed, to obtain final product.
Due to the easy moisture absorption of acarbose, poor fluidity, can not well take on a new look its mobility although having added lubricant；And
And acarbose raw material is relatively light, when therefore preparing Acarbose capsules agent according to conventional mixing method, it may appear that acarbose
Mix uneven with adjuvant, acarbose raw material largely can adsorb outside adjuvant, causes activity among capsule occur
Component content difference is big, underproof phenomenon even occurs, it is impossible to ensure the up-to-standard property of capsule；Simultaneously because acarbose
Do not wrapped up by adjuvant well, also result in preparation hygroscopicity increase and cause product quality defective, even can affect capsule
Agent medicine, in the dispersion of gastric, causes medicine dissolution rate in vivo to reduce, affects the performance of drug effect.
Summary of the invention
Based on above-mentioned technical problem, the present inventor is through substantial amounts of experimentation, it is provided that a kind of Acarbose capsules agent
Pharmaceutical composition and preparation method thereof.
The invention discloses a kind of Acarbose capsules agent medicine compositions, by weight percentage, by following components group
Become: acarbose 10-50%, microcrystalline Cellulose 5%-25%, silicon dioxide 0.2-3%, magnesium stearate 0.3-1%, starch 50-
75%, it is characterized by: (1) is by size-reduced and 80 mesh sieves excessively silicon dioxide and equivalent starch mix homogeneously；(2) by size-reduced also
The magnesium stearate crossing 80 mesh sieves is mixed homogeneously with step (1) gained mixed powder；(3) by size-reduced and 80 mesh sieves excessively microcrystalline celluloses
Element uses equal increments method to mix homogeneously with step (2) gained mixed powder；(4) by size-reduced and cross 80 mesh sieves acarbose with
Step (3) gained mixed powder mix homogeneously；(5) weigh the starch of recipe quantity 1/2 size-reduced and cross after 80 mesh sieves with step (4) institute
Obtain mixed powder mix homogeneously, add starch that is remaining size-reduced and that cross 80 mesh sieves and be sufficiently mixed uniformly；(6) by step (5) institute
Obtain mixed powder fill capsule.
Especially, Acarbose capsules agent medicine compositions disclosed by the invention, by weight percentage, preferably by following
Component forms: acarbose 25%, microcrystalline Cellulose 10%, silicon dioxide 0.4%, magnesium stearate 0.8%, starch 63.8%.
Wherein, step (3) uses equal increments method method particularly includes: 1. take step (2) gained mixed powder and through powder
The microcrystalline Cellulose mix homogeneously of broken and 80 mesh sieves excessively equivalent；2. step 1. gained mixed powder and size-reduced and 80 mesh sieves excessively are taken
The microcrystalline Cellulose mix homogeneously of equivalent；3. size-reduced under remainder and 80 mesh sieves excessively microcrystalline Cellulose mix with step 2. gained
Close powder mix homogeneously.
The invention discloses a kind of Acarbose capsules agent medicine compositions, by weight percentage, by following components group
Become: acarbose 25%, microcrystalline Cellulose 10%, silicon dioxide 0.4%, magnesium stearate 0.8%, starch 63.8%, its feature
For: (1) is by size-reduced and 80 mesh sieves excessively silicon dioxide and equivalent starch mix homogeneously；(2) by size-reduced and 80 mesh sieves excessively
Magnesium stearate is mixed homogeneously with step (1) gained mixed powder；(3) size-reduced and 80 mesh sieves excessively microcrystalline Cellulose are used equivalent
Incremental method is mixed homogeneously with step (2) gained mixed powder；(4) by size-reduced and 80 mesh sieves excessively acarbose and step (3) institute
Obtain mixed powder mix homogeneously；(5) weigh the starch of recipe quantity 1/2 size-reduced and cross after 80 mesh sieves with step (4) gained mixed powder
Mix homogeneously, adds starch that is remaining size-reduced and that cross 80 mesh sieves and is sufficiently mixed uniformly；(6) by step (5) gained mixed powder
Fill capsule.
Wherein, step (3) uses equal increments method method particularly includes: 1. take step (2) gained mixed powder and through powder
The microcrystalline Cellulose mix homogeneously of broken and 80 mesh sieves excessively equivalent；2. step 1. gained mixed powder and size-reduced and 80 mesh sieves excessively are taken
The microcrystalline Cellulose mix homogeneously of equivalent；3. size-reduced under remainder and 80 mesh sieves excessively microcrystalline Cellulose mix with step 2. gained
Close powder mix homogeneously.
Especially, starch and microcrystalline Cellulose carry out high temperature drying before sieving, and are preferably respectively by fine to starch and crystallite
Dimension element is put in high temperature oven and is dried 3 hours in 95-100 DEG C, or puts in fluidized drying pelletizer in 90-100 DEG C of dry 0.5-1.5
Hour.
The invention discloses a kind of Acarbose capsules agent medicine compositions, it is characterized by: by weight percentage, by with
Lower component forms: acarbose 25%, microcrystalline Cellulose 10%, silicon dioxide 0.4%, magnesium stearate 0.8%, starch
63.8%, it is characterized by: starch and microcrystalline Cellulose are put in high temperature oven and is dried 3 hours in 95-100 DEG C by (1) respectively, or put
In fluidized drying pelletizer in 90-100 DEG C after dry 0.5-1.5 hour through pulverizing and crossing 80 mesh sieves；(2) by size-reduced and mistake 80
The silicon dioxide of mesh sieve and equivalent starch mix 10 minutes；(3) by size-reduced and 80 mesh sieves excessively magnesium stearate and step (2) institute
Obtain mixed powder to mix 10 minutes；(4) take step (3) gained mixed powder and mix 10 minutes to obtain mixed powder A with equivalent microcrystalline Cellulose；
Take mixed powder A and mix 10 minutes to obtain mixed powder B with equivalent microcrystalline Cellulose；Take mixed powder B to mix with remaining microcrystalline Cellulose
10 minutes；(5) size-reduced and 80 mesh sieves excessively acarbose are mixed 15 minutes with step (4) gained mixed powder；(6) place is weighed
The starch of side's amount 1/2 mixes 15 minutes with step (5) gained mixed powder, adds remaining starch and mixes 40 minutes；(7) by step
(6) gained mixed powder fill capsule.
The invention discloses the preparation method of a kind of Acarbose capsules agent medicine compositions, it is characterized by: by weight hundred
Proportion by subtraction meter, composed of the following components: acarbose 10-50%, microcrystalline Cellulose 5%-25%, silicon dioxide 0.2-3%, tristearin
Acid magnesium 0.3-1%, starch 50-75%, prepare in accordance with the following methods: (1) by size-reduced and cross 80 mesh sieves silicon dioxide and etc.
Amount starch mix homogeneously；(2) size-reduced and 80 mesh sieves excessively magnesium stearate are mixed homogeneously with step (1) gained mixed powder；(3)
Equal increments method is used to mix homogeneously with step (2) gained mixed powder size-reduced and 80 mesh sieves excessively microcrystalline Cellulose；(4) will
Size-reduced and 80 mesh sieves excessively acarbose are mixed homogeneously with step (3) gained mixed powder；(5) starch of recipe quantity 1/2 is weighed
Size-reduced and cross after 80 mesh sieves and mix homogeneously with step (4) gained mixed powder, add shallow lake that is remaining size-reduced and that cross 80 mesh sieves
Powder is sufficiently mixed uniformly；(6) by step (5) gained mixed powder fill capsule.
Wherein, step (3) uses equal increments method method particularly includes: 1. take step (2) gained mixed powder and through powder
The microcrystalline Cellulose mix homogeneously of broken and 80 mesh sieves excessively equivalent；2. step 1. gained mixed powder and size-reduced and 80 mesh sieves excessively are taken
The microcrystalline Cellulose mix homogeneously of equivalent；3. size-reduced under remainder and 80 mesh sieves excessively microcrystalline Cellulose mix with step 2. gained
Close powder mix homogeneously.
The invention discloses the preparation method of a kind of Acarbose capsules agent medicine compositions, it is characterized by: by weight hundred
Proportion by subtraction meter, takes acarbose 25%, microcrystalline Cellulose 10%, silicon dioxide 0.4%, magnesium stearate 0.8%, starch 63.8%,
Prepare in accordance with the following methods: (1) is by size-reduced and 80 mesh sieves excessively silicon dioxide and equivalent starch mix homogeneously；(2) will be through powder
Broken and 80 mesh sieves excessively magnesium stearate are mixed homogeneously with step (1) gained mixed powder；(3) by size-reduced and 80 mesh sieves excessively crystallites
Cellulose uses equal increments method to mix homogeneously with step (2) gained mixed powder；(4) by size-reduced and 80 mesh sieves excessively A Kabo
Sugar is mixed homogeneously with step (3) gained mixed powder；(5) weigh after starch size-reduced mistake 80 mesh sieve of recipe quantity 1/2 with step (4)
Gained mixed powder mix homogeneously, adds remaining starch and is sufficiently mixed uniformly；(6) by step (5) gained mixed powder fill capsule.
Wherein, step (3) uses equal increments method method particularly includes: 1. by size-reduced for microcrystalline Cellulose mistake 80 mesh
Sieve, takes step (2) gained mixed powder and mixs homogeneously with the microcrystalline Cellulose of equivalent；2. step 1. gained mixed powder and equivalent are taken
Microcrystalline Cellulose mix homogeneously；3. take remaining microcrystalline Cellulose to mix homogeneously with step 2. gained mixed powder.
Especially, starch and microcrystalline Cellulose carry out high temperature drying before sieving, and are preferably respectively by fine to starch and crystallite
Dimension element is put in high temperature oven and is dried 3 hours in 95-100 DEG C, or puts in fluidized drying pelletizer in 90-100 DEG C of dry 0.5-1.5
Hour.
The invention discloses the preparation method of a kind of Acarbose capsules agent medicine compositions, it is characterized by: by weight hundred
Proportion by subtraction meter, takes acarbose 25%, microcrystalline Cellulose 10%, silicon dioxide 0.4%, magnesium stearate 0.8%, starch 63.8%,
Prepare in accordance with the following methods: starch and microcrystalline Cellulose are put in high temperature oven and is dried 3 hours in 95-100 DEG C by (1) respectively, or
Put in fluidized drying pelletizer and cross 80 mesh sieves after dry 0.5-1.5 hour in 90-100 DEG C；(2) silicon dioxide of 80 mesh sieves will be crossed
Mix 10 minutes with equivalent starch；(3) magnesium stearate crossing 80 mesh sieves is mixed 10 minutes with step (2) gained mixed powder；(4)
Take step (3) gained mixed powder and mix 10 minutes to obtain mixed powder A with equivalent microcrystalline Cellulose；Take mixed powder A fine with equivalent crystallite
Dimension element mixing obtains mixed powder B in 10 minutes；Take mixed powder B and mix 10 minutes with remaining microcrystalline Cellulose；(5) 80 mesh sieves will be crossed
Acarbose mixes 15 minutes with step (4) gained mixed powder；(6) starch weighing recipe quantity 1/2 mixes with step (5) gained
Powder mixes 15 minutes, adds remaining starch and mixes 40 minutes；(7) by step (6) gained mixed powder fill capsule.
The present inventor, through substantial amounts of experimentation, is surprised to find when adjusting silicon dioxide and magnesium stearate addition sequence
Time, there is the biggest difference in the dissolution of prepared Acarbose capsules agent medicine compositions: as be initially charged silicon dioxide and
Magnesium stearate, the product dissolution rate finally prepared, by silicon dioxide and stearic acid in customary preparation methods to be significantly faster than that
Magnesium is eventually adding the dissolution rate of products obtained therefrom.Because acarbose needs with the most at once taking, therefore acarbose is at stomach
Interior dissolution rate and degree have significant impact to the performance of drug effect.
The Acarbose capsules agent medicine compositions that the preparation method provided by the present invention is prepared, is effectively increased product
Quality, extends expiration date of drug, accelerates medicine dissolution rate in vivo, it is ensured that the curative effect of medicine.
Accompanying drawing explanation
Fig. 1 Acarbose capsules agent Dissolution profiles
The Dissolution profiles of A Acarbose capsules agent A
The Dissolution profiles of B Acarbose capsules agent B
The Dissolution profiles of C Acarbose capsules agent C
Detailed description of the invention
Below by embodiment, the present invention will be further described, but the present invention is not limited in listed by these embodiments
Hold.
Embodiment 1 prepares Acarbose capsules agent medicine compositions
Prescription: acarbose 100.00Kg microcrystalline Cellulose 40.00Kg silica 1 .60Kg
Magnesium stearate 3.20Kg starch 255.20Kg
Concrete preparation method is:
The starch and the microcrystalline Cellulose that take recipe quantity are put in high temperature oven respectively, cross 80 after being dried 3 hours in 95-100 DEG C
Mesh sieve is standby；Take the acarbose of recipe quantity, silicon dioxide and magnesium stearate 80 mesh sieves excessively respectively standby；
Silicon dioxide is put in HD-100 Mixers with Multi-direction Movement, add equivalent starch and mix 10 minutes, add magnesium stearate
Mix 10 minutes, add microcrystalline Cellulose 6.40Kg and mix 10 minutes, add microcrystalline Cellulose 12.80Kg and mix 10 minutes, will
Above-mentioned mixed powder installs to be determined in the HS1500 three-dimensional motion mixer that the speed of mainshaft is 12 revs/min, adds remaining crystallite fine
Dimension element mixing 10 minutes, adds acarbose and mixes 15 minutes, and the starch adding recipe quantity 1/2 mixes 15 minutes, adds remaining
Lower starch mixes 40 minutes, then mixed powder is put capsule filler 2# capsule and carries out filling, controls loading amount by loading amount requirement
Scope, makes every capsule containing acarbose 50mg.
Embodiment 2 Acarbose capsules agent medicine compositions
Prescription: acarbose 100.00Kg microcrystalline Cellulose 40.00Kg silica 1 .60Kg
Magnesium stearate 3.20Kg starch 255.20Kg
Concrete preparation method is:
The starch and the microcrystalline Cellulose that take recipe quantity are put in fluidized drying pelletizer SS030004 respectively, do in 90-100 DEG C
80 mesh sieves are crossed standby after dry 40 minutes；Take the acarbose of recipe quantity, silicon dioxide and magnesium stearate 80 mesh sieves excessively respectively standby；
Silicon dioxide is put in HD-100 Mixers with Multi-direction Movement, add equivalent starch and mix 10 minutes, add magnesium stearate
Mix 10 minutes, add microcrystalline Cellulose 6.40Kg and mix 10 minutes, add microcrystalline Cellulose 12.80Kg and mix 10 minutes, will
Above-mentioned mixed powder is put in the HD-1500A Mixers with Multi-direction Movement of electric machine frequency 50Hz, adds remaining microcrystalline Cellulose mixing 10
Minute, adding acarbose and mix 15 minutes, the starch adding recipe quantity 1/2 mixes 15 minutes, adds remaining starch mixing
40 minutes, then mixed powder is put capsule filler 2# capsule and carries out filling, control loading amount scope by loading amount requirement, make every
The grain capsule containing acarbose 50mg.
Embodiment 3 Acarbose capsules agent medicine compositions
Prescription: acarbose 500g microcrystalline Cellulose 200g silicon dioxide 8g
Magnesium stearate 16g starch 1276g
Concrete preparation method is:
The starch and the microcrystalline Cellulose that take recipe quantity are put in fluidized drying pelletizer SS030004 respectively, do in 90-100 DEG C
80 mesh sieves are crossed standby after dry 40 minutes；Take the acarbose of recipe quantity, silicon dioxide and magnesium stearate 80 mesh sieves excessively respectively standby；
The acarbose taking recipe quantity is put in HD-100 Mixers with Multi-direction Movement, adds equivalent starch and mixes 15 minutes, adds
Microcrystalline Cellulose mixes 10 minutes, adds remaining starch and mixes 15 minutes, adds silicon dioxide and magnesium stearate mixes 15 points
Clock, then puts mixed powder capsule filler 2# capsule and carries out filling, controls loading amount scope by loading amount requirement, makes every and contain
The capsule of acarbose 50mg.
The dissolution determination of test example 1 Acarbose capsules agent medicine compositions
1, instrument and reagent
Automatically dissolving-out tester: 708-DS joins 850-DS, Agilent；High benefit chromatography: Agilent 1100,
VWD, EzchromElite chem workstation；Chromatographic column: luna nh 2 column, 250 × 4.60mm, 5 μm；Electronic balance (thousand/
One): PB-403S, Mei Teletuo benefit company of Switzerland；Electronic balance (100,000/): XSE205DU, Switzerland's prunus mume (sieb.) sieb.et zucc. Teller
Torr benefit company: ultrasonic cleaner: SK7210HP, KUDOS company；
Acarbose reference substance: National Institute for Food and Drugs Control, content 95.8%, lot number: 100808-201203；
Acarbose capsules agent A (hereinafter referred to as A): prepare according to embodiment 1；
Acarbose capsules agent B (hereinafter referred to as B): prepare according to embodiment 3；
Acarbose capsules agent C (hereinafter referred to as C): prepare according to CN104546795A embodiment；
Acetonitrile: chromatographically pure, Merck acetonitrile, IA4IF64005；
Potassium dihydrogen phosphate: top grade is pure, Tianjin Kermel Chemical Reagent Co., Ltd., 20110526；
Disodium hydrogen phosphate: top grade is pure, Tianjin recovery development in science and technology company limited, 20140424
Other are commercially available analytical pure.
2, experimental technique and result
With reference to " dissolution of acarbose tablet is investigated. thank on the sunny side etc. and Chinese pharmacists .2011 the 1st phase of volume 14 " in
Experimental technique and " Chinese Pharmacopoeia " (version in 2010) two annex XC dissolution methods are measured.
Take each 12 of Acarbose capsules agent A, B, C, with purified water 900ml as dissolution medium, 37 DEG C ± 0.5 DEG C respectively,
Rotating speed 50r/min, uses basket method to carry out Dissolution Rate Testing, and respectively at 5,10,15,20,30,45,60min draw dissolution medium
5mL, 0.45 μm microporous filter membrane filters, and takes subsequent filtrate sample introduction and measures, draws corresponding Dissolution profiles, and result is as shown in Figure 1.
As shown in Figure 1, Acarbose capsules agent A dissolution rate in 15 minutes reaches more than 85%, dissolution in 15-30 minute
Rate is close to 100%；Dissolution rate is close to 60% in 30 minutes for Acarbose capsules agent B, and in 60 minutes, dissolution rate is close to 90%；
And Acarbose capsules agent C dissolution rate in 15-30 minute reaches 80%, in 60 minutes, dissolution rate is close to 100%.According to experiment
As a result, it is possible to determine that the Acarbose capsules agent medicine compositions provided according to the present invention has faster dissolution rate, therefore
Can preferably play drug action.
The stability experiment of test example 2 Acarbose capsules agent
1, reagent:
Acarbose capsules agent A (hereinafter referred to as A): prepare according to embodiment 1；
Acarbose capsules agent B (hereinafter referred to as B): prepare according to embodiment 3；
Acarbose capsules agent C (hereinafter referred to as C): prepare according to CN104546795A embodiment.
2, method and result:
According to " Chinese Pharmacopoeia " (version in 2010) two annex crude drug and pharmaceutical preparation stability test guideline, adopt
High wet test in testing with influence factor, investigates the change of its moisture.
Taking the content of Acarbose capsules agent A, B, C respectively, put and spread out into the thick thin layer of 10mm in culture dish, opening puts 25
DEG C, relative humidity (RH) be (90 ± 5) % constant humidity hermetic container in place 10 days, the 5th day and the 10th day sample, accurately claim
Test sample quality before and after amount test, moisture is shown in Table 1:
Table 1 Acarbose capsules agent water content detection result in high wet test
As seen from the results in Table 1, although Acarbose capsules agent in high wet test with the presence of moisture absorption deliquescence phenomenon, but Ah
Card ripple carbohydrate gum wafer A substantially than Acarbose capsules agent B and C in high humidity environment more stable, possess preferably at high humidity ring
Preparation stability in border.
Claims (6)
1. an Acarbose capsules agent medicine compositions, by weight percentage, composed of the following components: acarbose
25%, microcrystalline Cellulose 10%, silicon dioxide 0.4%, magnesium stearate 0.8%, starch 63.8%, it is characterized by: (1) will be through powder
Broken and 80 mesh sieves excessively silicon dioxide and equivalent starch mix homogeneously；(2) by size-reduced and 80 mesh sieves excessively magnesium stearate and step
Suddenly (1) gained mixed powder mix homogeneously；(3) size-reduced and 80 mesh sieves excessively microcrystalline Cellulose are used equal increments method and step
(2) gained mixed powder mix homogeneously, method particularly includes: 1. take step (2) gained mixed powder with size-reduced and cross 80 mesh sieves etc.
The microcrystalline Cellulose mix homogeneously of amount；2. the microcrystalline cellulose of step 1. gained mixed powder and size-reduced and 80 mesh sieves excessively equivalent is taken
Element mix homogeneously；3. size-reduced under remainder and 80 mesh sieves excessively microcrystalline Cellulose are mixed homogeneously with step 2. gained mixed powder；(4)
Size-reduced and 80 mesh sieves excessively acarbose are mixed homogeneously with step (3) gained mixed powder；(5) shallow lake of recipe quantity 1/2 is weighed
Powder is size-reduced and crosses after 80 mesh sieves and mixs homogeneously with step (4) gained mixed powder, adds remaining size-reduced and crosses 80 mesh sieves
Starch is sufficiently mixed uniformly；(6) by step (5) gained mixed powder fill capsule.
Acarbose capsules agent medicine compositions the most according to claim 1, is characterized by: by weight percentage, by
Following components forms: acarbose 25%, microcrystalline Cellulose 10%, silicon dioxide 0.4%, magnesium stearate 0.8%, starch
63.8%, it is characterized by: starch and microcrystalline Cellulose are put in high temperature oven and is dried 3 hours in 95-100 DEG C by (1) respectively, or put
In fluidized drying pelletizer in 90-100 DEG C after dry 0.5-1.5 hour through pulverizing and crossing 80 mesh sieves；(2) by size-reduced and mistake 80
The silicon dioxide of mesh sieve and equivalent starch mix 10 minutes；(3) by size-reduced and 80 mesh sieves excessively magnesium stearate and step (2) institute
Obtain mixed powder to mix 10 minutes；(4) take step (3) gained mixed powder and mix 10 minutes to obtain mixed powder A with equivalent microcrystalline Cellulose；
Take mixed powder A and mix 10 minutes to obtain mixed powder B with equivalent microcrystalline Cellulose；Take mixed powder B to mix with remaining microcrystalline Cellulose
10 minutes；(5) size-reduced and 80 mesh sieves excessively acarbose are mixed 15 minutes with step (4) gained mixed powder；(6) place is weighed
The starch of side's amount 1/2 mixes 15 minutes with step (5) gained mixed powder, adds remaining starch and mixes 40 minutes；(7) by step
(6) gained mixed powder fill capsule.
3. a preparation method for Acarbose capsules agent medicine compositions, is characterized by: by weight percentage, by following group
It is grouped into: acarbose 25%, microcrystalline Cellulose 10%, silicon dioxide 0.4%, magnesium stearate 0.8%, starch 63.8%, presses
Prepare according to following methods: (1) is by size-reduced and 80 mesh sieves excessively silicon dioxide and equivalent starch mix homogeneously；(2) by size-reduced
And cross 80 mesh sieves magnesium stearate mix homogeneously with step (1) gained mixed powder；(3) by fine for size-reduced and 80 mesh sieves excessively crystallites
Dimension element uses equal increments method to mix homogeneously with step (2) gained mixed powder, method particularly includes: 1. take the mixing of step (2) gained
Powder is mixed homogeneously with the microcrystalline Cellulose of equivalent that is size-reduced and that cross 80 mesh sieves；2. take step 1. gained mixed powder with size-reduced also
Cross the microcrystalline Cellulose mix homogeneously of the equivalent of 80 mesh sieves；3. size-reduced under remainder and 80 mesh sieves excessively microcrystalline Cellulose and step
2. gained mixed powder mix homogeneously；(4) size-reduced and 80 mesh sieves excessively acarbose are mixed all with step (3) gained mixed powder
Even；(5) weigh the starch of recipe quantity 1/2 size-reduced and mix homogeneously with step (4) gained mixed powder after crossing 80 mesh sieves, add
Remaining size-reduced and 80 mesh sieves excessively starch are sufficiently mixed uniformly；(6) by step (5) gained mixed powder fill capsule.
Preparation method the most according to claim 3, is characterized by: starch and microcrystalline Cellulose carry out high temperature before sieving to be done
Dry.
Preparation method the most according to claim 4, is characterized by: starch and microcrystalline Cellulose are put in high temperature oven in
95-100 DEG C is dried 3 hours, or puts in fluidized drying pelletizer dry 0.5-1.5 hour in 90-100 DEG C.
Preparation method the most according to claim 3, is characterized by: by weight percentage, takes acarbose 25%, crystallite
Cellulose 10%, silicon dioxide 0.4%, magnesium stearate 0.8%, starch 63.8%, prepare in accordance with the following methods: (1) respectively will
Starch and microcrystalline Cellulose are put in high temperature oven and are dried 3 hours in 95-100 DEG C, or put in fluidized drying pelletizer in 90-100
Cross 80 mesh sieves DEG C after dry 0.5-1.5 hour；(2) silicon dioxide and equivalent starch of crossing 80 mesh sieves are mixed 10 minutes；(3) will
The magnesium stearate crossing 80 mesh sieves mixes 10 minutes with step (2) gained mixed powder；(4) step (3) gained mixed powder and equivalent are taken
Microcrystalline Cellulose mixes 10 minutes to obtain mixed powder A；Take mixed powder A and mix 10 minutes to obtain mixed powder B with equivalent microcrystalline Cellulose；Take
Mixed powder B mixes 10 minutes with remaining microcrystalline Cellulose；(5) acarbose crossing 80 mesh sieves is mixed with step (4) gained
Powder mixes 15 minutes；(6) starch weighing recipe quantity 1/2 mixes 15 minutes with step (5) gained mixed powder, adds remaining shallow lake
Powder mixes 40 minutes；(7) by step (6) gained mixed powder fill capsule.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510388308.2A CN104940164B (en) | 2015-06-30 | 2015-06-30 | A kind of Acarbose capsules agent medicine compositions and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510388308.2A CN104940164B (en) | 2015-06-30 | 2015-06-30 | A kind of Acarbose capsules agent medicine compositions and preparation method thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN104940164A CN104940164A (en) | 2015-09-30 |
| CN104940164B true CN104940164B (en) | 2016-08-24 |
Family
ID=54155606
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201510388308.2A Active CN104940164B (en) | 2015-06-30 | 2015-06-30 | A kind of Acarbose capsules agent medicine compositions and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN104940164B (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107569461A (en) * | 2017-06-26 | 2018-01-12 | 安徽永生堂药业有限责任公司 | A kind of Simvastatin Tablets and preparation method thereof |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100464754C (en) * | 2007-03-12 | 2009-03-04 | 杭州中美华东制药有限公司 | Acarbose medicine composition and its prepn |
| CN101411715B (en) * | 2007-10-19 | 2012-03-28 | 杭州华东医药集团生物工程研究所有限公司 | Pharmaceutical composition containing acarbose |
| CN102688252A (en) * | 2012-06-12 | 2012-09-26 | 北京韩美药品有限公司 | Acarbose oral solid preparation composition and preparation method thereof |
| CN103315971B (en) * | 2013-06-13 | 2015-03-04 | 海南葫芦娃制药有限公司 | Acarbose tablets and preparation method thereof |
| CN104523653B (en) * | 2015-02-06 | 2017-03-29 | 杭州朱养心药业有限公司 | Acarbose capsules agent pharmaceutical composition |
-
2015
- 2015-06-30 CN CN201510388308.2A patent/CN104940164B/en active Active
Also Published As
| Publication number | Publication date |
|---|---|
| CN104940164A (en) | 2015-09-30 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN104434874B (en) | Tauroursodeoxycholic acid capsule and preparation method thereof | |
| CN102499923B (en) | Drug combination, as well as preparation method and application of same | |
| CN106265641B (en) | A kind of pharmaceutical composition and preparation method thereof containing vildagliptin and melbine | |
| CN106176653A (en) | A kind of pharmaceutical composition of sitagliptin | |
| CN104940164B (en) | A kind of Acarbose capsules agent medicine compositions and preparation method thereof | |
| CN105412026B (en) | Acotiamide hydrochloride hydrate piece and preparation method thereof | |
| JP2019516706A (en) | Novel crystalline form of dapagliflozin and method for producing and use thereof | |
| CN109793238A (en) | A kind of vitamin D inclusion powder and preparation method thereof and the application in health caring food tablet | |
| CN102772395A (en) | Sustained release preparation containing ambroxol hydrochloride and clenbuterol hydrochloride, and preparation method thereof | |
| CN104856970B (en) | A kind of vildagliptin tablet for treating type II diabetes | |
| CN107028912B (en) | A kind of preparation method of Irbesartan Capsules | |
| CN110917163A (en) | Solid oral paricalcitol preparation | |
| CN109156545A (en) | A kind of composition and preparation method thereof with regulating blood lipid action | |
| CN105640919B (en) | Nicergoline capsule and preparation method thereof | |
| CN108014086A (en) | A kind of preparation method of algal polysaccharide sulfate capsule | |
| CN110101687A (en) | A kind of metformin hydrochloride slow release preparation and preparation method thereof | |
| CN105213341A (en) | A kind of acarbose tablet and preparation method thereof | |
| CN103432090B (en) | Cyclovirobuxine D sublingual tablet as well as preparation method and application thereof | |
| CN103432124B (en) | The application of oxymatrine in preparation control medicine for treating diabetic nephropathy | |
| CN105147690A (en) | Pharmaceutical sildenafil citrate composition tablets for treating diseases of urinary surgery | |
| CN105640895A (en) | Cefadroxil granular preparation and preparation method thereof | |
| CN1762373A (en) | 'Xueshuantong' soft capsule and its preparation | |
| CN106580909A (en) | Solid drug composition containing sarpogrelate hydrochloride | |
| CN105663107B (en) | Compound amino acid capsule agent | |
| CN103565764B (en) | mitiglinide calcium composition tablet and preparation method thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| C56 | Change in the name or address of the patentee | ||
| CP03 | Change of name, title or address |
Address after: 646607 Luzhou city of Sichuan province Wangjiang town ponds Longmatan district road two No. six, No. eight Patentee after: Sichuan green leaf pharmaceutical Limited by Share Ltd Address before: 646100 Luzhou city of Sichuan province Wangjiang town ponds Longmatan district road two No. 6 Patentee before: SICHUAN LVYE BAO GUANG PHARMACEUTICAL INDUSTRY CO., LTD. |