CN104940164A - Acarbose capsula pharmaceutical composition and preparation method thereof - Google Patents
Acarbose capsula pharmaceutical composition and preparation method thereof Download PDFInfo
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Abstract
The invention discloses an acarbose pharmaceutical composition and a preparation method thereof, and particularly relates to an acarbose capsula pharmaceutical composition and a preparation method thereof. The acarbose capsula pharmaceutical composition prepared through the specific preparation method has the better quality stability and higher dissolution rate.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition for the treatment of diabetes and preparation method thereof, be specifically related to a kind of Acarbose capsules agent medicine composition and method of making the same.
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.In diabetics, patients with NIDDM accounts for more than 90%.
Acarbose (Acarbose) is a kind of alpha-glucosidase inhibitor, is used for the treatment of type Ⅱdiabetes mellitus, is obtained by actinomycete fermentation.Its pharmacological action suppresses the alpha-glucosidase of small intestinal, suppresses the polysaccharide of food to decompose, and makes that the absorption of sugar is corresponding to be slowed down, thus reduce postprandial hyperglycemia, coordinates Diet Therapy diabetes.Acarbose must with at once taking before the meal, hardly through intestinal absorption, so systemic adverse reactions is rare, only show as mild to moderate local gastrointestinal uncomfortable, as long as hold the principle of " starting in a small amount; slowly increase " over the course for the treatment of, compliance and the toleration of patient for treatment just can be improved.Therefore, acarbose because of its purposes wide, side effect is little, is more and morely paid attention to by clinician and uses.
Acarbose hygroscopicity is comparatively strong, therefore usually selects tablet but not capsule when preparing preparation, acarbose is prepared into capsule also there are some technical problems even if having in prior art.As CN104546795A discloses a kind of Acarbose capsules agent and method for making thereof, be specially: in described Acarbose capsules agent, active substance is acarbose; Described diluent can be selected from starch, microcrystalline Cellulose, modification pregelatinized Starch and combination thereof; Described lubricant is selected from: the Polyethylene Glycol, calcium stearate, zinc stearate, sodium stearyl fumarate etc. of magnesium stearate, stearic acid, molecular weight 4000-8000 and combination thereof; And/or described fluidizer is selected from: Pulvis Talci, silicon dioxide, micropowder silica gel etc. and combination thereof.The concrete method for making of this capsule is: (1) makes the mix lubricant of acarbose and recipe quantity through being ground into 80 mesh sieves even; (2) by advance through to pulverize and the diluent crossing 80 mesh sieves is mixed homogeneously with step (1) gained mixed powder; (3) fluidizer is mixed 5-10 minute with step (2) gained mixed powder in three-dimensional mixer, obtain homogeneous total mixture, as the implant of capsule; (4) gained implant is filled in capsule shells, capsule is sealed, to obtain final product.
Due to the easy moisture absorption of acarbose, poor fluidity, can not well to take on a new look its mobility although added lubricant; And acarbose raw material is lighter, when therefore preparing Acarbose capsules agent according to conventional mixing method, there will be acarbose mixes uneven with adjuvant, acarbose raw material can be adsorbed on adjuvant outside to a great extent, cause occurring that among capsule, active component content difference is large, even there is underproof phenomenon, the up-to-standard property of capsule cannot be ensured; Simultaneously because acarbose is not wrapped up by adjuvant well, the increase of preparation hygroscopicity also can be caused to cause product quality defective, even can affect the dispersion of capsule medicine at gastric, cause medicine dissolution rate in vivo to reduce, affect the performance of drug effect.
Summary of the invention
Based on above-mentioned technical problem, the present inventor, through a large amount of experimentatioies, provides a kind of Acarbose capsules agent medicine composition and method of making the same.
The invention discloses a kind of Acarbose capsules agent medicine compositions, by weight percentage, composed of the following components: acarbose 10-50%, microcrystalline Cellulose 5%-25%, silicon dioxide 0.2-3%, magnesium stearate 0.3-1%, starch 50-75%, is characterized by: (1) is by through pulverizing and crossing silicon dioxide and the equivalent starch mix homogeneously of 80 mesh sieves; (2) by through to pulverize and the magnesium stearate crossing 80 mesh sieves is mixed homogeneously with step (1) gained mixed powder; (3) by through to pulverize and the microcrystalline Cellulose crossing 80 mesh sieves adopts equal increments method to mix homogeneously with step (2) gained mixed powder; (4) by through to pulverize and the acarbose crossing 80 mesh sieves is mixed homogeneously with step (3) gained mixed powder; (5) starch taking recipe quantity 1/2 is mixed homogeneously with step (4) gained mixed powder after pulverizing and cross 80 mesh sieves, then adds remaining through pulverizing and crossing the abundant mix homogeneously of starch of 80 mesh sieves; (6) by step (5) gained mixed powder fill capsule.
Especially, Acarbose capsules agent medicine compositions disclosed by the invention, by weight percentage, preferably composed of the following components: acarbose 25%, microcrystalline Cellulose 10%, silicon dioxide 0.4%, magnesium stearate 0.8%, starch 63.8%.
Wherein, adopt in step (3) concrete grammar of equal increments method to be: 1. get step (2) gained mixed powder with through to pulverize and the microcrystalline Cellulose crossing the equivalent of 80 mesh sieves is mixed homogeneously; 2. get step 1. gained mixed powder with through to pulverize and the microcrystalline Cellulose crossing the equivalent of 80 mesh sieves is mixed homogeneously; 3. under remainder through pulverize and the microcrystalline Cellulose crossing 80 mesh sieves and step 2. gained mixed powder mix homogeneously.
The invention discloses a kind of 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%, is characterized by: (1) is by through pulverizing and crossing silicon dioxide and the equivalent starch mix homogeneously of 80 mesh sieves; (2) by through to pulverize and the magnesium stearate crossing 80 mesh sieves is mixed homogeneously with step (1) gained mixed powder; (3) by through to pulverize and the microcrystalline Cellulose crossing 80 mesh sieves adopts equal increments method to mix homogeneously with step (2) gained mixed powder; (4) by through to pulverize and the acarbose crossing 80 mesh sieves is mixed homogeneously with step (3) gained mixed powder; (5) starch taking recipe quantity 1/2 is mixed homogeneously with step (4) gained mixed powder after pulverizing and cross 80 mesh sieves, then adds remaining through pulverizing and crossing the abundant mix homogeneously of starch of 80 mesh sieves; (6) by step (5) gained mixed powder fill capsule.
Wherein, adopt in step (3) concrete grammar of equal increments method to be: 1. get step (2) gained mixed powder with through to pulverize and the microcrystalline Cellulose crossing the equivalent of 80 mesh sieves is mixed homogeneously; 2. get step 1. gained mixed powder with through to pulverize and the microcrystalline Cellulose crossing the equivalent of 80 mesh sieves is mixed homogeneously; 3. under remainder through pulverize and the microcrystalline Cellulose crossing 80 mesh sieves and step 2. gained mixed powder mix homogeneously.
Especially, starch and microcrystalline Cellulose carry out high temperature drying before sieving, and preferably put starch and microcrystalline Cellulose in 95-100 DEG C of drying 3 hours in high temperature oven respectively, or put 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, 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: starch and microcrystalline Cellulose are put in 95-100 DEG C of drying 3 hours in high temperature oven by (1) respectively, or to put in fluidized drying pelletizer after 90-100 DEG C of dry 0.5-1.5 hour through pulverizing and crossing 80 mesh sieves; (2) by through pulverizing and crossing the silicon dioxide of 80 mesh sieves and equivalent starch mixes 10 minutes; (3) by through to pulverize and the magnesium stearate crossing 80 mesh sieves mixes 10 minutes with step (2) gained mixed powder; (4) get step (3) gained mixed powder mix 10 minutes with equivalent microcrystalline Cellulose mixed powder A; Get mixed powder A mix 10 minutes with equivalent microcrystalline Cellulose mixed powder B; Get mixed powder B and mix 10 minutes with remaining microcrystalline Cellulose; (5) by through to pulverize and the acarbose crossing 80 mesh sieves mixes 15 minutes with step (4) gained mixed powder; (6) starch taking recipe quantity 1/2 mixes 15 minutes with step (5) gained mixed powder, then adds remaining starch and mix 40 minutes; (7) by step (6) gained mixed powder fill capsule.
The invention discloses a kind of preparation method of Acarbose capsules agent medicine compositions, it is characterized by: by weight percentage, composed of the following components: acarbose 10-50%, microcrystalline Cellulose 5%-25%, silicon dioxide 0.2-3%, magnesium stearate 0.3-1%, starch 50-75%, prepare: (1) is by through pulverizing and crossing silicon dioxide and the equivalent starch mix homogeneously of 80 mesh sieves in accordance with the following methods; (2) by through to pulverize and the magnesium stearate crossing 80 mesh sieves is mixed homogeneously with step (1) gained mixed powder; (3) by through to pulverize and the microcrystalline Cellulose crossing 80 mesh sieves adopts equal increments method to mix homogeneously with step (2) gained mixed powder; (4) by through to pulverize and the acarbose crossing 80 mesh sieves is mixed homogeneously with step (3) gained mixed powder; (5) starch taking recipe quantity 1/2 is mixed homogeneously with step (4) gained mixed powder after pulverizing and cross 80 mesh sieves, then adds remaining through pulverizing and crossing the abundant mix homogeneously of starch of 80 mesh sieves; (6) by step (5) gained mixed powder fill capsule.
Wherein, adopt in step (3) concrete grammar of equal increments method to be: 1. get step (2) gained mixed powder with through to pulverize and the microcrystalline Cellulose crossing the equivalent of 80 mesh sieves is mixed homogeneously; 2. get step 1. gained mixed powder with through to pulverize and the microcrystalline Cellulose crossing the equivalent of 80 mesh sieves is mixed homogeneously; 3. under remainder through pulverize and the microcrystalline Cellulose crossing 80 mesh sieves and step 2. gained mixed powder mix homogeneously.
The invention discloses a kind of preparation method of Acarbose capsules agent medicine compositions, it is characterized by: by weight percentage, get acarbose 25%, microcrystalline Cellulose 10%, silicon dioxide 0.4%, magnesium stearate 0.8%, starch 63.8%, prepare: (1) is by through pulverizing and crossing silicon dioxide and the equivalent starch mix homogeneously of 80 mesh sieves in accordance with the following methods; (2) by through to pulverize and the magnesium stearate crossing 80 mesh sieves is mixed homogeneously with step (1) gained mixed powder; (3) by through to pulverize and the microcrystalline Cellulose crossing 80 mesh sieves adopts equal increments method to mix homogeneously with step (2) gained mixed powder; (4) by through to pulverize and the acarbose crossing 80 mesh sieves is mixed homogeneously with step (3) gained mixed powder; (5) starch taking recipe quantity 1/2 was mixed homogeneously with step (4) gained mixed powder after pulverizing 80 mesh sieves, then added the abundant mix homogeneously of remaining starch; (6) by step (5) gained mixed powder fill capsule.
Wherein, adopt in step (3) concrete grammar of equal increments method to be: 1. by microcrystalline Cellulose through pulverizing 80 mesh sieves, get step (2) gained mixed powder and mix homogeneously with the microcrystalline Cellulose of equivalent; 2. get step 1. gained mixed powder mix homogeneously with the microcrystalline Cellulose of equivalent; 3. the microcrystalline Cellulose under remainder and step 2. gained mixed powder are mixed homogeneously.
Especially, starch and microcrystalline Cellulose carry out high temperature drying before sieving, and preferably put starch and microcrystalline Cellulose in 95-100 DEG C of drying 3 hours in high temperature oven respectively, or put in fluidized drying pelletizer in 90-100 DEG C of dry 0.5-1.5 hour.
The invention discloses a kind of preparation method of Acarbose capsules agent medicine compositions, it is characterized by: by weight percentage, get 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 95-100 DEG C of drying 3 hours in high temperature oven by (1) respectively, or to put in fluidized drying pelletizer crossed 80 mesh sieves after 90-100 DEG C of dry 0.5-1.5 hour; (2) silicon dioxide and equivalent starch of crossing 80 mesh sieves are mixed 10 minutes; (3) magnesium stearate crossing 80 mesh sieves is mixed 10 minutes with step (2) gained mixed powder; (4) get step (3) gained mixed powder mix 10 minutes with equivalent microcrystalline Cellulose mixed powder A; Get mixed powder A mix 10 minutes with equivalent microcrystalline Cellulose mixed powder B; Get mixed powder B and mix 10 minutes with remaining microcrystalline Cellulose; (5) acarbose crossing 80 mesh sieves is mixed 15 minutes with step (4) gained mixed powder; (6) starch taking recipe quantity 1/2 mixes 15 minutes with step (5) gained mixed powder, then adds remaining starch and mix 40 minutes; (7) by step (6) gained mixed powder fill capsule.
The present inventor is through a large amount of experimentatioies, be surprised to find when adjusting silicon dioxide and magnesium stearate addition sequence, there is very big-difference in the dissolution of prepared Acarbose capsules agent medicine compositions: as first added silicon dioxide and magnesium stearate, the product dissolution rate finally prepared, obviously faster than the dissolution rate in customary preparation methods, silicon dioxide and magnesium stearate finally being added products obtained therefrom.Because acarbose needs with at once taking before the meal, therefore acarbose has significant impact at the dissolution rate of gastric and the performance of degree to drug effect.
The Acarbose capsules agent medicine compositions prepared by preparation method provided by the invention, is effectively improve product quality, extends expiration date of drug, accelerates medicine dissolution rate in vivo, ensure 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 to content listed by these embodiments.
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:
Starch and the microcrystalline Cellulose of getting recipe quantity are put in high temperature oven respectively, cross 80 mesh sieves for subsequent use in 95-100 DEG C of drying after 3 hours; 80 mesh sieves are for subsequent use excessively respectively to get the acarbose of recipe quantity, silicon dioxide and magnesium stearate;
Silicon dioxide is put in HD-100 Mixers with Multi-direction Movement, add equivalent starch and mix 10 minutes, add magnesium stearate and mix 10 minutes, add microcrystalline Cellulose 6.40Kg and mix 10 minutes, add microcrystalline Cellulose 12.80Kg and mix 10 minutes, above-mentioned mixed powder is installed to determine the speed of mainshaft be in the HS1500 three-dimensional motion mixer of 12 revs/min, add remaining microcrystalline Cellulose and mix 10 minutes, add acarbose and mix 15 minutes, the starch adding recipe quantity 1/2 mixes 15 minutes, add remaining starch again and mix 40 minutes, then mixed powder is put capsule filler 2# capsule and carry out filling, loading amount scope is controlled by loading amount requirement, make 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:
Starch and the microcrystalline Cellulose of getting recipe quantity are put in fluidized drying pelletizer SS030004 respectively, cross 80 mesh sieves for subsequent use in 90-100 DEG C of drying after 40 minutes; 80 mesh sieves are for subsequent use excessively respectively to get the acarbose of recipe quantity, silicon dioxide and magnesium stearate;
Silicon dioxide is put in HD-100 Mixers with Multi-direction Movement, add equivalent starch and mix 10 minutes, add magnesium stearate and mix 10 minutes, add microcrystalline Cellulose 6.40Kg and mix 10 minutes, add microcrystalline Cellulose 12.80Kg and mix 10 minutes, above-mentioned mixed powder is put in the HD-1500A Mixers with Multi-direction Movement of electric machine frequency 50Hz, add remaining microcrystalline Cellulose and mix 10 minutes, add acarbose and mix 15 minutes, the starch adding recipe quantity 1/2 mixes 15 minutes, add remaining starch again and mix 40 minutes, then mixed powder is put capsule filler 2# capsule and carry out filling, loading amount scope is controlled by loading amount requirement, make every 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:
Starch and the microcrystalline Cellulose of getting recipe quantity are put in fluidized drying pelletizer SS030004 respectively, cross 80 mesh sieves for subsequent use in 90-100 DEG C of drying after 40 minutes; 80 mesh sieves are for subsequent use excessively respectively to get the acarbose of recipe quantity, silicon dioxide and magnesium stearate;
The acarbose getting recipe quantity is put in HD-100 Mixers with Multi-direction Movement, add equivalent starch and mix 15 minutes, add microcrystalline Cellulose and mix 10 minutes, add remaining starch again and mix 15 minutes, add silicon dioxide and magnesium stearate mixes 15 minutes, then mixed powder is put capsule filler 2# capsule and carry out filling, control loading amount scope by loading amount requirement, make every capsule containing acarbose 50mg.
The dissolution determination of test example 1 Acarbose capsules agent medicine compositions
1, instrument and reagent
Automatic 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 (one thousandth): PB-403S, Mei Teletuo benefit company of Switzerland; Electronic balance (100,000/): XSE205DU, Mei Teletuo benefit company of Switzerland: 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;
Sodium 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 etc. on the sunny side. Chinese pharmacists .2011 the 14th volume the 1st phase " in experimental technique and " Chinese Pharmacopoeia " (version in 2010) two annex XC dissolution methods measure.
Get each 12 of Acarbose capsules agent A, B, C respectively, with purified water 900ml for dissolution medium, 37 DEG C ± 0.5 DEG C, rotating speed 50r/min, adopts basket method to carry out Dissolution Rate Testing, respectively at 5,10,15,20,30,45,60min draws dissolution medium 5mL, 0.45 μm of microporous filter membrane filters, get subsequent filtrate sample introduction to measure, draw corresponding Dissolution profiles, the results are shown in Figure shown in 1.
As shown in Figure 1, Acarbose capsules agent A dissolution rate in 15 minutes reaches more than 85%, and in 15-30 minute, dissolution 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%.Experimentally result, can determine to have dissolution rate faster, therefore, it is possible to play drug action better according to Acarbose capsules agent medicine compositions provided by the invention.
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 the high wet test in influence factor's test, investigate the change of its moisture.
Get the content of Acarbose capsules agent A, B, C respectively, put in culture dish and spread out into the thick thin layer of 10mm, opening put 25 DEG C, relative humidity (RH) be in the constant humidity hermetic container of (90 ± 5) % place 10 days, the 5th day and sampling in the 10th day, test sample quality before and after precise 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 has moisture absorption deliquescence phenomenon to exist in high wet test, but Acarbose capsules agent A is obviously more stable in high humidity environment than Acarbose capsules agent B and C, possesses the preparation stability better in high humidity environment.
Claims (10)
1. an Acarbose capsules agent medicine compositions, by weight percentage, composed of the following components: acarbose 10-50%, microcrystalline Cellulose 5%-25%, silicon dioxide 0.2-3%, magnesium stearate 0.3-1%, starch 50-75%, is characterized by: (1) is by through pulverizing and crossing silicon dioxide and the equivalent starch mix homogeneously of 80 mesh sieves; (2) by through to pulverize and the magnesium stearate crossing 80 mesh sieves is mixed homogeneously with step (1) gained mixed powder; (3) by through to pulverize and the microcrystalline Cellulose crossing 80 mesh sieves adopts equal increments method to mix homogeneously with step (2) gained mixed powder; (4) by through to pulverize and the acarbose crossing 80 mesh sieves is mixed homogeneously with step (3) gained mixed powder; (5) starch taking recipe quantity 1/2 is mixed homogeneously with step (4) gained mixed powder after pulverizing and cross 80 mesh sieves, then adds remaining through pulverizing and crossing the abundant mix homogeneously of starch of 80 mesh sieves; (6) by step (5) gained mixed powder fill capsule.
2. Acarbose capsules agent medicine compositions according to claim 1, is characterized by: by weight percentage, composed of the following components: acarbose 25%, microcrystalline Cellulose 10%, silicon dioxide 0.4%, magnesium stearate 0.8%, starch 63.8%.
3. Acarbose capsules agent medicine compositions according to claim 1, is characterized by: adopt in step (3) concrete grammar of equal increments method to be: 1. get step (2) gained mixed powder with through to pulverize and the microcrystalline Cellulose crossing the equivalent of 80 mesh sieves is mixed homogeneously; 2. get step 1. gained mixed powder with through to pulverize and the microcrystalline Cellulose crossing the equivalent of 80 mesh sieves is mixed homogeneously; 3. under remainder through pulverize and the microcrystalline Cellulose crossing 80 mesh sieves and step 2. gained mixed powder mix homogeneously.
4. according to the arbitrary described Acarbose capsules agent medicine compositions of claim 1-3, it is characterized by: 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: starch and microcrystalline Cellulose are put in 95-100 DEG C of drying 3 hours in high temperature oven by (1) respectively, or to put in fluidized drying pelletizer after 90-100 DEG C of dry 0.5-1.5 hour through pulverizing and crossing 80 mesh sieves; (2) by through pulverizing and crossing the silicon dioxide of 80 mesh sieves and equivalent starch mixes 10 minutes; (3) by through to pulverize and the magnesium stearate crossing 80 mesh sieves mixes 10 minutes with step (2) gained mixed powder; (4) get step (3) gained mixed powder mix 10 minutes with equivalent microcrystalline Cellulose mixed powder A; Get mixed powder A mix 10 minutes with equivalent microcrystalline Cellulose mixed powder B; Get mixed powder B and mix 10 minutes with remaining microcrystalline Cellulose; (5) by through to pulverize and the acarbose crossing 80 mesh sieves mixes 15 minutes with step (4) gained mixed powder; (6) starch taking recipe quantity 1/2 mixes 15 minutes with step (5) gained mixed powder, then adds remaining starch and mix 40 minutes; (7) by step (6) gained mixed powder fill capsule.
5. the preparation method of an Acarbose capsules agent medicine compositions, it is characterized by: by weight percentage, composed of the following components: acarbose 10-50%, microcrystalline Cellulose 5%-25%, silicon dioxide 0.2-3%, magnesium stearate 0.3-1%, starch 50-75%, prepare: (1) is by through pulverizing and crossing silicon dioxide and the equivalent starch mix homogeneously of 80 mesh sieves in accordance with the following methods; (2) by through to pulverize and the magnesium stearate crossing 80 mesh sieves is mixed homogeneously with step (1) gained mixed powder; (3) by through to pulverize and the microcrystalline Cellulose crossing 80 mesh sieves adopts equal increments method to mix homogeneously with step (2) gained mixed powder; (4) by through to pulverize and the acarbose crossing 80 mesh sieves is mixed homogeneously with step (3) gained mixed powder; (5) starch taking recipe quantity 1/2 is mixed homogeneously with step (4) gained mixed powder after pulverizing and cross 80 mesh sieves, then adds remaining through pulverizing and crossing the abundant mix homogeneously of starch of 80 mesh sieves; (6) by step (5) gained mixed powder fill capsule.
6. preparation method according to claim 5, is characterized by: by weight percentage, composed of the following components: acarbose 25%, microcrystalline Cellulose 10%, silicon dioxide 0.4%, magnesium stearate 0.8%, starch 63.8%.
7. preparation method according to claim 5, is characterized by: adopt in step (3) concrete grammar of equal increments method to be: 1. get step (2) gained mixed powder with through to pulverize and the microcrystalline Cellulose crossing the equivalent of 80 mesh sieves is mixed homogeneously; 2. get step 1. gained mixed powder with through to pulverize and the microcrystalline Cellulose crossing the equivalent of 80 mesh sieves is mixed homogeneously; 3. under remainder through pulverize and the microcrystalline Cellulose crossing 80 mesh sieves and step 2. gained mixed powder mix homogeneously.
8. preparation method according to claim 5, is characterized by: starch and microcrystalline Cellulose carry out high temperature drying before sieving.
9. preparation method according to claim 8, is characterized by: starch and microcrystalline Cellulose are put in 95-100 DEG C of drying 3 hours in high temperature oven, or puts in fluidized drying pelletizer in 90-100 DEG C of dry 0.5-1.5 hour.
10. preparation method according to claim 5, it is characterized by: by weight percentage, get 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 95-100 DEG C of drying 3 hours in high temperature oven by (1) respectively, or to put in fluidized drying pelletizer crossed 80 mesh sieves after 90-100 DEG C of dry 0.5-1.5 hour; (2) silicon dioxide and equivalent starch of crossing 80 mesh sieves are mixed 10 minutes; (3) magnesium stearate crossing 80 mesh sieves is mixed 10 minutes with step (2) gained mixed powder; (4) get step (3) gained mixed powder mix 10 minutes with equivalent microcrystalline Cellulose mixed powder A; Get mixed powder A mix 10 minutes with equivalent microcrystalline Cellulose mixed powder B; Get mixed powder B and mix 10 minutes with remaining microcrystalline Cellulose; (5) acarbose crossing 80 mesh sieves is mixed 15 minutes with step (4) gained mixed powder; (6) starch taking recipe quantity 1/2 mixes 15 minutes with step (5) gained mixed powder, then adds remaining starch and mix 40 minutes; (7) by step (6) gained mixed powder fill capsule.
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| 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 |
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Patent Citations (5)
| 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 |
| 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 |
| CN103315971A (en) * | 2013-06-13 | 2013-09-25 | 海南葫芦娃制药有限公司 | Acarbose tablets and preparation method thereof |
| CN104523653A (en) * | 2015-02-06 | 2015-04-22 | 杭州朱养心药业有限公司 | Acarbose capsule pharmaceutical composition |
Cited By (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 |
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| CN104940164B (en) | 2016-08-24 |
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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. |