CN103536595A - Acipimox composition tablet - Google Patents
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Abstract
The invention provides an acipimox composition tablet, and belongs to the field of medicine and medicine production technology. The acipimox composition capsule comprises following raw materials and auxiliary materials, by weight, 400 parts of acipimox, 100 parts of chitosan nanoparticle, 400 parts of croscarmellose sodium, 650 parts of 4% hydroxypropyl methylcellulose 50% ethanol, 400 parts of carboxy methyl starch, and 12 parts of magnesium stearate. Advantages of the acipimox composition tablet are that: main drug solubility is improved further, that is to say, a uniform viscous suspension is obtained rapidly when the acipimox composition tablet is contacted with water, so that fine particles are obtained rapidly in gastrointestinal tract by disintegration, drug distribution area is enlarged, absorption points are increased, overhigh local drug concentration in gastrointestinal tract caused by common tablets and capsules is avoided, irritation on gastrointestinal mucosa is avoided, untoward effects are reduced, and adaptability of patients is increased. The acipimox composition tablet is convenient for patients to take; absorption speed is fast; and bioavailability is high.
Description
Technical field:
The present invention relates to medicine and medicine manufacture technology field, relate in particular to a kind of acipimox composition tablet.
Background technology:
In recent years, along with dietary habit change, living standard raising, operating pressure increase, hyperlipemia and hyperproteinemia patient are more and more, and patient group is rejuvenation more and more.Hyperlipemia and hyperproteinemia are one group of clinical common lipid metabolic disorder diseases, when the concentration of blood plasma lipide surpasses normal value height, become hyperlipemia in limited time, and in blood plasma, lipoprotein surpasses normal value height and is called hyperlipoproteinemia in limited time.Epidemiological study shows, increasing of blood plasma low density lipoprotein, LDL and Very Low Density Lipoprotein, is the key factor of early starting pulse atherosclerosis and coronary heart disease.Statistical analysis shows, the every reduction by 1% of serum cholesterol, and the pathogenetic risk of coronary disease will reduce by 2%.Therefore, reasonably diet, motion and Drug therapy are very important to hyperlipemia and patients with hyperlipoproteinemia.
Acipimox is nicotinic acid derivates, this medicine Main Function is in fatty tissue, by suppressing fatty tissue, discharge free fatty, reduce the synthetic of blood plasma low-density lipoprotein Pseudobulbus Bletillae (Rhizoma Bletillae) very low density lipoprotein (VLDL), thereby the level of blood plasma low-density lipoprotein Pseudobulbus Bletillae (Rhizoma Bletillae) very low density lipoprotein (VLDL) in reduction blood plasma, simultaneously by suppressing the active blood plasma HDL level that increases of hepatic lipase.
Acipimox Capsules is developed by Italian Farmitalia Carlo Erba company, and in 1985, in Italy's listing, specification was 250mg.Lunan Pharmacy Co. Ltd and calendar year 2001 obtain the New Drug Certificate of Acipimox Capsules.
Chitosan is unique alkaline polysaccharide that nature exists, nontoxic, have biological degradability and biocompatibility in body, and its similar is in cellulose, by American-European academia, be described as the protein that continues, fat, saccharide, the 6th vital principle after vitamin and inorganic salt.The chitosan whole world is about 10,000,000,000 t by biosynthetic chitin every year, more than can extracting chitosan 2,000,000,000 t, is really the natural biological organic resource of " inexhaustible ".Chitosan is a kind of aminopolysaccharide polymer, is that the chitin by natural non-activity obtains after deacetylation.Structure and the cellulose of chitosan are quite similar, and just the acetylamino on sugar ring C2 has replaced hydroxyl, and this acetylamino gives chitosan special characteristic, make it can be for pharmaceutical preparation aspect.Chitosan is easy to dissolve in weak acid solvent, it is worthy of note especially in solution after dissolving and contains amino, is alkalescence, has very strong hydrophilic, can be with hydrochloric acid and acetic acid etc. the inorganic or synthetic salt of organic acid.A lot of physiologically actives of chitosan make it at field of medicaments, have a wide range of applications.
And the tablet of being made by chitosan nano tabletting, the diluent in the time of can making chewable tablet, Sublingual tablet or oral mucosa sheet direct compression.In wet granule compression tablet, chitosan content increases, and the hardness of tablet reduces, and disintegration time extends, and can by changing the content of chitosan, regulate hardness and the disintegration time of tablet like this, also has stability.
The invention provides a kind of acipimox composition tablet, select chitosan nano as filler, ordinary preparation for acipimox, as capsule, its specification is 250mg/ grain, because of disintegrate and the slow abundant absorption that affects medicine of drug-eluting, the patient of old man, child and dysphagia takes often and has any problem, in treatment, remain in untoward reaction such as nauseating, vomiting, inappetence simultaneously, the object of the invention is to overcome above-mentioned shortcoming.
Summary of the invention:
An object of the present invention is to provide a kind of acipimox composition tablet, said composition principal agent is: aliskiren, chitosan nano.
For realizing the object of the invention, technical scheme realizes in the following way:
A composition tablet, by following weight portion supplementary material, made:
Acipimox composition tablet of the present invention be take acipimox as raw material, and 4% hypromellose 50% ethanol, chitosan nano, cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium and the magnesium stearate that are equipped with certain part by weight are made.
Because principal agent acipimox itself is poorly soluble, for increasing disintegration time and the dissolution of tablet, often need to add disintegrating agent.Cross-linking sodium carboxymethyl cellulose is the ether of water-soluble cellulose, and approximately having 70% carboxyl is sodium-salt type, have larger draw moist, existence due to cross-bond, water insoluble, the water that can absorb several times quantity in water expands and does not melt, and has good disintegration and compressibility.Carboxymethyl starch sodium water absorption is stronger, and after water suction, inflatable to original volume 300 times, are good disintegrating agents.Acipimox composition tablet of the present invention adopts carboxymethyl starch sodium and cross-linking sodium carboxymethyl cellulose coupling as disintegrating agent, disintegrate better effects if.Carboxymethyl starch sodium and cross-linking sodium carboxymethyl cellulose combined effect simultaneously also has good mobility and compressibility, can improve the mouldability of tablet, increases the hardness of tablet.
Chitosan nano has better swellability, mobility, compressibility and self-lubricity, and acipimox composition tablet of the present invention adopts chitosan nano can produce synergism to disintegrating agent as filler.
Because medicine itself is inadhesion or stickiness is less after mixing with adjuvant, for being bonded together, medicine and adjuvant often need to add binding agent.Hypromellose has advantages of that compression forming is good, there is the effect of lubricated and disintegrate, acipimox composition tablet of the present invention is usingd hypromellose not only can make medicine and adjuvant well bonding as binding agent, also can make the hardness of tablet and friability better.
Acipimox composition tablet of the present invention adopts magnesium stearate as lubricant, while making tabletting, can feed in raw material smoothly and slice, reduced sticking and reduced granule and granule, tablet and nib wall between frictional force, make unilateral smooth and beautiful appearance, improved production efficiency.
The concrete preparation method of acipimox composition tablet is as follows:
Step 1: respectively acipimox, chitosan nano, cross-linking sodium carboxymethyl cellulose and carboxymethyl starch sodium are sieved, then the cross-linking sodium carboxymethyl cellulose mix homogeneously of the acipimox of 400 weight portions, the chitosan nano of 100 parts and 400 parts is obtained to the first mixture standby;
Step 2: 4% hypromellose 50% ethanol of 650 weight portions is added to soft material processed in the first mixture, granulation after sieving;
Step 3: controlled humidity, below RH59%, makes to such an extent that granule is dried, sieves at 50～60 ℃ by step 2, adds institute's methyl starch sodium of 400 weight portions and the magnesium stearate of 12 weight portions to mix, tabletting, both.
Sieving as crossing 80 mesh sieves described in step 1.
Sieving as crossing 20 mesh sieves described in step 2.
Sieving as crossing 18 mesh sieves described in step 3.
The present invention also provides above-mentioned preparation method to make to obtain acipimox composition tablet.
Film-coat refers to during wrapping the more stable high molecular polymer clothing film of one deck outside the sheet heart is not subject to air with protection tablet the effects such as dampness, oxygen, increases stability, and can cover up bad smell, and less than the minor face impact of sugar-coat.
Therefore the invention provides a kind of can protection against the tide, the Film coated tablets of the acipimox composition tablet of lucifuge, isolated air increase medicine stability.
The Film coated tablets of acipimox composition tablet of the present invention is made by described acipimox composition tablet, medicinal film-coating premixing auxiliary material and 75% ethanol.Wherein, described medicinal film-coating premixing auxiliary material is as coating powder, and 75% ethanol is the lytic agent of coating powder.
Further, the weight ratio of described acipimox composition tablet and described medicinal film-coating premixing auxiliary material is 20:1, and the weight ratio of described medicinal film-coating premixing auxiliary material and 75% ethanol is 1:10.
The present invention also provides a kind of preparation method of Film coated tablets of acipimox composition tablet, it is characterized in that,
Step 1: get it filled with film-coating premixing auxiliary material, add 75% ethanol of its 10 times of weight to be mixed and made into coating solution;
Step 2: get it filled and be placed in seed-coating machine with the acipimox composition tablet recipe quantity of 20 times of weight of film-coating premixing auxiliary material, control inlet temperature at 55～65 ℃, adjust 5～10 revs/min of coating pan rotating speeds, by the acipimox composition tablet preheating of making by prescription 30～50 minutes, then spray into coating solution that step 1 makes to coating weightening finish 5%, dry both.
The present invention also provides above-mentioned preparation method worth acipimox composition film garment piece.
From above-mentioned technical scheme, can find out, the invention provides a kind of preparation method of acipimox composition tablet.Acipimox composition tablet disintegration rate of the present invention is fast, dissolution rate is high, good stability, dosage is accurate, content is even, taking convenience, be easy to carry, and raw material is easy to get, cost is low.The preparation method of acipimox composition tablet of the present invention is simple to operate, easily controls, and saving of work and time, is beneficial to industrialized great production.Acipimox composition film garment piece of the present invention has increased the stability of tablet, and sheet heavily increases little, little on disintegration rate impact.The preparation method of acipimox composition film garment piece of the present invention is simple to operate, with short production cycle, and production efficiency is high, is suitable for suitability for industrialized production.
Beneficial effect of the present invention is:
The present invention is acipimox composition tablet type, its advantage can further be improved principal agent dissolubility, meet water and can form rapidly even stickiness suspension, can resolve into fine particle in the rapid disintegrate of intestines and stomach, drug distribution area is increased, absorption point increases, avoid conventional tablet and capsule too high in gastrointestinal tract local drug concentration, the shortcomings such as stimulating gastrointestinal mucosa, reduce untoward reaction, improve patient's fitness, there is taking convenience, absorb fast, bioavailability high, and facilitate patient to take.
Through a large amount of experimental studies repeatedly, determined the final formulation and technology of acipimox tablet, and proved invention has above-mentioned advantage really in animal experiment, the acipimox tablet of gained can maintain acipimox in the existence of blood middle concentration, in test, we have selected multiple filler to compare, and are surprised to find, and not all medicinal filler that can be used for tablet can be applied to the present invention.One of difficult problem that the present invention solves is exactly the screening to filler, and the filler of finally selecting is chitosan nano.
The specific embodiment:
The embodiment of the invention discloses a kind of acipimox composition tablet preparation method.Those skilled in the art can use for reference content herein, suitably improve technological parameter and realize.Special needs to be pointed out is, all similar replacements and change apparent to those skilled in the artly, they are all deemed to be included in the present invention.Product of the present invention and method are described by preferred embodiment, and related personnel obviously can change method as herein described or suitably change and combination within not departing from content of the present invention, spirit and scope, realizes and apply the technology of the present invention.
In order further to understand the present invention, below in conjunction with embodiment, the present invention is described in detail.Wherein, acipimox, chitosan nano, cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, magnesium stearate, medicinal film-coating premixing auxiliary material and 75% ethanol are commercial goods.
Embodiment mono-:
Take acipimox as raw material, investigate the impact of each supplementary product consumption on medicine angle of repose, hardness, outward appearance, disintegrate, friability, dissolution.Each supplementary product consumption of writing out a prescription is in Table 1.
Stock and adjunct is sieved respectively, standby: by acipimox, chitosan nano, hypromellose, pregelatinized Starch, cross-linking sodium carboxymethyl cellulose, carboxymethylstach sodium, magnesium stearate mixes by recipe quantity, measure angle of repose, after tabletting, measure hardness, outward appearance, weight differential, disintegrate, friability, dissolution, the results are shown in Table 2.Wherein, hardness, outward appearance, weight differential, disintegrate, friability, dissolution determination method are with reference to two appendix of < < Chinese Pharmacopoeia > > version in 2005.Outward appearance: visual examination; Hardness, disintegrate, friability: tablet four-function analyzer.
Table 1 supplementary product consumption of respectively writing out a prescription
| Supplementary material | Prescription 1 | Prescription 2 | Prescription 3 | Prescription 4 |
| Acipimox | 20 | 20 | 20 | 20 |
| Chitosan nano | 6 | 5.5 | 5 | 4 |
| Cross-linking sodium carboxymethyl cellulose | 18 | 19 | 20 | 21 |
| 5% hypromellose 50% ethanol | 32.5 | 32.5 | / | / |
| 4% hypromellose 50% ethanol | / | / | 32.5 | 32.5 |
| Carboxymethyl starch sodium (additional) | 18 | 19 | 20 | 21 |
| Magnesium stearate | 0.6 | 0.6 | 0.6 | 0.6 |
Table 2 result of the test of respectively writing out a prescription
| Index | Prescription 1 | Prescription 2 | Prescription 3 | Prescription 4 |
| Angle of repose (degree) | / | 31.4 | 25.6 | 27.3 |
| Outward appearance | Complete bright and clean | Complete bright and clean | Complete bright and clean | Complete bright and clean |
| Weight differential | Against regulation | Up to specification | Up to specification | Up to specification |
| Hardness (Kg) | / | 6.94 | 6.96 | 6.95 |
| Friability (%) | / | 0.19 | 0.24 | 0.24 |
| Disintegration (dividing) | / | 17 | 11 | 16 |
From table 2 result, the investigation index such as 3 the angle of repose of writing out a prescription, hardness, friability is better than other prescriptions.
Embodiment 2:
With embodiment 1 prescription 3, prepare acipimox granule, take three parts and be respectively placed in load weighted flat weighing botle, be placed in respectively under RH43%, RH59%, RH70% condition, place after taking-up in 1,3,5 days, weigh respectively, investigate the impact of different humidity on medicine, calculate its granule absorbance, the results are shown in Table 3.
Table 3 hydroscopicity result of the test
| Condition | RH43% | RH59% | RH70% |
| Moisture absorption in 1 day weigh (%) | 0.21 | 0.29 | 0.61 |
| Moisture absorption in 3 days weightening finish (%) | 0.30 | 0.41 | 0.87 |
| Moisture absorption in 5 days weightening finish (%) | 0.41 | 0.54 | 1.39 |
From table 3 result, under the damp condition of RH70%, moisture absorption weightening finish obviously increases, and under the condition that is RH59% in humidity, moisture absorption is increased weight without significant change.Therefore must control space humidity in preparation process below RH59%.
Embodiment 3: acipimox composition tablet of the present invention
Preparation method: respectively by acipimox, chitosan nano, cross-linking sodium carboxymethyl cellulose and carboxymethyl starch sodium are crossed 80 mesh sieves, then by the acipimox of 4000g, the cross-linking sodium carboxymethyl cellulose mix homogeneously of 1000g chitosan nano and 4000g, the 4% hypromellose 50% ethanol soft material processed that adds 6500g, cross granulation after 20 mesh sieves, controlled humidity is below RH59%, the granule making is dry at 50 ~ 60 ℃, cross 18 mesh sieves, add the carboxymethyl starch sodium of 4000g and the magnesium stearate of 120g to mix, the shallow cambered surface punch die of Φ 11mm tabletting, both.
Embodiment 4: acipimox composition film garment piece of the present invention
Preparation method: get the medicinal film-coating premixing auxiliary material of 650g, add 6.5Kg75% ethanol to be mixed and made into coating solution, getting the acipimox composition tablet that 13Kg embodiment 3 makes is placed in seed-coating machine, control inlet temperature at 55 ~ 65 ℃, adjust 5 ~ 10 revs/min of coating pan rotating speeds, make the acipimox composition tablet preheating 30 ~ 50 minutes that embodiment 3 makes, then spray into coating solution to coating weightening finish and be about 5%, stop-spraying coating solution, blowing hot-air makes coated tablet dry, both.
Embodiment 5:
The prepared acipimox composition tablet of the embodiment of the present invention 3 of take is object of study, carries out comprehensive study on the stability, comprising: influence factor's test, accelerated test, long-time stability.The projects such as each experiment exam character, loss on drying, related substance, disintegration, dissolution, content.Each study on the stability experimental condition is with reference to the relevant regulations in < < Chinese Pharmacopoeia > > appendix, influence factor tests and investigates 10 days, accelerated test is investigated 6 months, that gas study on the stability to 36 month that wipes the sweat, the results are shown in Table 4 ~ 6.
1, the acipimox composition tablet that sample: embodiment 3 makes.
Experimental apparatus: high performance liquid chromatograph and chromatographic work station (Agilent company); Illumination phase (illumination 4000Lx); Chromatographic column: determination of related substances: C18250mm * 4.6mm, 5 μ m; Assay: C18250mm * 4.6mm, 5 μ m.
2, assay method:
2.1 influence factor's test methods: get test sample and put in open containers (culture dish), tablet is spread out into one deck, carry out hot test, high humility test, exposure experiments to light.Result of the test is in Table 4, and each experimental technique is as follows:
Hot test: get test sample and put in culture dish, place 10 days at 60 ℃ of temperature, sampled and test in the 5th day and the 10th day, detect by stability high spot reviews project, result of the test and comparison in 0 day.
High humility test: get 2 parts of test samples and be placed in culture dish, at 25 ℃, place 10 days under respectively at relative humidity 90% ± 5% and 75% ± 5% condition, in the 5th day and the 10th day, sample and detect, by stability high spot reviews project, detect, result of the test and comparison in 0 day.
Exposure experiments to light: get test sample and put in culture dish, being placed on illumination is to place 10 days in the lighting box under 4500Lx condition, samples and detects in the 5th day and the 10th day, detects result of the test and comparison in 0 day by stability high spot reviews project.
2.2 accelerated tests: according to the relevant regulations of Chinese Pharmacopoeia version medicine stability test guideline in 2005, test sample moral accelerated test is pressed commercially available back are carried out under temperature is 40 ℃ ± 2 ℃, the condition of relative humidity 75% ± 5%, and the time is 6 months.At duration of test respectively at the 1st, 2,3,6 samplings at the end of month once, by stability high spot reviews project, measure, the results are shown in Table 5.
2.3 long term tests: according to the relevant regulations of Chinese Pharmacopoeia version medicine stability test guideline in 2005, test sample moral long term test is pressed commercially available back, under being 25 ℃ ± 2 ℃, the condition of relative humidity 60% ± 10%, temperature carries out, time is 36 months, at duration of test, within 0th month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 36 months, sample once respectively, by stability high spot reviews project, test, the results are shown in Table 6.
Table 4 influence factor result of the test
Table 5 accelerated test result (40 ℃ ± 2 ℃, RH75% ± 5%)
Table 6 long-term test results (25 ℃ ± 2 ℃, RH60% ± 10%)
By the visible acipimox composition tablet of the present invention of table 4 result, under the experimental conditions such as each influence factor such as strong illumination, high temperature and high humidity, placed 10 days, carrying out face shaping, moisture, content and related substance etc. checks, the moisture absorption slightly under super-humid conditions, under illumination condition, related substance increases to some extent, all more stable under other conditions, indices all meets < < Chinese Pharmacopoeia > > regulation.By the visible acipimox composition tablet of the present invention of table 5 result, press commercially available back, under being 40 ℃ ± 2 ℃, relative humidity 75% ± 5% condition, temperature places 6 months, all there is not significant change in character, loss on drying, related substance, dissolution and content, meets < < Chinese Pharmacopoeia > > regulation.By the visible acipimox compositions sheet machine of the present invention of table 6 result, under being 25 ℃ ± 2 ℃, the condition of relative humidity 60% ± 10%, temperature placed 36 months, character, moisture, related substance, dissolution and content all meet < < Chinese Pharmacopoeia > > regulation, and indices has no significant change.Result shows that acipimox composition tablet of the present invention is stable and controllable for quality.
The present invention of take is according to the method described above object of study to the prepared acipimox Film coated tablets of embodiment 4, carries out comprehensive study on the stability.Result shows places 10 days under the experiment conditions such as each influence factor such as strong illumination, high temperature and high humidity, in temperature, be to place 36 months under 40 ℃ ± 10% condition, main quality index has no significant change, and shows that acipimox Film coated tablets of the present invention is stable and controllable for quality.
More than show and described ultimate principle of the present invention, principal character and advantage of the present invention.The technical staff of the industry should understand; the present invention is not restricted to the described embodiments; what in above-described embodiment and description, describe is only preference of the present invention; be not used for limiting the present invention; without departing from the spirit and scope of the present invention; the present invention also has various changes and modifications, and these changes and improvements all fall in the claimed scope of the invention.The claimed scope of the present invention is defined by appending claims and equivalent thereof.
Claims (8)
1. an acipimox composition tablet, is characterized in that, by following weight portion supplementary material, is made:
2. a preparation method for acipimox composition tablet described in claim 1, is characterized in that, comprises the steps:
Step 1: respectively acipimox, chitosan nano, cross-linking sodium carboxymethyl cellulose and carboxymethyl starch sodium are sieved, then the cross-linking sodium carboxymethyl cellulose mix homogeneously of the acipimox of 400 weight portions, the chitosan nano of 100 parts and 400 parts is obtained to the first mixture standby;
Step 2: 4% hypromellose 50% ethanol of 650 weight portions is added to soft material processed in the first mixture, granulation after sieving;
Step 3: controlled humidity, below RH59%, makes to such an extent that granule is dried, sieves at 50～60 ℃ by step 2, adds institute's methyl starch sodium of 400 weight portions and the magnesium stearate of 12 weight portions to mix, tabletting, both.
3. the preparation technology of acipimox composition tablet according to claim 2, is characterized in that, sieving as crossing 80 mesh sieves described in step 1.
4. the preparation technology of acipimox composition tablet according to claim 2, is characterized in that, sieving as crossing 20 mesh sieves described in step 2.
5. the preparation technology of acipimox composition tablet according to claim 2, is characterized in that, sieving as crossing 18 mesh sieves described in step 3.
6. the Film coated tablets of acipimox composition tablet described in a claim 1, it is characterized in that, by described acipimox composition tablet, medicinal film-coating premixing auxiliary material and 75% ethanol, made, described medicinal film-coating premixing auxiliary material is as coating powder, and 75% ethanol is the lytic agent of coating powder.
7. the Film coated tablets of acipimox composition tablet according to claim 6, it is characterized in that, the weight ratio of described acipimox composition tablet and described medicinal film-coating premixing auxiliary material is 20:1, and the weight ratio of described medicinal film-coating premixing auxiliary material and 75% ethanol is 1:10.
8. a preparation method for Film coated tablets described in claim 7, is characterized in that,
Step 1: get it filled with film-coating premixing auxiliary material, add 75% ethanol of its 10 times of weight to be mixed and made into coating solution;
Step 2: get it filled and be placed in seed-coating machine with the acipimox composition tablet recipe quantity of 20 times of weight of film-coating premixing auxiliary material, control inlet temperature at 55～65 ℃, adjust 5～10 revs/min of coating pan rotating speeds, by the acipimox composition tablet preheating of making by prescription 30～50 minutes, then spray into coating solution that step 1 makes to coating weightening finish 5%, dry both.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8202508B1 (en) * | 2011-09-08 | 2012-06-19 | Gp Medical, Inc. | Pharmaceutical composition of nanoparticles for protein drug delivery |
| CN103211785A (en) * | 2012-01-18 | 2013-07-24 | 北京天衡药物研究院 | Acipimox film-controlled slow-release pellet capsule |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8202508B1 (en) * | 2011-09-08 | 2012-06-19 | Gp Medical, Inc. | Pharmaceutical composition of nanoparticles for protein drug delivery |
| CN103211785A (en) * | 2012-01-18 | 2013-07-24 | 北京天衡药物研究院 | Acipimox film-controlled slow-release pellet capsule |
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