CN104352478A - Preparation method of furazolidone preparation - Google Patents
Preparation method of furazolidone preparation Download PDFInfo
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Abstract
The invention discloses a preparation method of a furazolidone preparation. The furazolidone preparation comprises the following raw materials in parts by weight: 100-300 parts of furazolidone, 4-100 parts of a filler, 4-20 parts of povidone, 0.5-10 parts of a solubilizer, 2-15 parts of sodium carboxymethyl starch, 0.5-3 parts of magnesium stearate and 0.5-3 parts of silicon dioxide. The preparation method comprises the following steps: adding water to povidone, and preparing a water solution of which the mass concentration is 10-35%; pouring the solubilizer into a povidone water solution and mixing evenly; mixing furazolidone with the filler, adding the povidone water solution containing the solubilizer to prepare a soft material; pelletizing, drying, and granulating; adding magnesium stearate, silicon dioxide and sodium carboxymethyl starch to the granulated particles; and mixing evenly, and filling an enteric capsule, so as to prepare the furazolidone preparation. The treatment concentration of the medicine can be enhanced by target drug release in human intestines, thus the sterilization effect of the medicine can be enhanced; the treatment effect of the furazolidone on the enteric infectious disease can also be improved; and the furazolidone preparation has relatively strong application value.
Description
Technical field
The present invention relates to medical art, specifically a kind of preparation method of furazolidone enteric coated capsule preparation.
Background technology
Furazolidone, chemistry 3-by name (5-furan feeds methylamino)-2-oxazolidone.These product are itrofurans antimicrobial drug.Certain antibacterial action is all had to Grain-positive and negative bacterium, comprise Salmonella, Shigella, escherichia coli, Klebsiella Pneumoniae, Enterobacter, S. aureus L-forms, enterococcus faecalis, micrococcus scarlatinae, vibrio cholera, Campylobacter, Bacteroides etc., under finite concentration, also have activity to trichomonacide, giardia lamblia stiles.Its mechanism of action is interference bacterial oxidation reductase thus blocks the homergy of antibacterial.
The atomic water-soluble and ethanol of furazolidone, is slightly soluble in chloroform, is insoluble to ether, be soluble in dimethyl formamide and Nitrocarbol..Bioavailability is in vivo lower.Furazolidone tablet another name is furaxone, is the furazolidone single preparations of ephedrine of current domestic unique listing.This kind dissolution in vitro is increased to 70% by the quality standard that state-promulgated pharmacopoeia is 2010 editions, and the tablet dissolution in vitro that the production technology of domestic this kind existing obtains is mostly 50-60%, does not far reach the requirement of the qualified limit of quality standard.Furazolidone tablet is increased to more than 85% according to dissolution specification, higher than commercially available dissolution in patent " a kind of preparation technology of Furazolidone tablet " (application number 201310225487.9) of our company's application.Furazolidone tablet mainly absorbs at stomach, suppresses the campylobacter pyloridis on gastric mucosa, clinical multiplex its treatment chronic gastritis and peptic ulcer, and therefore the domestic people of having even is made into gastric endocopy, improves its absorption at stomach.But modern pharmacy finds that the drug level in its tangible human body of furazolidone in intestinal is higher, and most of enteric infection pathogenic bacterias such as dysentery bacterium, Salmonella, escherichia coli etc. that it can be killed all exist in intestinal, find according in the drug sensitive experiment group of certain hospital, furazolidone compares other antibiotic, antibiotics is the strongest to the sensitivity of dysentery bacterium, is the choice drug for the treatment of bacillary dysentery.And furazolidone limits its effect suppressing pathogenic entero becteria undoubtedly in the absorption of stomach.At present, domestic formulation products furazolidone being used in intestinal release still belongs to blank, the targeting drug release of furazolidone in human body intestinal canal not only can strengthen the sterilization effect of medicine, can also improve the therapeutic effect of furazolidone treatment infectious intestinal disease, the using value that tool is stronger.The invention provides a kind of furazolidone enteric coated capsule, compare original Tabules, technique is simple, and drug release rate is fast, release amount is higher, by furazolidone targeting drug release in intestinal, can also be more conducive to the performance of the Absorption and curative effect improving medicine.
Summary of the invention
The object of this invention is to provide a kind of be different from traditional, technique is simple, cost is low, dissolution is high, bioavailability is high, the preparation method of the furazolidone enteric coated capsule of targeting drug release.
The preparation method of furazolidone enteric coated capsule of the present invention is as follows:
The weight proportion of raw material is:
Preparation method:
1) get polyvidone, add water, be made into the mass concentration aqueous solution of 10 ~ 35%;
2) solubilizing agent is poured in above-mentioned polyvidone aqueous solution, mixing;
3) get furazolidone and filler mix homogeneously, add the above-mentioned polyvidone aqueous solution soft material containing solubilizing agent, 16 ~ 20 orders are granulated, 55 ~ 70 DEG C of dryings, 16 ~ 40 order granulate;
4) add magnesium stearate, silicon dioxide and carboxymethyl starch sodium in the granule after granulate, mix homogeneously, fill enteric coated capsule and get final product;
Described filler is one or more in starch, pregelatinized Starch, lactose, cyclodextrin, hydroxypropyl cyclodextrin, Macrogol 4000, polyethylene glycol 6000;
Described solubilizing agent is one or more in sodium lauryl sulphate, poloxamer, Labraso, TC, PEG400.
The present invention's advantage is compared to existing technology:
1, domestic furazolidone is filled up in intestinal-specific release, the formulation blank of rapid delivery of pharmaceuticals.The targeting drug release of furazolidone in human body intestinal canal can strengthen the treatment concentration of medicine, and then strengthens the bactericidal effect of medicine, can also improve the therapeutic effect of furazolidone treatment infectious intestinal disease, the using value that tool is stronger.
2, the present invention compares original Tabules, and technique is simple, and drug release rate is fast, release amount is higher.Drug-eluting amount during in 1.3% sodium dodecyl sulfate solution dissolution medium 60 minutes reaches more than 93%, far above the technological level of tablet.Also more than 76% is reached according to the burst size of enteric coated capsule in the buffer salt of PH6.8.
The technical study of furazolidone enteric coated capsule of the present invention
1, experiment purpose: screen supplementary product kind, consumption and the process conditions that can make furazolidone enteric coated capsule satisfactory quality by experiment.
2, experimental technique: screening filler, solubilizing agent, binding agent, lubricant, technological parameter are to the quality influence of product.
3, prescription: but according to Chinese Pharmacopoeia 2010 editions two annex XD requirements, furazolidone enteric coated capsule should be insoluble to 0.1mol/L hydrochloric acid solution, and has a certain amount of burst size in the phosphate buffered saline(PBS) of PH6.8.In view of furazolidone is insoluble in water, and dissolution medium 1.3% sodium dodecyl sulfate solution used during the dissolution determination of Related product Furazolidone tablet is the alkaline solution of more than PH7, dissolution limit is 70%, therefore, with reference to the regulation of this standard and Chinese Pharmacopoeia, the burst size of furazolidone enteric coated capsule in the phosphate-buffered salt of PH6.8 must not lower than 70%.
4, detection method:
4.1 assays: precision takes each sample and reference substance in 200ml volumetric flask, adds dimethyl formamide 32ml, dissolve completely, ultrasonic 5 minutes of sample sets.Be diluted with water to scale, shake up, filter, precision measures in filtrate 10ml to 100ml measuring bottle, is diluted with water to scale, shakes up.Ultraviolet absorptivity is measured in 367nm place.Calculate.
The dissolution study of 4.2 capsule particles and capsule
Accurate label taking is shown the sample particle of content 100mg or the enteric coated capsule of sample particle is housed.By Chinese Pharmacopoeia version in 2010 two annex XC dissolution determination methods, with 1.3% sodium dodecyl sulfate solution 1000mL for dissolution medium, rotating speed is 120r/min, operates in accordance with the law.Get solution 10mL during 60min, microporous filter membrane filters, and precision measures subsequent filtrate 5mL and puts in 50mL measuring bottle, is diluted with water to scale, shakes up, and obtains need testing solution;
Get furazolidone reference substance and be about 20mg, accurately weighed, put in 200mL measuring bottle, after adding dimethyl formamide 20mL dissolving, be diluted with water to scale, shake up, precision measures 5mL, puts in 50mL measuring bottle, is diluted with water to scale, shake up, in contrast product solution.Get above-mentioned 2 kinds of solution, measure absorbance respectively at the wavelength place of 367nm.Calculation sample stripping quantity.
The release research of 4.3 enteric coated capsulees
Get the enteric coated capsule sample that granule is housed, according to Chinese Pharmacopoeia version in 2010 two annex XD release degree assay methods, measure 0.1mol/L hydrochloric acid solution 750ml, inject each stripping rotor, treat that dissolution medium temperature constant is at 37 DEG C ± 0.5 DEG C, get 6 respectively drop into turn in basket, rotating speed is 120r/min, after 2 hours, sampling 10mL, supplements 0.1mol/L hydrochloric acid solution 10mL simultaneously.Sample microporous filter membrane filters, and precision measures subsequent filtrate 5mL and puts in 50mL measuring bottle, is diluted with water to scale, shakes up, and obtains need testing solution 1; The 0.2mol/L sodium radio-phosphate,P-32 solution 250ml (regulating pH value to 6.8 with 2mol/L hydrochloric acid solution or 2mol/L sodium hydroxide solution if desired) that temperature is 37 DEG C ± 0.5 DEG C is added in above-mentioned acid solution, remain in operation 60 minutes, get solution 10mL, microporous filter membrane filters, precision measures subsequent filtrate 5mL and puts in 50mL measuring bottle, be diluted with water to scale, shake up, obtain need testing solution 2;
Get furazolidone reference substance and be about 20mg, accurately weighed, put in 200mL measuring bottle, after adding dimethyl formamide 20mL dissolving, be diluted with water to scale, shake up.Precision measures 5mL, puts in 50mL measuring bottle, is diluted with water to scale, shake up, in contrast product solution.
Get above-mentioned 3 kinds of solution, measure absorbance respectively at the wavelength place of 367nm.Calculate burst size.
Burst size in acid: in 6, the burst size of every is all not more than in 10% of labelled amount, 6 has 1 ~ 2 to be greater than 10%, but its mean release is not more than 10%.
Burst size in buffer: in 6, the burst size of every calculates by labelled amount and is all not less than 70%.
5, the investigation of different filler
Get 100g furazolidone, add different filler respectively, mixing, adds 50% alcoholic solution and granulates, dry, granulate.Investigate the impact on furazolidone, screening is beneficial to the adjuvant of furazolidone stripping.
Table 1
Matched group is the group not adding filler.
From above result: starch, pregelatinized Starch, lactose, cyclodextrin, hydroxypropyl cyclodextrin, Macrogol 4000, Macrogol 600 have the solubilization of more than 7% to furazolidone, also the effect of mobility of furazolidone of being significantly improved (is compared matched group to diminish angle of repose, the rate of outflow becomes large), therefore can select as filler.Above filler has obvious solubilizing effect when consumption 4g, and experiment also confirms the solubilization that also can ensure when consumption 100g furazolidone to be had to more than 7%, therefore, selects 4g ~ 100g to be the amount ranges of filler.
6, the investigation of different binding agent
Get 100g furazolidone, mix with filler respectively, add different binding agents and granulate, dry, granulate.Investigate the impact on furazolidone, screening is beneficial to the adjuvant of furazolidone stripping.
Table 2
From above result: in typical binders, polyvidone aqueous solution is the most obvious to furazolidone solubilization, improves the effect of mobility the most obviously (compare matched group to diminish angle of repose, the rate of outflow becomes large).Therefore, select polyvidone as binding agent.All can ensure there is obvious solubilization to furazolidone when also confirming concentration 10% ~ 30%, consumption 4g ~ 20g by experiment, concentration higher than 35% time, granule is excessively sticky, be difficult to granulate.Concentration lower than 10% time, solubilizing effect is not obvious.Therefore, select concentration 10% ~ 30%, consumption 4g ~ 20g is concentration and the amount ranges of polyvidone.
7, the investigation of different solubilizing agent
Get 100g furazolidone, the 10% polyvidone aqueous solution added respectively containing different cosolvent is granulated, dry, granulate.Investigate the impact on furazolidone, screening is beneficial to the adjuvant of furazolidone stripping.
Table 3
Reference substance does not add solubilizing agent group.
From above result: sodium lauryl sulphate, poloxamer, Labraso, TC, PEG400 have the solubilization of more than 4% to furazolidone, compare other adjuvant groups and improve comparatively obvious to the mobility of material.Therefore, can select as solubilizing agent.
8, the investigation of different disintegrating agent: investigate the impact on furazolidone, screening is beneficial to the disintegrating agent adjuvant of furazolidone stripping.
Table 4
Superdisintegrantes cross-linked pvp, cross-linking sodium carboxymethyl cellulose, Extra Sodium Carboxylmethyl Starch do not have obvious solubilization to furazolidone.The disintegrate of the outer addition of carboxymethyl starch sodium is the fastest, and release is slightly high.Therefore carboxymethyl starch sodium is selected to be main disintegrating agent, outer add mode.
9, lubricant is investigated the influence degree of the stripping of furazolidone
Need granule to have certain mobility in filling process, therefore, investigate the impact on furazolidone, screening is beneficial to the adjuvant of technique.
Table 5
Reference substance does not add lubricant group.
Better by the mobility of the known micropowder silica gel of above result and magnesium stearate group, and hydrophilic micropowder silica gel has faint dissolution effect, and hydrophobic magnesium stearate is not on the dissolution affecting furazolidone, there is slight dissolution effect on the contrary, consider the mobility of material, therefore select micropowder silica gel, magnesium stearate coupling together as lubricant, after coupling, mobility obviously strengthens, and angle of repose is 29., rate of outflow 10.9g/min.
10, the screening of different granulation sieve number
Furazolidone and filler are mixed, adds the polyvidone aqueous solution soft material containing solubilizing agent, use different meshes screen cloth to granulate respectively, investigate the impact that different-grain diameter granule discharges furazolidone.
Table 6
From result: the granulation between 16 order ~ 30 orders is not all very large on the impact of dissolution, and when 16 orders are granulated with lower screen cloth, granule is more thick and stiff, and release is slightly influenced.When more than 20 orders granulating, because screen cloth is meticulous, and material has certain viscosity, and sieve operating difficulties, therefore selects 16 ~ 20 orders as the technological parameter of granulating.
11, the screening of different granulate sieve number
By dried granule, use 10 orders, 16 orders, 18 orders, 24 orders, 30 orders, 40 orders, 50 orders and 60 object screen cloth granulate respectively, investigate different-grain diameter granule to the impact of filling mobility.
Table 7
From result: 40 orders are more with particle powder after upper screen cloth granulate, become angle of repose large, the rate of outflow diminishes, and material fluidity is deteriorated.During 14 order following granulate, coarse granule is comparatively large, and the RSD value of the filling difference of material, more than 2%, compares other order numbers slightly large.Granule is crossed slightly, and release and dissolution slightly delay.Mobility of particle between 16 order ~ 40 orders is good, and RSD value is little, and meet the requirement of filling, drug release rate is stablized, and therefore selects the technological parameter as granulate.
12, the screening of different baking temperature
By the granule after granulation, carry out drying at different temperatures respectively, every part of 1kg, be dried to the moisture of applicable tabletting, be about 3.5%, investigate temperature writing time to the impact of filling mobility.
Table 8
From result: 45 ~ 80 DEG C of releases on medicine and dissolution affect little, but during less than 55 DEG C dryings, institute's spended time is longer, and during more than 70 DEG C dryings, particle appearance has the sign of variable color.Therefore, 55 ~ 70 DEG C are selected as dry technological parameter.
Accompanying drawing explanation
Fig. 1 be furazolidone enteric coated capsule and granule 1.3% sodium dodecyl sulfate solution molten in stripping curve figure.
Fig. 2 is the release curve chart of furazolidone enteric coated capsule in the phosphoric acid buffer salt solvent liquid of PH6.8.
Detailed description of the invention
Embodiment: 1
Get furazolidone 100g and starch 10g mix homogeneously, add the polyvidone aqueous solution soft material of 20% mass concentration containing sodium lauryl sulphate 0.4g, Labraso 0.8g, polyvidone consumption 6g.16 orders are granulated, 70 DEG C of dryings, and 20 order granulate, add 1.5g magnesium stearate, 1.0g silicon dioxide and 4g carboxymethyl starch sodium mix homogeneously, fill enteric coated capsule and get final product.
Embodiment: 2
Get furazolidone 100g and pregelatinized Starch 4g mix homogeneously, add the polyvidone aqueous solution soft material of 10% mass concentration containing poloxamer 0.5g, TC 0.5g, polyvidone consumption 20g.18 orders are granulated, 60 DEG C of dryings, and 16 order granulate, add 0.5g magnesium stearate, 0.5g silicon dioxide and 2g carboxymethyl starch sodium mix homogeneously, fill enteric coated capsule and get final product.
Embodiment: 3
Get furazolidone 100g and Macrogol 4000 100g mix homogeneously, add the polyvidone aqueous solution soft material of 35% mass concentration containing PEG400 10g, polyvidone consumption 4g.20 orders are granulated, 65 DEG C of dryings, and 40 order granulate, add 3g magnesium stearate, 3g silicon dioxide and 15g carboxymethyl starch sodium mix homogeneously, fill enteric coated capsule and get final product.
Embodiment: 4
Get furazolidone 200g and cyclodextrin 10g mix homogeneously, add the polyvidone aqueous solution soft material of 20% mass concentration containing sodium lauryl sulphate 0.4g, Labraso 0.8g, polyvidone consumption 6g.16 orders are granulated, 55 DEG C of dryings, and 20 order granulate, add 1.5g magnesium stearate, 1.5g silicon dioxide and 6g carboxymethyl starch sodium mix homogeneously, fill enteric coated capsule and get final product.
Embodiment: 5
Get furazolidone 200g and hydroxypropyl cyclodextrin 4g mix homogeneously, add the polyvidone aqueous solution soft material of 10% mass concentration containing poloxamer 0.5g, TC 0.5g, polyvidone consumption 20g.16 orders are granulated, 60 DEG C of dryings, and 24 order granulate, add 0.5g magnesium stearate, 0.5g silicon dioxide and 2g carboxymethyl starch sodium mix homogeneously, fill enteric coated capsule and get final product.
Embodiment: 6
Get furazolidone 200g and lactose 50g, starch 50g mix homogeneously, add the polyvidone aqueous solution soft material of 35% mass concentration containing PEG400 10g, polyvidone consumption 6g.20 orders are granulated, 65 DEG C of dryings, and 40 order granulate, add 3g magnesium stearate, 3g silicon dioxide and 15g carboxymethyl starch sodium mix homogeneously, fill enteric coated capsule and get final product.
Embodiment: 7
Get furazolidone 300g and lactose 10g mix homogeneously, add the polyvidone aqueous solution soft material of 20% mass concentration containing sodium lauryl sulphate 0.4g, Macrogol 4000 .4g, Labraso 1.0g, polyvidone consumption 6g.16 orders are granulated, 70 DEG C of dryings, and 20 order granulate, add 1.5g magnesium stearate, 1.5g silicon dioxide and 6g carboxymethyl starch sodium mix homogeneously, fill enteric coated capsule and get final product.
Embodiment: 8
Get furazolidone 300g and polyethylene glycol 6000 100g mix homogeneously, add the polyvidone aqueous solution soft material of 10% mass concentration containing poloxamer 0.5g, TC 0.5g, polyvidone consumption 10g.10 orders are granulated, 60 DEG C of dryings, and 40 order granulate, add 0.5g magnesium stearate, 0.5g silicon dioxide and 2g carboxymethyl starch sodium mix homogeneously, fill enteric coated capsule and get final product.
Embodiment: 9
Get furazolidone 300g and starch 50g mix homogeneously, add the polyvidone aqueous solution soft material of 35% mass concentration containing PEG400 10g, polyvidone consumption 15g.20 orders are granulated, 65 DEG C of dryings, and 40 order granulate, add 3g magnesium stearate, 3g silicon dioxide and 15g carboxymethyl starch sodium mix homogeneously, fill enteric coated capsule and get final product.
The detection data of the furazolidone enteric coated capsule of table 9 embodiment 1 ~ 9 are as following table:
According to the dissolution in 1.3% sodium dodecyl sulfate solution and the detection method in the phosphate buffer of PH6.8 in enteric coated capsule technical study the 4th.Respectively when 5,10,15,30,45,60,90min, get solution 10mL (simultaneously supplementing the dissolution medium of same volume), calculate each time point stripping quantity.Take time as abscissa, stripping quantity is vertical coordinate, draws stripping curve, sees Fig. 1, Fig. 2.
Obtain can finding out in stripping curve Fig. 1 under 1.3% sodium dodecyl sulfate solution dissolution medium at furazolidone enteric coated capsule and granule thereof: when enteric coated capsule is at PH>7, capsule shells disintegrate needs 5 minutes, therefore at the drug-eluting initial stage, the stripping quantity of capsule can be fewer than granule, dissolution rate is slow, along with capsule shells dissolve break after, after 15 minutes, both stripping quantities are identical, and after 60 minutes, stripping quantity reaches more than 93%.
According to the release requirement of the enteric coated preparation in Chinese Pharmacopoeia 2010 editions two annex, furazolidone enteric coated capsule is insoluble in hydrochloric acid, meets States Pharmacopoeia specifications.Although good not in 1.3% sodium dodecyl sulfate solution of the releasing effect of furazolidone enteric coated capsule in the phosphoric acid buffer salt solvent liquid of PH6.8, but 5 minutes time, also discharge the furazolidone of 40%, more than 76% when 60 minutes, when 90 minutes, cumulative release amount reaches more than 80%, sees Fig. 2.
Claims (1)
1. a preparation method for furazolidone preparation, is characterized in that being carried out as follows:
The weight proportion of raw material is:
Preparation method:
1) get polyvidone, add water, be made into the mass concentration aqueous solution of 10 ~ 35%;
2) solubilizing agent is poured in above-mentioned polyvidone aqueous solution, mixing;
3) get furazolidone and filler mix homogeneously, add the above-mentioned polyvidone aqueous solution soft material containing solubilizing agent, 16 ~ 20 orders are granulated, 55 ~ 70 DEG C of dryings, 16 ~ 40 order granulate;
4) add magnesium stearate, silicon dioxide and carboxymethyl starch sodium in the granule after granulate, mix homogeneously, fill enteric coated capsule and get final product;
Described filler is one or more in starch, pregelatinized Starch, lactose, cyclodextrin, hydroxypropyl cyclodextrin, Macrogol 4000, polyethylene glycol 6000;
Described solubilizing agent is one or more in sodium lauryl sulphate, poloxamer, Labraso, TC, PEG400.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| RU2772430C1 (en) * | 2021-03-10 | 2022-05-19 | федеральное государственное автономное образовательное учреждение высшего образования Первый Московский государственный медицинский университет имени И.М. Сеченова Министерства здравоохранения Российской Федерации (Сеченовский университет) (ФГАОУ ВО Первый МГМУ им. И.М. Сеченова Минздрава России (Се | Rapidly dissolving dosage form of furazolidone and method for production thereof |
| CN116942717A (en) * | 2023-07-11 | 2023-10-27 | 四川尚锐生物医药有限公司 | Furazolidone-containing pharmaceutical composition and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| RU2772430C1 (en) * | 2021-03-10 | 2022-05-19 | федеральное государственное автономное образовательное учреждение высшего образования Первый Московский государственный медицинский университет имени И.М. Сеченова Министерства здравоохранения Российской Федерации (Сеченовский университет) (ФГАОУ ВО Первый МГМУ им. И.М. Сеченова Минздрава России (Се | Rapidly dissolving dosage form of furazolidone and method for production thereof |
| CN116942717A (en) * | 2023-07-11 | 2023-10-27 | 四川尚锐生物医药有限公司 | Furazolidone-containing pharmaceutical composition and preparation method thereof |
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