CN104983696A - Sodium prasterone sulfate dispersible tablet and preparation method thereof - Google Patents
Sodium prasterone sulfate dispersible tablet and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a sodium prasterone sulfate dispersible tablet and a preparation method thereof. The sodium prasterone sulfate dispersible tablet comprises sodium prasterone sulfate, solutizer, filler, a disintegrating agent, a flavoring agent and a lubricant. The sodium prasterone sulfate is in the micro powder form with the grain diameter ranging from 0.5 micrometer to 50 micrometers. The mass ratio of the sodium prasterone sulfate to the solutizer to the filler to the disintegrating agent to the flavoring agent to the lubricant is 1:(0.2-0.3):(1-2):(0.03-0.05):(0.5-2):(0.03-0.05). The sodium prasterone sulfate dispersible tablet can rapidly take an effect; the safety and curative effect of medicines are effectively improved; toxic and side effects are reduced; dosing is facilitated; and the taste is good.
Description
Technical field
The present invention relates to technical field of medicine, particularly, relate to sodium prasterone sulfate dispersible tablet and preparation method thereof.
Background technology
Sodium prasterone sulfate dosage form of going on the market at present is injection and injection powder pin, and it makes cervix maturation before being mainly used in full-term pregnancy induced labor clinically.
CN1509719 discloses sodium prasterone sulfate and is used for the treatment of climacteric syndrome, especially the novelty teabag of senile, the atrophic vaginitis of women.CN102429912 discloses medical composition and its use prepared by a kind of micronization prasterone or sodium prasterone sulfate.
Therefore, still need deeply about the research of sodium prasterone sulfate preparation at present.
Summary of the invention
The present invention is intended to solve one of technical problem in correlation technique at least to a certain extent.For this reason, one object of the present invention is to propose one can quick acting, improves Drug safety, reduces toxic and side effects, facilitates administration, good mouthfeel or the sodium prasterone sulfate dispersible tablet improving curative effect and preparation method thereof.
In one aspect of the invention, the invention provides a kind of sodium prasterone sulfate dispersible tablet.According to embodiments of the invention, this sodium prasterone sulfate dispersible tablet comprises: sodium prasterone sulfate, solubilizing agent, filler, disintegrating agent, correctives and lubricant, wherein, sodium prasterone sulfate is the micronized form that particle diameter is 0.5-50 micron, and the mass ratio of sodium prasterone sulfate, solubilizing agent, filler, disintegrating agent, correctives and lubricant is 1:(0.2-0.3): (1-2): (0.03-0.05): (0.5-2): (0.03-0.05).Inventor finds, can quick acting according to the sodium prasterone sulfate dispersible tablet of the embodiment of the present invention, effective raising Drug safety and curative effect, reduce toxic and side effects, and facilitate administration, good mouthfeel, simultaneously, this dispersible tablet can disintegrate be dispersed rapidly in water, the demand of sodium prasterone sulfate is conveniently taken by the special medication colony such as patient and old man that can meet dysphagia, to have disintegrate rapid for this dispersible tablet simultaneously, absorb fast and bioavailability high, and preparation is simple, the untoward reaction of medicine can be reduced, improve the advantages such as drug bioavailability.
According to embodiments of the invention, the mass ratio of sodium prasterone sulfate, solubilizing agent, filler, disintegrating agent, correctives and lubricant can be 1:(0.2-0.3): 1.72:0.04:1:0.04.Thus, the ratio of each component of sodium prasterone sulfate dispersible tablet is best, and sodium prasterone sulfate dispersible tablet is shorter for disintegration, and dissolution is higher, and the while of eutherapeutic, toxic and side effects is lower.If the ratio of each component is too high or too low, the performance of sodium prasterone sulfate dispersible tablet or effect are all undesirable.
According to embodiments of the invention, solubilizing agent can for being selected from least one in sodium lauryl sulphate, dodecyl sodium sulfate, hydroxypropylβ-cyclodextrin, meglumine.According to a concrete example of the present invention, solubilizing agent can be sodium lauryl sulphate.Thereby, it is possible to effectively improve the dissolubility of sodium prasterone sulfate, and then improve the bioavailability of sodium prasterone sulfate.According to an another concrete example of the present invention, solubilizing agent can be dodecyl sodium sulfate.Thereby, it is possible to effectively improve the dissolubility of sodium prasterone sulfate, and then improve the bioavailability of sodium prasterone sulfate.
According to embodiments of the invention, filler can for being selected from least one in lactose, microcrystalline Cellulose, starch, pregelatinized Starch, glucose.In some embodiments of the invention, filler can for being selected from least one in lactose, microcrystalline Cellulose, starch.According to a preferred embodiment of the present invention, filler can be microcrystalline Cellulose.
According to embodiments of the invention, disintegrating agent can for being selected from least one in polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, carboxymethylstach sodium.According to a preferred embodiment of the present invention, disintegrating agent can be at least one in polyvinylpolypyrrolidone and cross-linking sodium carboxymethyl cellulose.Thereby, it is possible to effectively promote the disintegrate of sodium prasterone sulfate dispersible tablet, disintegration time is shorter, quick result.
According to embodiments of the invention, correctives can for being selected from least one in sucrose, aspartame, strawberry essence, vanilla, fragrant citrus essence, flavoring banana essence.Thereby, it is possible to effectively regulate sodium prasterone sulfate to have preferably mouthfeel, be convenient to the patient consumes such as old man, child especially, effectively can solve the problem of patient medication compliance.
According to embodiments of the invention, lubricant can for being selected from least one in magnesium stearate, silicon dioxide, Pulvis Talci, stearic acid.According to a preferred embodiment of the present invention, lubricant can be magnesium stearate.Thus, the appearance of sodium prasterone sulfate dispersible tablet.
In another aspect of this invention, the invention provides a kind of method preparing foregoing sodium prasterone sulfate dispersible tablet.According to embodiments of the invention, the method comprises: by sodium prasterone sulfate and solubilizing agent mixing, and obtained mixture is carried out the micropowder compound particles that micronization processes to particle diameter is 0.5-50 micron; By micropowder compound particles and filler, disintegrating agent, correctives and mix lubricant, obtain raw mixture; And raw mixture is carried out tabletting, obtain sodium prasterone sulfate dispersible tablet.Inventor finds, utilizes the method according to the embodiment of the present invention, can fast and effeciently prepare sodium prasterone sulfate dispersible tablet, and step is simple, easy to operate.
According to embodiments of the invention, micropowder compound particles and filler, disintegrating agent, correctives and mix lubricant are utilized in total mixed machine and carry out.Thus, mixed effect is better, expects that uniformity of mixture is better.
According to embodiments of the invention, tabletting utilizes high speed tablet press to carry out.Thereby, it is possible to obtain satisfactory sodium prasterone sulfate dispersible tablet.
The object of this invention is to provide a kind of sodium prasterone sulfate dispersible tablet and preparation method thereof, the technical problem solved prepares the sodium prasterone sulfate dispersible tablet of quick acting, improve Drug safety, reduce toxic and side effects, facilitate administration, the dispersible tablet of good mouthfeel, raising curative effect and preparation method thereof, the demand that sodium prasterone sulfate is conveniently taken by the special medication colonies such as the patient of dysphagia and old man can be met simultaneously.
The present invention is by the following technical solutions: a kind of sodium prasterone sulfate dispersible tablet, the sodium prasterone sulfate dispersible tablet of its every sheet unit dose can consist of the following composition: sulfur acid prasterone sodium slutate 0.1g-0.25 weight portion, solubilizing agent 0.01g-0.05 weight portion, filler 0.01-0.2 weight portion, disintegrating agent 0.001-0.005 weight portion, correctives 0.1-0.25 weight portion, lubricant 0.001-0.005 weight portion, wherein, sodium prasterone sulfate is the micronized form that particle diameter is 0.5-50 micron.In some embodiments of the invention, the mass ratio of sodium prasterone sulfate, solubilizing agent, filler, disintegrating agent, correctives and lubricant can be 1:(0.2-0.3): (1-2): (0.03-0.05): (0.5-2): (0.03-0.05).Inventor finds, can quick acting according to the sodium prasterone sulfate dispersible tablet of the embodiment of the present invention, rapid disintegrate also disperses, thus effectively improve Drug safety and curative effect, reduction toxic and side effects and facilitate administration, good mouthfeel, meanwhile, the demand of sodium prasterone sulfate is conveniently taken by the special medication colony such as patient and old man that this dispersible tablet can meet dysphagia.
According to embodiments of the invention, solubilizing agent can for being selected from least one in sodium lauryl sulphate, dodecyl sodium sulfate, hydroxypropylβ-cyclodextrin, meglumine.According to a concrete example of the present invention, solubilizing agent can be sodium lauryl sulphate.According to an another concrete example of the present invention, solubilizing agent can be dodecyl sodium sulfate.Thereby, it is possible to effectively improve the dissolubility of sodium prasterone sulfate, and then improve the bioavailability of sodium prasterone sulfate.Sodium lauryl sulphate and dodecyl sodium sulfate safety non-toxic, it is easily molten in water.Further, the present inventor by experiment, unexpected discovery, sodium prasterone sulfate: the weight proportion of solubilizing agent is at 1:(0.1-0.5), now, the result of extraction of sodium prasterone sulfate is good, when sodium prasterone sulfate: the weight proportion of sodium lauryl sulphate is at 1:(0.2-0.3) time, the effect of its stripping is best.This is because water can be incorporated into around sodium prasterone sulfate by hydrophobe effect by sodium lauryl sulphate, and causes the dissolution of sodium prasterone sulfate to increase.
According to embodiments of the invention, filler can for being selected from least one in lactose, microcrystalline Cellulose, starch, pregelatinized Starch, glucose.In some embodiments of the invention, filler can for being selected from least one in lactose, microcrystalline Cellulose, starch.According to a preferred embodiment of the present invention, filler can be microcrystalline Cellulose.Preferably, the weight ratio of sodium prasterone sulfate, microcrystalline Cellulose is 1:(1-2).Thus, contribute to the compressibility improving sodium prasterone sulfate, be conducive to molding, be conducive to the performance of drug effect simultaneously, reduce toxic and side effects.
According to embodiments of the invention, disintegrating agent can for being selected from least one in polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, carboxymethylstach sodium.According to a preferred embodiment of the present invention, disintegrating agent can be polyvinylpolypyrrolidone.Thereby, it is possible to effectively promote the disintegrate of sodium prasterone sulfate dispersible tablet, disintegration time is shorter, quick result.According to a further advantageous embodiment of the invention, disintegrating agent can be cross-linking sodium carboxymethyl cellulose.Thereby, it is possible to effectively promote the disintegrate of sodium prasterone sulfate dispersible tablet, disintegration time is shorter, quick result.
According to embodiments of the invention, correctives can for being selected from least one in sucrose, aspartame, strawberry essence, vanilla, fragrant citrus essence, flavoring banana essence.Thereby, it is possible to effectively regulate sodium prasterone sulfate to have preferably mouthfeel, be convenient to the patient consumes such as old man, child especially, effectively can solve the problem of patient medication compliance.Preferably, when the weight ratio of sodium prasterone sulfate and correctives is 1:(1-5) time, the mouthfeel of sodium prasterone sulfate dispersible tablet is excellent and moderate, and when most preferably the weight ratio of sodium prasterone sulfate, correctives is 1:1, it has the most excellent moderate mouthfeel.Below the compliance problem of gerontal patient to this sodium prasterone sulfate dispersible tablet is well solved.
According to embodiments of the invention, lubricant can for being selected from least one in magnesium stearate, silicon dioxide, Pulvis Talci, stearic acid.According to a preferred embodiment of the present invention, lubricant can be magnesium stearate.Thus, easy and granule mixes, unilateral smooth and beautiful appearance after tabletting.
According to the concrete example of the present invention, the mass ratio of sodium prasterone sulfate, solubilizing agent, filler, disintegrating agent, correctives and lubricant can be 1:(0.2-0.3): 1.72:0.04:1:0.04.Thus, the ratio of each component of sodium prasterone sulfate dispersible tablet is best, and sodium prasterone sulfate dispersible tablet is shorter for disintegration, and dissolution is higher, and the while of eutherapeutic, toxic and side effects is lower.If the ratio of each component is too high or too low, the performance of sodium prasterone sulfate dispersible tablet or effect are all undesirable.
Present invention also offers the preparation method of sodium prasterone sulfate dispersible tablet, the preparation method of sodium prasterone sulfate dispersible tablet comprises the steps:
1) by the sodium prasterone sulfate of recipe quantity, solubilizing agent mixing, the granule that micronization processes is 0.5-50 micron (μm) to particle diameter is carried out, for subsequent use;
2) by the filler of recipe quantity, disintegrating agent, correctives, lubricant and above-mentioned steps 1) in granule be added in total mixed machine, mix homogeneously;
3) by above-mentioned steps 2) in powder, through high speed tablet press tabletting, to obtain sodium prasterone sulfate dispersible tablet.
In a preferred embodiment of the invention, the preparation method of sodium prasterone sulfate dispersible tablet comprises the steps:
A) by the sodium prasterone sulfate of recipe quantity, sodium lauryl sulphate mixing, the granule that micronization processes is 0.5-50 micron (μm) to particle diameter is carried out, for subsequent use;
B) by the microcrystalline Cellulose of recipe quantity, polyvinylpolypyrrolidone, correctives, magnesium stearate and above-mentioned steps A) in granule be added in total mixed machine, mix homogeneously;
C) by above-mentioned steps B) in powder, through high speed tablet press tabletting, to obtain sodium prasterone sulfate dispersible tablet.
Sodium prasterone sulfate dispersible tablet of the present invention, first mixes sodium prasterone sulfate and solubilizing agent such as sodium lauryl sulphate, carries out the micro powder granule that micronization processes obtains sodium prasterone sulfate; By filler as microcrystalline Cellulose, disintegrating agent such as polyvinylpolypyrrolidone, correctives and magnesium stearate are mixed homogeneously with above-mentioned granule, tabletting obtains sodium prasterone sulfate dispersible tablet.The sodium prasterone sulfate dispersible tablet that the present invention prepares, the patient and the gerontal patient that are applicable to dysphagia use.
The technique effect that the present invention is useful embodies as follows:
1, according to the sodium prasterone sulfate dispersible tablet that the embodiment of the present invention prepares, for sodium prasterone sulfate micro powder granule and the common tabletting of adjuvant obtain, have good medicine stability, and medicine is after long-time placement, appearance character and dissolution etc. all can not change.
2, good according to the sodium prasterone sulfate dispersible tablet mouthfeel of embodiment of the present invention gained, there is good compliance and toleration, be convenient to the patient of dysphagia especially and improve the demand of the using sulfated prasterone sodium slutate of the specific groups such as old man.
3, simple according to the preparation method of the embodiment of the present invention, be suitable for suitability for industrialized production.
Embodiments of the invention are described below in detail.Embodiment described below is exemplary, only for explaining the present invention, and can not be interpreted as limitation of the present invention.Unreceipted concrete technology or condition in embodiment, according to the technology described by the document in this area or condition or carry out according to product description.Agents useful for same or the unreceipted production firm person of instrument, being can by the conventional products of commercial acquisition.
Embodiment 1: the prescription screening of sodium prasterone sulfate dispersible tablet
For the sodium prasterone sulfate dispersible tablet of 100mg specification.
Preparation method comprises the steps:
1) by sodium prasterone sulfate, solubilizing agent mixing, the granule that micronization processes is 0.5-50 micron (μm) to particle diameter is carried out, for subsequent use;
2) utilize total mixed machine, the granule that the filler microcrystalline Cellulose of recipe quantity, disintegrating agent polyvinylpolypyrrolidone, correctives and magnesium stearate and above-mentioned steps 1 obtain is mixed homogeneously;
3) pressed powder that high speed tablet press will obtain in above-mentioned steps 2 is utilized, to obtain sodium prasterone sulfate dispersible tablet.
Prescription screening is in table 1, and prescription screening the results are shown in Table 2.
Table 1 prescription screening table
Table 2 prescription screening result
By the prescription screening result of upper table 2, from disintegration and dissolution, prescription 3-prescription 6 effect is all better, comprehensive from mouthfeel, disintegration and dissolution, the sodium prasterone sulfate dispersible tablet of prescription 3, prescription 6 gained, is better than other prescription, now, sodium prasterone sulfate: solubilizing agent: disintegrating agent: the weight proportion of correctives is 1:(0.2-0.3): 0.04:1, its effect shown is best.
Embodiment 2
Prescription: sodium prasterone sulfate 10g, sodium lauryl sulphate 2g, microcrystalline Cellulose 17.2g, polyvinylpolypyrrolidone 0.4g, sucrose 10g, magnesium stearate 0.4g, make 100.
Preparation technology:
1) by the sodium prasterone sulfate of recipe quantity, sodium lauryl sulphate mixing, the granule that micronization processes is 0.5-50 micron (μm) to particle diameter is carried out, for subsequent use;
2) total mixed machine is utilized the microcrystalline Cellulose of recipe quantity, polyvinylpolypyrrolidone, sucrose and magnesium stearate to be mixed homogeneously with above-mentioned steps 1;
3) utilize high speed tablet press by the pressed powder in above-mentioned steps 2, to obtain sodium prasterone sulfate dispersible tablet.
In addition, carried out influence factor's experiment in 30 days to the sodium prasterone sulfate dispersible tablet formulation that this formula preparation obtains, to investigate the stability of pharmaceutical preparation, the stability data experimental result of preparation is in table 3.
Table 3 preparation 30 days influence factor's experimental results
In above-mentioned table 3, related substance refers to the product of degrading in the intermediate, by-product etc. or storage transportation produced in building-up process.Labelled amount refers to the theoretic inventory of principal agent.Content refers to that principal agent accounts for the percentage by weight of labelled amount.
Conclusion: the sodium prasterone sulfate dispersible tablet steady quality of gained of the present invention.
Embodiment 3
Prescription: sodium prasterone sulfate 10g, dodecyl sodium sulfate 2g, microcrystalline Cellulose 20g, cross-linking sodium carboxymethyl cellulose 0.4g, sucrose 10g, magnesium stearate 0.4g, make 100.
Preparation technology: with embodiment 2.
Embodiment 4
Prescription: sodium prasterone sulfate 10g, dodecyl sodium sulfate 3g, microcrystalline Cellulose 17.2g, polyvinylpolypyrrolidone 0.4g, sucrose 10g, magnesium stearate 0.4g, make 100.
Preparation technology: with embodiment 2.
Embodiment 5
Prescription: sodium prasterone sulfate 10g, dodecyl sodium sulfate 2.5g, microcrystalline Cellulose 10g, polyvinylpolypyrrolidone 0.4g, sucrose 10g, magnesium stearate 0.4g, make 100.
Preparation technology: with embodiment 2.
Embodiment 6
Prescription: sodium prasterone sulfate 10g, sodium lauryl sulphate 2.5g, microcrystalline Cellulose 16g, polyvinylpolypyrrolidone 0.4g, sucrose 10g, magnesium stearate 0.4g, make 100.
Preparation technology: with embodiment 2.
Embodiment 7
Prescription: sodium prasterone sulfate 10g, sodium lauryl sulphate 3g, microcrystalline Cellulose 15g, cross-linking sodium carboxymethyl cellulose 0.4g, sucrose 10g, magnesium stearate 0.4g, make 100.
Preparation technology: with embodiment 2.
Embodiment 8
Prescription: sodium prasterone sulfate 10g, dodecyl sodium sulfate 2g, microcrystalline Cellulose 20g, cross-linking sodium carboxymethyl cellulose 0.4g, aspartame 10g, magnesium stearate 0.4g, make 100.
Preparation technology: with embodiment 2.
Embodiment 9
Prescription: sodium prasterone sulfate 10g, dodecyl sodium sulfate 3g, microcrystalline Cellulose 17.2g, polyvinylpolypyrrolidone 0.4g, strawberry essence 10g, magnesium stearate 0.4g, make 100.
Preparation technology: with embodiment 2.
Embodiment 10
Prescription: sodium prasterone sulfate 10g, dodecyl sodium sulfate 2.5g, microcrystalline Cellulose 10g, polyvinylpolypyrrolidone 0.4g, vanilla 10g, magnesium stearate 0.4g, make 100.
Preparation technology: with embodiment 2.
Embodiment 11
Prescription: sodium prasterone sulfate 10g, sodium lauryl sulphate 2.5g, microcrystalline Cellulose 16g, polyvinylpolypyrrolidone 0.4g, fragrant citrus essence 10g, magnesium stearate 0.4g, make 100.
Preparation technology: with embodiment 2.
Embodiment 12
Prescription: sodium prasterone sulfate 10g, sodium lauryl sulphate 3g, microcrystalline Cellulose 15g, cross-linking sodium carboxymethyl cellulose 0.4g, flavoring banana essence 10g, magnesium stearate 0.4g, make 100.
Preparation technology: with embodiment 2.
In like manner, inventor uses the same method, and to the sodium prasterone sulfate dispersible tablet that embodiment 3-embodiment 12 prepares, has carried out the stability experiment research of 30 days influence factors, result shows, by the equal steady quality of sodium prasterone sulfate dispersible tablet of gained of the present invention.
Embodiment 13: confirmatory experiment
Reference Chinese Pharmacopoeia 2010 editions two annex X A, annex X C second method measure disintegration and the dissolution (dissolution medium is 0.1N hydrochloric acid, volume 900mL, rotating speed 50 revs/min) of the sample of embodiment 2-embodiment 12 respectively.Mouthfeel is by attempting in volunteer's mouth, the results are shown in Table 4.
Table 4
| Index | Character | Mouthfeel | Disintegration (second) | Dissolution (%) |
| Embodiment 2 | Qualified | Sweet taste is moderate | 45 | 97 |
| Embodiment 3 | Qualified | Sweet taste is moderate | 55 | 93 |
| Embodiment 4 | Qualified | Sweet taste is moderate | 49 | 95 |
| Embodiment 5 | Qualified | Sweet taste is moderate | 53 | 94 |
| Embodiment 6 | Qualified | Sweet taste is moderate | 56 | 93 |
| Embodiment 7 | Qualified | Sweet taste is moderate | 56 | 94 |
| Embodiment 8 | Qualified | Sweet taste is moderate | 55 | 95 |
| Embodiment 9 | Qualified | Sweet taste is moderate | 52 | 95 |
| Embodiment 10 | Qualified | Sweet taste is moderate | 60 | 94 |
| Embodiment 11 | Qualified | Sweet taste is moderate | 52 | 95 |
| Embodiment 12 | Qualified | Sweet taste is moderate | 50 | 93 |
By the result of upper table 4, apply prescription and the preparation technology of embodiment 2-embodiment 12 of the present invention, the sodium prasterone sulfate dispersible tablet obtained, its disintegration and dissolution are all good.Embodiments of the invention show good preparation stability effect, improve Drug safety and effectiveness, and are conducive to using medicine to the patient of dysphagia and old man.
In the description of this description, specific features, structure, material or feature that the description of reference term " embodiment ", " some embodiments ", " example ", " concrete example " or " some examples " etc. means to describe in conjunction with this embodiment or example are contained at least one embodiment of the present invention or example.In this manual, to the schematic representation of above-mentioned term not must for be identical embodiment or example.And the specific features of description, structure, material or feature can combine in one or more embodiment in office or example in an appropriate manner.In addition, when not conflicting, the feature of the different embodiment described in this description or example and different embodiment or example can carry out combining and combining by those skilled in the art.
Although illustrate and describe embodiments of the invention above, be understandable that, above-described embodiment is exemplary, can not be interpreted as limitation of the present invention, and those of ordinary skill in the art can change above-described embodiment within the scope of the invention, revises, replace and modification.
Claims (10)
1. a sodium prasterone sulfate dispersible tablet, is characterized in that, comprising: sodium prasterone sulfate, solubilizing agent, filler, disintegrating agent, correctives and lubricant,
Wherein, described sodium prasterone sulfate is the micronized form that particle diameter is 0.5-50 micron,
The mass ratio of described sodium prasterone sulfate, described solubilizing agent, described filler, described disintegrating agent, described correctives and described lubricant is 1:(0.2-0.3): (1-2): (0.03-0.05): (0.5-2): (0.03-0.05).
2. sodium prasterone sulfate dispersible tablet according to claim 1, it is characterized in that, the mass ratio of described sodium prasterone sulfate, described solubilizing agent, described filler, described disintegrating agent, described correctives and described lubricant is 1:(0.2-0.3): 1.72:0.04:1:0.04.
3. sodium prasterone sulfate dispersible tablet according to claim 1, it is characterized in that, described solubilizing agent is be selected from least one in sodium lauryl sulphate, dodecyl sodium sulfate, hydroxypropylβ-cyclodextrin, meglumine, is preferably at least one in sodium lauryl sulphate, dodecyl sodium sulfate.
4. sodium prasterone sulfate dispersible tablet according to claim 1, it is characterized in that, described filler is be selected from least one in lactose, microcrystalline Cellulose, starch, pregelatinized Starch, glucose, preferably be selected from least one in lactose, microcrystalline Cellulose, starch, be more preferably microcrystalline Cellulose.
5. sodium prasterone sulfate dispersible tablet according to claim 1, it is characterized in that, described disintegrating agent is be selected from least one in polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, carboxymethylstach sodium, is preferably at least one in polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose.
6. sodium prasterone sulfate dispersible tablet according to claim 1, is characterized in that, described correctives is be selected from least one in sucrose, aspartame, strawberry essence, vanilla, fragrant citrus essence, flavoring banana essence.
7. sodium prasterone sulfate dispersible tablet according to claim 1, is characterized in that, described lubricant is be selected from least one in magnesium stearate, silicon dioxide, Pulvis Talci, stearic acid, is preferably magnesium stearate.
8. prepare a method for the sodium prasterone sulfate dispersible tablet according to any one of claim 1-7, it is characterized in that, comprising:
By sodium prasterone sulfate and solubilizing agent mixing, and obtained mixture is carried out the micropowder compound particles that micronization processes to particle diameter is 0.5-50 micron;
By described micropowder compound particles and filler, disintegrating agent, correctives and mix lubricant, obtain raw mixture;
Described raw mixture is carried out tabletting, obtains described sodium prasterone sulfate dispersible tablet.
9. method according to claim 8, is characterized in that, described micropowder compound particles and filler, disintegrating agent, correctives and mix lubricant is utilized total mixed machine to carry out.
10. method according to claim 8, is characterized in that, described tabletting utilizes high speed tablet press to carry out.
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1509719A (en) * | 2002-12-25 | 2004-07-07 | 庞 飞 | Medicine for treating climacteric syndrome |
| CN102429912A (en) * | 2011-10-26 | 2012-05-02 | 庞飞 | Pharmaceutical composition prepared with micronized prasterone or sodium prasterone sulfate and use thereof |
| CN103652927A (en) * | 2013-12-30 | 2014-03-26 | 重庆喜旋生物科技有限公司 | Dispersible tablet of maca, preparation method and application thereof |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1509719A (en) * | 2002-12-25 | 2004-07-07 | 庞 飞 | Medicine for treating climacteric syndrome |
| CN102429912A (en) * | 2011-10-26 | 2012-05-02 | 庞飞 | Pharmaceutical composition prepared with micronized prasterone or sodium prasterone sulfate and use thereof |
| CN103652927A (en) * | 2013-12-30 | 2014-03-26 | 重庆喜旋生物科技有限公司 | Dispersible tablet of maca, preparation method and application thereof |
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Application publication date: 20151021 |