CN103463085A - Rapidly released fexofenadine pills and preparation method thereof - Google Patents
Rapidly released fexofenadine pills and preparation method thereof Download PDFInfo
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Abstract
The invention discloses rapidly released fexofenadine pills and a preparation method thereof. The rapidly released fexofenadine pills take water as a solvent, are high in concentration of effective drugs, are simple in process, have an environment-friendly effect, are suitable for industrial production, can be applied fast, stably and efficiently and allow fexofenadine to be rapidly released in a human body. According to the technical essentials disclosed by the invention, the pills are prepared by covering a fexofenadine mixed suspension solution on the surfaces of pseudo ephedrine sustained-release pellets, wherein each 100ml of fexofenadine mixed suspension solution contains 5.0g-35.0g of fexofenadine; the preparation process comprises the following steps: adding a disintegrating agent and a bonding agent into purified water; then adding the fexofenadine; when the mixed suspension solution starts to become sticky, stopping adding the fexofenadine, and adding an anti-sticking agent; repeating the operations until the fexofenadine and the anti-sticking agent of the prescribed doses are added; then treating the mixed suspension solution by a colloid mill; placing the pseudo ephedrine sustained-release pellets into a multifunctional coating machine and spraying the fexofenadine mixed suspension solution; and drying and sieving to obtain the rapidly released fexofenadine pills. The rapidly-released fexofenadine pills and the preparation method thereof belong to the technical field of medicines.
Description
Technical field
The invention discloses a kind of fexofenadine piller and preparation method thereof, specifically, is fexofenadine piller of a kind of quick release and preparation method thereof, belongs to medical technical field.
Background technology
Fexofenadine is the active metabolite of antihistamine drug terfenadine in human body, and selectively acting, in periphery H1-receptor, is used its hydrochlorate usually.Have good effect, onset rapidly, without central nervous system unify cardiovascular response, safe outside, can treat the illness such as seasonal allergic rhinitis, skin allergy, urticaria and allergic asthma, and above-mentioned patient accounts for 10～25% of whole world total population, fexofenadine becomes the medicine in the situation of selling well world.
The administering mode of fexofenadine is oral administration normally, have and absorb rapidly, about 1～3 hour blood drug level peaking after single oral dose, after oral 60mg, 120mg and 180mg, drug serum peak concentration Cmax is respectively 142mg/ml, 427mg/ml, 494mg/ml.The fexofenadine protein binding rate is about 60～70%, and the elimination half-life is about 14.4 hours.Therefore, fexofenadine is made quick releasing formulation usually at present.In preparation process, generally adopt and add in two ways raw material: a kind of be raw material as addition, outer addition or inside and outside addition in solid, another kind is wiring solution-forming, by the solution method of adding medicine to.Yet fexofenadine hydrochloride is white crystalline powder, be soluble in methanol (1g ︰ 0.95～0.96ml), be dissolved in ethanol (1g ︰ 13～15ml), be dissolved in hardly acetone (more than 1g ︰ 10000ml), soluble,very slightly is in water (1g ︰ 600～700ml).If water is cooked solvent, can only be made into suspension.
Chinese patent CN101316580A discloses a kind of preparation method of fexofenadine suspension, this patent adopts buffer system to regulate the aqueous suspension of pH4.25～9.4, with weight/volume (g/100mL), calculate, it comprises approximately 0.03% to about 4.80% fexofenadine amphoteric ion type dihydrate form.
Chinese patent CN101822646A discloses a kind of fexofenadine hydrochloride orally disintegrating tablet and preparation method thereof, and its principal agent fexofenadine is to dissolve fully with ethanol, finally makes tablet; Chinese patent CN101500542A discloses the controlled release preparation that shows basic zero level release dynamics, and its principal agent fexofenadine is to carry out spray coating after preparing as solvent with isopropyl alcohol.Above-mentioned two patents have all been used organic solvent preparation fexofenadine, and there is again certain danger in its manufacture process neither environmental protection.And organic solvent preparation fexofenadine solution, easily cause the relative substance of fexofenadine extremely to increase, and increased the side effect of medicine, reduced the safety of medication.
Chinese patent CN102512389A discloses a kind of fexofenadine hydrochloride Orally disintegrating pharmaceutical composition, and its principal agent is polyvidone, purified water preparation for fexofenadine; Chinese patent CN101919853A discloses pharmaceutical composition, Its Preparation Method And Use, and its principal agent is hypromellose, purified water preparation for fexofenadine; The fexofenadine of above-mentioned two patents has all only been used conventional binding agent, there is no disintegrating agent in prescription, and its principal agent Fexofenadine is difficult to quick release.And these two patents all do not disclose the preparation method of fexofenadine suspension.In fact, the preparation process of fexofenadine suspension has the phenomenon of a kind of " moment solidifies ": slowly add fexofenadine in the purified water under stirring, when the concentration that adds fexofenadine to approximately 5% the time, suspension can solidify moment, can not carry out again remaining operation, to subsequent production, bring very large puzzlement.
The effective dose of the routine of fexofenadine is: 60mg, 120mg, 180mg.Piller generally adopts solution or suspension to add medicine to.If the concentration of fexofenadine suspension is too low, what the amount of fexofenadine suspension (weight) will be very is large, and the operating process of the piller medicine-feeding of whole fexofenadine just becomes very very long, unfavorable suitability for industrialized production.Therefore, improve concentration being significant on suitability for industrialized production of fexofenadine suspension.
Summary of the invention
For the problems referred to above, the object of the present invention is to provide fexofenadine piller of a kind of quick release and preparation method thereof, the method makes water as solvent, and active drug concentration is high, and technique is simple, and environmental protection is suitable for suitability for industrialized production; And the piller medicine-feeding that can make fexofenadine is quick, stable, the medicine-feeding rate is high, and Fexofenadine fixes in human body and can discharge fast.
For solving the problems of the technologies described above, last technical scheme provided by the invention is such: this fexofenadine piller discharged fast is that pseudoephedrine slow-release micro-pill surface parcel fexofenadine suspension is made, and the every 100ml of described fexofenadine suspension is containing fexofenadine 5.0～35.0g.
The fexofenadine piller of above-mentioned quick release, in described fexofenadine piller, the mass ratio of pseudoephedrine slow-release micro-pill and fexofenadine suspension is 1 ︰ 0.6～4.2.
The fexofenadine piller of above-mentioned quick release, described fexofenadine suspension is comprised of the raw material of following weight parts: 26～182 parts of fexofenadines, 1～10 part of binding agent, 4～30 parts of disintegrating agents, 2～20 parts of antiplastering aids, 300～960 parts, water.
Further, the fexofenadine piller of above-mentioned quick release, described fexofenadine suspension is comprised of the raw material of following weight parts: 100 parts of fexofenadines, 8 parts of hypromelloses, 20 parts of pregelatinized Starch, 10 parts of Pulvis Talci, 500 parts, water.
The present invention also provides the preparation method of this fexofenadine piller discharged fast, and the method comprises the steps: successively
1) prepare suspension
Take the purified water of 300～960 weight portions, add the disintegrating agent of 4～30 weight portions under stirring, 1～10 weight portion binding agent, the rear part fexofenadine that slowly adds stirs, when suspension starts retrogradation, stop adding fexofenadine, add antiplastering aid, continue stirring until suspension thinning, slowly add again fexofenadine, when suspension starts retrogradation, stop adding fexofenadine, again add antiplastering aid, continue stirring until suspension thinning, repeat aforesaid operations until add to 26～182 parts of fexofenadine total amounts, 2～20 parts of antiplastering aid total amounts, become uniform suspension by milling treatment of colloid again,
2) prepare the fexofenadine release pills:
Type B error ephedrine slow-release micro-pill 100 weight portions are put in the Multifunctional coating machine, regulate suitable parameter, the blower fan frequency is 22.00～45.00Hz, and inlet temperature is 40.0～60.0 ℃, and temperature of charge is 35.0～58.0 ℃, spouting velocity 80～150rpm, atomizing pressure 2.00～3.20bar, spray into 60～420 weight portion fexofenadine suspensions, drying, sieve, obtain.
1) preparation method of the fexofenadine piller of above-mentioned quick release, the described suspension mixing speed for preparing is 300～3000rpm.
Further, the preparation method of the fexofenadine piller of above-mentioned quick release, one of them or combination in any that described binding agent is hyprolose, hypromellose, copolyvidone, starch, dextrin; Described antiplastering aid is magnesium stearate, calcium stearate, talcous one of them or combination in any; One of them or combination in any that described disintegrating agent is carboxymethyl starch sodium, pregelatinized Starch, polyvinylpolypyrrolidone, crosslinked carboxymethyl fecula sodium, cross-linked carboxymethyl fiber sodium, low-substituted hydroxypropyl cellulose, microcrystalline Cellulose.
Compared with prior art, technical scheme provided by the invention has following advantage:
1) this method makes water as solvent, safety, environmental protection;
2) this method makes water as solvent, can not cause the relative substance of fexofenadine extremely to increase, and has reduced the side effect of medicine, has improved the safety of medication;
3) the suspension concentration 5.0%～35.0% of this method, apparently higher than suspension concentration in prior art approximately 0.03%～approximately 4.80%, obviously shorten the piller medicine-feeding time, improved production efficiency; Technique is simple, is suitable for industrialized great production;
4) it is quick, stable that this method can make the piller medicine-feeding of fexofenadine, in human body, can discharge fast.
The accompanying drawing explanation
Fig. 1: the stripping curve of 6.8pH medium fexofenadine;
Fig. 2: the stripping curve of aqueous medium fexofenadine;
Fig. 3; 3.0pH the stripping curve of medium fexofenadine.
The specific embodiment
Below in conjunction with the specific embodiment; claim of the present invention is described in further detail; but do not form any limitation of the invention, the modification of any limited number of time of making in the claims in the present invention scope, still within claim protection domain of the present invention.
Embodiment 1
The fexofenadine piller of a kind of quick release provided by the invention, pseudoephedrine slow-release micro-pill surface parcel fexofenadine suspension is made, and its fexofenadine suspension prescription is: fexofenadine 100g, hypromellose 8g, pregelatinized Starch 20g, Pulvis Talci 10g, water 500g.
Its preparation method comprises the steps: successively
1) prepare the fexofenadine suspension
Take the 500g purified water, add the 8g hypromellose under stirring, the 20g pregelatinized Starch, slowly add fexofenadine after stirring (800rpm) evenly, when suspension starts retrogradation, stop adding fexofenadine, add appropriate Pulvis Talci, continue to stir (800rpm) thinning to suspension, slowly add again fexofenadine, when suspension starts retrogradation, stop fexofenadine, the Pulvis Talci of addition, continue to stir (800rpm) thinning to suspension, repeat aforesaid operations, until add the fexofenadine (100g) of recipe quantity, Pulvis Talci (10g), become uniform suspension by milling treatment of colloid again, obtain, measure the suspension granularity as follows:
| Particle size distribution | Granularity (μ m) |
| D10(lower limit particle diameter) | 4.73 |
| The D50(mean diameter) | 13.97 |
| D97(upper limit particle diameter) | 35.03 |
2) prepare the fexofenadine release pills:
Type B error ephedrine slow-release micro-pill 255g puts in the Multifunctional coating machine, regulate suitable parameter, the blower fan frequency is 22.00～45.00Hz, and inlet temperature is 40.0～60.0 ℃, and temperature of charge is 35.0～58.0 ℃, spouting velocity 80～150rpm, atomizing pressure 2.00～3.20bar, spray into above-mentioned fexofenadine suspension, drying, cross 16 mesh sieves, obtain.
Embodiment 2
The fexofenadine piller of a kind of quick release provided by the invention, pseudoephedrine slow-release micro-pill surface parcel fexofenadine suspension forms, and its fexofenadine suspension prescription is: fexofenadine 60g, hyprolose 3g, carboxymethyl starch sodium 6g, magnesium stearate 2g, water 409g.
Preparation method comprises the steps: successively
1) prepare the fexofenadine suspension
Take the 409g purified water, add the 3g hyprolose under stirring, the 6g carboxymethyl starch sodium, slowly add fexofenadine after stirring (1200rpm) evenly, when suspension starts retrogradation, stop adding fexofenadine, add appropriate magnesium stearate, continue to stir (1200rpm) thinning to suspension, slowly add again fexofenadine, when suspension starts retrogradation, stop fexofenadine, add appropriate magnesium stearate, continue to stir (1200rpm) thinning to suspension, repeat aforesaid operations, until add the fexofenadine (60g) of recipe quantity, magnesium stearate (2g), become uniform suspension by milling treatment of colloid again, obtain, measure the suspension granularity as follows:
| Particle size distribution | Granularity (μ m) |
| D10(lower limit particle diameter) | 4.92 |
| The D50(mean diameter) | 14.07 |
| D97(upper limit particle diameter) | 36.13 |
2) prepare the fexofenadine release pills:
Type B error ephedrine slow-release micro-pill 240g puts in the Multifunctional coating machine, regulate suitable parameter, the blower fan frequency is 22.00～45.00Hz, and inlet temperature is 40.0～60.0 ℃, and temperature of charge is 35.0～58.0 ℃, spouting velocity 80～150rpm, atomizing pressure 2.00～3.20bar, spray into above-mentioned fexofenadine suspension, drying, cross 18 mesh sieves, obtain.
Embodiment 3
The fexofenadine piller that another kind provided by the invention discharges fast, pseudoephedrine slow-release micro-pill surface parcel fexofenadine suspension forms, and its fexofenadine suspension prescription is: fexofenadine 120g, copolyvidone 6g, microcrystalline Cellulose 10g, calcium stearate 4g, water 360g.
Preparation method comprises the steps: successively
1) prepare the fexofenadine suspension
Take the 360g purified water, add the 6g copolyvidone under stirring, the 10g microcrystalline Cellulose, slowly add fexofenadine after stirring (1500rpm) evenly, when suspension starts retrogradation, stop adding fexofenadine, add appropriate calcium stearate, continue to stir (1500rpm) thinning to suspension, slowly add again fexofenadine, when suspension starts retrogradation, stop fexofenadine, add appropriate calcium stearate, continue to stir (1500rpm) thinning to suspension, repeat aforesaid operations, until add the fexofenadine (120g) of recipe quantity, calcium stearate (4g), become uniform suspension by milling treatment of colloid again, obtain, measure the suspension granularity as follows:
| Particle size distribution | Granularity (μ m) |
| D10(lower limit particle diameter) | 4.73 |
| The D50(mean diameter) | 13.97 |
| D97(upper limit particle diameter) | 35.03 |
2) prepare the fexofenadine release pills:
Type B error ephedrine slow-release micro-pill 333g puts in the Multifunctional coating machine, regulate suitable parameter, the blower fan frequency is 22.00～45.00Hz, and inlet temperature is 40.0～60.0 ℃, and temperature of charge is 35.0～58.0 ℃, spouting velocity 80～150rpm, atomizing pressure 2.00～3.20bar, spray into above-mentioned fexofenadine suspension, drying, cross 14 mesh sieves, obtain.
Embodiment 4
The fexofenadine piller that another kind provided by the invention discharges fast, pseudoephedrine slow-release micro-pill surface parcel fexofenadine suspension forms, and its fexofenadine suspension prescription is: fexofenadine 180g, dextrin 12g, pregelatinized Starch 18g, Pulvis Talci 9g, water 295g.
Preparation method comprises the steps: successively
1) prepare the fexofenadine suspension
Take the 295g purified water, add the 12g dextrin under stirring, the 18g pregelatinized Starch, slowly add fexofenadine after stirring (2000rpm) evenly, when suspension starts retrogradation, stop adding fexofenadine, add appropriate Pulvis Talci, continue to stir (2000rpm) thinning to suspension, slowly add again fexofenadine, when suspension starts retrogradation, stop fexofenadine, add appropriate Pulvis Talci, continue to stir (2000rpm) thinning to suspension, repeat aforesaid operations, until add the fexofenadine (180g) of recipe quantity, Pulvis Talci (9g), become uniform suspension by milling treatment of colloid again, obtain, measure the suspension granularity as follows:
| Particle size distribution | Granularity (μ m) |
| D10(lower limit particle diameter) | 4.73 |
| The D50(mean diameter) | 13.97 |
| D97(upper limit particle diameter) | 35.03 |
2) prepare the fexofenadine release pills:
Type B error ephedrine slow-release micro-pill 563g puts in the Multifunctional coating machine, regulate suitable parameter, the blower fan frequency is 22.00～45.00Hz, and inlet temperature is 40.0～60.0 ℃, and temperature of charge is 35.0～58.0 ℃, spouting velocity 80～150rpm, atomizing pressure 2.00～3.20bar, spray into above-mentioned fexofenadine suspension, drying, cross 16 mesh sieves, obtain.
Effect of the present invention below provide fexofenadine medicine-feeding rate situation testing result in the various embodiments described above, in Table 1 in order better to illustrate; Fexofenadine release pills stripping situation, consult accompanying drawing (Fig. 1, the stripping curve of pH6.8 medium fexofenadine; Fig. 2, the stripping curve of aqueous medium fexofenadine; Fig. 3, the stripping curve of pH3.0 medium fexofenadine); Acceleration for stabilization implementations (placement condition: 40 ℃ of temperature, humidity 75% ± 10%), consult table 2; Use the variation of the relative substance of different solvent fexofenadine suspensions, consult table 3.
Table 1 fexofenadine medicine-feeding yield
| Embodiment | Medicine-feeding yield (%) |
| Embodiment 1 | 96.6 |
| Embodiment 2 | 97.8 |
| Embodiment 3 | 96.0 |
| Embodiment 4 | 97.2 |
Table 2 fexofenadine release pills accelerated test result
Table 3 fexofenadine release pills influence factor result of the test
Claims (9)
1. the fexofenadine piller discharged fast, is characterized in that, this fexofenadine piller is that pseudoephedrine slow-release micro-pill surface parcel fexofenadine suspension is made, and the every 100ml of described fexofenadine suspension is containing fexofenadine 5.0～35.0g.
2. the fexofenadine piller of quick release according to claim 1, is characterized in that, in described fexofenadine piller, the mass ratio of pseudoephedrine slow-release micro-pill and fexofenadine suspension is 1 ︰ 0.6～4.2.
3. the fexofenadine piller of quick release according to claim 1, is characterized in that, described fexofenadine suspension is comprised of the raw material of following weight parts: 26～182 parts of fexofenadines, 1～10 part of binding agent, 4～30 parts of disintegrating agents, 2～20 parts of antiplastering aids, 300～960 parts, water.
4. the fexofenadine piller of quick release according to claim 3, is characterized in that, described fexofenadine suspension is comprised of the raw material of following weight parts: 100 parts of fexofenadines, 8 parts of hypromelloses, 20 parts of pregelatinized Starch, 10 parts of Pulvis Talci, 500 parts, water.
5. prepare the fexofenadine piller of quick release claimed in claim 1, it is characterized in that, comprise the steps: successively
1) prepare suspension
Take the purified water of 300～960 weight portions, add the disintegrating agent of 4～30 weight portions under stirring, 1～10 weight portion binding agent, the rear part fexofenadine that slowly adds stirs, when suspension starts retrogradation, stop adding fexofenadine, add antiplastering aid, continue stirring until suspension thinning, slowly add again fexofenadine, when suspension starts retrogradation, stop adding fexofenadine, again add antiplastering aid, continue stirring until suspension thinning, repeat aforesaid operations until add to 26～182 parts of fexofenadine total amounts, 2～20 parts of antiplastering aid total amounts, become uniform suspension by milling treatment of colloid again,
2) prepare the fexofenadine release pills:
Type B error ephedrine slow-release micro-pill 100 weight portions are put in multi-functional granulating coated machine, regulate parameter, the blower fan frequency is 22.00～45.00Hz, and inlet temperature is 40.0～60.0 ℃, 35.0～58.0 ℃ of temperature of charge, spouting velocity 80～150rpm, atomizing pressure 2.00～3.20bar, spray into 60～420 weight portion fexofenadine suspensions, drying, sieve, obtain.
6. the preparation method of the fexofenadine piller of quick release according to claim 5, is characterized in that, the described mixing speed for preparing suspension is 300～3000rpm.
7. the preparation method of the fexofenadine piller of quick release according to claim 5, is characterized in that, one of them or combination in any that described binding agent is hyprolose, hypromellose, copolyvidone, starch, dextrin.
8. the preparation method of the fexofenadine piller of quick release according to claim 5, is characterized in that, described antiplastering aid is magnesium stearate, calcium stearate, talcous one of them or combination in any.
9. the preparation method of the fexofenadine piller of quick release according to claim 5, it is characterized in that one of them or combination in any that described disintegrating agent is carboxymethyl starch sodium, pregelatinized Starch, polyvinylpolypyrrolidone, crosslinked carboxymethyl fecula sodium, cross-linked carboxymethyl fiber sodium, low-substituted hydroxypropyl cellulose, microcrystalline Cellulose.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| JP6286096B1 (en) * | 2017-08-01 | 2018-02-28 | ロート製薬株式会社 | Pharmaceutical tablets |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1813730A (en) * | 2005-11-22 | 2006-08-09 | 陈茜 | Fexofenadine hydrochloride dropping pill and its preparing method |
| CN101500542A (en) * | 2006-07-11 | 2009-08-05 | 共有药物有限公司 | Controlled-release formulations |
| CN101919853A (en) * | 2009-06-12 | 2010-12-22 | 广东环球制药有限公司 | Pharmaceutical composition, preparation method and application thereof |
| CN102512389A (en) * | 2011-12-27 | 2012-06-27 | 天津市嵩锐医药科技有限公司 | Fexofenadine hydrochloride oral disintegrating drug composition |
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Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1813730A (en) * | 2005-11-22 | 2006-08-09 | 陈茜 | Fexofenadine hydrochloride dropping pill and its preparing method |
| CN101500542A (en) * | 2006-07-11 | 2009-08-05 | 共有药物有限公司 | Controlled-release formulations |
| CN101919853A (en) * | 2009-06-12 | 2010-12-22 | 广东环球制药有限公司 | Pharmaceutical composition, preparation method and application thereof |
| CN102512389A (en) * | 2011-12-27 | 2012-06-27 | 天津市嵩锐医药科技有限公司 | Fexofenadine hydrochloride oral disintegrating drug composition |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP6286096B1 (en) * | 2017-08-01 | 2018-02-28 | ロート製薬株式会社 | Pharmaceutical tablets |
| JP2019026609A (en) * | 2017-08-01 | 2019-02-21 | ロート製薬株式会社 | Pharmaceutical tablet |
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| CP03 | Change of name, title or address |
Address after: Three road 528300 Guangdong city of Foshan province Shunde Ronggui high tech Park Keyuan cross No. 2 Patentee after: SINOPHARM GUANGDONG GLOBAL PHARMACEUTICAL CO., LTD. Address before: Three road 528300 in Guangdong province Foshan city Shunde District of Ronggui high tech Park Keyuan cross No. 2 Patentee before: Huanqiu Pharmaceutical Co., Ltd., Guangdong |