CN1634056A - Rotundine orally disintegrating tablet and its preparing process - Google Patents
Rotundine orally disintegrating tablet and its preparing process Download PDFInfo
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- CN1634056A CN1634056A CN 200410044066 CN200410044066A CN1634056A CN 1634056 A CN1634056 A CN 1634056A CN 200410044066 CN200410044066 CN 200410044066 CN 200410044066 A CN200410044066 A CN 200410044066A CN 1634056 A CN1634056 A CN 1634056A
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- rotundine
- mentholum
- ethanol
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- mannitol
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Abstract
The invention relates to a Rotundine orally disintegrating tablet and its preparing process, which is prepared by using Rotundine as medicament, and using lactose, mannitol, low substituted methylcellulose propylene glycol ether, magnesium stearate, crystalline cellulose, 95% ethanol, menthol as material by a finite proportion through wet method granulation and pelleting. The prepared orally disintegrating tablet has a hardness of 1.0-3.5 kg, the tablet can be disintegrated within 1 minute, the disintegrated powder can pass through 24 mesh sieve.
Description
Technical field:
The present invention relates to field of medicine preparations, belong to oral administration system, be rotundine orally disintegrating tablet preparation and preparation method thereof.
Background technology:
Oral cavity disintegration tablet (also being oral instant-dissolving tablet) is a kind of novel dosage form that emerges rapidly in the medicament field in recent years.It has taking convenience, it is fast to absorb, bioavailability is high and to advantages such as the effect of digestive tract mucous membrane irritation are little.Water can not needed when taking, disintegrate rapidly in the 60s in the oral cavity.Though the lyophilization sheet is comparatively ripe in numerous preparation technologies, too high, the complex process of cost is very strict to the requirement of preparation condition, is difficult to be suitable for the reality of domestic pharmacy.The preparation forward cost direction low, that technology is simple, mouthfeel good, quality is high of oral cavity disintegration tablet develops at present.Also there is same problem in the rotundine oral cavity disintegration tablet.
Summary of the invention:
For solving too high, the complex process of cost of present production rotundine oral cavity disintegration tablet, to the very strict problem of the requirement of preparation condition, development and design of the present invention rotundine orally disintegrating tablet preparation and preparation method thereof; With rotundine is medicine, with lactose, mannitol, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline Cellulose, 95% ethanol, Mentholum is material, by 1: 0.2～2.5: 0.2～5.0: 0.2～1.0: 0.2～1.0: 0.1～1.0: 0.01～0.2 proportion ingredient, adopt the wet granule compression tablet method, utilize common tablet machine,, make the rotundine oral cavity disintegration tablet by control process parameters, the mouthfeel of rotundine oral cavity disintegration tablet is good, and disintegration time is at 15-60 between second.Its preparation method is:
1. rotundine is crossed 100 mesh sieves, adjuvant is crossed 100 mesh sieves respectively, and adjuvant is put 50 ℃ of baking oven bakings 3 hours, and is standby.
2. get the mannitol and the rotundine mixing of recipe quantity.
3. in addition with the recipe quantity lactose, by the equivalent incremental method with 2. go on foot the mixture mixing.
4. Mentholum is dissolved in an amount of 95% ethanol, makes the Mentholum alcoholic solution.
5. Mentholum ethanol liquid is evenly joined and 3. go on foot in the gained mixture, make ethanol evaporation at 40 ℃ of baking oven inner dryings, 5 minutes consuming time.
6. with distilled water with said mixture system soft material, with 30 mesh sieve system granules, wet granular put 40 ℃ the oven dry 30 minutes.The dried granule of gained is through 30 mesh sieve granulate, adds the magnesium stearate of recipe quantity and microcrystalline Cellulose, low-substituted hydroxypropyl cellulose immediately, mix homogeneously.
7. measure intermediate content.
8. adopt the shallow camber stamping of 6.0～8.5mm, control strip focuses on 100～200mg/ sheet, and tablet hardness is controlled at 1.0～3.5kg.
9. the rotundine oral cavity disintegration tablet finished product packing with gained gets final product.
Rotundine Orally disintegrating of the present invention or solution tablet preparation, it is main adopting water soluble adjuvant, can fast disintegrate separate and the most of dissolving of adjuvant when running into saliva.Then,, follow saliva swallowing, need not drink water, good mouthfeel, no sand feeling and bitterness sense with the natural swallowing act of human body.This tablet is taken medicine to some function of deglutition patient bad and water intaking inconvenience convenience is provided.Adopt the wet granule compression tablet method, utilize common tablet machine, the simple cost of technology is low, has vast market prospect.
Description of drawings:
Fig. 1 is a rotundine oral cavity disintegration tablet preparation technology flow chart.
The specific embodiment:
Embodiment 1: the preparation of rotundine oral cavity disintegration tablet
1. the 30g rotundine is crossed 100 mesh sieves, adjuvant is crossed 100 mesh sieves respectively, and adjuvant is put 50 ℃ of baking oven bakings 3 hours, and is standby.
2. get mannitol and the rotundine mixing of 20g.
3. in addition with the 30g lactose, by the equivalent incremental method with 2. go on foot the mixture mixing.
4. Mentholum is dissolved in the 3mL95% ethanol, makes the Mentholum alcoholic solution.
5. 0.6g Mentholum ethanol liquid is evenly joined and 3. go on foot in the gained mixture, make ethanol evaporation at 40 ℃ of baking oven inner dryings, 5 minutes consuming time.
6. with distilled water with said mixture system soft material, with 30 mesh sieve system granules, wet granular put 40 ℃ the oven dry 30 minutes.The dried granule of gained is through 30 mesh sieve granulate, adds the magnesium stearate of 0.3g and 1.5g microcrystalline Cellulose, 4g low-substituted hydroxypropyl cellulose immediately, mix homogeneously.
7. measure intermediate content.
8. adopt the shallow camber stamping of 6.0～8.5mm, control strip focuses on the 100mg/ sheet, and tablet hardness is controlled at 1.0～3.5kg.
9. the rotundine oral cavity disintegration tablet finished product packing with gained gets final product.
The oral administration test, disintegration time is between the 15-30S in the oral cavity, mouthfeel does not have bitterness well.
Embodiment 2: the preparation of rotundine oral cavity disintegration tablet
1. the 30g rotundine is crossed 100 mesh sieves, adjuvant is crossed 100 mesh sieves respectively, and adjuvant is put 50 ℃ of baking oven bakings 3 hours, and is standby.
2. get mannitol and the rotundine mixing of 30g.
3. in addition with the 20g lactose, by the equivalent incremental method with 2. go on foot the mixture mixing.
4. the 1.2g Mentholum is dissolved in the 1.5mL95% ethanol, makes the Mentholum alcoholic solution.
5. Mentholum ethanol liquid is evenly joined and 3. go on foot in the gained mixture, make ethanol evaporation at 40 ℃ of baking oven inner dryings, 5 minutes consuming time.
6. with distilled water with said mixture system soft material, with 30 mesh sieve system granules, wet granular put 40 ℃ the oven dry 30 minutes.The dried granule of gained is through 30 mesh sieve granulate, adds the magnesium stearate of 0.15g and 5.0g microcrystalline Cellulose, 8g low-substituted hydroxypropyl cellulose immediately, mix homogeneously.
7. measure intermediate content.
8. adopt the shallow camber stamping of 6.0～8.5mm, control strip focuses on the 100mg/ sheet, and tablet hardness is controlled at 1.0～3.5kg.
9. the rotundine oral cavity disintegration tablet finished product packing with gained gets final product.
The oral administration test, disintegration time is between the 25-40S in the oral cavity, mouthfeel does not have bitterness well.
Claims (2)
1, a kind of rotundine orally disintegrating tablet preparation, with the rotundine is material medicine, with lactose, mannitol, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline Cellulose, 95% ethanol, Mentholum is a material, it is characterized in that: with medicine rotundine and lactose, mannitol, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline Cellulose, 95% ethanol, these materials of Mentholum are by 1: 0.2～2.5: 0.2～5.0: 0.2～1.0: 0.2～1.0: 0.1～1.0: 0.01～0.2 proportion ingredient, adopt the wet granule compression tablet method, making hardness is 1.0～3.5kg, being placed in the oral cavity was disintegratable in 1 minute, powder after the disintegrate can be by the rotundine oral cavity disintegration tablet of 24 mesh sieves.
2, a kind of preparation method of rotundine orally disintegrating tablet preparation, it is characterized in that: medicine rotundine and lactose, mannitol, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline Cellulose, 95% ethanol, Mentholum are pressed 1: 0.2～2.5: 0.2～5.0: 0.2～1.0: 0.2～1.0: 0.1～1.0: 0.01～0.2 proportion ingredient, and concrete preparation method is:
1. rotundine is crossed 100 mesh sieves, adjuvant is crossed 100 mesh sieves respectively, and adjuvant is put 50 ℃ of baking oven bakings 3 hours, and is standby;
2. get the mannitol and the rotundine mixing of recipe quantity;
3. in addition with the recipe quantity lactose, by the equivalent incremental method with 2. go on foot the mixture mixing;
4. Mentholum is dissolved in an amount of 95% ethanol, makes the Mentholum alcoholic solution;
5. Mentholum ethanol liquid is evenly joined and 3. go on foot in the gained mixture, make ethanol evaporation at 40 ℃ of baking oven inner dryings, 5 minutes consuming time;
6. with distilled water with said mixture system soft material, with 30 mesh sieve system granules, wet granular put 40 ℃ the oven dry 30 minutes.The dried granule of gained is through 30 mesh sieve granulate, adds the magnesium stearate of recipe quantity and microcrystalline Cellulose, low-substituted hydroxypropyl cellulose immediately, mix homogeneously;
7. measure intermediate content;
8. adopt the shallow camber stamping of 6.0～8.5mm, control strip focuses on 100～200mg/ sheet, and tablet hardness is controlled at 1.0～3.5kg;
9. the rotundine oral cavity disintegration tablet finished product packing with gained gets final product.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410044066 CN1634056A (en) | 2004-11-18 | 2004-11-18 | Rotundine orally disintegrating tablet and its preparing process |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410044066 CN1634056A (en) | 2004-11-18 | 2004-11-18 | Rotundine orally disintegrating tablet and its preparing process |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1634056A true CN1634056A (en) | 2005-07-06 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200410044066 Pending CN1634056A (en) | 2004-11-18 | 2004-11-18 | Rotundine orally disintegrating tablet and its preparing process |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1634056A (en) |
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2004
- 2004-11-18 CN CN 200410044066 patent/CN1634056A/en active Pending
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| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |