CN100336515C - Oral disintegration tablet of ectractive from ginkgo leaf and preparation method - Google Patents
Oral disintegration tablet of ectractive from ginkgo leaf and preparation method Download PDFInfo
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- CN100336515C CN100336515C CNB2004100734410A CN200410073441A CN100336515C CN 100336515 C CN100336515 C CN 100336515C CN B2004100734410 A CNB2004100734410 A CN B2004100734410A CN 200410073441 A CN200410073441 A CN 200410073441A CN 100336515 C CN100336515 C CN 100336515C
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Abstract
The present invention provides an oral disintegration tablet of extract from ginkgo leaf and a preparation method, the oral disintegration tablet of extract from ginkgo leaf can cover the bitter of the medicine. The oral disintegration tablet contains extract from ginkgo leaf and an excipient required by the oral disintegration tablet, and the extract from ginkgo leaf is coating granules wrapped with coating materials. The dosage of the coating materials is 0.5 to 1 time of the weight of the extract from ginkgo leaf. The preparation method of the present invention comprises (1) the preparation of coating particles, (2) the preparation of the oral disintegration tablet. The oral disintegration tablet of the present invention has the advantages of favorable mouth feelings and rapid disintegration time and overcomes the problems that other tablets have insufferable bitterness without modifying the taste, or the ingestion of excessive sugar substances caused by the application of excessive sweetening agents for modifying the taste, etc. Compared with the current technology that other coatings cover the taste, the coating method of the present invention can make the preparation process easy and save manufacturing cost without large-sized coating machines.
Description
Technical field
The present invention relates to pharmaceutical preparation and preparation method, relate generally to Folium Ginkgo extract and preparation method thereof, especially about Folium Ginkgo extract oral cavity disintegration tablet and preparation method.
Background technology
Chinese patent 02134126.5,02116223.9 has been described the wherein dispersible tablet of Folium Ginkgo extract and the preparation of slow releasing tablet respectively.They all do not relate to the flavoring problem, and the mouthfeel of Folium Ginkgo extract own is extremely bitter.Chinese patent 00126538.5 has been described the preparation of Folium Ginkgo extract chewable tablet, and its flavoring all adopts the interpolation sweeting agent, the method for flavouring agent.The absorption of too much glucide is its shortcoming.
At present used drug coating technical matters is complicated, and fluidized bed coating need be used this main equipment of fluid bed, is not that each unit all is with good conditionsi; The shortcoming of microencapsulation coating is that loss is bigger in the medicament microcapsule process, but also will carry out the mensuration of envelop rate to medicine, offers medicine according to content of dispersion.
Summary of the invention
An object of the present invention is to provide the oral disintegration tablet of ectractive from ginkgo leaf that can cover the bitterness of medicine own, this oral cavity disintegration tablet contains Folium Ginkgo extract and the required excipient of oral cavity disintegration tablet, and Folium Ginkgo extract is the coated granule that is wrapped with coating material.Oral cavity disintegration tablet consists of coated granule: the weight ratio of excipient is 1: 1～1: 3.The consumption of coating material is 0.5～1 times of Folium Ginkgo extract weight.Coating material is selected methylcellulose and/or ethyl cellulose for use.Excipient comprises disintegrating agent, diluent, correctives, fluidizer.
Another object of the present invention provides the preparation method of Folium Ginkgo extract oral cavity disintegration tablet, is achieved through the following technical solutions:
1. the preparation of coated granule: the coating material of recipe quantity is dissolved in solvent, and solvent is selected the solvent to human body safety, mainly is Diluted Alcohol, the every 10ml dissolving of consumption 10-150mg coating material, preferred 50-100mg makes coating solution, then Folium Ginkgo extract is added coating solution, stir, ultrasonic making is uniformly dispersed, and the liquid that obtains is got solid Folium Ginkgo extract clathrate 60 ℃ of forced air dryings, pulverizes, cross 100 order mesh screens, promptly get coated granule;
2. the preparation of oral cavity disintegration tablet: the Folium Ginkgo extract coated granule that sieves is added in an amount of correctives and diluent, and correctives is at 0.5%-1%, and diluent is preferably between 35%-50%, with 5%PVP
30Aqueous solution granulate, oven dry adds disintegrating agent and fluidizer, disintegrating agent can be selected the superpower disintegrating agent of 10%-20% for use and/or select the 4%-7% gas-producing disintegrant for use, the fluidizer consumption is at 0.5%-1.5%, granulate is made slice, thin piece on rotary tablet machine.
Adjuvants all in the tablet of the present invention all must be crossed 100 order mesh screens.
Used diluent is microcrystalline Cellulose commonly used in the pharmaceuticals industry, lactose, mannitol etc.
Optional sucrose, aspartame, menthol, stevioside and their mixture of then comprising of correctives.In fact active component coated granule of the present invention has greatly been covered the bitterness of Folium Ginkgo extract itself, does not add correctives and also can stand basically, adds a spot of correctives and can obtain good mouthfeel.
The optional magnesium stearate commonly used of fluidizer.
Oral cavity disintegration tablet need be in 30 seconds disintegrate rapidly, so in the selection of disintegrating agent, need to select the adjuvant of superpower disintegrate effect, as cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, polyvinylpolypyrrolidone.Sometimes need to add certain effervescent, in order to reach quickly disintegrated purpose.
Main feature of the present invention is: this tablet that (1) provides has good mouthfeel and disintegration fast, has overcome the not insufferable bitterness that brings of flavoring or use too much sweeting agent flavoring and cause the problems such as absorption of too much glucide of other tablet.(2) though similar in disintegrate to other oral cavity disintegration tablet with the tablet of excipient adding active component compacting, can be once the disintegrate in of contact saliva in the oral cavity less than 30 seconds time, but the active material powder of parcel can reduce contacting of medicine and taste bud, thereby reaches good mouthfeel.(3) coating method of the present invention's employing and the difference of other coating taste masking technology at present are not need large-scale coating machine, can make preparation technology easy, save production cost.
The specific embodiment
The present invention is described further by the following non-limiting example that provides.
Embodiment 1: the oral cavity disintegration tablet that contains the 80mg Folium Ginkgo extract
Referring to table 1, the unit that has provided tablet of the present invention forms and the percentage ratio composition
Table 1
| Composition | Unit forms | Percentage ratio (%) |
| Folium Ginkgo extract | 80mg | 16.7 |
| Ethyl cellulose | 40mg | 8.3 |
| Diluted Alcohol | 8ml | ------ |
| Lactose | 240mg | 50.0 |
| Aspartame | 2.4mg | 0.5 |
| Sodium bicarbonate | 9mg | 1.9 |
| Citric acid | 10.2mg | 2.1 |
| Cross-linking sodium carboxymethyl cellulose | 96mg | 20.0 |
| Magnesium stearate | 2.4mg | 0.5 |
| Amount to | 480mg | 100.0 |
Preparation method:
(1) ethyl cellulose of recipe quantity is dissolved in the Diluted Alcohol coating solution.
(2) Folium Ginkgo extract that takes by weighing recipe quantity joins in the coating solution, stirs, and ultra-sonic dispersion is even.
The solid clathrates of (3) 60 ℃ of forced air dryings was pulverized 100 orders and was obtained the active component coated granule.
(4) table 1 is listed adjuvant is crossed 100 orders, takes by weighing recipe quantity, with coated granule, lactose, aspartame mix homogeneously.
(5) with 5%PVP
30Aqueous solution be binding agent system soft material, cross 24 mesh sieves and granulate.
(6) wet granular is in 50-60 ℃ of oven dry, 20 mesh sieve granulate.
(7) adding citric acid, sodium bicarbonate, cross-linking sodium carboxymethyl cellulose and magnesium stearate continues to mix 1 to 5 minute.
(8) on rotary tablet machine, make slice, thin piece.
Tablet according to this method preparation is less than 30 seconds, good mouthfeel in intraoral average disintegration time.
The active component coated granule preparation of this tablet is simple, and the tablet that makes on this basis uses a spot of aspartame just can solve the extremely bitter problem of Folium Ginkgo extract mouthfeel.
Implement 2, contain the oral cavity disintegration tablet of 80mg Folium Ginkgo extract
Referring to table 2, the unit that has provided tablet of the present invention forms and the percentage ratio composition
Table 2
| Composition | Unit forms | Percentage ratio (%) |
| Folium Ginkgo extract | 80mg | 16.7 |
| Methylcellulose | 40mg | 8.3 |
| Diluted Alcohol | 8ml | --- |
| Mannitol | 100mg | 20.8 |
| Microcrystalline Cellulose | 140mg | 24.2 |
| Stevioside | 2.8mg | 0.6 |
| Menthol | 2mg | 0.4 |
| Citric acid | 13mg | 2.7 |
| Sodium bicarbonate | 11mg | 2.3 |
| Crospovidone | 86.4mg | 18.0 |
| Magnesium stearate | 4.8mg | 1.0 |
| Amount to | 480mg | 100.0 |
Preparation method is with embodiment 1
The result: the tablet of this law compacting is less than 20 seconds in intraoral average disintegration time, and less use glucide just can solve sensory issues.
Implement 3, contain the oral cavity disintegration tablet of 80mg Folium Ginkgo extract
Referring to table 3, the unit that has provided this tablet forms and the percentage ratio composition
Table 3
| Composition | Unit forms | Percentage ratio (%) |
| Folium Ginkgo extract | 80mg | 20.0 |
| Methylcellulose | 20mg | 5.0 |
| Ethyl cellulose | 20mg | 5.0 |
| Diluted Alcohol | 10ml | --- |
| Mannitol | 76mg | 19.0 |
| Microcrystalline Cellulose | 100mg | 25.0 |
| Sucrose | 1.4mg | 0.4 |
| Menthol | 1mg | 0.2 |
| Citric acid | 15mg | 3.8 |
| Sodium bicarbonate | 13mg | 3.2 |
| Carboxymethyl starch sodium | 68mg | 14.25 |
| Magnesium stearate | 5.6mg | 1.4 |
| Amount to | 400mg | 100.0 |
Prepare with embodiment 1 method.
The result: the tablet of this law compacting is less than 25 seconds in intraoral average disintegration time, and less use glucide just can solve sensory issues.
Implement 4, contain the oral cavity disintegration tablet of 80mg Folium Ginkgo extract
Referring to table 4, the unit that has provided this tablet forms and the percentage ratio composition
Table 4
| Composition | Unit forms | Percentage ratio (%) |
| Folium Ginkgo extract | 80mg | 25.0 |
| Methylcellulose | 40mg | 12.5 |
| Ethyl cellulose | 40mg | 12.5 |
| Diluted Alcohol | 8ml | --- |
| Mannitol | 50mg | 15.6 |
| Microcrystalline Cellulose | 62mg | 19.4 |
| Stevioside | 1mg | 0.3 |
| Menthol | 0.6mg | 0.2 |
| Citric acid | 7mg | 2.2 |
| Sodium bicarbonate | 5.8mg | 1.8 |
| Carboxymethyl starch sodium | 32mg | 14.25 |
| Magnesium stearate | 1.6mg | 0.5 |
| Amount to | 320mg | 100.0 |
Prepare with embodiment 1 method.
Zhi Bei tablet is less than 30 seconds, good mouthfeel in intraoral average disintegration time according to the method.
Implement 5, contain the oral cavity disintegration tablet of 80mg Folium Ginkgo extract
Referring to table 5, the unit that has provided this tablet forms and the percentage ratio composition
Table 5
| Composition | The unit prescription | Percentage ratio (%) |
| Folium Ginkgo extract | 80mg | 20.0 |
| Methylcellulose | 80mg | 20.0 |
| Diluted Alcohol | 8ml | --- |
| Lactose | 100mg | 25.0 |
| Microcrystalline Cellulose | 60mg | 15.0 |
| Sucrose | 2mg | 0.5 |
| Citric acid | 15mg | 3.8 |
| Sodium bicarbonate | 13mg | 3.2 |
| Crospovidone | 44mg | 11.0 |
| Magnesium stearate | 6mg | 1.5 |
| Amount to | 400mg | 100.0 |
Prepare with embodiment 1 method.
Zhi Bei tablet is less than 30 seconds, good mouthfeel in intraoral average disintegration time according to the method.
Implement 6, contain the oral cavity disintegration tablet of 80mg Folium Ginkgo extract
Referring to table 6, the unit that has provided this tablet forms and the percentage ratio composition
Table 6
| Composition | Unit forms | Percentage ratio (%) |
| Folium Ginkgo extract | 80mg | 22.8 |
| Ethyl cellulose | 80mg | 22.8 |
| Diluted Alcohol | 8ml | --- |
| Lactose | 80mg | 22.8 |
| Mannitol | 40.4mg | 11.5 |
| Sucrose | 1.5mg | 0.4 |
| Menthol | 1mg | 0.3 |
| Citric acid | 11.3mg | 3.2 |
| Sodium bicarbonate | 10mg | 2.8 |
| Crospovidone | 42.7mg | 12.1 |
| Magnesium stearate | 4.6mg | 1.3 |
| Amount to | 351.5mg | 100.0 |
Prepare with embodiment 1 method.
Zhi Bei tablet is less than 30 seconds, good mouthfeel in intraoral average disintegration time according to the method.
Implement 7, contain the oral cavity disintegration tablet of 80mg Folium Ginkgo extract
Referring to table 7, the unit that has provided this tablet forms and the percentage ratio composition
Table 7
| Composition | Unit forms | Percentage ratio (%) |
| Folium Ginkgo extract | 80mg | 22.2 |
| Ethyl cellulose | 64mg | 17.8 |
| Diluted Alcohol | 8ml | --- |
| Lactose | 100mg | 27.8 |
| Microcrystalline Cellulose | 60mg | 12.2 |
| Sucrose | 2.9mg | 0.8 |
| Citric acid | 10mg | 2.8 |
| Sodium bicarbonate | 8mg | 2.2 |
| Cross-linking sodium carboxymethyl cellulose | 47.5mg | 13.2 |
| Magnesium stearate | 3.6mg | 1.0 |
| Amount to | 360mg | 100.0 |
Prepare with embodiment 1 method.
Zhi Bei tablet is less than 30 seconds, good mouthfeel in intraoral average disintegration time according to the method.
Implement 8, contain the oral cavity disintegration tablet of 80mg Folium Ginkgo extract
Referring to table 8, the unit that has provided this tablet forms and the percentage ratio composition
Table 8
| Composition | Unit forms | Percentage ratio (%) |
| Folium Ginkgo extract | 80mg | 17.1 |
| Ethyl cellulose | 35mg | 7.5 |
| Methylcellulose | 25mg | 5.4 |
| Diluted Alcohol | 7ml | --- |
| Mannitol | 150mg | 32.1 |
| Microcrystalline Cellulose | 83.4mg | 17.9 |
| Sucrose | 3mg | 0.6 |
| Aspartame | 1.7mg | 0.4 |
| Citric acid | 10mg | 2.1 |
| Sodium bicarbonate | 8.7mg | 1.9 |
| Cross-linking sodium carboxymethyl cellulose | 65.3mg | 14.0 |
| Magnesium stearate | 4.7mg | 1.0 |
| Amount to | 466.7mg | 100.0 |
Prepare with embodiment 1 method.
Zhi Bei tablet is less than 30 seconds, good mouthfeel in intraoral average disintegration time according to the method.
Claims (3)
1. oral disintegration tablet of ectractive from ginkgo leaf, contain the required excipient of Folium Ginkgo extract and oral cavity disintegration tablet, it is characterized in that: Folium Ginkgo extract is the coated granule that is wrapped with coating material, oral cavity disintegration tablet consists of coated granule: the excipient weight ratio is 1: 1～1: 3, the consumption that wraps agricultural material is 0.5～1 times of Folium Ginkgo extract weight, and coating material is selected methylcellulose and/or ethyl cellulose for use.
2. the preparation method of oral disintegration tablet of ectractive from ginkgo leaf according to claim 1 is characterized in that: be achieved through the following technical solutions:
(1) preparation of coated granule: the coating material of recipe quantity is dissolved in solvent, solvent is selected Diluted Alcohol, consumption is that every 10ml Diluted Alcohol dissolving 10-150mg wraps agricultural material, makes coating solution, then Folium Ginkgo extract is added coating solution, stir, ultrasonic making is uniformly dispersed, and the liquid that obtains is got solid Folium Ginkgo extract clathrate 60 ℃ of forced air dryings, pulverizes, cross 100 order mesh screens, promptly get coated granule;
(2) preparation of oral cavity disintegration tablet: the Folium Ginkgo extract coated granule that sieves is added in the diluent of the correctives of 0.5%-1% and 35%-50%, with 5%PVP
30Aqueous solution granulate, oven dry adds superpower disintegrating agent of 10%-20% and/or 4%-7% gas-producing disintegrant, 0.5%-1.5% fluidizer, granulate is made slice, thin piece on rotary tablet machine, perhaps add the adjuvant direct compression.
3. the preparation method of oral disintegration tablet of ectractive from ginkgo leaf according to claim 2, it is characterized in that: used adjuvant must be crossed 100 order mesh screens in the step (2).
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004100734410A CN100336515C (en) | 2004-12-13 | 2004-12-13 | Oral disintegration tablet of ectractive from ginkgo leaf and preparation method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004100734410A CN100336515C (en) | 2004-12-13 | 2004-12-13 | Oral disintegration tablet of ectractive from ginkgo leaf and preparation method |
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| CN100336515C true CN100336515C (en) | 2007-09-12 |
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Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN100394917C (en) * | 2005-09-21 | 2008-06-18 | 重庆康刻尔制药有限公司 | Bilobanoate oral-cavity disintegrating tablet and preparation method |
| CN102716102B (en) * | 2012-05-30 | 2014-02-05 | 杭州康恩贝制药有限公司 | Mecobalamin tablet and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1478466A (en) * | 2002-08-30 | 2004-03-03 | 赵本樱 | Dispersion tablet containing Chinese medicine active component |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1478466A (en) * | 2002-08-30 | 2004-03-03 | 赵本樱 | Dispersion tablet containing Chinese medicine active component |
Non-Patent Citations (5)
| Title |
|---|
| 口服固体速释制剂及其制备技术 黄胜炎，中国医药工业杂志，第27卷第2期 2000 * |
| 口腔崩解片的研制 张辉 樊红灿，海南医学，第14卷第9期 2003 * |
| 口腔速容片的研究进展 刘梅 崔光华，国外医学 药学分册，第6期 2000 * |
| 银杏叶口腔崩解片的研制及质量评价 叶兵 刘忠荣 及元乔 鲍锐，天然产物研究与开发，第15卷第4期 2003 * |
| 银杏叶口腔研制及质量评价 叶兵 刘忠荣 及元乔 鲍锐，天然产物研究与开发，第15卷第4期 2003 * |
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Assignee: HANGZHOU CONBA PHARMACEUTICAL Co.,Ltd. Assignor: ZHEJIANG CONBA PHARMACEUTICAL RESEARCH DEVELOPMENT CO.,LTD. Contract fulfillment period: 2007.9.15 to 2015.9.14 Contract record no.: 2008330000660 Denomination of invention: Oral disintegration tablet of ectractive from ginkgo leaf and preparation method Granted publication date: 20070912 License type: Exclusive license Record date: 20080925 |
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Free format text: EXCLUSIVE LICENCE; TIME LIMIT OF IMPLEMENTING CONTACT: 2007.9.15 TO 2015.9.14 Name of requester: HANGZHOU KANG ENBEI PHARMACEUTICAL CO., LTD. Effective date: 20080925 |
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