CN100360128C - Huperzine-A oral cavity disintegration tablet and its preparation method - Google Patents
Huperzine-A oral cavity disintegration tablet and its preparation method Download PDFInfo
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- CN100360128C CN100360128C CNB2005101320898A CN200510132089A CN100360128C CN 100360128 C CN100360128 C CN 100360128C CN B2005101320898 A CNB2005101320898 A CN B2005101320898A CN 200510132089 A CN200510132089 A CN 200510132089A CN 100360128 C CN100360128 C CN 100360128C
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- China
- Prior art keywords
- huperzine
- mannitol
- parts
- preparation
- microcrystalline cellulose
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
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- ZRJBHWIHUMBLCN-SEQYCRGISA-N Huperzine A Natural products N1C(=O)C=CC2=C1C[C@H]1/C(=C/C)[C@]2(N)CC(C)=C1 ZRJBHWIHUMBLCN-SEQYCRGISA-N 0.000 title claims abstract description 34
- 238000002360 preparation method Methods 0.000 title claims abstract description 19
- ZRJBHWIHUMBLCN-UHFFFAOYSA-N Shuangyiping Natural products N1C(=O)C=CC2=C1CC1C(=CC)C2(N)CC(C)=C1 ZRJBHWIHUMBLCN-UHFFFAOYSA-N 0.000 title claims description 33
- ZRJBHWIHUMBLCN-BMIGLBTASA-N rac-huperzine A Natural products N1C(=O)C=CC2=C1C[C@@H]1C(=CC)[C@@]2(N)CC(C)=C1 ZRJBHWIHUMBLCN-BMIGLBTASA-N 0.000 title claims description 33
- ZRJBHWIHUMBLCN-YQEJDHNASA-N huperzine A Chemical compound N1C(=O)C=CC2=C1C[C@H]1\C(=C/C)[C@]2(N)CC(C)=C1 ZRJBHWIHUMBLCN-YQEJDHNASA-N 0.000 title claims description 32
- 210000000214 mouth Anatomy 0.000 title claims description 25
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims abstract description 31
- 229930195725 Mannitol Natural products 0.000 claims abstract description 30
- 239000000594 mannitol Substances 0.000 claims abstract description 30
- 235000010355 mannitol Nutrition 0.000 claims abstract description 30
- 229920003081 Povidone K 30 Polymers 0.000 claims abstract description 11
- 239000008187 granular material Substances 0.000 claims abstract description 10
- 235000010603 pastilles Nutrition 0.000 claims description 17
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 16
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 16
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 16
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 16
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 16
- 239000011248 coating agent Substances 0.000 claims description 15
- 238000000576 coating method Methods 0.000 claims description 15
- 230000001476 alcoholic effect Effects 0.000 claims description 12
- 239000011230 binding agent Substances 0.000 claims description 11
- 239000004005 microsphere Substances 0.000 claims description 11
- 239000002245 particle Substances 0.000 claims description 9
- 108010011485 Aspartame Proteins 0.000 claims description 8
- 235000010357 aspartame Nutrition 0.000 claims description 8
- 239000000605 aspartame Substances 0.000 claims description 8
- IAOZJIPTCAWIRG-QWRGUYRKSA-N aspartame Chemical compound OC(=O)C[C@H](N)C(=O)N[C@H](C(=O)OC)CC1=CC=CC=C1 IAOZJIPTCAWIRG-QWRGUYRKSA-N 0.000 claims description 8
- 229960003438 aspartame Drugs 0.000 claims description 8
- 239000004148 curcumin Substances 0.000 claims description 8
- 235000019359 magnesium stearate Nutrition 0.000 claims description 8
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims description 4
- 238000005469 granulation Methods 0.000 claims description 4
- 230000003179 granulation Effects 0.000 claims description 4
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims description 4
- 229940031703 low substituted hydroxypropyl cellulose Drugs 0.000 claims description 4
- 238000002156 mixing Methods 0.000 claims description 4
- 239000007779 soft material Substances 0.000 claims description 4
- 239000002671 adjuvant Substances 0.000 claims description 3
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 abstract description 6
- 239000000544 cholinesterase inhibitor Substances 0.000 abstract description 4
- 150000001875 compounds Chemical class 0.000 abstract description 4
- 239000003085 diluting agent Substances 0.000 abstract description 4
- ZQPQGKQTIZYFEF-WCVJEAGWSA-N Huperzine Natural products C1([C@H]2[C@H](O)C(=O)N[C@H]2[C@@H](O)C=2C=CC=CC=2)=CC=CC=C1 ZQPQGKQTIZYFEF-WCVJEAGWSA-N 0.000 abstract description 3
- 238000005516 engineering process Methods 0.000 abstract description 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 abstract 2
- 239000000853 adhesive Substances 0.000 abstract 2
- 239000004480 active ingredient Substances 0.000 abstract 1
- 239000000243 solution Substances 0.000 description 17
- 239000003814 drug Substances 0.000 description 6
- 238000012360 testing method Methods 0.000 description 4
- 208000024827 Alzheimer disease Diseases 0.000 description 3
- 229940122041 Cholinesterase inhibitor Drugs 0.000 description 3
- 238000000034 method Methods 0.000 description 3
- 238000013112 stability test Methods 0.000 description 3
- 238000004090 dissolution Methods 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 238000005286 illumination Methods 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 239000002904 solvent Substances 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- 206010013786 Dry skin Diseases 0.000 description 1
- 206010036631 Presenile dementia Diseases 0.000 description 1
- 206010039966 Senile dementia Diseases 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 229940022698 acetylcholinesterase Drugs 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 230000001149 cognitive effect Effects 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 230000009748 deglutition Effects 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- 230000006870 function Effects 0.000 description 1
- -1 huperzine A chemical compound Chemical class 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000006187 pill Substances 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- 230000009747 swallowing Effects 0.000 description 1
Abstract
The present invention discloses huperzine a which is an anticholinesterase compound, an oral disintegration tablet and a preparation method thereof. The oral disintegration tablet uses huperzine an as active ingredients. The present invention is characterized in that the oral disintegration tablet contains mannitol used as a diluting agent, wherein the mannitol is 40% to 70% of the weight of the tablet, and the mannitol of 50% to 60% is preferable; the mannitol is prepared into granules of 30 meshes with an adhesive agent, PVP-K30 ethanol solution of 2% is preferably used as the adhesive agent, and the granules are packed. The prepared oral disintegration tablet has the good disintegration time and the good administration mouth feel, the technology is simple and stable, and the present invention is suitable for industrial mass preparation.
Description
Technical field
The present invention relates to a kind of huperzine A chemical compound of cholinesterase inhibitor, also relate to huperzine-A oral cavity disintegration tablet and preparation method thereof.
Background technology
Huperzine compounds in the Huperziaceae plant is a kind of cholinesterase inhibitor of reversibility efficiently, has optionally anti-acetylcholinesterase activity, can improve obviously that memory of elderly person goes down and the memory and the cognitive competence of presenile dementia.
Disclosed a kind of extraction separation method among CN1306960A, the CN1448390A from huperzine A.
The preparation of huperzine A, the research of existing tablet, capsule, drop pill, injection etc.Because dysmnesia and dull-witted old people suffer from the suitable colony of huperzine A, and old people's function of deglutition is generally not good enough, be made into oral cavity disintegration tablet, medicine is disintegratable or dissolving once putting into that mouth do not need water or only need low amounts of water, only doing several swallowing acts can obey medicine down smoothly, and this will make things convenient for patient's medication greatly.
Disclosed oral cavity disintegration tablet of a kind of huperzine A and preparation method thereof among the CN1568985A.Contain a large amount of sugar in the disclosed huperzine-A oral cavity disintegration tablet as adjuvant, thereby be unfavorable for patients of senile dementia, be unfavorable for that particularly the old people who avoids sugar takes.
Summary of the invention
The inventor is surprisingly found out that, by selecting for use mannitol as main diluent, controls the consumption of mannitol, and prepared huperzine-A oral cavity disintegration tablet has useful especially drug release rate (being disintegration).In addition, by changing the adding method of material, unexpectedly obtained good tabletting effect.
For this reason, the invention provides a kind of cholinesterase inhibitor chemical compound, it is the huperzine A with following formula I structure:
Formula I
The present invention also provides a kind of oral cavity disintegration tablet, and it, is characterized in that comprising and account for sheet and weigh 40%～70%, preferred 50%～60% mannitol as diluent as active component with huperzine A.
Above-mentioned described oral cavity disintegration tablet, wherein said mannitol is by making the granule pan feeding with binding agent; As preferred version, mannitol is by making the granule pan feeding of 30 mesh sieves as binding agent with 2%PVP-K30 (30 POVIDONE K 30 BP/USP-30) alcoholic solution.
As preferred embodiment, a kind of oral cavity disintegration tablet of the present invention, it is characterized in that: calculate by weight, 0.05～0.2 part of huperzine A, 50～60 parts in mannitol, 35～50 parts of microcrystalline Cellulose celphere, 2～5 parts of low-substituted hydroxypropyl celluloses, 3～6 parts of crospolyvinylpyrrolidone, 3～7 parts of microcrystalline Cellulose, 0.2～1 part of aspartame, 0.2～1 part of flavoring orange essence, 0.5～2 part of magnesium stearate, 0.5～2 part of Eudradit E-100, the 30 POVIDONE K 30 BP/USP of granulation usefulness-30 binding agent is an amount of, and is an amount of as the alcoholic solution of solvent.
As more preferred, a kind of oral cavity disintegration tablet of the present invention is characterized in that: calculate by weight, 0.05 part of huperzine A, 60 parts in mannitol, 40 parts of microcrystalline Cellulose celphere, 3.5 parts of low-substituted hydroxypropyl celluloses, 4.7 parts of crospolyvinylpyrrolidone, 5.9 parts of microcrystalline Cellulose, 0.5 part of aspartame, 0.5 part of flavoring orange essence, 1 part of magnesium stearate, Eudradit
1 part of E-100, the 30 POVIDONE K 30 BP/USP of granulation usefulness-30 binding agent is an amount of, and is an amount of as the alcoholic solution of solvent.
The preparation method of oral cavity disintegration tablet of the present invention comprises following steps:
(1) preparation huperzine A pastille microsphere;
(2) preparation mannitol particles;
(3) other adjuvant mixes tabletting in the mannitol particles that makes of huperzine A pastille microsphere that step (1) is made and step (2) and the prescription.
Wherein, above-mentioned described step (1) is: 1. with Eudradit
E-100 is dissolved in alcoholic solution and obtains coating solution, 2. huperzine A is dissolved in and obtains the pastille coating solution in the coating solution, 3. the microcrystalline Cellulose celphere is placed coating pan, the pastille coating solution evenly is wrapped in makes huperzine A pastille microsphere on the celphere.
Wherein, above-mentioned described step (2) is: mannitol is binding agent system soft material with the 2%PVP-K30 alcoholic solution, makes 30 mesh sieve granules.
Wherein, above-mentioned described step (3) is: mannitol particles that huperzine A pastille microsphere that step (1) is made and step (2) make and low-substituted hydroxypropyl cellulose, crospolyvinylpyrrolidone, microcrystalline Cellulose, aspartame, flavoring orange essence uniform mixing, add magnesium stearate, tabletting.
The present invention finds, if the mannitol diluent is used as medicine with former powder type, mobile bad in the technical process then influences the quality of tabletting and oral cavity disintegration tablet.By being binding agent system soft material with the 2%PVP-K30 alcoholic solution with it, make 30 mesh sieve granules, with granule mode pan feeding, carry out the mixing of materials tabletting, good fluidity helps technological operation.
Formula I structure huperzine chemical compound of the present invention and oral cavity disintegration tablet thereof can be used for treating diseases such as dysmnesia, alzheimer disease.
The preparation method of oral cavity disintegration tablet of the present invention, preparation technology is simple, stable, has good flowability in the tabletting process, is suitable for industrialized great production especially.Prepared oral cavity disintegration tablet is investigated through every indexs such as disintegrate time limits, and the result is good.
Specific embodiments
Further specify the present invention below by embodiment, but this is not considered to scope of the present invention has been constituted restriction.
Embodiment 1: preparation embodiment
Huperzine A 0.05 gram, microcrystalline Cellulose celphere 40.0 grams, Eudradit
E-100 1.0 grams, mannitol 60 grams, low-substituted hydroxypropyl cellulose 3.5 grams, crospolyvinylpyrrolidone 4.7 grams, microcrystalline Cellulose 5.9 grams, aspartame 0.5 gram, flavoring orange essence 0.5 gram, magnesium stearate 1.0 grams, each is an amount of for PVP-K30 and alcoholic solution.
Preparation huperzine A pastille microsphere:
With Eudradit
E-100 is dissolved in the alcoholic solution of 30ml and fully stirs and makes dissolving, and is standby as coating solution;
Huperzine A is dissolved in the coating solution of making pastille in the above-mentioned coating solution;
The microcrystalline Cellulose celphere is placed coating pan, above-mentioned pastille coating solution is wrapped on the celphere equably, make the pastille microsphere.
The preparation mannitol particles:
Getting mannitol, is that binding agent is made soft material with the 2%PVP-K30 alcoholic solution, and 30 mesh sieves are granulated, and wet granular was 50 degrees centigrade of dryings 1 hour, and 30 mesh sieve granulate obtain mannitol particles.
With the even mistake 30 mesh sieve uniform mixing of above-mentioned huperzine A pastille microsphere, mannitol particles and low-substituted hydroxypropyl cellulose, crospolyvinylpyrrolidone, microcrystalline Cellulose, aspartame, the flavoring orange essence that makes, add magnesium stearate, be pressed into 1000.
Embodiment 2: stability test
Get the prepared oral cavity disintegration tablet of embodiment 1, tablet be laid in the plate, carry out strong illumination test (under illumination: the 4500lx ± 500lx), Continuous irradiation 10 days;
Get the prepared oral cavity disintegration tablet of embodiment 1, be put in the surface plate, in 60 ℃ ± 2 ℃ calorstat, placed 10 days, carry out thimble test;
Get the prepared oral cavity disintegration tablet of embodiment 1, in the environment of relative humidity 75% ± 5%, placed 10 days, carry out the high humidity stability test;
Respectively at sampling in 10 days, check its character, disintegration time, dissolution, related substance and content.The results are shown in Table 1.It is all up to specification that the result shows that product stability is tested every index.
Table 1 stability test result
| Classification | Outward appearance | Disintegration (second) | Dissolution (%) | Related substance (%) | Assay (%) |
| 10 days high humiditys of 10 days high temperature of 0 day high light 10 days | Off-white color sheet off-white color sheet off-white color sheet off-white color sheet, unilateral moisture absorption | 17 22 19 16 | 91.2 83.1 80.7 89.1 | 0.21 0.49 0.76 0.60 | 100.0 89.0 86.2 95.3 |
Embodiment 3: contrast test
Embodiment 3a: weigh 10% except that the consumption of mannitol accounts for sheet, all the other make huperzine-A oral cavity disintegration tablet with embodiment 1.
Embodiment 3b: weigh 30% except that the consumption of mannitol accounts for sheet, all the other make huperzine-A oral cavity disintegration tablet with embodiment 1.
Be index with taking mouthfeel the disintegration with medicine, investigates the product of embodiment 1 and the product of embodiment 3.The results are shown in Table 2.
Table 2 mannitol consumption comparative test result
| Embodiment 1 | Embodiment 3a: | Embodiment 3b: | |
| Take mouthfeel disintegration | 17 seconds good | 42 seconds are not good | 31 seconds are not good |
Claims (4)
1, a kind of oral cavity disintegration tablet, with huperzine A as active component, it is characterized in that forming: calculate by weight by following component, 0.05～0.2 part of huperzine A, 50～60 parts in mannitol, 35～50 parts of microcrystalline Cellulose celphere, 2～5 parts of low-substituted hydroxypropyl celluloses, 3～6 parts of crospolyvinylpyrrolidone, 3～7 parts of microcrystalline Cellulose, 0.2～1 part of aspartame, 0.2～1 part of flavoring orange essence, 0.5～2 part of magnesium stearate, 0.5～2 part of Eudradit E-100, the 30 POVIDONE K 30 BP/USP of granulation usefulness-30 binding agent is an amount of, and wherein said mannitol is by making the granule pan feeding of 30 mesh sieves as binding agent with 2% polyvidone-K30 alcoholic solution.
2, oral cavity disintegration tablet according to claim 1 is characterized in that being made up of following component: calculate 0.05 part of huperzine A by weight, 60 parts in mannitol, 40 parts of microcrystalline Cellulose celphere, 3.5 parts of low-substituted hydroxypropyl celluloses, 4.7 parts of crospolyvinylpyrrolidone, 5.9 parts of microcrystalline Cellulose, 0.5 part of aspartame, 0.5 part of flavoring orange essence, 1 part of magnesium stearate, 1 part of Eudradit E-100, the 30 POVIDONE K 30 BP/USP of granulation usefulness-30 binding agent is an amount of.
3, the preparation method of claim 1 or 2 described oral cavity disintegration tablets, it comprises following steps:
(1) preparation huperzine A pastille microsphere;
(2) preparation mannitol particles;
(3) other adjuvant mixes tabletting in the mannitol particles that makes of huperzine A pastille microsphere that step (1) is made and step (2) and the prescription;
Wherein:
Described step (1) is: 1. Eudradit E-100 is dissolved in alcoholic solution and obtains coating solution, 2. huperzine A is dissolved in and obtains the pastille coating solution in the coating solution, 3. the microcrystalline Cellulose celphere is placed coating pan, the pastille coating solution evenly is wrapped in makes huperzine A pastille microsphere on the celphere;
Described step (2) is: mannitol is binding agent system soft material with 2% polyvidone-K30 alcoholic solution, makes 30 mesh sieve granules.
4, preparation method according to claim 3, wherein said step (3) is: mannitol particles that huperzine A pastille microsphere that step (1) is made and step (2) make and low-substituted hydroxypropyl cellulose, crospolyvinylpyrrolidone, microcrystalline Cellulose, aspartame, flavoring orange essence uniform mixing, add magnesium stearate, tabletting.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005101320898A CN100360128C (en) | 2005-12-23 | 2005-12-23 | Huperzine-A oral cavity disintegration tablet and its preparation method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005101320898A CN100360128C (en) | 2005-12-23 | 2005-12-23 | Huperzine-A oral cavity disintegration tablet and its preparation method |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1823769A CN1823769A (en) | 2006-08-30 |
| CN100360128C true CN100360128C (en) | 2008-01-09 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2005101320898A Expired - Fee Related CN100360128C (en) | 2005-12-23 | 2005-12-23 | Huperzine-A oral cavity disintegration tablet and its preparation method |
Country Status (1)
| Country | Link |
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| CN (1) | CN100360128C (en) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101785762B (en) * | 2009-10-20 | 2013-04-24 | 浙江万邦药业股份有限公司 | Huperzine A orally disintegrating tablets and preparation method thereof |
| CN106511348B (en) * | 2016-11-02 | 2019-04-19 | 中山大学 | Huperzine skeleton particle, oral disintegrating tablet and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1568985A (en) * | 2003-07-21 | 2005-01-26 | 北京小伙伴医药生物技术有限公司 | Orally disintegrating tablet of Huperzine A and its preparation |
| CN1658838A (en) * | 2002-06-10 | 2005-08-24 | 维塔科学有限公司 | Orally disintegrating tablets and process for obtaining them |
-
2005
- 2005-12-23 CN CNB2005101320898A patent/CN100360128C/en not_active Expired - Fee Related
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1658838A (en) * | 2002-06-10 | 2005-08-24 | 维塔科学有限公司 | Orally disintegrating tablets and process for obtaining them |
| CN1568985A (en) * | 2003-07-21 | 2005-01-26 | 北京小伙伴医药生物技术有限公司 | Orally disintegrating tablet of Huperzine A and its preparation |
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| Publication number | Publication date |
|---|---|
| CN1823769A (en) | 2006-08-30 |
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Effective date of registration: 20191122 Address after: 1500008 3 / F, west side of building 13, Shuangtai Electric Power Industrial Park, No. 469, Xianfeng Road, Nangang District, Harbin City, Heilongjiang Province Patentee after: Harbin Kexin Bicheng Pharmaceutical Technology Development Co.,Ltd. Address before: 100083, Beijing, Xueyuan Road, Haidian District No. 30 Tiangong building, block A, room 15, room 15 Patentee before: COSCI MED-TECH Co.,Ltd. |
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Granted publication date: 20080109 |