CN101623317B - Serrate club moss oral disintegrating tablet and preparation method thereof - Google Patents

Serrate club moss oral disintegrating tablet and preparation method thereof Download PDF

Info

Publication number
CN101623317B
CN101623317B CN 200810129659 CN200810129659A CN101623317B CN 101623317 B CN101623317 B CN 101623317B CN 200810129659 CN200810129659 CN 200810129659 CN 200810129659 A CN200810129659 A CN 200810129659A CN 101623317 B CN101623317 B CN 101623317B
Authority
CN
China
Prior art keywords
serrate
add
huperzine
disintegrating tablet
preparation
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.)
Active
Application number
CN 200810129659
Other languages
Chinese (zh)
Other versions
CN101623317A (en
Inventor
谢金生
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Wanbond Pharmaceutical Group Co., Ltd
Original Assignee
ZHEJIANG WANBANG PHARMACEUTICAL CO Ltd
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by ZHEJIANG WANBANG PHARMACEUTICAL CO Ltd filed Critical ZHEJIANG WANBANG PHARMACEUTICAL CO Ltd
Priority to CN 200810129659 priority Critical patent/CN101623317B/en
Publication of CN101623317A publication Critical patent/CN101623317A/en
Application granted granted Critical
Publication of CN101623317B publication Critical patent/CN101623317B/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Abstract

The invention relates to a serrate club moss oral disintegrating tablet and a preparation method thereof. The method comprises the following steps: dissolving serrate club moss extract in a proper solvent; preparing a solid dispersion through dispersively spraying the mixture in an auxiliary material or dripping the mixture in a fused substrate; crushing the solid dispersion; adding the substance into the auxiliary material; stirring the mixture evenly; adding a bonding agent into the mixture for granulating; drying the granulates; adding lubricant into the granulates; and tabletting the granulates.

Description

Serrate club moss oral disintegrating tablet and manufacture method thereof
Technical field
The invention belongs to field of medicaments, be specifically related to a kind of serrate club moss oral disintegrating tablet and manufacture method thereof.
Background technology
Huperzine Serrate P.E is from China's Chinese herbal medicine Huperziaceae plant Herba Lycopodii serrati (Chinese herbal and crude drugs preparations that extracts the plant such as Huperzia serrata (Thunb.) Trev, mainly contain huperzine A, huperzine B, the ingredients such as flavone, and wherein huperzine A is a kind of efficient, the intracerebroventricuacetylcholine acetylcholine esterase inhibitor of high selectivity, true acetylcholine esterase had selective inhibitory, easily pass through blood brain barrier, long action time, has the promotion memory represents, the effect that hypermnesis keeps, China medicine worker in 1970 inhibitory action of Huperziaceae plant to acetylcholine esterase that begin one's study, the bright grade of Tang Xi in 1986 huperzine A of reporting for work first is improved the effect of learning and memory in rats, nineteen ninety-five the domestic huperzine A tablet of at first developing, be applied to treat senile dementia, the diseases such as benign memory deficits, huperzine B also have the pharmacological action of similar huperzine A.Clinical evaluation shows: compare with similar drugs, huperzine A has rapid-action, easily sees through blood brain barrier, and long action time can make things convenient for the advantages such as oral application.Existing market is sold and to be mainly contained huperzine A tablet, capsule, because huperzine A is water insoluble, has and draws moistly, and principal agent dosage is few, uses comminution by gas stream or the equivalent legal system of progressively increasing standby when the Huperzine-A Tablets, Tests for Uniformity of traditional method preparation and capsule.Have in the market medicine and healthcare food preparation now, also do not contain the Chinese medicine preparation that preparation, particularly oral cavity disintegration tablet are this efficiently, bioavailability is high of the pure Chinese herbal medicine of huperzine A, huperzine B.The exploitation serrate club moss oral disintegrating tablet has widely practical value
The present invention makes serrate club moss oral disintegrating tablet by solvent-applied dispersion and solid dispersion technology, correct and overcome some defectives when making huperzine A orally disintegrating tablets agent, capsule, serrate club moss oral disintegrating tablet volume of the present invention is little, can be oral, need not water delivery service, great convenience is provided particularly for child and elderly patients, the serrate club moss oral disintegrating tablet of using the present invention's preparation has efficiently, reaches the high characteristics of bioavailability.
Summary of the invention
The present invention is logical to be that solvent-applied dispersion method and solid dispersion technology are made serrate club moss oral disintegrating tablet, had even release, and dissolution and dissolution rate are stable, the steady quality characteristics.Because serrate club moss oral disintegrating tablet agent volume is little, easy to carry and use, can be oral, and this oral cavity disintegration tablet bioavailability is high.With the common huperzine A orally disintegrating tablets agent of manufacturing, capsule, oral cavity disintegration tablet supplementary product consumption of the present invention is few, need not complicated, the expensive device such as micronization relatively, working condition and production equipment are simple, reduce and pollute, and reduce labor intensity, reduce production costs, show characteristics of the present invention.
The selected adjuvant of the present invention all meets the pharmaceutic adjuvant of medicinal requirements, sum up by lot of experiments, obtain a result, this drug component forms and comprises: Huperzine Serrate P.E, appropriate amount of auxiliary materials, wherein adjuvant comprises the fillibility adjuvant and has the plasticity adjuvant, and the fillibility adjuvant has cross-linking sodium carboxymethyl cellulose, polyethylene glycol 6000, Macrogol 4000, polyoxyethylene stearate (40) ester, polyoxyethylene sorbitan monoleate, xylitol, mannitol, lactose, sucrose, microcrystalline Cellulose, Pulvis Talci, sodium bicarbonate, calcium hydrogen phosphate, magnesium stearate, aluminium stearate, sodium stearate, insect wax, Cera Flava, stearyl alcohol, spermol, hydroxypropyl emthylcellulose (HPMC), hydroxyethyl-cellulose (HEC), HPMC (HPC-Na), ethyl cellulose, polyvinylpyrrolidone and A Siba are sweet.The plasticity adjuvant has gelatin, Resina persicae, arabic gum, corn starch, dextrin, alginic acid, glucosamine.
Best substrate adjuvant of the present invention is that cross-linking sodium carboxymethyl cellulose, hydroxypropyl emthylcellulose (HPMC), ethyl cellulose (HEC), HPMC (HPC-Na), microcrystalline Cellulose are 0.3 with the ratio of the weight of lactose, mannitol: 1-0.5: 1.Xylitol is 1 with the ratio of the weight of starch: 0.3-1: 0.5, or the ratio of sorbitol and the weight of starch is 1: 0.2-1: 0.5.Huperzine Serrate P.E is 1 with the ratio of the weight of adjuvant in the pharmaceutical composition of the present invention: 20-1: 800.
Preferred pharmaceutical composition Chinese medicine of the present invention is 1 with the ratio of adjuvant: 60-1: 700.
Best pharmaceutical composition Chinese medicine of the present invention is 1 with the ratio of adjuvant: 80-1: 600.
The content of preparation of Chinese medicine of the present invention calculates with huperzine A, is 0.03-1% (weight ratio), or 50-1000 μ g/ sheet.
The ratio of the adjuvant of pharmaceutical composition of the present invention and the consumption of medicine all is in pharmaceutics and the pharmacopeia allowed band, feeds intake by metering, makes the huperzine A content in every oral cavity disintegration tablet serrate club moss oral disintegrating tablet reach the requirement (50 μ g-800 μ g/ sheet) that pharmacopeia is stipulated.The prepared serrate club moss oral disintegrating tablet of the present invention has easy, the steady quality of preparation, and clinical administration is convenient, characteristics that can be oral.
The present invention is based on dissolution with solvents method and solid dispersion law technology, A: with 1 weight portion Huperzine Serrate P.E and 20 to 100 parts by weight solvent through being dissolved into homogeneous solution, add proper amount of surfactant, join in the substrate of 60 to 800 weight portions by the phase process for dispersing that disperses spray to add, stir, after the interpolation lubricant stirs, direct compression, drying is made serrate club moss oral disintegrating tablet.B: or granulate in granulator by wet granulation process, drying is mixed, tabletting, and drying is made serrate club moss oral disintegrating tablet.C: or with 1 weight portion Huperzine Serrate P.E and 20 to 100 parts by weight solvent through being dissolved into homogeneous solution, add proper amount of surfactant, stir; add in the substrate that melting stirs, stir, cooling; pulverize, become the Herba Lycopodii serrati solid dispersion, add an amount of adjuvant; mix homogeneously, direct compression or in granulator, granulate drying by wet granulation process; mix; tabletting, drying is made serrate club moss oral disintegrating tablet.
Specific implementation method
One, example 1
Figure GSB00000725611500021
Make 1000 oral cavity disintegration tablets
Method for making: Huperzine Serrate P.E is dissolved in fully dissolving in the ethanol, add polyoxyethylene sorbitan monoleate, stir, become the dispersion ethanol of Huperzine Serrate P.E, spray adds in the adjuvant of cross-linking sodium carboxymethyl cellulose, methylcellulose, citric acid, mannitol and the sweet composition of A Siba of mix homogeneously, is stirred well to evenly, adds the magnesium stearate mix homogeneously, tabletting, and get final product.
Two, example 2
Prescription:
Figure GSB00000725611500031
Make 1000
Method for making: Huperzine Serrate P.E is dissolved in the ethanol.Fully dissolving, add polyoxyethylene sorbitan monoleate, stir, become the dispersion ethanol of Huperzine Serrate P.E, spray adds in the adjuvant of cross-linking sodium carboxymethyl cellulose, micropowder silica gel, polyvinylpyrrolidone and the sweet composition of A Siba of mix homogeneously, is stirred well to evenly, adds the magnesium stearate mix homogeneously, direct compression, and get final product.
Three, example 3,
Prescription
Figure GSB00000725611500032
Make 1000
Method for making: Huperzine Serrate P.E is dissolved in fully dissolving in the ethanol, add polyoxyethylene sorbitan monoleate, stir, become the dispersion ethanol of Huperzine Serrate P.E, add in the adjuvant of cross-linking sodium carboxymethyl cellulose, micropowder silica gel, mannitol, lactose and the sweet composition of A Siba of mix homogeneously, be stirred well to evenly, add again the magnesium stearate mix homogeneously, tabletting, drying, and get final product.
Four, example 4
Prescription
Figure GSB00000725611500033
Make 1000
Method for making: Huperzine Serrate P.E is dissolved in the ethanol, fully dissolving, add polyoxyethylene sorbitan monoleate, stir, become the dispersion ethanol of Huperzine Serrate P.E, add the Macrogol 4000, polyoxyethylene stearate of 80 ℃ of lower meltings { in the substrate that the 40} ester forms, be stirred well to evenly, cooling becomes the Herba Lycopodii serrati solid dispersion, pulverize and add in the adjuvant of cross-linking sodium carboxymethyl cellulose, lactose and the sweet composition of A Siba of mix homogeneously, be stirred well to evenly, add the magnesium stearate mix homogeneously, tabletting, drying, and get final product.
Five, example 5,
Prescription
Figure GSB00000725611500041
Make 1000
Method for making: Huperzine Serrate P.E is dissolved in fully dissolving in the ethanol, add polyoxyethylene sorbitan monoleate, stir, become the dispersion ethanol of Huperzine Serrate P.E, add in the adjuvant that cross-linking sodium carboxymethyl cellulose, micropowder silica gel, citric acid and the mannitol of mix homogeneously have formed, be stirred well to evenly, add the magnesium stearate mix homogeneously, tabletting, drying, and get final product.
Six, example 6,
Prescription:
Figure GSB00000725611500042
Make 1000 oral cavity disintegration tablets
Press oral cavity disintegration tablet, coating, method for making: Huperzine Serrate P.E is dissolved in the ethanol.Fully dissolving, add polyoxyethylene sorbitan monoleate, stir, become the dispersion ethanol of Huperzine Serrate P.E, spray adds hydroxypropyl cellulose, citric acid, micropowder silica gel, mannitol, the lactose of mix homogeneously, be stirred well to evenly, granulate with the polyvinylpyrrolidone alcoholic solution, 60 ℃ lower dry, granulate, add the magnesium stearate mix homogeneously, tabletting, and get final product.
Seven, example 7
Prescription:
Make 1000
Method for making: Huperzine Serrate P.E is dissolved in the ethanol.Fully dissolving adds polyoxyethylene sorbitan monoleate, stirs, become the dispersion ethanol of Huperzine Serrate P.E, spray add cross-linking sodium carboxymethyl cellulose, citric acid, lactose, mannitol, the A Siba of mix homogeneously sweet in, be stirred well to evenly, granulate with the polyvinylpyrrolidone alcoholic solution, 60 ℃ lower dry, granulate adds the magnesium stearate mix homogeneously, tabletting, drying, and get final product.

Claims (1)

1. a serrate club moss oral disintegrating tablet is characterized in that, its composition and preparation method are as follows:
Figure FSB00000931156000011
Make 1000
Method for making: Huperzine Serrate P.E is dissolved in the ethanol, fully dissolving, add polyoxyethylene sorbitan monoleate, stir, become the dispersion ethanol of Huperzine Serrate P.E, add in Macrogol 4000 80 ℃ of lower meltings, the substrate that polyoxyethylene stearate (40) ester forms, be stirred well to evenly, cooling becomes the Herba Lycopodii serrati solid dispersion, pulverize and add in the adjuvant of cross-linking sodium carboxymethyl cellulose, lactose and the sweet composition of A Siba of mix homogeneously, be stirred well to evenly, add the magnesium stearate mix homogeneously, tabletting, drying, and get final product.
CN 200810129659 2008-07-07 2008-08-05 Serrate club moss oral disintegrating tablet and preparation method thereof Active CN101623317B (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN 200810129659 CN101623317B (en) 2008-07-07 2008-08-05 Serrate club moss oral disintegrating tablet and preparation method thereof

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN200810137881.6 2008-07-07
CN200810137881 2008-07-07
CN 200810129659 CN101623317B (en) 2008-07-07 2008-08-05 Serrate club moss oral disintegrating tablet and preparation method thereof

Publications (2)

Publication Number Publication Date
CN101623317A CN101623317A (en) 2010-01-13
CN101623317B true CN101623317B (en) 2013-03-06

Family

ID=41519412

Family Applications (1)

Application Number Title Priority Date Filing Date
CN 200810129659 Active CN101623317B (en) 2008-07-07 2008-08-05 Serrate club moss oral disintegrating tablet and preparation method thereof

Country Status (1)

Country Link
CN (1) CN101623317B (en)

Also Published As

Publication number Publication date
CN101623317A (en) 2010-01-13

Similar Documents

Publication Publication Date Title
CN101708336B (en) Novel medicinal premixing auxiliary material
CN114129527B (en) Miniature tablet and preparation method and preparation thereof
CN105935358B (en) One seed sand library is than bent Valsartan sustained release agent and preparation method thereof
CN101816637B (en) Leflunomide tablet preparation and preparation method thereof
WO2019024949A1 (en) Manufacturing method of oral dosage form containing berberine, oral dosage form containing berberine and use thereof
CN109875972B (en) Olmesartan medoxomil and amlodipine pharmaceutical composition
CN107913256A (en) A kind of macitentan oral disnitegration tablet for treating pulmonary hypertension and preparation method thereof
CN106667936A (en) Sofosbuvir tablet and preparation method thereof
CN101804084B (en) Solid dispersion and preparation method thereof
CN101623317B (en) Serrate club moss oral disintegrating tablet and preparation method thereof
CA2492156C (en) Tablet composition containing kampo medicinal extract and its manufacturing process
CN103655512B (en) Vaginal fenticonazole nitrate soft capsule and preparation method thereof
CN101804038A (en) Huperzine A preparation for treating schizophrenia and nervous function damage and preparation method thereof
CN102824644B (en) High-stability sustained-release tablet prepared by using hydroxy propyl cellulose
CN101658544B (en) Controlled release tablets of huperzia serrata and method for preparing same
CN101785762B (en) Huperzine A orally disintegrating tablets and preparation method thereof
CN101991859A (en) Beta-cyclodextrin inclusion compound of huperzine A, and preparation method and preparation thereof
CN110354093A (en) A kind of mosapride citrate pharmaceutical composition
KR100735904B1 (en) Tablet composition containing extract of natural herbal plants and its manufacturing process
CN103768060B (en) Compound tablet of ibuprofen, pseudoephedrine hydrochloride and chlorpheniramine maleate
CN101658543A (en) Huperzia serrata tablets and method for preparing same
CN101890057A (en) Herba Pteridis Multifidae preparation that treatment gastrointestinal tract, urinary tract infection and the heart, cerebrovascular disease are used and preparation method thereof
TWI734247B (en) Cellulose composition and lozenge
TWI723621B (en) Cellulose composition, lozenge and orally disintegrating tablet
CN100415269C (en) Method for preparing cow-bezoar snake bile Sichuan fritillary bulb dispersive tablet

Legal Events

Date Code Title Description
C06 Publication
PB01 Publication
C10 Entry into substantive examination
SE01 Entry into force of request for substantive examination
ASS Succession or assignment of patent right

Owner name: ZHEJIANG WORLDBEST PHARMACEUTICAL CO., LTD.

Free format text: FORMER OWNER: XIE JINSHENG

Effective date: 20100915

C41 Transfer of patent application or patent right or utility model
COR Change of bibliographic data

Free format text: CORRECT: ADDRESS; FROM: 317500 NO.133, WANSHOU ROAD, TAIPING STREET, WENLING CITY, ZHEJIANG PROVINCE TO: 317500 NO.28, BAIZHANG NORTH ROAD, CHENGDONG STREET, WENLING CITY, ZHEJIANG PROVINCE

TA01 Transfer of patent application right

Effective date of registration: 20100915

Address after: 317500 east of Zhejiang province Wenling city streets Baizhang Road No. 28

Applicant after: Zhejiang Worldbest Pharmaceutical Co., Ltd.

Address before: 317500 No. 133 Taiping Street, Zhejiang, Wanshou Road, Wenling

Applicant before: Xie Jinsheng

C53 Correction of patent for invention or patent application
CB02 Change of applicant information

Address after: 317500 east of Zhejiang province Wenling city streets Baizhang Road No. 28

Applicant after: Zhejiang Wanbang Pharmaceutical Co., Ltd.

Address before: 317500 east of Zhejiang province Wenling city streets Baizhang Road No. 28

Applicant before: Zhejiang Worldbest Pharmaceutical Co., Ltd.

COR Change of bibliographic data

Free format text: CORRECT: APPLICANT; FROM: ZHEJIANG WORLDBEST PHARMACEUTICAL CO., LTD. TO: ZHEJIANG WANBANG PHARMACEUTICAL CO., LTD.

C14 Grant of patent or utility model
GR01 Patent grant
C56 Change in the name or address of the patentee

Owner name: WANBANGDE PHARMACEUTICAL GROUP CO., LTD.

Free format text: FORMER NAME: ZHEJIANG WANBANG PHARMACEUTICAL CO., LTD.

CP01 Change in the name or title of a patent holder

Address after: 317500 east of Zhejiang province Wenling city streets Baizhang Road No. 28

Patentee after: WANBANGDE PHARMACEUTICAL GROUP CO., LTD.

Address before: 317500 east of Zhejiang province Wenling city streets Baizhang Road No. 28

Patentee before: Zhejiang Wanbang Pharmaceutical Co., Ltd.

CP03 Change of name, title or address

Address after: 317500, Zhejiang Province, Taizhou City, Wenling Province Street 28 North Zhang Road

Patentee after: Wanbond Pharmaceutical Group Co., Ltd

Address before: 317500, 28 North Road, Chengdong street, Zhejiang, Wenling

Patentee before: ZHEJIANG WANBANG PHARMACEUTICAL PLC

CP03 Change of name, title or address