CN106551911A - A kind of stable pleasure is cut down for Buddhist nun's pharmaceutical composition and preparation method thereof - Google Patents
A kind of stable pleasure is cut down for Buddhist nun's pharmaceutical composition and preparation method thereof Download PDFInfo
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- CN106551911A CN106551911A CN201510601301.4A CN201510601301A CN106551911A CN 106551911 A CN106551911 A CN 106551911A CN 201510601301 A CN201510601301 A CN 201510601301A CN 106551911 A CN106551911 A CN 106551911A
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Abstract
The invention discloses a kind of stable pleasure is cut down for Buddhist nun's pharmaceutical composition and preparation method thereof, it cuts down cyclodextrin clathrate and pharmaceutically acceptable other carriers for Buddhist nun comprising active component pleasure, using cryodesiccated dry granulation process, the temperature and humidity in strict control preparation process is prepared from.The present invention is by pleasure is cut down for Buddhist nun's cyclodextrin inclusion compound, the preparation technology of lyophilization and dry granulation is employed simultaneously, largely overcome principal agent pleasure to cut down for Buddhist nun easily moisture absorption, stability extreme difference, the shortcoming that oral formulations cannot be prepared into, disintegrate is not affected simultaneously, nor affect on the dissolution of principal agent composition, and this product is not coated tablet, it is to avoid the slower shortcoming of conventional coated tablet dissolution.
Description
Technical field
The invention belongs to technical field of medicine, relate in particular to a kind of can be used for oral pleasure and cut down for Buddhist nun's pharmaceutical composition and preparation method thereof.
Background technology
Lenvatinib (E7080) is a kind of Mutiple Targets inhibitor, act on VEGFR2 (KDR)/VEGFR3 (Flt-4) most effective, it is slightly weak to VEGFR1/Flt-1 action effects, act on VEGFR2/3 to be compared to for FGFR1, high 10 times or so of PDGFR α/β selectivitys.E7080 effectively suppresses angiogenesis, also significantly inhibits VEGF/KDR and SCF/KIT signal paths.According to extracorporeal receptor L-Tyrosine and serine/threonine kinase assay, E7080 suppresses Flt-1, KDR, and Flt-4, and except these kinases, E7080 also suppresses FGFR1 and PDGFR tyrosine kinase.
U.S. FDA approval lenvatinib treatment aggressive, differentiated thyroid carcinoma (DTC) patient, it is adaptable to which after radioiodine therapy is received, disease still deteriorates（Radioiodine refractory disease）Patient.
Pleasure is cut down to have for Buddhist nun and draws moist, and the unstable chemcial property under humidification, heating condition is susceptible to decompose, and medical surfaces easily occur gelation, as moisture absorption causes the delayed situation of dissolution.
Physical and chemical stability and dissolubility for Buddhist nun are cut down in order to improve pleasure, the present inventor is by research with great concentration, substantial amounts of screening has been carried out to the prescription composition of preparation, using cyclodextrin inclusion compound and the united preparation technology of lyophilization, strictly control the temperature and humidity condition of each step preparation process, prepared with high stability, can oral pleasure cut down for nylon 6 combination preparation.The inventors discovered that pleasure is cut down for Buddhist nun due to its special chemical constitution; stable complex can be formed with cyclodextrin clathrate; this special structure considerably increases pleasure and cuts down dissolubility and physical and chemical stability for Buddhist nun; so as to enhance the stability of pharmaceutical preparation; from light; oxygen, heat and some factors impact and protected, make pharmaceutical efficacy and prolonged shelf life.As drug molecule is interacted with the hydroxyl on cyclodextrin, and increase the dissolubility and dissolution rate of medicine.Cover the bad stink of medicine and reduce zest, improve bioavailability.
The content of the invention
The purpose of the present invention is mainly cut down for Buddhist nun's piece and preparation method thereof there is provided a kind of stable pleasure, improve the unstability of such medicine by prescription and technique, make obtained tablet steady quality, while with higher dissolution, dissolved in gastric juice rapidly, quick acting.
For achieving the above object, present invention employs following technical scheme：
A kind of stable pleasure is cut down for Buddhist nun's pharmaceutical composition and preparation method thereof, it is characterised in that cut down for Buddhist nun's cyclodextrin clathrate containing the pleasure by weight percentage for 10%～30% in the pharmaceutical composition, wherein pleasure is cut down is calculated as 1 with ratio by mass part of cyclodextrin for Buddhist nun:3～6.
Wherein, cyclodextrin is selected from α-CD, β-CD, γ-CD, hydroxypropyl-α-CD, hydroxy propyl-Beta-CD, one or more in hydroxypropyl-γ-CD.
Binding agent in the pharmaceutical composition also containing percentage by weight 5%～30%, 5%～25% disintegrating agent, 20%～45% filler, 0.3～2% lubricant.
Preferably, cut down for Buddhist nun's cyclodextrin clathrate containing the pleasure of percentage by weight 10% in the pharmaceutical composition, 25% binding agent, 18% disintegrating agent, 45% filler, 2% lubricant, wherein it is 1 that pleasure cuts down the ratio for Buddhist nun and cyclodextrin:3.
Preferably, cut down for Buddhist nun's cyclodextrin clathrate containing the pleasure of percentage by weight 30% in the pharmaceutical composition, 20% binding agent, 10% disintegrating agent, 38% filler, 2% lubricant, wherein it is 1 that pleasure cuts down the ratio for Buddhist nun and cyclodextrin:5.
Wherein, binding agent is selected from one or more in hypromellose, sodium carboxymethyl cellulose, starch slurry；Disintegrating agent is selected from one or more in low-substituted hydroxypropyl cellulose, starch, polyvidone, Microcrystalline Cellulose, carboxymethyl starch sodium, polyvinylpolypyrrolidone；The one kind of lubricant in magnesium stearate, sodium stearyl fumarate, stearic acid, Pulvis Talci, micropowder silica gel.
Wherein, filler is Mannitol, Lactose, glucose, maltose, one or more the mixture in soluble dextrins.
Prepare pleasure and cut down the method for Buddhist nun's pharmaceutical composition, it is characterised in that comprise the steps：
A, each supplementary material is weighed by recipe quantity；
B, by cyclodextrin in purified water, be slowly added to pleasure according to prescription ratio and cut down for Buddhist nun's raw material, stirring is obtained uniform solution, and lyophilization is obtained lyophilizing mixture I；
C, lyophilizing mixture I is crushed or micronizing, cross 100 mesh sieves, binding agent, disintegrating agent, filler are added in prescription ratio, mixed more than 5 minutes, add the lubricant of recipe quantity half, mix more than 1 minute, obtain mixture II；
D, by mixture II put in dry granulating machine pelletize, by remaining lubricant add granule in, mix more than 1 minute, obtain mixture III, put in vacuum drier be dried；
E, dried mixture III is carried out into tabletting by powder vertical compression using tablet machine, put in vacuum drier and be dried；
F, obtained tablet is carried out aluminum-plastic packaged, then Aluminum-plastic composite bag is together wrapped into medicinal desiccant.
Wherein, cryodesiccated condition is：- 10 DEG C～-40 DEG C of pre-freezing temperature scope；The parameter of evacuation：Pressure is less than or equal to 100Pa, -10 DEG C～-30 DEG C of temperature range；Drying condition is：Pressure is 0-30 DEG C less than or equal to 100 Pa, temperature.
Further, cryodesiccated condition is：- 15 DEG C～-30 DEG C of pre-freezing temperature scope；The parameter of evacuation：Pressure is less than or equal to 80Pa, -10 DEG C～-20 DEG C of temperature range；Drying condition is：Pressure is 10-25 DEG C less than or equal to 80Pa, temperature.
Freeze Drying Technique is that the material containing large quantity of moisture is frozen into solid in advance, then appropriate heating makes vapor directly distil out from solid under vacuum, and material is stayed in ice shelf when freezing in itself, therefore dried small product size is almost unchanged.Whole drying is carried out at a lower temperature.Cryodesiccated advantage mainly has：Frozen drying is particularly suitable to many heat-sensitive substances, and such as protein, microorganism etc. will not occur degeneration or inactivation；During frozen drying, the loss of product volatile component is little；During frozen drying, can effectively suppress the growth of microorganism and the effect of enzyme；Frozen drying basic guarantee original structure of product, will not occur concentration phenomena；Dried product is loose porous in spongy, dissolves, can return to the original form rapidly after adding water；Oxygen is substantially free of during vacuum drying, therefore some oxidizable materials are protected；Frozen drying can exclude more than 95% moisture content, and dried product can be saved and not degenerate for a long time.
Specific embodiment
:
The specific embodiment of form, is described in further detail again to the above of the present invention by the following examples.But this should not be interpreted as above-mentioned subject area of the invention and be only limitted to below example.All technologies realized based on the above of the present invention belong to the scope of the present invention.
Embodiment 1：
Pleasure cut down for Buddhist nun's piece prescription composition pleasure cut down for Buddhist nun
10g
Hydroxypropyl-α-CD
30g
Starch slurry
50g
Polyvidone
36g
Lactose
90g
Pulvis Talci
4g
Make 1000
Specific preparation method：
A, recipe quantity hydroxypropyl-α-CD cyclodextrins are weighed in pure water, weigh recipe quantity pleasure to cut down in Buddhist nun's addition cyclodextrin, stir to solution clear, form pleasure to cut down for Buddhist nun's cyclodextrin clathrate, lyophilization, pre-freezing temperature is -40 DEG C, 85Pa, evacuation at -20 DEG C, 100 Pa, is dried prepared lyophilizing mixture I at 20 DEG C；
B, lyophilizing mixture I is crushed, cross 100 mesh sieves, starch slurry, polyvidone, Lactose are added in prescription ratio, mixed more than 5 minutes, add Pulvis Talci, mix more than 1 minute, obtain mixture II；
C, by mixture II put in dry granulating machine pelletize, by remaining Pulvis Talci add granule in, mix more than 1 minute, obtain mixture III, put in vacuum drier be dried；
D, dried mixture III is adopted into tabletting machine, put in vacuum drier and be dried；
E, obtained tablet is carried out aluminum-plastic packaged, then Aluminum-plastic composite bag is together wrapped into medicinal desiccant.
Further, cryodesiccated condition is：- 10 DEG C～-40 DEG C of pre-freezing temperature scope；The parameter of evacuation is less than or equal to 100Pa, -10 DEG C～-30 DEG C of temperature range；Drying condition be 0-30 DEG C, less than or equal to 100Pa.
Testing result：
（1）The tablet for according to said method preparing, hardness are 3.0kg；
（2）The tablet for according to said method preparing, its disintegration be 1 point 52 seconds；
（3）The tablet for according to said method preparing, its dissolution are 99%.
The detection method of disintegration：Checked according to the method under 2005 editions two annex XA inspection technique disintegration items of Chinese Pharmacopoeia.
The detection method of dissolution：This product is taken, according to dissolution method（2005 editions two the 3rd methods of annex XC of Chinese Pharmacopoeia）, with water 100ml as dissolution medium, rotating speed is 75 turns per minute, is operated in accordance with the law, during Jing 30 minutes, takes 100 μ l of solution injection liquid chromatograph sample introductions.Separately seeking pleasure, it is appropriate for Buddhist nun's reference substance to cut down, and the solution of 0.5 μ g/ml is made with dehydrated alcohol, and precision measures this solution 1ml and is placed in 10ml volumetric flasks, is diluted with water to scale and obtains final product reference substance solution, be measured in the same method, and calculates the stripping quantity per piece.Limit for labelled amount 80%.
Embodiment 2：
Pleasure is cut down for Buddhist nun
10g
Hydroxypropyl-γ-CD
50g
Hypromellose 40g
Carboxymethyl starch sodium 20g
Mannitol
76g
Magnesium stearate
4g
Specific preparation method：
A, recipe quantity hydroxypropyl-γ-CD cyclodextrins are weighed in pure water, weigh recipe quantity pleasure to cut down in Buddhist nun's addition cyclodextrin, stir to solution clear, form pleasure to cut down for Buddhist nun's cyclodextrin clathrate, lyophilization, pre-freezing temperature is -30 DEG C, 75 Pa, evacuation at -20 DEG C, 90 Pa, is dried prepared lyophilizing mixture I at 20 DEG C；
B, lyophilizing mixture I is crushed, cross 100 mesh sieves, hydroxypropyl cellulose, Mannitol, carboxymethyl starch sodium are added in prescription ratio, mixed more than 5 minutes, add magnesium stearate, mix more than 1 minute, obtain mixture II；
D, by mixture II put in dry granulating machine pelletize, by remaining magnesium stearate add granule in, mix more than 1 minute, obtain mixture III, put in vacuum drier be dried；
E, dried mixture III is adopted into tabletting machine, put in vacuum drier and be dried；
F, obtained tablet is carried out aluminum-plastic packaged, then Aluminum-plastic composite bag is together wrapped into medicinal desiccant.
Testing result：
（1）The tablet for according to said method preparing, hardness are 3.5kg；
（2）The tablet for according to said method preparing, its disintegration be 1 point 13 seconds；
（3）The tablet for according to said method preparing, its dissolution are 105%.
Comparative example 1：
Pleasure cuts down the prescription composition for Buddhist nun's piece
Pleasure is cut down for Buddhist nun
10g
Hydroxypropyl-α-CD
20g
Starch slurry
50g
Polyvidone
36g
Lactose
90g
Pulvis Talci
4g
Make 1000
Specific preparation method：
A, weigh recipe quantity Hydroxyproply-α-cyclodextrin and be dissolved in pure water, weigh recipe quantity pleasure to cut down in Buddhist nun's addition cyclodextrin solution, stir to solution clear, form pleasure to cut down for Buddhist nun's cyclodextrin clathrate, lyophilization, pre-freezing temperature is -30 DEG C, 75 Pa, evacuation at -20 DEG C, 90 Pa, is dried prepared lyophilizing mixture I at 20 DEG C；
B, lyophilizing mixture I is crushed, cross 100 mesh sieves, starch slurry, polyvidone, Lactose are added in prescription ratio, mixed more than 5 minutes, add magnesium stearate, mix more than 1 minute, obtain mixture II；
D, by mixture II put in dry granulating machine pelletize, by remaining magnesium stearate add granule in, mix more than 1 minute, obtain mixture III, put in vacuum drier be dried；
E, dried mixture III is adopted into tabletting machine, put in vacuum drier and be dried；
F, obtained tablet is carried out aluminum-plastic packaged, then Aluminum-plastic composite bag is together wrapped into medicinal desiccant.
Testing result：
（1）The tablet for according to said method preparing, hardness are 3.6kg；
（2）The tablet for according to said method preparing, its disintegration be 3 points 54 seconds；
（3）The tablet for according to said method preparing, its dissolution are 92%.
As can be seen here, when pleasure is cut down for Buddhist nun with cyclodextrin weight part ratio not 1:In 3～6, the disintegrating property and dissolution of obtained pharmaceutical composition is all not as good as the pharmaceutical composition of the present invention.
Comparative example 2：
Pleasure cuts down the prescription composition for Buddhist nun's piece
Pleasure is cut down for Buddhist nun
10g
Starch slurry
50g
Polyvidone
36g
Lactose
90g
Pulvis Talci
4g
Make 1000
Step of preparation process is as follows：
1) pleasure is cut down for 50-70 DEG C of drying of Buddhist nun and other adjuvants to moisture ＜ 3.0%, crosses 100 mesh sieves standby.
2) weigh happy cutting down by recipe quantity to put in Quick-stirring granulator after mix homogeneously for Buddhist nun, diluent, disintegrating agent, with 2% hydroxypropyl methyl cellulose aqueous solution soft material, the granulation of 24 mesh sieves.
3) wet granular puts 50-70 DEG C of drying in drying baker, and 20 mesh sieve granulate obtain dry particl, adds lubricant always to be mixed, gained granule is carried out tabletting and obtains tablet.
Test example 1：Pleasure cut down for Buddhist nun's cyclodextrin clathrate prepare tablet about material (total impurities) investigation
Influence factor tests
In Example 1-2 and comparative example 1, pleasure is cut down for Buddhist nun's tablet, put illumination (4500LX ± 500LX), high temperature (60 DEG C) respectively, place under the conditions of high humidity (92.5%), respectively at the 5th day, the relevant material result of sampling detection in 10 days it is as shown in table 2：1. embodiment 1-2 of table material (%) relevant with 1 influence factor's testing inspection of comparative example
During pleasure is cut down for Buddhist nun's piece influence factor test, the character and content of tablet are not changed substantially, and the pleasure that can be seen that the present invention by the result of the test of table 1 is cut down and is far below comparative example for the relevant material of Buddhist nun's piece.Illustrate that the tablet prepared by the present invention can improve the stability of medicine, extend the storage life of preparation.
Claims (8)
1. a kind of stable pleasure is cut down for Buddhist nun's pharmaceutical composition and preparation method thereof, it is characterised in that cut down for Buddhist nun's cyclodextrin clathrate containing the pleasure by weight percentage for 10%～30% in the pharmaceutical composition, wherein pleasure is cut down is calculated as 1 with ratio by mass part of cyclodextrin for Buddhist nun:3～6.
2. a kind of stable pleasure according to claim 1 is cut down for Buddhist nun's pharmaceutical composition and preparation method thereof, it is characterised in that the cyclodextrin that described pleasure is cut down in the cyclodextrin clathrate for Buddhist nun is selected from the combination of one or more in α-CD, β-CD, γ-CD, hydroxypropyl-α-CD, hydroxy propyl-Beta-CD, hydroxypropyl-γ-CD.
3. a kind of stable pleasure according to claim 1 and 2 is cut down for Buddhist nun's pharmaceutical composition and preparation method thereof, it is characterized in that the binding agent in the pharmaceutical composition also containing percentage by weight 5%～30%, 5%～25% disintegrating agent, 20%～45% filler, 0.3～2% lubricant.
4. a kind of stable pleasure according to Claims 1-4 is cut down for Buddhist nun's pharmaceutical composition and preparation method thereof, it is characterised in that described binding agent is selected from one or more in hypromellose, sodium carboxymethyl cellulose, starch slurry；Described disintegrating agent is selected from one or more in low-substituted hydroxypropyl cellulose, starch, polyvidone, Microcrystalline Cellulose, carboxymethyl starch sodium, polyvinylpolypyrrolidone；The one kind of described lubricant in magnesium stearate, sodium stearyl fumarate, stearic acid, Pulvis Talci, micropowder silica gel.
5. a kind of stable pleasure according to claim 1 to 5 is cut down for Buddhist nun's pharmaceutical composition and preparation method thereof, it is characterised in that described filler is Mannitol, Lactose, glucose, maltose, one or more the mixture in soluble dextrins.
6. a kind of pleasure for preparing as claimed in claim 1 cuts down the method for Buddhist nun's pharmaceutical composition, it is characterised in that comprise the steps：A, each supplementary material is weighed by recipe quantity；B, by cyclodextrin in purified water, be slowly added to pleasure according to prescription ratio and cut down for Buddhist nun's raw material, stirring is obtained uniform solution, and lyophilization is obtained lyophilizing mixture I；C, lyophilizing mixture I is crushed or micronizing, cross 100 mesh sieves, binding agent, disintegrating agent, filler are added in prescription ratio, mixed more than 5 minutes, add the lubricant of recipe quantity half, mix more than 1 minute, obtain mixture II；D, by mixture II put in dry granulating machine pelletize, by remaining lubricant add granule in, mix more than 1 minute, obtain mixture III, put in vacuum drier be dried；E, dried mixture III is carried out into tabletting by powder vertical compression using tablet machine, put in vacuum drier and be dried；
F, obtained tablet is carried out aluminum-plastic packaged, then Aluminum-plastic composite bag is together wrapped into medicinal desiccant.
7. a kind of pleasure for preparing according to claim 7 cuts down preparation method for Buddhist nun's pharmaceutical composition, it is characterised in that cryodesiccated condition is：- 10 DEG C～-30 DEG C of pre-freezing temperature scope；The parameter of evacuation：Pressure is less than or equal to 100Pa, -10 DEG C～-30 DEG C of temperature range；Drying condition is：Pressure is 0-30 DEG C less than or equal to 100Pa, temperature.
8. a kind of pleasure for preparing according to claim 8 cuts down preparation method for Buddhist nun's tablet medicament composition, it is characterised in that cryodesiccated condition is：- 15 DEG C～-20 DEG C of pre-freezing temperature scope；The parameter of evacuation：Pressure is less than or equal to 80Pa, -10 DEG C～-20 DEG C of temperature range；Drying condition is：Pressure is 10-25 DEG C less than or equal to 80Pa, temperature.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2018151177A1 (en) * | 2017-02-15 | 2018-08-23 | 大鵬薬品工業株式会社 | Pharmaceutical composition |
| CN110693839A (en) * | 2019-11-19 | 2020-01-17 | 乐普药业股份有限公司 | Solid dispersion of varlitinib mesylate and preparation method and application thereof |
| EP3620453A1 (en) * | 2018-09-07 | 2020-03-11 | Indena S.p.A. | New crystal form of lenvatinib |
| CN112190583A (en) * | 2019-07-08 | 2021-01-08 | 成都苑东生物制药股份有限公司 | Levatinib pharmaceutical composition and preparation method thereof |
-
2015
- 2015-09-21 CN CN201510601301.4A patent/CN106551911A/en active Pending
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2018151177A1 (en) * | 2017-02-15 | 2018-08-23 | 大鵬薬品工業株式会社 | Pharmaceutical composition |
| US11110062B2 (en) | 2017-02-15 | 2021-09-07 | Taiho Pharmaceutical Co., Ltd. | Pharmaceutical composition |
| EP3620453A1 (en) * | 2018-09-07 | 2020-03-11 | Indena S.p.A. | New crystal form of lenvatinib |
| WO2020048968A1 (en) * | 2018-09-07 | 2020-03-12 | Indena S.P.A. | New crystal form of lenvatinib |
| CN112190583A (en) * | 2019-07-08 | 2021-01-08 | 成都苑东生物制药股份有限公司 | Levatinib pharmaceutical composition and preparation method thereof |
| CN110693839A (en) * | 2019-11-19 | 2020-01-17 | 乐普药业股份有限公司 | Solid dispersion of varlitinib mesylate and preparation method and application thereof |
| CN110693839B (en) * | 2019-11-19 | 2022-03-08 | 乐普药业股份有限公司 | Solid dispersion of varlitinib mesylate and preparation method and application thereof |
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Application publication date: 20170405 |