CN104546780A - Daclatasvir film coating tablet preparation and preparation method thereof - Google Patents
Daclatasvir film coating tablet preparation and preparation method thereof Download PDFInfo
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- CN104546780A CN104546780A CN201410760947.2A CN201410760947A CN104546780A CN 104546780 A CN104546780 A CN 104546780A CN 201410760947 A CN201410760947 A CN 201410760947A CN 104546780 A CN104546780 A CN 104546780A
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- dacca
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Abstract
The invention discloses a daclatasvir film coating tablet preparation. The preparation is prepared from the following active ingredients in percentage by mass: 12.0-20.0 percent of daclatasvir, 2.0-8.0 percent of a disintegrating agent, 50.0-80.0 percent of a diluting agent and 0.5-1.5 percent of a lubricating agent, wherein the disintegrating agent is one or more of croscarmellose sodium, hydroxypropyl methylcellulose and sodium carboxymethyl starch, one or two of sodium carboxymethylcellulose and hydroxypropyl methylcellulose as first choice, and preferably sodium carboxymethylcellulose; the diluting agent is one or more of microcrystalline cellulose, lactose anhydrous, mannitol and polyethylene glycol, one or two of microcrystalline cellulose and mannitol as first choice, and preferably microcrystalline cellulose; and the lubricating agent is one or more of magnesium stearate, talcum powder, aerosil and calcium stearate, one or two of magnesium stearate and aerosil, and preferably magnesium stearate. The daclatasvir film coating tablet preparation has the advantages of simple process, high yield, good stability and the like, and is easy for large-scale industrial production.
Description
Technical field
The invention discloses his Wei film coating tablet preparation of a kind of Dacca and preparation method thereof, be applied to the preparation field of the treatment preparation of hepatitis C.
Background technology
Hepatitis C, referred to as hepatitis C or hepatitis C, is that one infects by hepatitis C virus (Hepatitis C Virus, HCV) viral hepatitis caused, mainly calculates approach through blood transfusion or injection etc. and propagate.
His Wei film coating tablet preparation (Daclatasvir) of Dacca, its trade name Aklinza
?, for Bristol-Myers Squibb Co. of the U.S. is original, be a class anti-hepatitis C ucleosides NS5A AG14361.Data shows, his Wei of his Wei Lianhe Dacca, Dacca in hepatitis C treatment, cure rate reaches 100%, in Asia, population infection gene: II type (Simmonds 1b) hepatitis C virus is maximum, and this type hepatitis C virus is a kind of virus form lower to old medicine responsiveness, and his Wei of Dacca has significant curative effect on this type viral therapy, in April, 2013, FDA has authorized its noiseless plain hepatitis C medicine " breakthrough medicine " qualification.
His Wei film coating tablet preparation of Dacca is applicable to the patient infecting genotype 1 b (Asia HCV infection person is mainly 1b type) HCV virus, these product are especially applicable to those not withstand disturbance elements (flu-like symptom that can cause sufferings), or once to the patient of old medicine invalid (is difficult to the patients treated especially).
In NS5A inhibitor daclatasvir (BMS-790052) administration 6 hours, in serum, HCV rna level is about fall and reaches two orders of magnitude, but, NS5A does not have known enzyme function, make be difficult to understand the action model (MOA) of Daclatasvir and estimate its antiviral efficacy, dynamics of virus model let us action model (MOA) to virus during HCV therapy has had important understanding and has understood the effectiveness of multiple anti-HCV medicament, the life cycle effect multiple dimensioned model prediction of bound drug in HCV cell, Daclatasvir can the life cycle of blocking virus effectively, can the synthesis of blocking virus RNA and the assembling/secretion of virion 99% and 99.8%, in more accurate data display serum, the HCV half-life is than short about 4 times that estimate before, it is 45 minutes.
U.S.'s Bristol Myers Squibb have submitted the application for quotation of its complete oral hepatitis C test medicine November to Japanese Health Administration mechanism, pharmaceutical manufacturer submits the application for quotation not comprising the Remedies for hepatitis C thing of two kinds of old medicines of standard to first time to submit to application for quotation to indicate to Japanese Drug and BMD specifically, and old medicated bag draws together injectable interferon or ribavirin pill.Ribavirin is not had in this drug regimen, thus the disagreeable side effect of ribavirin is avoided, it is the potential threat of lucky moral, there is thousands of hepatitis C patients to postpone treatment according to statistics and wait for that expectation will start the new drug of listing next year, to avoid tedious interferon side effect, doctor also likes the therapeutic scheme not needing ribavirin, and ribavirin can cause anemia, erythra and other side effect.
With high costs compared to traditional remedies HCV therapy, process is complicated, cure rate is low and side effect is large, new AG14361 have selectivity good, can oral, the advantage such as side effect is little, and SVR24 is better, the complicated process of preparation of his Wei of existing Dacca, cost compare is high, because we have huge breakthrough in the preparation technology of his Wei of Dacca, greatly reduce its production cost, thus great majority are lived in the patient of under-developed area, in the near future, just HCV can be cured completely with lower expense.
The domestic research about his Wei film coating tablet preparation of Dacca is at present still blank.
Summary of the invention
For solving the defect of prior art, the invention discloses that a kind of technique is simple, yield is high, good stability, his the Wei film coating tablet preparation of Dacca being applicable to the large production of industrial mass and preparation method thereof.
The invention discloses his Wei film coating tablet preparation of a kind of Dacca, by mass percentage, be made up of following active component: his Wei 12.0-20.0% of Dacca, disintegrating agent 2.0-8.0%, diluent 50.0-80.0%, lubricant 0.5-1.5%, described disintegrating agent adopts cross-linking sodium carboxymethyl cellulose, hypromellose, one or more in carboxymethyl starch sodium, first-selected sodium carboxymethyl cellulose, one or both in hypromellose, preferably carboxymethyl cellulose sodium, described diluent adopts microcrystalline Cellulose, Lactis Anhydrous, mannitol, one or more in Polyethylene Glycol, first-selected microcrystalline Cellulose, one or both in mannitol, preferably microcrystalline cellulose, described lubricant adopt in magnesium stearate, Pulvis Talci, micropowder silica gel, calcium stearate one or more, one or both in first-selected magnesium stearate, micropowder silica gel, preferred magnesium stearate.
The invention discloses the preparation method of his Wei film coating tablet preparation of a kind of Dacca, its preparation technology is as follows:
(1), material pretreatment: his Wei of Dacca, disintegrating agent, diluent, lubricant are sieved for subsequent use;
(2), mix: take his Wei of active medicine Dacca of recipe quantity and disintegrating agent, diluent, mix lubricant are even;
(3), the powder mixed in (2) is positioned over dry granulating machine to granulate;
(4), always mix: by even to the disintegrating agent of dry granule obtained by (3) and recipe quantity, mix lubricant;
(5), plain sheet is suppressed: placed in high speed rotary tablet press by granule obtained in (4) and suppress;
(6), film coating: carry out film coating by qualified obtained in (5), to obtain final product.
The object of this invention is to provide his Wei film coating tablet preparation of a kind of Dacca, blood drug level is stablized, and medicining times once a day, because this medicine is without the need to drug combination, improves the convenience of patient medication.
His Wei film coating tablet preparation of Dacca of the present invention and preparation method thereof has investigated the impact on medicine disintegration and stripping thereof of one or more materials in disintegrating agent (cross-linking sodium carboxymethyl cellulose, hypromellose, carboxymethyl starch sodium) and diluent (microcrystalline Cellulose, Lactis Anhydrous, mannitol, Polyethylene Glycol) and consumption thereof, experimental result shows: when disintegrating agent consumption is less than 2.0%, tablet is difficult to disintegrate, and then affects the release of effective ingredient.
Suitable disintegrating agent in this drug component is a kind of cellulose family, and in one embodiment, this disintegrating agent is hypromellose, in another embodiment, this disintegrating agent is cross-linking sodium carboxymethyl cellulose, and its amount ranges is the 2.0-8.0% of recipe quantity, preferred 4.0-6.0%.By his Wei film coating tablet preparation of homemade Dacca and commercially available Dacca, he contrasts by Wei film coating tablet preparation, experimental result shows: his Wei film coating of tablets sheet 1h stripping drug level of Dacca is 60.0-80.0%, 2h reaches 80.0-90.0%, and stripping result is with former to grind medicine dissolved corrosion more similar.
His Wei film coating tablet preparation of Dacca of the present invention and preparation method thereof has investigated the impact of variable grain particle diameter on the plain sheet of compacting, particle diameter is the granule of 0.150-0.180mm, its good fluidity, but because particle diameter is excessive, made tablet in animal body result of extraction is bad, affect medicine absorption in vivo, cause drug effect poor; And the granule of particle diameter 0.0630-0.0750mm, its compressibility is strong, uniform filling and in animal body drug-eluting satisfactory for result, drug effect is remarkable.
His Wei film coating tablet preparation of Dacca of the present invention and preparation method thereof, can end finger number=(tapped density-bulk density) × 100% to pressing exponential sum Hausner comparative measurements; Hausner compare=decides density/bulk density, and experimental result shows: can end finger number be 8.0%, and within the scope of 6.0-10.0%, Hausner ratio is that 1.05 compressibility are better.
His Wei Su thin membrane coated tablet of a kind of Dacca of his Wei film coating tablet preparation of Dacca of the present invention and preparation method thereof compacting, its figure of tablet is regular pentagon, its internal diameter d=10mm, smooth in appearance is bright, this plain sheet is through film coating, and displaing yellow, homogeneity is good.
His Wei film coating tablet preparation of Dacca of the present invention and preparation method thereof obtains thin membrane coated tablet, after patient is oral, medicine is uniformly dispersed at gastrointestinal tract, impact by gastric emptying rate is less, so that the individual variation produced is relatively little, drug-eluting behavior can not be affected simultaneously, make drug substance stable stripping, reach best therapeutic effect.
His Wei film coating tablet preparation of a kind of Dacca prepared by the present invention, quality standard and former to grind medicine about the same, technique is simple, has filled up the domestic blank without this kind of preparation, has broken import preparation to domestic price fixing.
accompanying drawing illustrates:
Fig. 1 is his Wei film coating tablet preparation (embodiment 1) stripping curve figure of Dacca;
Fig. 2 is his Wei film coating tablet preparation (embodiment 2) stripping curve figure of Dacca;
Fig. 3 is his Wei film coating tablet preparation (embodiment 3) stripping curve figure of Dacca;
Fig. 4 is his Wei film coating tablet preparation (embodiment 4) stripping curve figure of Dacca;
Fig. 5 is his Wei film coating tablet preparation (embodiment 5) stripping curve figure of Dacca;
Fig. 6 is his Wei film coating tablet preparation (embodiment 6) stripping curve figure of Dacca.
Detailed description of the invention
The invention discloses his Wei film coating tablet preparation of a kind of Dacca, by mass percentage, be made up of following active component: his Wei 12.0-20.0% of Dacca, disintegrating agent 2.0-8.0%, diluent 50.0-80.0%, lubricant 0.5-1.5%, described disintegrating agent adopts cross-linking sodium carboxymethyl cellulose, hypromellose, one or more in carboxymethyl starch sodium, first-selected sodium carboxymethyl cellulose, one or both in hypromellose, preferably carboxymethyl cellulose sodium, described diluent adopts microcrystalline Cellulose, Lactis Anhydrous, mannitol, one or more in Polyethylene Glycol, first-selected microcrystalline Cellulose, one or both in mannitol, preferably microcrystalline cellulose, described lubricant adopt in magnesium stearate, Pulvis Talci, micropowder silica gel, calcium stearate one or more, one or both in first-selected magnesium stearate, micropowder silica gel, preferred magnesium stearate.
The invention discloses the preparation method of his Wei film coating tablet preparation of a kind of Dacca, its preparation technology is as follows:
(1), material pretreatment: his Wei of Dacca, disintegrating agent, diluent, lubricant are sieved for subsequent use;
(2), mix: take his Wei of active medicine Dacca of recipe quantity and disintegrating agent, diluent, mix lubricant are even;
(3), the powder mixed in (2) is positioned over dry granulating machine to granulate;
(4), always mix: by even to the disintegrating agent of dry granule obtained by (3) and recipe quantity, mix lubricant;
(5), plain sheet is suppressed: placed in high speed rotary tablet press by granule obtained in (4) and suppress;
(6), film coating: carry out film coating by qualified obtained in (5), to obtain final product.
In the present invention, his Wei film coating tablet preparation dissolution method of described Dacca is for medium with hydrochloric acid and SDS buffer, adopt certain rotating speed, under temperature is 37.0 DEG C of conditions, through SDS medium stripping 0,30,45,60,120 min, the filtrate of getting each time point is respectively detected, and detection method detects according to containing the detection method under quantifier.
Below in conjunction with embodiment, embodiment of the present invention are described in detail, described embodiment is only for illustration of the present invention, should not be considered as limiting scope of the present invention, unreceipted actual conditions person in embodiment, conveniently condition is carried out, agents useful for same or instrument unreceipted production business men person, be conventional products, commercially available and obtain.
embodiment 1
Prescription:
Composition recipe quantity (mg/ sheet)
His Wei 60 of Dacca
Cross-linking sodium carboxymethyl cellulose 21
Microcrystalline Cellulose 273
Magnesium stearate 3
According to above-mentioned recipe quantity, preparation technology is as follows:
(1), material pretreatment: by his Wei, cross-linking sodium carboxymethyl cellulose, microcrystalline Cellulose, Magnesium Stearate of Dacca, for subsequent use;
(2), mix: his Wei and cross-linking sodium carboxymethyl cellulose, microcrystalline Cellulose, the magnesium stearate mix homogeneously of active medicine Dacca taking recipe quantity;
(3), the powder mixed in (2) is positioned over dry granulating machine to granulate;
(4), always mix: the cross-linking sodium carboxymethyl cellulose of dry granule obtained by (3) and recipe quantity, magnesium stearate are mixed homogeneously;
(5), plain sheet is suppressed: placed in high speed rotary tablet press by granule obtained in (4) and suppress;
(6), film coating: carry out film coating by qualified obtained in (5), to obtain final product.
embodiment 2
Prescription:
Composition recipe quantity (mg/ sheet)
His Wei 60 of Dacca
Hypromellose 21
Microcrystalline Cellulose 270
Magnesium stearate 6
According to above-mentioned recipe quantity, preparation technology is as follows:
(1), material pretreatment: by his Wei, hypromellose, microcrystalline Cellulose, Magnesium Stearate of Dacca, for subsequent use;
(2), mix: his Wei and hypromellose, microcrystalline Cellulose, the magnesium stearate mix homogeneously of active medicine Dacca taking recipe quantity;
(3), the powder mixed in (2) is positioned over dry granulating machine to granulate;
(4), always mix: the hypromellose of dry granule obtained by (3) and recipe quantity, magnesium stearate are mixed homogeneously;
(5), plain sheet is suppressed: placed in high speed rotary tablet press by granule obtained in (4) and suppress;
(6), film coating: carry out film coating by qualified obtained in (5), to obtain final product.
embodiment 3
Prescription:
Composition recipe quantity (mg/ sheet)
His Wei 60 of Dacca
Cross-linking sodium carboxymethyl cellulose 21
Lactis Anhydrous 270
Magnesium stearate 6
According to above-mentioned recipe quantity, preparation technology is as follows:
(1), material pretreatment: by his Wei, cross-linking sodium carboxymethyl cellulose, Lactis Anhydrous, Magnesium Stearate of Dacca, for subsequent use;
(2), mix: his Wei and cross-linking sodium carboxymethyl cellulose, Lactis Anhydrous, the magnesium stearate mix homogeneously of active medicine Dacca taking recipe quantity;
(3), the powder mixed in (2) is positioned over dry granulating machine to granulate;
(4), always mix: the cross-linking sodium carboxymethyl cellulose of dry granule obtained by (3) and recipe quantity, magnesium stearate are mixed homogeneously;
(5), plain sheet is suppressed: placed in high speed rotary tablet press by granule obtained in (4) and suppress;
(6), film coating: carry out film coating by qualified obtained in (5), to obtain final product.
embodiment 4
Prescription:
Composition recipe quantity (mg/ sheet)
His Wei 60 of Dacca
Cross-linking sodium carboxymethyl cellulose 21
Microcrystalline Cellulose 135
Lactis Anhydrous 135
Magnesium stearate 6
According to above-mentioned recipe quantity, preparation technology is as follows:
(1), material pretreatment: by his Wei, cross-linking sodium carboxymethyl cellulose, microcrystalline Cellulose, Lactis Anhydrous, Magnesium Stearate of Dacca, for subsequent use;
(2), mix: his Wei and cross-linking sodium carboxymethyl cellulose, microcrystalline Cellulose, Lactis Anhydrous, the magnesium stearate mix homogeneously of active medicine Dacca taking recipe quantity;
(3), the powder mixed in (2) is positioned over dry granulating machine to granulate;
(4), always mix: the cross-linking sodium carboxymethyl cellulose of dry granule obtained by (3) and recipe quantity, magnesium stearate are mixed homogeneously;
(5), plain sheet is suppressed: placed in high speed rotary tablet press by granule obtained in (4) and suppress;
(6), film coating: carry out film coating by qualified obtained in (5), to obtain final product.
embodiment 5
Prescription:
Composition recipe quantity (mg/ sheet)
His Wei 60 of Dacca
Cross-linking sodium carboxymethyl cellulose 21
Microcrystalline Cellulose 135
Lactis Anhydrous 135
Micropowder silica gel 6
According to above-mentioned recipe quantity, preparation technology is as follows:
(1), material pretreatment: his Wei of Dacca, cross-linking sodium carboxymethyl cellulose, microcrystalline Cellulose, Lactis Anhydrous, micropowder silica gel are sieved for subsequent use;
(2), mix: his Wei and cross-linking sodium carboxymethyl cellulose, microcrystalline Cellulose, Lactis Anhydrous, the micropowder silica gel mix homogeneously of active medicine Dacca taking recipe quantity;
(3), the powder mixed in (2) is positioned over dry granulating machine to granulate;
(4), always mix: the cross-linking sodium carboxymethyl cellulose of dry granule obtained by (3) and recipe quantity, micropowder silica gel are mixed homogeneously;
(5), plain sheet is suppressed: placed in high speed rotary tablet press by granule obtained in (4) and suppress;
(6), film coating: carry out film coating by qualified obtained in (5), to obtain final product.
embodiment 6
Prescription:
Composition recipe quantity (mg/ sheet)
His Wei 60 of Dacca
Cross-linking sodium carboxymethyl cellulose 21
Microcrystalline Cellulose 135
Lactis Anhydrous 135
Magnesium stearate 3
Micropowder silica gel 3
According to above-mentioned recipe quantity, preparation technology is as follows:
(1), material pretreatment: his Wei of Dacca, cross-linking sodium carboxymethyl cellulose, microcrystalline Cellulose, Lactis Anhydrous, magnesium stearate, micropowder silica gel are sieved for subsequent use;
(2), mix: his Wei and cross-linking sodium carboxymethyl cellulose, microcrystalline Cellulose, Lactis Anhydrous, magnesium stearate, the micropowder silica gel mix homogeneously of active medicine Dacca taking recipe quantity;
(3), the powder mixed in (2) is positioned over dry granulating machine to granulate;
(4), always mix: the cross-linking sodium carboxymethyl cellulose of dry granule obtained by (3) and recipe quantity, magnesium stearate, micropowder silica gel are mixed homogeneously;
(5), plain sheet is suppressed: placed in high speed rotary tablet press by granule obtained in (4) and suppress;
(6), film coating: carry out film coating by qualified obtained in (5), to obtain final product.
His Wei film coating tablet preparation of the Dacca that (embodiment 6) is prepared by the present invention and the U.S. of Yuan Yanyao company Bristol Myers Squibb produce thin membrane coated tablet carries out disintegration, stripping is tested: under 37 DEG C of conditions, through SDS medium stripping 0 relatively, 30,45, the stripping of 60,120 min he.
His Wei film coating tablet preparation of table 1 Dacca and formerly grind medicine Aklinza
?dissolution study
Table 1
embodiment 7
His Wei thin membrane coated tablet preparation stability of Dacca is investigated
In order to evaluate the stability of his Wei film coating tablet preparation of the Dacca described in the present invention further, with reference to Chinese Pharmacopoeia (2012 editions) two annex XIXC crude drug and pharmaceutical preparation stability test guideline, place 6 months under temperature 40 ± 2 DEG C, relative humidity are the condition of 75% ± 5, in the 1st, 2,3,6 the end of month is respectively to his Wei film coating tablet preparation (prepared by embodiment 5) of Dacca with formerly grind medicine Aklinza
?carry out character, content, related substance and release to detect.
Character checks
Check sample with visual method, result is as shown in table 2 below, and result shows: the Dacca prepared by the present invention he do not change in stability assessment phase character by Wei film coating tablet preparation.
The detection of content and related substance
In the present invention, the detection method of his Wei thin membrane coated tablet formulation content of described Dacca and related substance is with octyl silicon bonded silica gel for filler, and mobile phase is acetonitrile, methanol, phosphate buffer, flow velocity is 1.0mL/min, determined wavelength is 219nm, carries out detecting (the results are shown in Table 2).Result shows: the stability of his its content of Wei film coating tablet preparation of the Dacca prepared by the present invention and related substance meets the regulation in ICH Q3B.
The detection of dissolution
Carry out dissolution detection to this routine sample, result shows: the Dacca prepared by the present invention he have good stability by Wei film coating tablet preparation dissolution.
Table 2
Claims (4)
1. his Wei film coating tablet preparation of a Dacca, by mass percentage, it is characterized in that: be made up of following active component: his Wei 12.0-20.0% of Dacca, disintegrating agent 2.0-8.0%, diluent 50.0-80.0%, lubricant 0.5-1.5%, described disintegrating agent adopts cross-linking sodium carboxymethyl cellulose, hypromellose, one or more in carboxymethyl starch sodium, first-selected sodium carboxymethyl cellulose, one or both in hypromellose, preferably carboxymethyl cellulose sodium, described diluent adopts microcrystalline Cellulose, Lactis Anhydrous, mannitol, one or more in Polyethylene Glycol, first-selected microcrystalline Cellulose, one or both in mannitol, preferably microcrystalline cellulose, described lubricant adopt in magnesium stearate, Pulvis Talci, micropowder silica gel, calcium stearate one or more, one or both in first-selected magnesium stearate, micropowder silica gel, preferred magnesium stearate.
2. his Wei film coating tablet preparation of a kind of Dacca according to claim 1, is characterized in that: its preparation technology is as follows:
(1), material pretreatment: his Wei of Dacca, disintegrating agent, diluent, lubricant are sieved for subsequent use;
(2), mix: take his Wei of active medicine Dacca of recipe quantity and disintegrating agent, diluent, mix lubricant are even;
(3), the powder mixed in (2) is positioned over dry granulating machine to granulate;
(4), always mix: by even to the disintegrating agent of dry granule obtained by (3) and recipe quantity, mix lubricant;
(5), plain sheet is suppressed: placed in high speed rotary tablet press by granule obtained in (4) and suppress;
(6), film coating: carry out film coating by qualified obtained in (5), to obtain final product.
3. his Wei film coating tablet preparation of a kind of Dacca obtained by claim 1 or 2, it is characterized in that: figure of tablet is regular pentagon, its internal diameter d=10mm, smooth in appearance is bright, this plain sheet through film coating, displaing yellow.
4. his Wei film coating tablet preparation of a kind of Dacca obtained by claim 1 or 2, is characterized in that: once a day, this medicine is without the need to drug combination for medicining times.
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|---|---|---|---|
| CN201410760947.2A CN104546780A (en) | 2014-12-12 | 2014-12-12 | Daclatasvir film coating tablet preparation and preparation method thereof |
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Cited By (1)
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| CN110037991A (en) * | 2019-04-12 | 2019-07-23 | 杭州华东医药集团新药研究院有限公司 | Stable China advanced in years is for Buddhist nun's pharmaceutical composition and preparation method thereof |
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| CN110037991A (en) * | 2019-04-12 | 2019-07-23 | 杭州华东医药集团新药研究院有限公司 | Stable China advanced in years is for Buddhist nun's pharmaceutical composition and preparation method thereof |
| WO2020207441A1 (en) * | 2019-04-12 | 2020-10-15 | 杭州华东医药集团新药研究院有限公司 | Stable mefatinib pharmaceutical composition and preparation method therefor |
| CN110037991B (en) * | 2019-04-12 | 2021-07-27 | 杭州华东医药集团新药研究院有限公司 | Stable maihuatinib pharmaceutical composition and preparation method thereof |
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