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A kind of pharmaceutical composition and preparation method thereof

A technology for medicinal salts and solid preparations, applied in the field of pharmaceutical preparations, can solve the problems of poor prognosis and low survival rate of B-cell lymphoma

Active Publication Date: 2021-09-03
JIANGSU HENGRUI MEDICINE CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

B-cell lymphomas have a poor prognosis and survival remains low with current treatment options

Method used

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  • A kind of pharmaceutical composition and preparation method thereof
  • A kind of pharmaceutical composition and preparation method thereof
  • A kind of pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] Example 1: Solid dispersion

[0058]The (R) -4- amino-1- (1- (but-2-ynyl group) pyrrolidin-3-yl) -3- (4- (2,6-difluorophenoxy) phenyl) - 1,6-dihydro -7H- pyrrolo [2,3-d] pyridazin-7-one (referred to as compound a) and different types of support materials for preparing solid dispersions, particular formulation as shown in table 1:

[0059] Table 1

[0060]

[0061] Preparation method (a coprecipitation method):

[0062] According to the formula of compound A and the amount of said carrier material, and completely dissolved in N, N- dimethylacetamide (DMF) in accordance with N, N- dimethylacetamide with purified water 1:15 (g / ratio g), the weighed prescribed amount of purified water, the solvent containing the compound a and the support material was added dropwise to the water flow rate of 30g / min, the precipitated white flocculent precipitate was filtered, washed, and dried to obtain.

[0063] Dissolution experiments

[0064] Determination Method II (paddle) according ...

Embodiment 2

[0073] Compound A and hypromellose acetate succinate weight ratio of 1 to prepare a solid dispersion, and the resulting solid dispersion was ground to achieve a particle size suitable for requirements, in accordance with the formulation design weighed amount of a formulation solid dispersion, microcrystalline cellulose and lactose, were added and crosslinked sodium carboxymethylcellulose, crosslinked povidone, sodium carboxymethyl starch, low-substituted hydroxypropylcellulose as a disintegrator, with hydroxypropyl granulated cellulose as a binder, granulated poured into the tank, after mixing, granulating binder is added; wet granulated material on marshy and dried, then the dry granules (moisture less than 3%) were dry sieved, added prescribed amount of magnesium stearate, mixed uniformly. The resulting total mixed particles were pressed into a tablet. DETAILED proportion prescription of Table 4.

[0074] Table 4

[0075]

[0076] Dissolution experiments

[0077] Determination...

Embodiment 3

[0082] Compound A and hypromellose acetate succinate mass ratio of 1 by the preparation of solid dispersions by coprecipitation, the resulting solid dispersion was ground in accordance with the formulation design weighed amount of a solid dispersion formulation , lactose and microcrystalline cellulose, crosslinked sodium carboxymethyl cellulose, hydroxypropyl methyl cellulose, respectively, polyvinylpyrrolidone, pregelatinised starch, hydroxypropyl cellulose as binder granulated, it is poured into the granulation tank, after mixing, granulating binder is added; wet granulated material on marshy and dried, then the dry particles (less than 3% water content) were dry sieved, added prescribed amount of stearyl magnesium mixed. The resulting total mixed particles were pressed into a tablet. DETAILED proportion prescription in Table 6.

[0083] Table 6

[0084]

[0085] Dissolution experiments

[0086] Determination Method II (paddle) according to China Pharmacopoeia 2015 Edition Gen...

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PUM

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Abstract

A solid dispersion, a preparation method thereof, and a solid formulation comprising the solid dispersion. The solid dispersion contains (R)-4-amino-1-(1-(but-2-ynoyl)pyrrolidin-3-yl)-3-(4-(2,6-difluorophenoxy )phenyl)-1,6-dihydro-7H-pyrrolo[2,3-d]pyridazin-7-one or a pharmaceutically acceptable salt thereof and a carrier material selected from hypromellose acetate Sucuccinate, Hypromellose Phthalate.

Description

Technical field [0001] This disclosure belongs to the field of pharmaceutical preparations, and specific to a (R) -4-amino-1- (1- (but-2-aeriene) pyrrolidine-3-yl) -3- (4- (2, 6) - Difluorophenoxy) phenyl) -1,6-dihydro-7H-pyrrolus [2,3-D] pyridazine-7-ketone solid dispersion and preparation method thereof. Background technique [0002] B cell lymphoma is one of the common malignant tumors affecting human health, accounting for 70-80% of malignant lymphoma, and the incidence of incidence is one of the common malignant tumors in my country. The occurrence of genetic factors, biological factors, and physicochemical factors of B cell lymphoma are affected by various factors. B cell lymphoma prognosis is poor, and the survival rate is still lower under existing treatment. [0003] Rheumatoid Arthritis, RA) is a chronic autoimmune disease that is mainly involved in small joints. The pathological characteristics are mainly inflammatory cells and the hyperplasia, hypertrophy and bone dam...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/50A61K9/26A61K47/14A61K47/38A61P19/02
CPCA61P19/02A61K31/5025A61K9/146A61P35/00A61K9/2018A61K9/1652A61K47/38A61K31/501A61K9/10
Inventor 张代美张婷婷丁欢
Owner JIANGSU HENGRUI MEDICINE CO LTD
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