Pharmaceutical composition containing pyrroloquinoline quinone trilithium salt nonahydrate, capsule and preparation method thereof

A technology of pyrroloquinoline quinone and hydrate, which is applied in the field of pharmaceutical preparations, can solve the problems of reduced production efficiency, impact on the stability of the crystal form of pyrroloquinoline quinone trilithium salt nonahydrate, and difficulties in subsequent processing, so as to improve production efficiency and yield, good stability and dissolution effect, and solve the effect of easy aggregation and agglomeration

Active Publication Date: 2021-01-29
SHANGHAI RIXIN BIOTECHNOLOGY CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

If the metal salt forms a thin sheet with a rigid structure after rolling, it will not only make subsequent processing difficult and reduce production efficiency, but also long-term rolling and repeated crushing will cause the equipment to heat up, affecting the performance of pyrroloquinoline quinone trilithium salt nonahydrate. crystal form stability
In addition, forced sizing will make the prepared granules hard and cause a decrease in the dissolution rate
If incr

Method used

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  • Pharmaceutical composition containing pyrroloquinoline quinone trilithium salt nonahydrate, capsule and preparation method thereof
  • Pharmaceutical composition containing pyrroloquinoline quinone trilithium salt nonahydrate, capsule and preparation method thereof
  • Pharmaceutical composition containing pyrroloquinoline quinone trilithium salt nonahydrate, capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1 to Embodiment 4

[0065] Examples 1 to 4 Compositions, Capsules and Preparations Containing Pyrroloquinoline Quinone Trilithium Salt Nonahydrate

[0066] The prescription composition of table 1 embodiment 1

[0067]

[0068] Note: The contents prepared by prescription No.1, No.2, No.3 and No.4 are poured into No. 3, No. 3, No. 4 and No. 3 hypromellose hollow capsules respectively.

[0069] The prescription composition of table 2 embodiment 2

[0070]

[0071] Note: The contents prepared by prescription No.5, No.6, No.7 and No.8 are poured into No. 4, No. 3, No. 3 and No. 3 hypromellose hollow capsules respectively.

[0072] The prescription composition of table 3 embodiment 3

[0073]

[0074] Note: The contents prepared by prescription No.9, No.10 and No.12 are poured into No.4, No.4 and No.2 hypromellose hollow capsules respectively. The contents prepared by prescription No.11 are poured into No. 2 gelatin hollow capsules.

[0075] The prescription composition of table 4 embodime...

Embodiment 1

[0079] Example 1 (Prescription No.1~No.4), Example 2 (Prescription No.5~No.8), Example 3 (Prescription No.9~No.12), Example 4 (Prescription No.13 and prescription No.15) preparation method:

[0080] (1) Raw material pretreatment: sieve the raw material of pyrroloquinoline quinone trilithium salt nonahydrate with 30 meshes, and sieve the excipients with 40 meshes;

[0081] (2) Ingredients: According to the proportion of the process prescription, weigh the raw material drug and auxiliary materials of pyrroloquinoline quinone trilithium salt nonahydrate;

[0082] (3) Pre-mixing: add pyrroloquinoline quinone trilithium salt nonahydrate API and all excipients into a multi-directional motion mixer, and mix at a speed of 20 rpm for 15 minutes to make the mixture uniform;

[0083] (4) Dry granulation: Add the homogeneously mixed pyrroloquinoline quinone trilithium salt nonahydrate API and all excipients to the dry granulator at a temperature of 15°C to 25°C and a relative humidity of...

Embodiment 4

[0088] The preparation method of embodiment 4 (prescription No.14 and prescription No.16):

[0089] (1) Raw material pretreatment: sieve the raw material of pyrroloquinoline quinone trilithium salt nonahydrate with 30 meshes, and sieve the excipients with 40 meshes;

[0090] (2) Ingredients: According to the proportion of the process prescription, weigh the raw material drug and excipients of pyrroloquinoline quinone trilithium salt nonahydrate, including internally added excipients and externally added excipients;

[0091] (3) Pre-mixing: add pyrroloquinoline quinone trilithium salt nonahydrate API and internally added excipients into a multi-directional motion mixer, and mix at a speed of 20 rpm for 15 minutes to make the mixture uniform;

[0092] (4) Dry granulation: at a temperature of 15°C to 25°C and a relative humidity of 45% to 55%, add the evenly mixed raw material drug of pyrroloquinoline quinone trilithium salt nonahydrate and internally added excipients to the dry ...

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Abstract

The invention discloses a pharmaceutical composition containing a pyrroloquinoline quinone trilithium salt nonahydrate, a capsule and a preparation method thereof. The pharmaceutical composition comprises the following components in parts by weight: 1.0 part of the pyrroloquinoline quinone trilithium salt nonahydrate, and pharmaceutically acceptable auxiliary materials, wherein the pharmaceutically acceptable auxiliary materials comprise 0.16 part by weight to 0.48 part by weight of colloidal silicon dioxide. According to the pharmaceutical composition containing the pyrroloquinoline quinine trilithium salt nonahydrate, the capsule containing the composition and the preparation method thereof, provided by the invention, the crystal form of the pyrroloquinoline quinine trilithium salt nonahydrate can be ensured to have relatively good stability and dissolution effect; and moreover, the dose of auxiliary materials is reduced as much as possible while relatively high drug content of eachunit of preparation is ensured, the preparation is convenient for elderly patients to take, and the medication compliance of the elderly patients is improved.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a pharmaceutical composition containing pyrroloquinoline quinone trilithium salt nonahydrate, a capsule containing the composition and a preparation method thereof. Background technique [0002] The compound represented by formula (I) is pyrroloquinoline quinone trilithium salt nonahydrate, chemical name 4,5-dioxo-4,5-dihydro-1H-pyrrolo[2,3-f]quinoline- 2,7,9-Lithium tricarboxylate nonahydrate, molecular formula C 14 h 3 Li 3 N 2 o 8 9H 2 O, with a molecular weight of 510.14, is a drug candidate that is expected to be used in the treatment of various neurodegenerative diseases such as Parkinson's disease and Alzheimer's disease. [0003] (I) [0004] Chinese invention patent applications 200910048873.9 and 201310270885.2 respectively disclose the lithium salt salt form and the nonahydrate crystal form of pyrroloquinoline quinone compounds....

Claims

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Application Information

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IPC IPC(8): A61K31/4745A61K9/48A61K47/04A61P25/28A61P25/16
CPCA61K31/4745A61K9/1611A61P25/28A61P25/16A61K9/1652A61K9/1635A61K9/1623A61K9/485A61K9/4858A61K9/4866
Inventor 张寰
Owner SHANGHAI RIXIN BIOTECHNOLOGY CO LTD
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