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Medicinal preparation containing active pharmaceutical ingredient phenethyl caffeate and preparation method thereof

A technology of phenethyl caffeate and pharmaceutical preparations, which is applied to medical preparations containing active ingredients, drug combinations, and pharmaceutical formulas, and can solve problems such as uneven content of preparations, increased viscosity, and low dissolution rate

Inactive Publication Date: 2021-05-04
欧德福瑞(北京)医疗健康科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Due to the poor water solubility of phenethyl caffeate, the dissolution rate is low when it is made into pharmaceutical preparations
The inventors found that the dissolution rate can be greatly improved after crushing treatment, but when the particle size is controlled too low, the generated static electricity is too large, and the viscosity also increases significantly. Even if lubricants and glidants are added, the content of the preparation is likely to be uneven

Method used

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  • Medicinal preparation containing active pharmaceutical ingredient phenethyl caffeate and preparation method thereof
  • Medicinal preparation containing active pharmaceutical ingredient phenethyl caffeate and preparation method thereof
  • Medicinal preparation containing active pharmaceutical ingredient phenethyl caffeate and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Embodiment 1, the particle size distribution detection of caffeic acid phenethyl ester crude drug after the mechanical pulverization of jet mill

[0038] Take by weighing phenethyl caffeate 50g, adopt airflow type pulverizer to carry out mechanical pulverization, the pulverizer motor speed is 25000 revs / min, the caffeic acid phenethyl caffeate powder that cloth filter bag collects after pulverizing carries out particle size detection with laser particle size detector, As a result, the particle size was: D90 24.06 μm, D50 10.52 μm. See details figure 1 .

Embodiment 2

[0039] Example 2, the particle size distribution detection of caffeic acid phenethyl ester crude drug micronized by jet mill

[0040]Weigh 50g of caffeic acid phenethyl ester, use jet mill for micronization treatment, caffeic acid phenethyl ester powder collected by cloth filter bag is detected by laser particle size detector, and the particle size is: D90 20.33μm, D50 8.096μm . See details figure 2 .

Embodiment 3

[0041] Embodiment 3, the preparation of the capsule preparation containing caffeic acid phenethyl ester crude drug

[0042] The treated phenethyl caffeate powder of Example 1 was used. Weigh 30.0g of pulverized phenethyl caffeate, 4.5g of talcum powder, and 3.0g of silicon dioxide to pass through a 60-mesh sieve and mix once, then put it into a 10-liter hopper mixer, add microcrystalline cellulose pH102125g, spray dry 128.5 g of mannitol and 9.0 g of crospovidone XP were mixed for 30 minutes (frequency 20 rpm), filled with 1# gelatin empty capsules, and each capsule was filled with a filling capacity of 300 mg. After the filling is completed, the filling volume difference inspection, content uniformity inspection and dissolution inspection are respectively carried out.

[0043] (1) Loading difference check

[0044] Take 20 capsules and weigh the total weight of 7.578g. The total weight of 20 empty capsules is 1.496g. The average empty capsule weight is 0.075g / capsule. The ca...

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Abstract

The invention provides a medicinal preparation containing an active pharmaceutical ingredient phenethyl caffeate and a preparation method thereof. In order to enable the medicinal preparation containing the active pharmaceutical ingredient phenethyl caffeate to meet the requirement of rapid dissolution, the active pharmaceutical ingredient phenethyl caffeate is crushed and controlled in 15[mu]m-35[mu]m of particle size D90 and 3[mu]m-14[mu]m of particle size D50. Afterwards, the micronized phenethyl caffeate is prepared into an oral solid preparation that can be capsules, tablets, suspension particles or dry suspension. The prepared oral solid preparation meets various related detection requirements in 2015 edition Chinese pharmacopoeia and can be used for treating neurological diseases such as amyotrophic lateral sclerosis and Parkinson's disease.

Description

technical field [0001] The invention relates to particle size control of a bulk drug and its application, more specifically, a pharmaceutical preparation containing a bulk drug of phenethyl caffeate and a preparation method thereof. Background technique [0002] Caffeic acid phenylethyl ester has been identified as one of the main active components in propolis. Many biological activities of propolis are related to caffeic acid phenylethyl ester. hotspot. Specifically, phenethyl caffeate includes the following effects: [0003] (1) Antioxidant effect [0004] The catechol structure contained in the structure of caffeic acid phenethyl ester is a strong antioxidant. Sudina's experiment proved that 10 μm of caffeic acid phenethyl ester can completely block the production of active oxidative substances in neutrophils and block the xanthine oxidase system. Moreover, studies have found that propolis containing caffeic acid phenylethyl ester has stronger antioxidant activity tha...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/216A61K9/48A61K9/20A61P25/00A61P25/16
CPCA61K31/216A61K9/4866A61K9/4858A61K9/2027A61K9/2054A61K9/2013A61K9/2018A61P25/00A61P25/16
Inventor 吕久安刘晔罗永明谢亚楠
Owner 欧德福瑞(北京)医疗健康科技有限公司