Colchicine composition for external use and preparation method thereof

A composition for external use, the technology of colchicine, applied in colchicine liniment, the field of colchicine external composition for preventing or treating gouty arthritis, can solve the problem of not yet formed, inconsistent severity of toxicity, absorption of vitamin B12 It can relieve pain, take effect quickly, and have no systemic side effects.

Active Publication Date: 2018-05-22
BEIJING HUMANWELL JUNWEI PHARM TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

2. Due to the inconsistency in the understanding of the curative effect and risk of colchicine in the treatment of gout, and the severity of its toxicity, it is necessary to be cautious when choosing this drug
5. Blood routine and liver and kidney function must be tested regularly
6. This drug can cause reversible vitamin B12 malabsorption
[0006] The research results of the above literature reveal that changing the route of administration of colchicine and transdermal absorption can become a new breakthrough in the research of new dosage forms of the drug, but these studies have not yet become commercial products to serve the majority of patients

Method used

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  • Colchicine composition for external use and preparation method thereof
  • Colchicine composition for external use and preparation method thereof
  • Colchicine composition for external use and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Embodiment one, the prescription research of colchicine liniment

[0033] 1 Instruments and reagents

[0034] 1.1 Instrument

[0035] Agilont 1260 high performance liquid chromatograph (Agilent company) includes G131K quaternary gradient pump, G13298 sample injector, G1316A column thermostat, G1315D DAD detector, and the workstation is: Chemstation for LC 3D systems. VV-1800 UV-Vis Spectrophotometer (Shimadzu, Japan); KS-2500 Ultrasonic Instrument (Ningbo Kesheng Instrument Factory); pH 211A Acidity Meter (Italy HANNA); BP211D Precision Electronic Balance (Sartorius, Germany); ZORBAX C 18 Chromatographic column (150mm×4.60mm, 5μm, Agilent company); YB-3 clarity detector (Tianjin University Precision Instrument Factory); DHG-9140A electric heating constant temperature blast drying oven (Shanghai-Heng Technology Co., Ltd.); SDC- Type II high-purity water device (Institute of Health Equipment, Academy of Military Medical Sciences); SHZ-D (III) circulating water vacuum p...

Embodiment 2

[0100] Embodiment 2, the anti-inflammatory effect of colchicine liniment on gout model animals

[0101] 1. Materials and methods

[0102] 1.1 Drugs and reagents Colchicine liniment (prescription 4 in Table 1-1, also 2.5.1 prescription i in Example 1, colchicine content is 0.2w / v%), colchicine (Yunnan Kunming Pharmaceutical Co., Ltd. Company pharmaceutical factory, content 99.79%), sodium urate (provided by Sigma company), prostaglandin E2 (PGE2) radioimmunoassay kit (provided by Beijing East Asia Institute of Immunology Technology), tumor necrosis factor-α (TNF-α) kit ( Institute of Military Medical Sciences).

[0103] 1.2 Experimental animals SD rats, male, clean grade, weighing 200-250g, were provided by the Experimental Animal Center of the Academy of Military Medical Sciences, and were tested after 3 days of normal feeding in the laboratory.

[0104] 1.3 Method

[0105] 1.3.1 Establishment of acute gouty arthritis model according to CODERRE classic method (Coderre TJ, W...

Embodiment 3

[0125] Example 3: Research on irritation and sensitization of colchicine liniment to skin

[0126] Toxicology research is a key link in drug research and development, which determines whether the drug can enter the clinic and whether the drug is safe to use. Chemical drug irritation and allergy refer to chemical drug preparations administered through eyes, ears, nose, oral cavity, respiratory tract, joint cavity, skin, rectum, vagina, vein, artery, muscle, subcutaneous, paravenous and intrathecal, etc. Drugs, local toxicity (such as irritation and allergy, etc.) and / or systemic toxicity (such as anaphylaxis and hemolysis, etc.) produced by the drug. It is an integral part of the preclinical safety evaluation.

[0127] The colchicine liniment of the present invention is a novel dosage form of colchicine. The invention of this dosage form is based on the fact that the effective therapeutic dose under the oral dose of the colchicine tablet is close to the systemic poisoning dose, ...

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Abstract

The invention relates to a colchicine composition for external use and a preparation method thereof. The colchicine composition is transdermally absorbed and comprises following components: colchicine, a solvent, a cosolvent, optional infiltration aid, and optional emulsifier. The colchicine composition can effectively prevent or treat gouty arthritis, is well transdermally absorbed, has a quick effect, and has prominent advantages in administration route and dosage form, compared with oral preparations. The colchicine composition is nonirritant and non-allergic to skin, barely has any toxic or side effect, and has the advantages of high stability, controllable quality, simple production technology, and suitability for industrial production.

Description

technical field [0001] The invention belongs to the field of medicine, in particular to the field of medicine for treating gouty arthritis. Specifically, the present invention relates to a colchicine topical composition for preventing or treating gouty arthritis, especially a colchicine liniment, and a preparation method thereof. Background technique [0002] Gout is a disease caused by the disorder of purine metabolism in the body. It is mainly manifested as hyperuricemia. Urate crystallizes in joints, kidneys and connective tissues, which can cause local inflammation of joints and infiltration of granulocytes, leading to gout attacks. The incidence of gout is increasing year by year worldwide. In my country, its incidence rate is also increasing year by year, and the age of onset is showing a trend of younger age, which brings a huge burden to the society. According to statistics, there are hundreds of millions of potential gout patients in my country at present, and abo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/165A61K47/40A61K47/22A61K47/14A61K47/10A61P19/06A61P19/02
CPCA61K47/10A61K47/14A61K47/22A61K9/0014A61K31/165A61K47/6951A61K47/44A61P19/06A61P19/02A61K47/26Y02A50/30
Inventor 高永良
Owner BEIJING HUMANWELL JUNWEI PHARM TECH CO LTD
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