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A kind of external preparation containing vitamin K1 and preparation method thereof

A technology for external preparations and vitamins, which is applied in the direction of medical preparations containing active ingredients, medical preparations with non-active ingredients, and pharmaceutical formulas, etc. It can solve the problem that vitamin K1 is difficult to penetrate the stratum corneum, it is difficult to reach the rash, and the efficiency is low. problems, to achieve the effect of prolonging the use period and adaptability to use, and no greasy feeling

Active Publication Date: 2019-12-13
YANGZIJIANG PHARMA GROUP SHANGHAI HAINI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the overall effective rate of this vitamin K1 emulsion is low. The main reason is that vitamin K1 is not easy to penetrate the stratum corneum, and it is difficult to reach the dermis where the rash occurs, which limits the further clinical application of vitamin K1 to a certain extent.
[0007] However, the research and development of a vitamin K1 external preparation with high absorption rate, good therapeutic effect and stability against the skin toxicity produced by EGFR drugs is still a difficult problem to be solved urgently

Method used

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  • A kind of external preparation containing vitamin K1 and preparation method thereof
  • A kind of external preparation containing vitamin K1 and preparation method thereof
  • A kind of external preparation containing vitamin K1 and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-11

[0038] Example 1-11, cream containing vitamin K1

[0039] The creams containing vitamin K1 were prepared according to Examples 1-11 shown in Table 1, respectively.

[0040] Table 1. Prescription of Vitamin K1 Cream (w / w%)

[0041]

[0042]

[0043] Preparation of vitamin K1 compound cream:

[0044] ①Preparation of oil phase: heat the cream base to 70~80℃ to melt, stir to mix evenly, then add vitamin K1, antioxidants, preservatives and fat-soluble skin penetration enhancer, dissolve and mix well to obtain mixed solution A ;

[0045] ② Preparation of the water phase: mix the emulsifier, antioxidant, and water-soluble skin penetration enhancer, add to water, heat to 70-80°C, stir, dissolve and mix to obtain mixed solution B;

[0046] ③Add the mixed solution A of step ① to the mixed solution B of step ②, keep the temperature at 70~80℃, stir for 30min, stir and cool to 40℃, add menthol, camphor or borneol, stir at 40℃ for 15min, add pH adjuster Adjust the pH to 5.0-7.0, stir and cool to 20°...

Embodiment 12-22

[0047] Example 12-22, gel containing vitamin K1

[0048] According to the prescriptions of Examples 12-22 shown in Table 2, the gels containing vitamin K1 were prepared.

[0049] Table 2. Prescription of Vitamin K1 Gel (w / w%)

[0050]

[0051] Preparation of vitamin K1 gel:

[0052] ① Add the gel base and thickener to distilled water, and after standing for 8-12 hours, add water-soluble skin penetration enhancer and antioxidant, and mix well to obtain mixed solution A;

[0053] ② Add vitamin K1 and fat-soluble skin penetration enhancer to ethanol, stir to dissolve and mix, to obtain mixed solution B;

[0054] ③ Add the mixed solution B of step ② to the mixed solution A of step ①, stir and mix evenly, add a pH regulator to adjust the pH to 5.0-7.0, and stir evenly to obtain.

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, and relates to an external preparation containing vitamin K1 and a preparation method thereof. The external preparation containing vitamin K1 provided by the invention can be used for moderate to severe skin toxicity caused by epidermal growth factor receptor (EGFR)-related anti-tumor drugs, and can effectively treat acne-like rash and itching caused by EGFR-related anti-tumor drugs Symptoms such as redness, swelling, dry skin, and mucositis can ensure continued treatment with anti-EGFR-targeted drugs. In addition, the external preparation containing vitamin K1 provided by the invention can increase the penetration of vitamin K1 through the stratum corneum to reach the dermis lesions, and can quickly relieve moderate to severe skin diseases caused by epidermal growth factor receptor-related antitumor drugs. In addition, the vitamin K1-containing external preparation provided by the present invention can be made into cream or gel, which has the advantages of moisturizing, cooling and no greasy feeling, is suitable for whole body coating, and is more conducive to the exertion of drug efficacy.

Description

Technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to an external preparation containing vitamin K1 and a preparation method thereof. Background technique [0002] Tumors have become the biggest killer of human health, and mankind has spared no effort to find the best way to treat tumors. In recent years, as people's understanding of tumorigenesis mechanisms and gene molecular typing has continued to deepen, the research of targeted drugs has gradually become a major breakthrough in the field of tumor treatment, and has received general attention from the medical community. More and more anti-tumor Molecular targeted drugs have been used in clinics and exert good curative effects. Anti-tumor molecular targeted drugs mainly include: afatinib, erlotinib, gefitinib, cetuximab and trastuzumab antibody-drug conjugates, etc. Targeted drugs are used in many tumors There have been breakthroughs in the treatment field, which g...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/06A61K47/18A61K47/22A61K47/44A61K47/10A61K31/122A61P17/00A61P17/16A61P17/02
CPCA61K47/10A61K47/18A61K47/22A61K47/44A61P17/00A61P17/02A61P17/16A61K9/0014A61K9/06A61K31/122A61K47/46
Inventor 倪海华蒋新国姜锋徐赟潘新庄卫红
Owner YANGZIJIANG PHARMA GROUP SHANGHAI HAINI PHARMA
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