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Shikonin temperature-sensitive hydrogel and preparation method and application thereof

A temperature-sensitive, shikonin technology, applied in the field of pharmacy, can solve the problems of complex production process of effervescent agent, slow dissolving speed of suppository, inaccurate dosage of administration, etc. Dose-accurate results

Inactive Publication Date: 2019-06-07
XI AN JIAOTONG UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Wherein, when shikonin is used for vaginal administration, it is often made into common traditional gels, effervescents, suppositories, etc., all of which have deficiencies, such as the inaccurate dosage of common traditional gels, effervescents, etc. The production process is complicated, the cost is high, the packaging requirements are strict, the suppository dissolves slowly, the drug is uneven, the matrix is ​​easily lost together with the drug after melting, and all three have the disadvantages of inconvenient administration
When shikonin is used to treat damaged / inflamed / burned skin or mucous membranes, it is often made into sprays and films. The disadvantage of the former is that it stays at the site of application for a short time, while the latter has a small drug load
Among the poloxamer polymers, the research on poloxamer 407 (P407) is the most in-depth, but because the phase transition temperature of low-concentration P407 is not sensitive, and the phase-transition temperature of high-concentration P407 is low, so limited its use

Method used

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  • Shikonin temperature-sensitive hydrogel and preparation method and application thereof
  • Shikonin temperature-sensitive hydrogel and preparation method and application thereof
  • Shikonin temperature-sensitive hydrogel and preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0070] Embodiment 1 Preparation and evaluation of shikonin thermosensitive sterile hydrogel

[0071] 1. Preparation of shikonin thermosensitive sterile hydrogel

[0072] 1) Preparation of pH4.0 citrate buffer

[0073] Take citric acid (C 6 h 8 o 7 ·H 2 (0) 5.25g in a 250mL beaker, add 200mL ultrapure water, stir with a glass rod to dissolve it, transfer it to a 250mL measuring bottle, rinse the beaker and glass rod several times with ultrapure water, and constant volume to obtain 0.1mol / L citric acid solution. Take sodium citrate (C 6 h 5 Na 3 o 7 2H 2 O) 2.94g in a 100mL beaker, add 80mL of ultrapure water, stir with a glass rod to dissolve it, transfer it to a 100mL measuring bottle, rinse the beaker and glass rod with a small amount of purified water several times, and constant volume to obtain 0.1mol / L Sodium citrate solution. Take 165mL of the above 0.1mol / L citric acid solution and 85mL of 0.1mol / L sodium citrate solution in a 500mL beaker, add 200mL ultrapu...

Embodiment 2

[0120] Example 2 Preparation and evaluation of shikonin temperature-sensitive sterile hydrogel spray

[0121] 1. Preparation of shikonin thermosensitive sterile hydrogel spray

[0122] Take the shikonin sterile hydrogel solution prepared in Example 1, fill and seal it in a 60mL manual spray bottle under aseptic operation, and obtain it.

[0123] 2. Evaluation of shikonin thermosensitive sterile hydrogel spray

[0124] 1) Investigation of the total number of sprays per bottle and the amount of each spray of shikonin thermosensitive sterile hydrogel spray

[0125] Take 3 batches of samples, 3 bottles per batch, and measure the total number of sprays per bottle with reference to the four sprays of the 2015 edition of the "Chinese Pharmacopoeia", all of which are not less than 500 sprays.

[0126] Take 3 batches of samples, 3 bottles per batch, and measure the amount of each spray according to the four sprays of the "Chinese Pharmacopoeia" 2015 edition, and the amount of each sp...

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Abstract

The present invention discloses a shikonin temperature-sensitive aseptic hydrogel, a preparation method and an application thereof, and belongs to the technical field of pharmaceutics. A hydrogel carrier does not use a crosslinking agent, which avoids damages to human body by the crosslinking agent. The preparation method is simple, experimental conditions are mild, no special equipment is needed,investment cost is low, used reagents are conventional reagents, and the shikonin temperature-sensitive hydrogel is convenient for industrial implementation and environmentally friendly. When the shikonin temperature-sensitive hydrogel is used for vaginal administration, the shikonin temperature-sensitive hydrogel has advantages of convenient administration, easy dosage control, uniform distribution, long administration time, etc.; and when the shikonin temperature-sensitive hydrogel is used for burnt skin or inflammatory and damaged skin or mucosal surfaces, the shikonin temperature-sensitive hydrogel has advantages of small stimulation to wound surfaces, easy spreading, uniform distribution, convenient administration, accurate dosage, etc. By loading main medicines and corresponding medicinal auxiliary materials, the shikonin temperature-sensitive hydrogel play moisturizing, repairing, disinfection, sterilization and therapeutic effects, at the same time can form a layer of protective film on surface of lesion, and realizes aseptic maintenance and wound protection for the lesion.

Description

technical field [0001] The invention belongs to the technical field of pharmacy, and relates to a shikonin temperature-sensitive sterile hydrogel and a preparation method and application thereof. Background technique [0002] Shikonin (5,8-dihydroxy-2-[(1R)-1-hydroxy-4-methylpent-3-enyl]naphthalene-1,4-dione, C 16 h 16 o 5 ) is a naphthoquinone compound extracted from the natural plant Comfrey, which has various pharmacological activities such as anti-inflammatory, anti-oxidation, immune regulation, anti-tumor, anti-bacterial, anti-viral, hypoglycemic, and liver protection. It has a wide range of clinical applications, and is often used as an adjuvant drug for liver and gallbladder diseases in the treatment of acute and chronic hepatitis. In addition, it is also used to treat herpes simplex virus keratitis, dermatitis, eczema, vaginitis, cervicitis, flat Warts, psoriasis, burns and promoting wound healing, etc. Nowadays, the common preparation forms of shikonin are mainl...

Claims

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Application Information

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IPC IPC(8): A61K9/06A61K9/12A61K31/122A61K31/222A61K47/10A61P17/02A61P29/00A61P31/04A61P31/10A61P31/02A61P15/02
Inventor 张继业莫菲张沛沛马佳杨广德林蓉杨显伟
Owner XI AN JIAOTONG UNIV
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