CN-121971569-A - Gel emplastrum for oxaliplatin peripheral neurotoxicity and preparation method thereof

CN121971569ACN 121971569 ACN121971569 ACN 121971569ACN-121971569-A

Abstract

The invention provides a gel emplastrum for oxaliplatin peripheral neurotoxicity and a preparation method thereof, and relates to the field of traditional Chinese medicines, wherein the gel emplastrum comprises a backing layer, a paste layer and an anti-adhesion layer, the paste layer is a gel layer formed by a traditional Chinese medicine extract and a matrix for loading the traditional Chinese medicine extract, the traditional Chinese medicine extract is prepared from a traditional Chinese medicine composition, the traditional Chinese medicine composition comprises astragalus mongholicus, angelica sinensis, rhizoma sparganii, rhizoma curcumae zedoariae, cassia twig, radix achyranthis bidentatae and lumbricus in a mass ratio of 6:3:2:2:2:4:2, and the matrix comprises a framework material, a cross-linking agent, a cross-linking regulator, a thickening agent, a humectant, a complexing agent, pure water, a preservative, a penetration enhancer, a thermal sensation regulator and a high-performance emulsifying thickening agent. The invention can solve the problems that the use mode of the blood activating and stasis removing prescription mainly used for soaking and washing in the prior art is inconvenient, the compliance of patients is poor, the rate of medicines entering the bodies of the patients is not easy to control, the blood concentration in the bodies of the patients is difficult to maintain stably, and the treatment progress of peripheral neurotoxicity is difficult to control.

Inventors

HUA YUJIAO
CHEN YANYAN
DING YONGJUAN
WU RUIRONG
LU TINGXUN
GE XIAOSONG
Lv juan

Assignees

江南大学附属医院

Dates

Publication Date: 20260505
Application Date: 20260203

Claims (6)

1. The gel emplastrum for oxaliplatin peripheral neurotoxicity is characterized by comprising a back lining layer, a paste layer and an anti-adhesion layer, wherein the paste layer is a gel layer formed by a traditional Chinese medicine extract and a matrix for loading the traditional Chinese medicine extract; The traditional Chinese medicine extract is prepared from a traditional Chinese medicine composition, wherein the traditional Chinese medicine composition comprises astragalus membranaceus, angelica sinensis, vinegar-processed rhizoma sparganii, vinegar-processed rhizoma curcumae, cassia twig, radix achyranthis bidentatae and wide earthworm, and the mass ratio of the traditional Chinese medicine composition is 6:3:2:2:4:2; The matrix comprises a framework material, a cross-linking agent, a cross-linking regulator, a thickening agent, a humectant, a complexing agent, pure water, a preservative, a penetration enhancer, a thermal sensation regulator and a high-performance emulsifying thickening agent.
2. The gel patch for oxaliplatin peripheral neurotoxicity according to claim 1, wherein the weight of the astragalus membranaceus is 180g, the weight of the angelica sinensis is 90g, the weight of the rhizoma sparganii is 60g, the weight of the rhizoma curcumae zedoariae is 60g, the weight of the cassia twig is 60g, the weight of the achyranthes bidentata is 120g, and the weight of the lumbricus is 60g.
3. The gel patch for oxaliplatin peripheral neurotoxicity according to claim 2, wherein the Chinese medicinal extract is an alcohol extract of the Chinese medicinal composition, and the preparation method comprises the specific steps of weighing the Chinese medicinal materials in the Chinese medicinal composition according to weight, adding 70% ethanol which is 8 times of the Chinese medicinal composition, reflux-extracting for 2 times, 1.5h each time, recovering ethanol, and concentrating the liquid medicine by rotary evaporation to 5.0g/mL to obtain the Chinese medicinal extract.
4. The gel patch for oxaliplatin peripheral neurotoxicity of claim 1, wherein the framework material is sodium polyacrylate, the cross-linking agent is aluminum glycinate, the cross-linking regulator is tartaric acid, the thickening agent is a polyacrylic acid solution with the concentration of 20%, the humectant is glycerin, the complexing agent is EDTA, the thermal sensation regulator is vanillyl butyl ether, the high-performance emulsifying thickening agent is sodium acrylate or an acrylamide-dimethyl taurate copolymer, and the penetration enhancer is azone.
5. The gel patch for oxaliplatin peripheral neurotoxicity according to claim 4, wherein the paste layer comprises 8.00% of the framework material, 0.15% of the cross-linking agent, 0.25% of the cross-linking regulator, 20.00% of the thickener, 25.00% of the humectant, 0.05% of the complexing agent, 36.77% of the pure water, 0.20% of the preservative, 0.50% of the penetration enhancer, 0.08% of the thermal sensation regulator, 1.00% of the high-performance emulsifying thickener and 8% of the Chinese medicinal extract.
6. A method for preparing a gel patch for oxaliplatin peripheral neurotoxicity according to any one of claims 1 to 5, comprising the steps of: S101, sequentially adding a framework material, a cross-linking agent and a complexing agent into a humectant, and uniformly stirring after each addition to obtain a phase A; S102, mixing and uniformly stirring pure water, a crosslinking regulator, a preservative, a thickening agent and the traditional Chinese medicine extract to obtain a phase B; S103, mixing a high-performance emulsifying thickener, a thermal sensation regulator and a penetration enhancer to form a C phase; s104, adding the phase C into the phase B stirred at high speed to form BC mixed solution; s105, sequentially adding the BC mixed solution and the A phase subjected to pulping treatment into a vacuum stirrer, vacuumizing and stirring to form a viscous colloid; And S106, placing the viscous glue into a coater after the vacuum stirrer is vacuumized, coating the viscous glue on the back lining layer by the coater, covering an anti-sticking layer after curing more than 12 h, and cutting the adhesive layer to obtain the gel emplastrum.

Description

Gel emplastrum for oxaliplatin peripheral neurotoxicity and preparation method thereof Technical Field The invention relates to the field of traditional Chinese medicines, in particular to a gel emplastrum for oxaliplatin peripheral neurotoxicity and a preparation method thereof. Background Oxaliplatin, namely L-OHP, is widely used as a third-generation platinum anti-tumor medicament for treating digestive system tumors such as colorectal cancer, gastric cancer and the like, has good clinical curative effect and high use rate, and is particularly suitable for treating digestive tract tumors, but the oxaliplatin has adverse reactions such as peripheral neurotoxicity, namely OIPN, which are common and unique adverse reactions after oxaliplatin chemotherapy, and the most common symptoms comprise numbness, proprioception, acupuncture, hyperalgesia of hands and feet or ectopic pain, and the incidence rate of peripheral neuropathy caused by the oxaliplatin is extremely high, so that the life quality of patients and even the treatment of tumors are influenced. The traditional Western medicine treatment method for peripheral neurotoxicity has high cost, more side effects and unobvious curative effect, and therefore, the traditional Chinese medicine treatment method is adopted, wherein the formula for promoting blood circulation to remove blood stasis has the effects of promoting blood circulation to remove blood stasis, promoting qi and blood circulation to remove blood stasis, removing obstruction in collaterals and the like, and is suitable for treating the peripheral neurotoxicity. The clinical use mode of the prescription for activating blood circulation and dissolving stasis is mainly soaking and washing, the use mode of the prescription is limited by conditions, the prescription is not easy to carry, the decoction is inconvenient, the compliance of patients is poor, furthermore, the soaking and washing mode is influenced by factors such as skin permeability, soaking and washing time, liquid medicine dilution degree and the like, the accurate regulation and control are difficult, the rate of the medicine entering the patients is not beneficial to control, the bioavailability of the medicine is limited, and the bioavailability is fluctuated, so that the blood concentration in the patients is difficult to maintain stably, and the peripheral neurotoxicity treatment progress is difficult to control. Disclosure of Invention Aiming at the problems, the gel emplastrum for oxaliplatin peripheral neurotoxicity and the preparation method thereof can solve the problems that the blood activating and stasis removing prescription is inconvenient to use in a using mode mainly comprising soaking and washing, the patient compliance is poor, the rate of the medicine entering the patient is not easy to control, the blood concentration in the patient is difficult to stably maintain, and the peripheral neurotoxicity treatment progress is difficult to control in the prior art. In order to achieve the above purpose, the technical scheme adopted by the invention is as follows: The invention provides a gel emplastrum for oxaliplatin peripheral neurotoxicity, which comprises a backing layer, a paste layer and an anti-adhesion layer, wherein the paste layer is a gel layer formed by a traditional Chinese medicine extract and a matrix for loading the traditional Chinese medicine extract; The traditional Chinese medicine extract is prepared from a traditional Chinese medicine composition, wherein the traditional Chinese medicine composition comprises astragalus membranaceus, angelica sinensis, vinegar-processed rhizoma sparganii, vinegar-processed rhizoma curcumae, cassia twig, radix achyranthis bidentatae and wide earthworm, and the mass ratio of the traditional Chinese medicine composition is 6:3:2:2:4:2; The matrix comprises a framework material, a cross-linking agent, a cross-linking regulator, a thickening agent, a humectant, a complexing agent, pure water, a preservative, a penetration enhancer, a thermal sensation regulator and a high-performance emulsifying thickening agent. The gel emplastrum for oxaliplatin peripheral neurotoxicity provided by the invention is preferably 180g of astragalus membranaceus, 90g of angelica sinensis, 60g of rhizoma sparganii with vinegar, 60g of rhizoma curcumae with vinegar, 60g of cassia twig, 120g of radix achyranthis bidentatae and 60g of lumbricus with wide range of earthworms. The gel emplastrum for oxaliplatin peripheral neurotoxicity is preferably an alcohol extract of the traditional Chinese medicine composition, and specifically comprises the steps of weighing medicinal materials in the traditional Chinese medicine composition according to weight, adding 70% ethanol which is 8 times of the traditional Chinese medicine composition, carrying out reflux extraction for 2 times, 1.5 h each time, recovering ethanol, and concentrating the liquid medicine to 5.0g/mL by rotary evaporation to obtain t