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CN-121971368-A - Minoxidil liniment and preparation method and application thereof

CN121971368ACN 121971368 ACN121971368 ACN 121971368ACN-121971368-A

Abstract

The invention belongs to the technical field of pharmacy, and in particular relates to minoxidil liniment and a preparation method and application thereof. The minoxidil liniment comprises minoxidil, an alcohol solution, a stabilizer, oat extract and water, wherein the stabilizer comprises EDTA-tetrasodium, panthenol and hydroxypropyl cellulose. The invention optimizes the preparation process by utilizing the synergistic effect of EDTA-tetrasodium, panthenol and hydroxypropyl cellulose, can effectively improve the effectiveness and stability of minoxidil serving as a raw material medicine, prolongs the effective period of minoxidil and improves the medication compliance. The oat extract is used as the auxiliary material of the liniment, so that the side effect of minoxidil is reduced, the possible red swelling, itching and uncomfortable feeling caused by minoxidil can be effectively reduced, the damaged scalp skin barrier can be helped to be repaired, the micro-inflammation around hair follicles is reduced, and a healthier environment is created for hair growth.

Inventors

  • TANG WENXING
  • SHEN YUNTONG
  • LI ZEWEI

Assignees

  • 广州琥瑞医药科技发展有限公司

Dates

Publication Date
20260505
Application Date
20260303

Claims (10)

  1. 1. The minoxidil liniment is characterized by comprising minoxidil, an alcohol solution, a stabilizer, oat extract and water, wherein the stabilizer comprises EDTA-tetrasodium, panthenol and hydroxypropyl cellulose.
  2. 2. Minoxidil liniment according to claim 1, wherein the mass ratio of EDTA-tetrasodium, panthenol and hydroxypropyl cellulose is 0.5-1.5:1.5-2:1-1.5.
  3. 3. The minoxidil liniment according to claim 1, wherein the alcohol solution is a mixed solution of anhydrous ethanol and propylene glycol in a volume ratio of 4-6:2-4.
  4. 4. The minoxidil liniment according to claim 1, wherein the minoxidil liniment comprises, by weight, 5-8% minoxidil, 60-80% alcohol solution, 3-5% stabilizer, 1-2% oat extract and water with the balance being up to 100%.
  5. 5. The minoxidil liniment according to claim 4, wherein the minoxidil liniment comprises, by weight, 5-7% minoxidil, 65-70% alcohol solution, 4-5% stabilizer, 1.5-2% oat extract and water in balance to 100%.
  6. 6. A method of preparing minoxidil liniment according to any one of claims 1 to 5, comprising the steps of: (1) Firstly mixing EDTA-tetrasodium, panthenol and hydroxypropyl cellulose in water, and then adding oat extract to obtain a water phase; (2) Then minoxidil is dissolved in the alcohol solution to obtain an alcohol phase; (3) Finally adding alcohol phase into water phase, regulating pH value, uniformly stirring so as to obtain minoxidil liniment.
  7. 7. The method according to claim 6, wherein the mixing in the step (1) comprises dissolving EDTA-tetrasodium and panthenol in water, and adding hydroxypropyl cellulose at 500-1000 rpm.
  8. 8. The method according to claim 6, wherein the oat extract is added in step (1) and then subjected to ultrasonic treatment, wherein the ultrasonic treatment is performed at a temperature of 20-30 ℃, for a time of 15-25 min, and at a frequency of 50-100 kHz.
  9. 9. The method according to claim 6, wherein in the step (3), the pH is adjusted to 4-6 by citric acid, the stirring speed is 500-1000 rpm, and the stirring time is 30-60 min.
  10. 10. Use of minoxidil liniment according to any one of claims 1-5 or obtained by the process of preparation according to any one of claims 6-9 in the manufacture of a medicament for preventing hair loss.

Description

Minoxidil liniment and preparation method and application thereof Technical Field The invention belongs to the technical field of pharmacy, and in particular relates to minoxidil liniment and a preparation method and application thereof. Background Minoxidil is an aminopyridine potassium channel opener that can cause vasodilation and premature entry of resting hair follicles into anagen phase and increase hair follicle size, and has a positive effect on hair growth mainly due to minoxidil sulfate, a metabolite thereof. Because of the indissolvable nature of minoxidil bulk drug, the current preparation technology is mostly directly dissolved in solvent, and high-concentration organic reagent is usually required to be added for dissolution, and propylene glycol, ethanol and the like are common. The concentration of propylene glycol as penetration enhancer and dissolvent is usually up to 30-50%, for example, the solubility of minoxidil is difficult to reach more than 2% without propylene glycol. However, high concentration propylene glycol is liable to cause allergic reactions such as user's rash, and to achieve good therapeutic effect, it is necessary to spray the medicine several times, and repeated use may further cause adverse reactions of patients. As disclosed in chinese patent publication No. CN119280151a, a process for preparing minoxidil liniment is disclosed, which comprises mixing propylene glycol, absolute ethanol, and about 40% of purified water until there is no obvious delamination, and finally adding minoxidil, stirring and dissolving. Another patent publication number CN121102179a of the invention discloses a minoxidil film coating agent, and a preparation method and application thereof, wherein the minoxidil film coating agent comprises 40-60% of propylene glycol, 3-7% of polyvinyl alcohol, 20-30% of ethanol, 1-7% of minoxidil and the balance of water. The minoxidil coating agent disclosed by the invention has excellent skin permeability, can effectively convey the medicine to a required position, can ensure that the medicine is released at a skin fixing position in the medicine release process, is accurately administered, and reduces the irritation of liquid medicine flow to other positions, thereby achieving a good treatment effect. However, minoxidil dosage forms prepared by the above-mentioned invention are still inferior in terms of effectiveness and stability, and therefore, there is a need in the art to provide minoxidil liniment which is superior in effectiveness and stability, can improve patient medication compliance, and can reduce side effects. Disclosure of Invention Aiming at the problems existing in the prior art, the invention provides minoxidil liniment and a preparation method and application thereof. In order to achieve the above purpose, the technical scheme adopted by the invention is as follows: a minoxidil liniment comprises minoxidil, alcohol solution, stabilizer, herba Avenae Fatuae extract and water, wherein the stabilizer comprises EDTA-tetrasodium, panthenol and hydroxypropyl cellulose. Preferably, the mass ratio of EDTA-tetrasodium, panthenol and hydroxypropyl cellulose is 0.5-1.5:1.5-2:1-1.5. More preferably, the mass ratio of EDTA-tetrasodium, panthenol and hydroxypropyl cellulose is 0.8-1.2:1.8-2:1-1.2. Further preferably, the mass ratio of EDTA-tetrasodium, panthenol and hydroxypropyl cellulose is 1:2:1. Preferably, the alcohol solution is a mixed solution of anhydrous ethanol and propylene glycol in a volume ratio of 4-6:2-4. More preferably, the alcohol solution is a mixed solution of anhydrous ethanol and propylene glycol in a volume ratio of 5:3. Preferably, the composition comprises, by weight, 5-8% minoxidil, 60-80% alcoholic solution, 3-5% stabilizer, 1-2% oat extract and water with the balance being up to 100%. More preferably, the composition comprises, by weight, minoxidil 5-7%, an alcoholic solution 65-70%, a stabilizer 4-5%, an oat extract 1.5-2% and water in balance up to 100%. Further preferably, the composition comprises, by weight, minoxidil 6%, an alcoholic solution 70%, a stabilizer 4%, oat extract 2% and water in balance up to 100%. The invention provides a preparation method of the minoxidil liniment, which comprises the following steps: (1) Firstly mixing EDTA-tetrasodium, panthenol and hydroxypropyl cellulose in water, and then adding oat extract to obtain a water phase; (2) Then minoxidil is dissolved in the alcohol solution to obtain an alcohol phase; (3) Finally adding alcohol phase into water phase, regulating pH value, uniformly stirring so as to obtain minoxidil liniment. Preferably, the mixing process in the step (1) comprises dissolving EDTA-tetrasodium and panthenol in water, and adding hydroxypropyl cellulose at a rotation speed of 500-1000 rpm. Preferably, the oat extract is added in step (1) and then subjected to ultrasonic treatment, wherein the ultrasonic treatment is carried out at a temperature of 20-30 ℃, the ultrasonic t