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CN-122005444-A - Stable low-irritation benzalkonium chloride contraceptive gel and preparation method thereof

CN122005444ACN 122005444 ACN122005444 ACN 122005444ACN-122005444-A

Abstract

The invention discloses a stable low-irritation benzalkonium chloride contraceptive gel and a preparation method thereof, belonging to the technical field of biological medicine manufacturing, wherein the method comprises the steps of dissolving hypromellose in purified water, and then adding benzalkonium chloride and chlorhexidine gluconate to obtain a bacteriostatic matrix phase; and premixing beta-sitosterol and hydroxypropyl-beta-cyclodextrin, adding aloe gel lyophilized powder, glycerol, regulating adjuvants, undecylenic acid glyceride and ectoin, homogenizing to obtain activity enhancing phase, adding the activity enhancing phase into antibacterial matrix phase, mixing, and sterilizing with ozone. Compared with the prior art, the invention obviously enhances the sterilization effect and reduces the mucous membrane irritation while reducing the dosage of the bactericide, effectively improves the stability of the product and builds a proper slightly acidic environment, thereby realizing the unification of sterilization, protection and stability.

Inventors

  • LIN HONGJI
  • LIAO YIJING

Assignees

  • 吉安长江生物药业有限公司

Dates

Publication Date
20260512
Application Date
20260330

Claims (10)

  1. 1. A preparation method of stable low-irritation benzalkonium chloride contraceptive gel, which is characterized by comprising the following steps: Step 1, taking purified water, heating and stirring, adding hydroxypropyl methylcellulose, stirring, adding the purified water, continuously stirring, cooling, adding benzalkonium chloride and chlorhexidine gluconate, and stirring to obtain a bacteriostatic matrix phase; Step 2, mixing and stirring beta-sitosterol, hydroxypropyl-beta-cyclodextrin, aloe gel lyophilized powder, glycerol and adjusting auxiliary materials, adding undecylenic acid glyceride and ectoin, and homogenizing to obtain an activity enhancing phase; And step 3, adding the activity enhancing phase in the step 2 into the antibacterial matrix phase in the step 1, stirring at constant temperature, and then performing ozone sterilization to obtain the benzalkonium chloride contraceptive gel.
  2. 2. The method for preparing a stable low-irritation benzalkonium chloride contraceptive gel in accordance with claim 1, wherein the method comprises the following steps in parts by weight: Step 1, taking 20-30 parts of purified water, heating and stirring, adding 1-3 parts of hypromellose, stirring for 5-15min, adding 20-30 parts of purified water, continuously stirring for 5-15min, cooling to below 40 ℃, adding 0.05-0.25 part of benzalkonium chloride and 0.01-0.03 part of chlorhexidine gluconate, and stirring at 100-500rpm for 5-30min to obtain a bacteriostatic matrix phase; Step 2, mixing and stirring 0.3-0.8 part of beta-sitosterol, 0.3-0.8 part of hydroxypropyl-beta-cyclodextrin, 0.005-1 part of aloe gel freeze-dried powder, 1-3 parts of glycerol and 0.1-0.3 part of adjusting auxiliary materials for 5-30min, adding 0.05-0.2 part of undecylenic acid glyceride and 0.05-0.2 part of ectoin, homogenizing to obtain an activity enhancing phase; And step 3, adding the activity enhancing phase in the step 2 into the antibacterial matrix phase in the step 1, stirring at constant temperature, and then performing ozone sterilization to obtain the benzalkonium chloride contraceptive gel.
  3. 3. The method for preparing a stable low-irritation benzalkonium chloride contraceptive gel according to claim 1 or2, wherein the homogenization in step 2 is carried out at 3000-5000rpm for 1-5min.
  4. 4. The method for preparing a stable low-irritation benzalkonium chloride contraceptive gel according to claim 1 or 2, wherein the ozone sterilization time in step3 is 3-8min and the ozone concentration is 0.1-0.5mg/L.
  5. 5. The method for preparing a stable low-irritation benzalkonium chloride contraceptive gel according to claim 1 or 2, wherein the constant temperature stirring in step 3 is stirring at a constant temperature of 35-40 ℃ at 100-500rpm for 5-30min.
  6. 6. The method for preparing a stable low-irritation benzalkonium chloride contraceptive gel according to claim 1 or 2, wherein the heating and stirring in step 1 is performed by heating to 80-100 ℃ and stirring at 100-500 rpm.
  7. 7. The method for preparing a stable low-irritation benzalkonium chloride contraceptive gel according to claim 1 or 2, wherein the regulating auxiliary material is at least one of betaine, L-proline, sorbitol, glycerophosphorylcholine, trehalose, and allantoin.
  8. 8. The method for preparing the stable low-irritation benzalkonium chloride contraceptive gel according to claim 1 or 2, wherein the regulating auxiliary material is formed by combining betaine and allantoin according to the mass ratio of 0.5-2:0.5-2.
  9. 9. The method for preparing a stable low-irritation benzalkonium chloride contraceptive gel in accordance with claim 1, further comprising the steps of: Step 1, taking 20-30 parts of purified water, heating and stirring, adding 0.05-0.2 part of lactic acid and 0.1-0.4 part of sodium lactate, adding 1-3 parts of hypromellose, stirring for 5-15min, adding 20-30 parts of purified water, continuously stirring for 5-15min, cooling to below 40 ℃, adding 0.05-0.25 part of benzalkonium chloride and 0.01-0.03 part of chlorhexidine gluconate, and stirring for 5-30min at 100-500rpm to obtain a bacteriostatic matrix phase; Step 2, mixing and stirring 0.3-0.8 part of beta-sitosterol, 0.3-0.8 part of hydroxypropyl-beta-cyclodextrin, 0.005-1 part of aloe gel freeze-dried powder, 1-3 parts of glycerol and 0.1-0.3 part of adjusting auxiliary materials for 5-30min, adding 0.05-0.2 part of undecylenic acid glyceride and 0.05-0.2 part of ectoin, homogenizing to obtain an activity enhancing phase; And step 3, adding the activity enhancing phase in the step 2 into the antibacterial matrix phase in the step 1, stirring at constant temperature, and then performing ozone sterilization to obtain the benzalkonium chloride contraceptive gel.
  10. 10. A stable, low-irritation benzalkonium chloride contraceptive gel prepared by the method of any one of claims 1-9.

Description

Stable low-irritation benzalkonium chloride contraceptive gel and preparation method thereof Technical Field The invention relates to the technical field of biological medicine manufacturing, in particular to a stable and low-irritation benzalkonium chloride contraceptive gel and a preparation method thereof. Background The invention relates to the technical field of biological medicine manufacturing, in particular to a stable and low-irritation benzalkonium chloride contraceptive gel and a preparation method thereof. Benzalkonium chloride, which is a cationic surfactant, has an exact killing effect on bacteria and is widely applied to contraceptive and sterilization products, but how to reduce the irritation to mucous membrane and improve the storage stability of the product while guaranteeing the sterilization efficacy is always a technical problem of continuous attention of the technicians in the field. In the prior art, patent application number 200410088709.8 discloses benzalkonium chloride contraceptive gel which adopts high-content benzalkonium chloride as a single sterilization component, and can realize quick sterilization, but the high-concentration benzalkonium chloride has strong irritation to vaginal mucous membrane and can damage the microecological balance of the vagina after long-term use, and patent publication number CN106177274A reduces irritation to a certain extent by adding electrolytic water, aloe gel and other components, but the preparation method is only simple physical mixing, does not consider the interaction among the components and the stability problem in the long-term storage process, has single sterilization mechanism, and is difficult to realize mucous membrane repair and microecological adjustment while effectively killing pathogens. In summary, there is still a lack of benzalkonium chloride contraceptive gel in the prior art which can not only kill bacteria efficiently, but also has good mucosa compatibility and storage stability, and can perform synergistic sterilization and repair functions. Therefore, how to realize synergy under the condition of lower bactericide dosage, how to reduce irritation and prolong the effective period of the product through scientific compatibility of functional auxiliary materials, and how to improve the stability of active ingredients through process optimization become technical problems to be solved in the field. Disclosure of Invention Aiming at the defects of the prior art, the invention aims to provide a stable and low-irritation benzalkonium chloride contraceptive gel and a preparation method thereof. In order to achieve the above object, the present invention adopts the following technical scheme: a preparation method of stable low-irritation benzalkonium chloride contraceptive gel comprises the following steps: Step 1, taking purified water, heating and stirring, adding hydroxypropyl methylcellulose, stirring, adding the purified water, continuously stirring, cooling, adding benzalkonium chloride and chlorhexidine gluconate, and stirring to obtain a bacteriostatic matrix phase; Step 2, mixing and stirring beta-sitosterol, hydroxypropyl-beta-cyclodextrin, aloe gel lyophilized powder, glycerol and adjusting auxiliary materials, adding undecylenic acid glyceride and ectoin, and homogenizing to obtain an activity enhancing phase; And step 3, adding the activity enhancing phase in the step 2 into the antibacterial matrix phase in the step 1, stirring at constant temperature, and then performing ozone sterilization to obtain the benzalkonium chloride contraceptive gel. The preparation method of the stable low-irritation benzalkonium chloride contraceptive gel comprises the following steps of: Step 1, taking 20-30 parts of purified water, heating and stirring, adding 1-3 parts of hypromellose, stirring for 5-15min, adding 20-30 parts of purified water, continuously stirring for 5-15min, cooling to below 40 ℃, adding 0.05-0.25 part of benzalkonium chloride and 0.01-0.03 part of chlorhexidine gluconate, and stirring at 100-500rpm for 5-30min to obtain a bacteriostatic matrix phase; Step 2, mixing and stirring 0.3-0.8 part of beta-sitosterol, 0.3-0.8 part of hydroxypropyl-beta-cyclodextrin, 0.005-1 part of aloe gel freeze-dried powder, 1-3 parts of glycerol and 0.1-0.3 part of adjusting auxiliary materials for 5-30min, adding 0.05-0.2 part of undecylenic acid glyceride and 0.05-0.2 part of ectoin, homogenizing to obtain an activity enhancing phase; And step 3, adding the activity enhancing phase in the step 2 into the antibacterial matrix phase in the step 1, stirring at constant temperature, and then performing ozone sterilization to obtain the benzalkonium chloride contraceptive gel. The homogenization in the step 2 is homogenizing at 3000-5000rpm for 1-5min. The regulating auxiliary material is at least one of betaine, L-proline, sorbitol, glycerophosphorylcholine, trehalose and allantoin. Preferably, the regulating auxiliary material is