Female recombinant collagen antibacterial gel and preparation method thereof

Abstract

The invention relates to the technical field of gel for women, and provides recombinant collagen antibacterial gel for women and a preparation method of the recombinant collagen antibacterial gel for women, and the recombinant collagen antibacterial gel for women comprises the following components in percentage by weight: 0.1-1.9% of carbomer; 0.8 to 1.1 parts of recombinant collagen; 1 to 1.5 parts of hydroxyethyl cellulose; 0.1 to 0.3 part of sodium hydroxide; 0.2 to 1.5 parts of isomaltooligosacharide; 3-8 parts of propylene glycol; 0.1 to 1 part of sodium ethyl paraben; 0.1 to 1 part of sodium ethyl paraben; 80 to 95 parts of purified water; the traditional Chinese medicine composition is used for treating itching, erosion, pain and private part peculiar smell symptoms caused by cervicitis and vaginitis and reducing leucorrhea increase. The preparation method comprises the following steps: S1, raw material acceptance inspection; s2, material picking; s3, weighing and batching; s4, preparing; s5, filling; s6, inner packaging; s7, external packaging; and S8, warehousing. According to the technical scheme, the problems that the application effect is poor, a film-shaped structure of the antibacterial gel has large gaps, part of gaps still exist, and part of small pathogenic microorganisms can enter a human body through the gaps are solved.

Description

Technical Field

[0001] The present invention relates to the technical field of gel for women, and in particular to a recombinant collagen antibacterial gel for women and a preparation method thereof. Background Art

[0002] Women's health has always been a concern for people. For example, cervicitis and vaginitis are common gynecological diseases in adult women. They can cause various physical discomforts and are very harmful to the human body. They can cause infertility and a series of complications, and need to be treated in time.

[0003] After searching, the application publication number is CN115590877A, which is a carbomer gynecological gel. The invention contains carbomer, which can provide a moist environment to promote wound healing; induce erosive tissue cells to produce low-molecular glycoprotein endogenous interferon, anti-virus, regulate immunity, reduce inflammation, promote healing, and is effectively used in the treatment of gynecological diseases;

[0004] The existing principle is mainly to form a protective film on the vaginal wall through raw materials such as carbomer, thereby preventing the colonization of pathogenic microorganisms;

[0005] However, the above-mentioned existing antibacterial gel for women and its preparation method have poor application effect. Its membrane structure has large gaps and some gaps still exist, and some smaller pathogenic microorganisms will enter the human body through the gaps. Therefore, we propose a recombinant collagen antibacterial gel for women and its preparation method. Summary of the invention

[0006] The present invention proposes a recombinant collagen antibacterial gel for women and a preparation method thereof, which solves the problem mentioned in the background technology that the existing antibacterial gel for women and its preparation method have poor application effects, have large gaps in their membrane structures, and still have some gaps, and some smaller pathogenic microorganisms can enter the human body through the gaps.

[0007] The technical solution of the present invention is as follows:

[0008] A recombinant collagen antibacterial gel for women, the weight percentages of its components are as follows:

[0009] Carbomer 0.1-1.9;

[0010] Recombinant collagen 0.8-1.1;

[0011] Hydroxyethyl cellulose 1-1.5;

[0012] Sodium hydroxide 0.1-0.3;

[0013] Isomaltooligosaccharide 0.2-1.5;

[0014] Propylene glycol 3-8;

[0015] Sodium ethylparaben 0.1-1;

[0016] Sodium ethylparaben 0.1-1;

[0017] Purified water 80-95;

[0018] It is used to treat itching, erosion, pain, and vaginal odor caused by cervicitis and vaginitis, and to reduce the increase of leucorrhea;

[0019] The prepared gel is placed in a gel dispenser, and the drug is administered through the gel dispenser. When using, simply open the package and apply the product directly to the vulva or vagina, 1 to 2 times a day.

[0020] The present invention also includes a method for preparing a recombinant collagen antibacterial gel for women, the preparation method comprising the following steps:

[0021] S1 Raw material acceptance inspection;

[0022] S2 picks materials;

[0023] S3 weighing and batching;

[0024] S4 preparation;

[0025] S5 filling;

[0026] S6 inner packaging;

[0027] S7 outer packaging;

[0028] S8 storage;

[0029] Among them, the S4 configuration is specifically:

[0030] Pre-mixed powder:

[0031] ① Mix carbomer and hydroxyethyl cellulose and set aside;

[0032] ② The above materials are added into propylene glycol water through a compressed air feeding device by a five-point serpentine method for dispersion. After dispersion, stirring, homogenization and heating are performed. The parameters are controlled as follows:

[0033] Stirring time: 40 minutes, stirring speed 65 rpm-75 rpm;

[0034] Homogenization time: 40 minutes, 2000±100 rpm;

[0035] Heating time: 40 minutes, 45℃~50℃;

[0036] ③ Add alkaline water, specifically, dissolve sodium hydroxide in water that accounts for one tenth of the total water volume of the formula, take 1 / 3 of the above solution, add it, and then stir, homogenize and heat. The parameters are controlled as follows;

[0037] Stirring time: 10 minutes, stirring speed 65 rpm-75 rpm;

[0038] Homogenization time: 0 min;

[0039] Heating time: stop;

[0040] ④Add protein water, specifically recombinant collagen water, the amount of recombinant collagen water added is 1 part of the total water volume to dissolve;

[0041] ⑤ Add alkaline water, specifically, add alkaline water, the amount of alkaline water added is 1 / 3 of the alkaline solution in step ③, stir and homogenize again, and the parameters are controlled as follows:

[0042] Stirring time: 10 minutes, stirring speed 65 rpm-75 rpm;

[0043] Homogenization time: 5 minutes, 1000±100 rpm;

[0044] ⑥ Add sugar water and oligosaccharide, the amount added is 1 part of the total water volume;

[0045] ⑦ Add alkaline water, the amount of alkaline water added is the amount of alkaline solution remaining in step ③;

[0046] Stirring time: 10 minutes, stirring speed 65 rpm-75 rpm;

[0047] Homogenization time: 5 minutes, 500±50 rpm;

[0048] S5 filling is specifically:

[0049] Fill the configured gel into the gelator through the filling equipment, and check whether the intermediate product after filling meets the filling quantity specified in the product technical requirements.

[0050] As a further technical solution of the present invention, S1 raw material acceptance inspection is specifically: staff inspects incoming raw materials and puts them into storage after inspection and acceptance;

[0051] S2 material collection is as follows: the production workshop collects materials according to the production instructions and operating procedures. After collecting materials, the materials are transported to the raw material temporary storage room, packaging material temporary storage room or receiving post according to the management regulations;

[0052] S3 weighing and batching are as follows:

[0053] (1) The operator checks the name, batch number, quantity and other information of the recombinant collagen antibacterial gel for women to be produced according to the production instructions. If they are consistent with the production instructions, the operator takes the raw materials to the weighing and batching room;

[0054] (2) The operator at the weighing and batching post shall weigh each material according to the batch production instructions; the weighed materials shall be independently reviewed by the reviewer, and cross-weighing shall not be allowed during the weighing process to prevent wrong weighing and mixing of materials.

[0055] As a further technical solution of the present invention, S6 inner packaging specifically comprises: receiving inner packaging materials and intermediate products, doing preparatory work, and then automatically placing the gelator into the inner packaging materials by the machine;

[0056] S7 outer packaging is as follows: the inner packaging material is automatically placed into the outer packaging by the machine, and trial coding is performed. The process supervisor and QA will review the batch production instruction sheet and quality standard requirements, confirm that the printing quality of the printed samples meets the requirements, and start the coding production operation. During the coding process, large boxes that are missed are detected and re-printed in time; large boxes with coding that do not meet the quality requirements are picked out and placed in the specified location for unified processing; large boxes with qualified coding are neatly placed in the specified location, and the materials are marked and transferred to the box packing personnel in a unified manner;

[0057] After the packing personnel have completed the boxing acceptance, they will pack the boxes and package them uniformly after the boxing is completed.

[0058] The specific steps for S8 warehousing are as follows: after the finished product packaging inspection is passed, the process leader will fill out the "Finished Product Warehouse Entry Form" as required, hand it over to the warehouse manager, and go through the finished product warehousing procedures in accordance with the "Finished Product Warehousing, Pending Inspection, Storage, and Outbound Standard Operating Procedures". The finished product will be put into storage after being signed by the workshop director.

[0059] As a further technical solution of the present invention, the weighing, preparation, filling and inner packaging processes are carried out in a Class D clean area, and the temperature and humidity requirements of the clean area are: temperature 18°C ​​to 26°C, humidity 45% to 65%.

[0060] As a further technical solution of the present invention, the outer packaging is in a general production area, and the temperature and humidity requirements are: temperature 10°C ~ 30°C, humidity 25% ~ 75%.

[0061] As a further technical solution of the present invention, a Class D clean area means that clean clothes should cover the hair, beard and other relevant parts; suitable work clothes and shoes or shoe covers should be worn; and appropriate measures should be taken to avoid bringing in pollutants from outside the clean area.

[0062] The working principle and beneficial effects of the present invention are:

[0063] 1. The present invention prepares and applies the recombinant collagen antibacterial gel for women, which can effectively form a protective film on the vaginal wall, physically isolate the vaginal wall from external bacteria, thereby preventing the colonization of pathogenic microorganisms, and has a good effect on the symptoms of itching, erosion, pain, and vaginal odor caused by cervicitis and vaginitis, and can also reduce the increase of leucorrhea.

[0064] 2. The recombinant collagen antibacterial gel for women obtained by the present invention has good film-forming property, the gel is denser after film formation, and the final film-forming bacteria isolation performance is stronger; it not only has good film-forming property, but also has strong repair ability, and the formula is more scientific, and the application effect of the recombinant collagen antibacterial gel for women finally prepared is better; at the same time, by adding prebiotics to the formula, the microecological balance after the gel is formed can be effectively adjusted, and the pH value environment of the cavity can be quickly restored. The pH value of the gel is maintained in a slightly acidic state, which is more conducive to the restoration of the optimal physiological pH of the cavity, so as to achieve the purpose of quickly restoring the self-cleaning ability of the human body; while adding prebiotics (isomaltooligosaccharides) to form a film, the bacterial flora is also balanced and restored to the optimal physiological state; by adding oligosaccharides with prebiotic properties, it can be metabolized and utilized by beneficial bacteria such as bifidobacteria and lactic acid bacteria, promote the proliferation of beneficial bacteria, and play a role in regulating the balance of the bacterial flora in the cavity and restoring the microecological environment. BRIEF DESCRIPTION OF THE DRAWINGS

[0065] The present invention will be further described in detail below in conjunction with the accompanying drawings and specific embodiments.

[0066] Figure 1 The present invention is a flow chart of the method for preparing the recombinant collagen antibacterial gel for women.

[0067] In the figure: ※ indicates a key process. DETAILED DESCRIPTION

[0068] The following will be combined with the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0069] Example 1

[0070] A recombinant collagen antibacterial gel for women, the weight percentages of its components are as follows:

[0071] Carbomer 0.1; recombinant collagen 1.1; hydroxyethyl cellulose 1.5; sodium hydroxide 0.3; isomaltooligosaccharide 0.2; propylene glycol 3; sodium ethylparaben 0.1; sodium butylparaben 0.1; purified water 90.8;

[0072] It is used to treat itching, erosion, pain, and vaginal odor caused by cervicitis and vaginitis, and to reduce the increase of leucorrhea;

[0073] The prepared gel is placed in a gel dispenser, and the drug is administered through the gel dispenser. When using, simply open the package and apply the product directly to the vulva or vagina, 1 to 2 times a day.

[0074] like Figure 1 As shown, this embodiment adopts the following preparation method, which includes the following steps: S1 raw material acceptance inspection;

[0075] S2 picks materials;

[0076] S3 weighing and batching;

[0077] S4 preparation;

[0078] S5 filling;

[0079] S6 inner packaging;

[0080] S7 outer packaging;

[0081] S8 storage;

[0082] Among them, S1 raw material acceptance inspection is specifically: staff inspect the incoming raw materials, and put them into storage after inspection and acceptance;

[0083] S2 material collection is as follows: the production workshop collects materials according to the production instructions and operating procedures. After collecting materials, the materials are transported to the raw material temporary storage room, packaging material temporary storage room or receiving post according to the management regulations;

[0084] S3 weighing and batching are as follows:

[0085] (1) The operator checks the name, batch number, quantity and other information of the recombinant collagen antibacterial gel for women to be produced according to the production instructions. If they are consistent with the production instructions, the operator takes the raw materials to the weighing and batching room;

[0086] (2) The operator at the weighing and batching post shall weigh each material according to the batch production instructions; the weighed materials shall be independently reviewed by the reviewer, and cross-weighing shall not be allowed during the weighing process to prevent wrong weighing and mixing of materials.

[0087] S4 preparation is as follows: Pre-mixed powder:

[0088] ① Mix carbomer and hydroxyethyl cellulose and set aside;

[0089] ② The above materials are added into propylene glycol water through a compressed air feeding device by a five-point serpentine method for dispersion. After dispersion, stirring, homogenization and heating are performed. The parameters are controlled as follows:

[0090] Stirring time: 40 minutes, stirring speed 65 rpm-75 rpm; homogenization time: 40 minutes, 2000±100 rpm; heating time: 40 minutes, 45℃~50℃;

[0091] ③ Add alkaline water, specifically, dissolve sodium hydroxide in water that accounts for one tenth of the total water volume of the formula, take 1 / 3 of the above solution, add it, and then stir, homogenize and heat. The parameters are controlled as follows: stirring time: 10 minutes, stirring speed 65 rpm-75 rpm; homogenization time: 0 minutes; heating time: stop;

[0092] ④Add protein water, specifically recombinant collagen water, the amount of recombinant collagen water added is 1 part of the total water volume to dissolve;

[0093] ⑤ Add alkaline water, specifically, add alkaline water, the amount of alkaline water added is 1 / 3 of the alkaline solution in step ③, stir and homogenize again, and the parameters are controlled as follows: stirring time: 10 minutes, stirring speed 65 rpm-75 rpm; homogenization time: 5 minutes, 1000±100 rpm;

[0094] ⑥ Add sugar water and oligosaccharide, the amount added is 1 part of the total water volume;

[0095] ⑦ Add alkaline water, the amount of alkaline water added is the amount of alkaline solution remaining in step ③; stirring time: 10 minutes, stirring speed 65 rpm-75 rpm; homogenization time: 5 minutes, 500±50 rpm;

[0096] S5 filling is specifically:

[0097] Fill the configured gel into the gelator through the filling equipment, and check whether the intermediate product after filling meets the filling quantity specified in the product technical requirements.

[0098] S6 inner packaging specifically involves: receiving inner packaging materials and intermediate products, doing preparatory work, and then automatically placing the gelator into the inner packaging materials through the machine;

[0099] S7 outer packaging is as follows: the inner packaging material is automatically placed into the outer packaging by the machine, and trial coding is performed. The process supervisor and QA will review the batch production instruction sheet and quality standard requirements, confirm that the printing quality of the printed samples meets the requirements, and start the coding production operation. During the coding process, large boxes that are missed are detected and re-printed in time; large boxes with coding that do not meet the quality requirements are picked out and placed in the specified location for unified processing; large boxes with qualified coding are neatly placed in the specified location, and the materials are marked and transferred to the box packing personnel in a unified manner;

[0100] After the packing personnel have completed the boxing acceptance, they will pack the boxes and package them uniformly after the boxing is completed.

[0101] The specific steps for S8 warehousing are as follows: after the finished product packaging inspection is passed, the process leader will fill out the "Finished Product Warehouse Entry Form" as required, hand it over to the warehouse manager, and go through the finished product warehousing procedures in accordance with the "Finished Product Warehousing, Pending Inspection, Storage, and Outbound Standard Operating Procedures". The finished product will be put into storage after being signed by the workshop director.

[0102] The weighing, preparation, filling and inner packaging processes are carried out in a Class D clean area. The temperature and humidity requirements for the clean area are: temperature 18℃~26℃, humidity 45%~65%.

[0103] The outer packaging is in the general production area, and the temperature and humidity requirements are: temperature 10℃~30℃, humidity 25%~75%.

[0104] Class D clean area means that clean clothes should cover the hair, beard and other relevant parts; suitable work clothes and shoes or shoe covers should be worn; and appropriate measures should be taken to avoid bringing in pollutants from outside the clean area.

[0105] Example 2

[0106] A recombinant collagen antibacterial gel for women, the weight percentages of its components are as follows:

[0107] Carbomer 1.9; recombinant collagen 0.8; hydroxyethyl cellulose 1; sodium hydroxide 0.1; isomaltooligosaccharide 1.5; propylene glycol 8; sodium ethylparaben 1; sodium butylparaben 1; purified water 94;

[0108] It is used to treat itching, erosion, pain, and vaginal odor caused by cervicitis and vaginitis, and to reduce the increase of leucorrhea;

[0109] The prepared gel is placed in a gel dispenser, and the drug is administered through the gel dispenser. When using, simply open the package and apply the product directly to the vulva or vagina, 1 to 2 times a day.

[0110] like Figure 1 As shown, this embodiment adopts the following preparation method, which includes the following steps: S1 raw material acceptance inspection;

[0111] S2 picks materials;

[0112] S3 weighing and batching;

[0113] S4 preparation;

[0114] S5 filling;

[0115] S6 inner packaging;

[0116] S7 outer packaging;

[0117] S8 storage;

[0118] Among them, S1 raw material acceptance inspection is specifically: staff inspect the incoming raw materials, and put them into storage after inspection and acceptance;

[0119] S2 material collection is as follows: the production workshop collects materials according to the production instructions and operating procedures. After collecting materials, the materials are transported to the raw material temporary storage room, packaging material temporary storage room or receiving post according to the management regulations;

[0120] S3 weighing and batching are as follows:

[0121] (1) The operator checks the name, batch number, quantity and other information of the recombinant collagen antibacterial gel for women to be produced according to the production instructions. If they are consistent with the production instructions, the operator takes the raw materials to the weighing and batching room;

[0122] (2) The operator at the weighing and batching post shall weigh each material according to the batch production instructions; the weighed materials shall be independently reviewed by the reviewer, and cross-weighing shall not be allowed during the weighing process to prevent wrong weighing and mixing of materials.

[0123] S4 preparation is as follows: Pre-mixed powder:

[0124] ① Mix carbomer and hydroxyethyl cellulose and set aside;

[0125] ② The above materials are added into propylene glycol water through a compressed air feeding device by a five-point serpentine method for dispersion. After dispersion, stirring, homogenization and heating are performed. The parameters are controlled as follows:

[0126] Stirring time: 40 minutes, stirring speed 65 rpm-75 rpm; homogenization time: 40 minutes, 2000±100 rpm; heating time: 40 minutes, 45℃~50℃;

[0127] ③ Add alkaline water, specifically, dissolve sodium hydroxide in water that accounts for one tenth of the total water volume of the formula, take 1 / 3 of the above solution, add it, and then stir, homogenize and heat. The parameters are controlled as follows: stirring time: 10 minutes, stirring speed 65 rpm-75 rpm; homogenization time: 0 minutes; heating time: stop;

[0128] ④Add protein water, specifically recombinant collagen water, the amount of recombinant collagen water added is 1 part of the total water volume to dissolve;

[0129] ⑤ Add alkaline water, specifically, add alkaline water, the amount of alkaline water added is 1 / 3 of the alkaline solution in step ③, stir and homogenize again, and the parameters are controlled as follows: stirring time: 10 minutes, stirring speed 65 rpm-75 rpm; homogenization time: 5 minutes, 1000±100 rpm;

[0130] ⑥ Add sugar water and oligosaccharide, the amount added is 1 part of the total water volume;

[0131] ⑦ Add alkaline water, the amount of alkaline water added is the amount of alkaline solution remaining in step ③; stirring time: 10 minutes, stirring speed 65 rpm-75 rpm; homogenization time: 5 minutes, 500±50 rpm;

[0132] S5 filling is specifically:

[0133] Fill the configured gel into the gelator through the filling equipment, and check whether the intermediate product after filling meets the filling quantity specified in the product technical requirements.

[0134] S6 inner packaging specifically involves: receiving inner packaging materials and intermediate products, doing preparatory work, and then automatically placing the gelator into the inner packaging materials through the machine;

[0135] S7 outer packaging is as follows: the inner packaging material is automatically placed into the outer packaging by the machine, and trial coding is performed. The process supervisor and QA will review the batch production instruction sheet and quality standard requirements, confirm that the printing quality of the printed samples meets the requirements, and start the coding production operation. During the coding process, large boxes that are missed are detected and re-printed in time; large boxes with coding that do not meet the quality requirements are picked out and placed in the specified location for unified processing; large boxes with qualified coding are neatly placed in the specified location, and the materials are marked and transferred to the box packing personnel in a unified manner;

[0136] After the packing personnel have completed the boxing acceptance, they will pack the boxes and package them uniformly after the boxing is completed.

[0137] The specific steps for S8 warehousing are as follows: after the finished product packaging inspection is passed, the process leader will fill out the "Finished Product Warehouse Entry Form" as required, hand it over to the warehouse manager, and go through the finished product warehousing procedures in accordance with the "Finished Product Warehousing, Pending Inspection, Storage, and Outbound Standard Operating Procedures". The finished product will be put into storage after being signed by the workshop director.

[0138] The weighing, preparation, filling and inner packaging processes are carried out in a Class D clean area. The temperature and humidity requirements for the clean area are: temperature 18℃~26℃, humidity 45%~65%.

[0139] The outer packaging is in the general production area, and the temperature and humidity requirements are: temperature 10℃~30℃, humidity 25%~75%.

[0140] Class D clean area means that clean clothes should cover the hair, beard and other relevant parts; suitable work clothes and shoes or shoe covers should be worn; and appropriate measures should be taken to avoid bringing in pollutants from outside the clean area.

[0141] Example 3

[0142] A recombinant collagen antibacterial gel for women, the weight percentages of its components are as follows:

[0143] Carbomer 0.3; recombinant collagen 0.85; hydroxyethyl cellulose 1.2; sodium hydroxide 0.2; isomaltooligosaccharide 0.25; propylene glycol 3; sodium ethylparaben 0.2; sodium butylparaben 0.2; purified water 93.8;

[0144] It is used to treat itching, erosion, pain, and vaginal odor caused by cervicitis and vaginitis, and to reduce the increase of leucorrhea;

[0145] The prepared gel is placed in a gel dispenser, and the drug is administered through the gel dispenser. When using, simply open the package and apply the product directly to the vulva or vagina, 1 to 2 times a day.

[0146] like Figure 1 As shown, this embodiment adopts the following preparation method, which includes the following steps: S1 raw material acceptance inspection;

[0147] S2 picks materials;

[0148] S3 weighing and batching;

[0149] S4 preparation;

[0150] S5 filling;

[0151] S6 inner packaging;

[0152] S7 outer packaging;

[0153] S8 storage;

[0154] Among them, S1 raw material acceptance inspection is specifically: staff inspect the incoming raw materials, and put them into storage after inspection and acceptance;

[0155] S2 material collection is as follows: the production workshop collects materials according to the production instructions and operating procedures. After collecting materials, the materials are transported to the raw material temporary storage room, packaging material temporary storage room or receiving post according to the management regulations;

[0156] S3 weighing and batching are as follows:

[0157] (1) The operator checks the name, batch number, quantity and other information of the recombinant collagen antibacterial gel for women to be produced according to the production instructions. If they are consistent with the production instructions, the operator takes the raw materials to the weighing and batching room;

[0158] (2) The operator at the weighing and batching post shall weigh each material according to the batch production instructions; the weighed materials shall be independently reviewed by the reviewer, and cross-weighing shall not be allowed during the weighing process to prevent wrong weighing and mixing of materials.

[0159] S4 preparation is as follows: Pre-mixed powder:

[0160] ① Mix carbomer and hydroxyethyl cellulose and set aside;

[0161] ② The above materials are added into propylene glycol water through a compressed air feeding device by a five-point serpentine method for dispersion. After dispersion, stirring, homogenization and heating are performed. The parameters are controlled as follows:

[0162] Stirring time: 40 minutes, stirring speed 65 rpm-75 rpm; homogenization time: 40 minutes, 2000±100 rpm; heating time: 40 minutes, 45℃~50℃;

[0163] ③ Add alkaline water, specifically, dissolve sodium hydroxide in water that accounts for one tenth of the total water volume of the formula, take 1 / 3 of the above solution, add it, and then stir, homogenize and heat. The parameters are controlled as follows: stirring time: 10 minutes, stirring speed 65 rpm-75 rpm; homogenization time: 0 minutes; heating time: stop;

[0164] ④Add protein water, specifically recombinant collagen water, the amount of recombinant collagen water added is 1 part of the total water volume to dissolve;

[0165] ⑤ Add alkaline water, specifically, add alkaline water, the amount of alkaline water added is 1 / 3 of the alkaline solution in step ③, stir and homogenize again, and the parameters are controlled as follows: stirring time: 10 minutes, stirring speed 65 rpm-75 rpm; homogenization time: 5 minutes, 1000±100 rpm;

[0166] ⑥ Add sugar water and oligosaccharide, the amount added is 1 part of the total water volume;

[0167] ⑦ Add alkaline water, the amount of alkaline water added is the amount of alkaline solution remaining in step ③; stirring time: 10 minutes, stirring speed 65 rpm-75 rpm; homogenization time: 5 minutes, 500±50 rpm;

[0168] S5 filling is specifically:

[0169] Fill the configured gel into the gelator through the filling equipment, and check whether the intermediate product after filling meets the filling quantity specified in the product technical requirements.

[0170] S6 inner packaging specifically involves: receiving inner packaging materials and intermediate products, doing preparatory work, and then automatically placing the gelator into the inner packaging materials through the machine;

[0171] S7 outer packaging is as follows: the inner packaging material is automatically placed into the outer packaging by the machine, and trial coding is performed. The process supervisor and QA will review the batch production instruction sheet and quality standard requirements, confirm that the printing quality of the printed samples meets the requirements, and start the coding production operation. During the coding process, large boxes that are missed are detected and re-printed in time; large boxes with coding that do not meet the quality requirements are picked out and placed in the specified location for unified processing; large boxes with qualified coding are neatly placed in the specified location, and the materials are marked and transferred to the box packing personnel in a unified manner;

[0172] After the packing personnel have completed the boxing acceptance, they will pack the boxes and package them uniformly after the boxing is completed.

[0173] The specific steps for S8 warehousing are as follows: after the finished product packaging inspection is passed, the process leader will fill out the "Finished Product Warehouse Entry Form" as required, hand it over to the warehouse manager, and go through the finished product warehousing procedures in accordance with the "Finished Product Warehousing, Pending Inspection, Storage, and Outbound Standard Operating Procedures". The finished product will be put into storage after being signed by the workshop director.

[0174] The weighing, preparation, filling and inner packaging processes are carried out in a Class D clean area. The temperature and humidity requirements for the clean area are: temperature 18℃~26℃, humidity 45%~65%.

[0175] The outer packaging is in the general production area, and the temperature and humidity requirements are: temperature 10℃~30℃, humidity 25%~75%.

[0176] Class D clean area means that clean clothes should cover the hair, beard and other relevant parts; suitable work clothes and shoes or shoe covers should be worn; and appropriate measures should be taken to avoid bringing in pollutants from outside the clean area.

[0177] Example 4

[0178] A recombinant collagen antibacterial gel for women, the weight percentages of its components are as follows:

[0179] Carbomer 0.3; recombinant collagen 1; hydroxyethyl cellulose 1.2; sodium hydroxide 0.25; isomaltooligosaccharide 0.35; propylene glycol 3; sodium ethylparaben 0.1; sodium butylparaben 0.2; purified water 93.6;

[0180] It is used to treat itching, erosion, pain, and vaginal odor caused by cervicitis and vaginitis, and to reduce the increase of leucorrhea;

[0181] The prepared gel is placed in a gel dispenser, and the drug is administered through the gel dispenser. When using, simply open the package and apply the product directly to the vulva or vagina, 1 to 2 times a day.

[0182] The present invention also includes a method for preparing a recombinant collagen antibacterial gel for women, the preparation method comprising the following steps:

[0183] S1 Raw material acceptance inspection;

[0184] S2 picks materials;

[0185] S3 weighing and batching;

[0186] S4 preparation;

[0187] S5 filling;

[0188] S6 inner packaging;

[0189] S7 outer packaging;

[0190] S8 storage;

[0191] Among them, S1 raw material acceptance inspection is specifically: staff inspect the incoming raw materials, and put them into storage after inspection and acceptance;

[0192] S2 material collection is as follows: the production workshop collects materials according to the production instructions and operating procedures. After collecting materials, the materials are transported to the raw material temporary storage room, packaging material temporary storage room or receiving post according to the management regulations;

[0193] S3 weighing and batching are as follows:

[0194] (1) The operator checks the name, batch number, quantity and other information of the recombinant collagen antibacterial gel for women to be produced according to the production instructions. If they are consistent with the production instructions, the operator takes the raw materials to the weighing and batching room;

[0195] (2) The operator at the weighing and batching post shall weigh each material according to the batch production instructions; the weighed materials shall be independently reviewed by the reviewer, and cross-weighing shall not be allowed during the weighing process to prevent wrong weighing and mixing of materials.

[0196] S4 preparation is as follows: Pre-mixed powder:

[0197] ① Mix carbomer and hydroxyethyl cellulose and set aside;

[0198] ② The above materials are added into propylene glycol water through a compressed air feeding device by a five-point serpentine method for dispersion. After dispersion, stirring, homogenization and heating are performed. The parameters are controlled as follows:

[0199] Stirring time: 40 minutes, stirring speed 65 rpm-75 rpm; homogenization time: 40 minutes, 2000±100 rpm; heating time: 40 minutes, 45℃~50℃;

[0200] ③ Add alkaline water, specifically, dissolve sodium hydroxide in water that accounts for one tenth of the total water volume of the formula, take 1 / 3 of the above solution, add it, and then stir, homogenize and heat. The parameters are controlled as follows: stirring time: 10 minutes, stirring speed 65 rpm-75 rpm; homogenization time: 0 minutes; heating time: stop;

[0201] ④Add protein water, specifically recombinant collagen water, the amount of recombinant collagen water added is 1 part of the total water volume to dissolve;

[0202] ⑤ Add alkaline water, specifically, add alkaline water, the amount of alkaline water added is 1 / 3 of the alkaline solution in step ③, stir and homogenize again, and the parameters are controlled as follows: stirring time: 10 minutes, stirring speed 65 rpm-75 rpm; homogenization time: 5 minutes, 1000±100 rpm;

[0203] ⑥ Add sugar water and oligosaccharide, the amount added is 1 part of the total water volume;

[0204] ⑦ Add alkaline water, the amount of alkaline water added is the amount of alkaline solution remaining in step ③; stirring time: 10 minutes, stirring speed 65 rpm-75 rpm; homogenization time: 5 minutes, 500±50 rpm;

[0205] S5 filling is specifically:

[0206] Fill the configured gel into the gelator through the filling equipment, and check whether the intermediate product after filling meets the filling quantity specified in the product technical requirements.

[0207] S6 inner packaging specifically involves: receiving inner packaging materials and intermediate products, doing preparatory work, and then automatically placing the gelator into the inner packaging materials through the machine;

[0208] S7 outer packaging is as follows: the inner packaging material is automatically placed into the outer packaging by the machine, and trial coding is performed. The process supervisor and QA will review the batch production instruction sheet and quality standard requirements, confirm that the printing quality of the printed samples meets the requirements, and start the coding production operation. During the coding process, large boxes that are missed are detected and re-printed in time; large boxes with coding that do not meet the quality requirements are picked out and placed in the specified location for unified processing; large boxes with qualified coding are neatly placed in the specified location, and the materials are marked and transferred to the box packing personnel in a unified manner;

[0209] After the packing personnel have completed the boxing acceptance, they will pack the boxes and package them uniformly after the boxing is completed.

[0210] The specific steps for S8 warehousing are as follows: after the finished product packaging inspection is passed, the process leader will fill out the "Finished Product Warehouse Entry Form" as required, hand it over to the warehouse manager, and go through the finished product warehousing procedures in accordance with the "Finished Product Warehousing, Pending Inspection, Storage, and Outbound Standard Operating Procedures". The finished product will be put into storage after being signed by the workshop director.

[0211] The weighing, preparation, filling and inner packaging processes are carried out in a Class D clean area. The temperature and humidity requirements for the clean area are: temperature 18℃~26℃, humidity 45%~65%.

[0212] The outer packaging is in the general production area, and the temperature and humidity requirements are: temperature 10℃~30℃, humidity 25%~75%.

[0213] Class D clean area means that clean clothes should cover the hair, beard and other relevant parts; suitable work clothes and shoes or shoe covers should be worn; and appropriate measures should be taken to avoid bringing in pollutants from outside the clean area.

[0214] Example 5

[0215] A recombinant collagen antibacterial gel for women, the weight percentages of its components are as follows:

[0216] Carbomer 0.4; recombinant collagen 1.05; hydroxyethyl cellulose 1.4; sodium hydroxide 0.3; isomaltooligosaccharide 0.3; propylene glycol 4.25; sodium ethylparaben 0.15; sodium butylparaben 0.15; purified water 92;

[0217] It is used to treat itching, erosion, pain, and vaginal odor caused by cervicitis and vaginitis, and to reduce the increase of leucorrhea;

[0218] The prepared gel is placed in a gel dispenser, and the drug is administered through the gel dispenser. When using, simply open the package and apply the product directly to the vulva or vagina, 1 to 2 times a day.

[0219] The present invention also includes a method for preparing a recombinant collagen antibacterial gel for women, the preparation method comprising the following steps:

[0220] S1 Raw material acceptance inspection;

[0221] S2 picks materials;

[0222] S3 weighing and batching;

[0223] S4 preparation;

[0224] S5 filling;

[0225] S6 inner packaging;

[0226] S7 outer packaging;

[0227] S8 storage;

[0228] Among them, S1 raw material acceptance inspection is specifically: staff inspect the incoming raw materials, and put them into storage after inspection and acceptance;

[0229] S2 material collection is as follows: the production workshop collects materials according to the production instructions and operating procedures. After collecting materials, the materials are transported to the raw material temporary storage room, packaging material temporary storage room or receiving post according to the management regulations;

[0230] S3 weighing and batching are as follows:

[0231] (1) The operator checks the name, batch number, quantity and other information of the recombinant collagen antibacterial gel for women to be produced according to the production instructions. If they are consistent with the production instructions, the operator takes the raw materials to the weighing and batching room;

[0232] (2) The operator at the weighing and batching post shall weigh each material according to the batch production instructions; the weighed materials shall be independently reviewed by the reviewer, and cross-weighing shall not be allowed during the weighing process to prevent wrong weighing and mixing of materials.

[0233] S4 preparation is as follows: Pre-mixed powder:

[0234] ① Mix carbomer and hydroxyethyl cellulose and set aside;

[0235] ② The above materials are added into propylene glycol water through a compressed air feeding device by a five-point serpentine method for dispersion. After dispersion, stirring, homogenization and heating are performed. The parameters are controlled as follows: stirring time: 40 minutes, stirring speed 65 rpm-75 rpm; homogenization time: 40 minutes, 2000±100 rpm; heating time: 40 minutes, 45°C-50°C;

[0236] ③ Add alkaline water, specifically, dissolve sodium hydroxide in water that accounts for one tenth of the total water volume of the formula, take 1 / 3 of the above solution, add it, and then stir, homogenize and heat. The parameters are controlled as follows: stirring time: 10 minutes, stirring speed 65 rpm-75 rpm; homogenization time: 0 minutes; heating time: stop;

[0237] ④Add protein water, specifically recombinant collagen water, the amount of recombinant collagen water added is 1 part of the total water volume to dissolve;

[0238] ⑤ Add alkaline water, specifically, add alkaline water, the amount of alkaline water added is 1 / 3 of the alkaline solution in step ③, stir and homogenize again, and the parameters are controlled as follows:

[0239] Stirring time: 10 minutes, stirring speed 65 rpm-75 rpm; homogenization time: 5 minutes, 1000±100 rpm;

[0240] ⑥ Add sugar water and oligosaccharide, the amount added is 1 part of the total water volume;

[0241] ⑦ Add alkaline water, the amount of alkaline water added is the amount of alkaline solution remaining in step ③; stirring time: 10 minutes, stirring speed 65 rpm-75 rpm; homogenization time: 5 minutes, 500±50 rpm;

[0242] S5 filling is specifically:

[0243] Fill the configured gel into the gelator through the filling equipment, and check whether the intermediate product after filling meets the filling quantity specified in the product technical requirements.

[0244] S6 inner packaging specifically involves: receiving inner packaging materials and intermediate products, doing preparatory work, and then automatically placing the gelator into the inner packaging materials through the machine;

[0245] S7 outer packaging is as follows: the inner packaging material is automatically placed into the outer packaging by the machine, and trial coding is performed. The process supervisor and QA will review the batch production instruction sheet and quality standard requirements, confirm that the printing quality of the printed samples meets the requirements, and start the coding production operation. During the coding process, large boxes that are missed are detected and re-printed in time; large boxes with coding that do not meet the quality requirements are picked out and placed in the specified location for unified processing; large boxes with qualified coding are neatly placed in the specified location, and the materials are marked and transferred to the box packing personnel in a unified manner;

[0246] After the packing personnel have completed the boxing acceptance, they will pack the boxes and package them uniformly after the boxing is completed.

[0247] The specific steps for S8 warehousing are as follows: after the finished product packaging inspection is passed, the process leader will fill out the "Finished Product Warehouse Entry Form" as required, hand it over to the warehouse manager, and go through the finished product warehousing procedures in accordance with the "Finished Product Warehousing, Pending Inspection, Storage, and Outbound Standard Operating Procedures". The finished product will be put into storage after being signed by the workshop director.

[0248] The weighing, preparation, filling and inner packaging processes are carried out in a Class D clean area. The temperature and humidity requirements for the clean area are: temperature 18℃~26℃, humidity 45%~65%.

[0249] The outer packaging is in the general production area, and the temperature and humidity requirements are: temperature 10℃~30℃, humidity 25%~75%.

[0250] Class D clean area means that clean clothes should cover the hair, beard and other relevant parts; suitable work clothes and shoes or shoe covers should be worn; and appropriate measures should be taken to avoid bringing in pollutants from outside the clean area.

[0251] Example 6

[0252] A recombinant collagen antibacterial gel for women, the weight percentages of its components are as follows:

[0253] Carbomer 0.4;

[0254] Recombinant collagen 1.1;

[0255] Hydroxyethylcellulose 1;

[0256] Sodium hydroxide 0.15;

[0257] Isomaltooligosaccharide 0.25;

[0258] Propylene glycol 5;

[0259] Ethylparaben sodium 0.2;

[0260] Sodium butylparaben 0.1;

[0261] Purified water 91.8;

[0262] It is used to treat itching, erosion, pain, and vaginal odor caused by cervicitis and vaginitis, and to reduce the increase of leucorrhea;

[0263] The prepared gel is placed in a gel dispenser, and the drug is administered through the gel dispenser. When using, simply open the package and apply the product directly to the vulva or vagina, 1 to 2 times a day.

[0264] The present invention also includes a method for preparing a recombinant collagen antibacterial gel for women, the preparation method comprising the following steps:

[0265] S1 Raw material acceptance inspection;

[0266] S2 picks materials;

[0267] S3 weighing and batching;

[0268] S4 preparation;

[0269] S5 filling;

[0270] S6 inner packaging;

[0271] S7 outer packaging;

[0272] S8 storage;

[0273] Among them, S1 raw material acceptance inspection is specifically: staff inspect the incoming raw materials, and put them into storage after inspection and acceptance;

[0274] S2 material collection is as follows: the production workshop collects materials according to the production instructions and operating procedures. After collecting materials, the materials are transported to the raw material temporary storage room, packaging material temporary storage room or receiving post according to the management regulations;

[0275] S3 weighing and batching are as follows:

[0276] (1) The operator checks the name, batch number, quantity and other information of the recombinant collagen antibacterial gel for women to be produced according to the production instructions. If they are consistent with the production instructions, the operator takes the raw materials to the weighing and batching room;

[0277] (2) The operator at the weighing and batching post shall weigh each material according to the batch production instructions; the weighed materials shall be independently reviewed by the reviewer, and cross-weighing shall not be allowed during the weighing process to prevent wrong weighing and mixing of materials.

[0278] S4 preparation is as follows: Pre-mixed powder:

[0279] ① Mix carbomer and hydroxyethyl cellulose and set aside;

[0280] ② The above materials are added into propylene glycol water through a compressed air feeding device by a five-point serpentine method for dispersion. After dispersion, stirring, homogenization and heating are performed. The parameters are controlled as follows: stirring time: 40 minutes, stirring speed 65 rpm-75 rpm; homogenization time: 40 minutes, 2000±100 rpm; heating time: 40 minutes, 45°C-50°C;

[0281] ③ Add alkaline water, specifically, dissolve sodium hydroxide in water that accounts for one tenth of the total water volume of the formula, take 1 / 3 of the above solution, add it, and then stir, homogenize and heat. The parameters are controlled as follows: stirring time: 10 minutes, stirring speed 65 rpm-75 rpm; homogenization time: 0 minutes; heating time: stop;

[0282] ④Add protein water, specifically recombinant collagen water, the amount of recombinant collagen water added is 1 part of the total water volume to dissolve;

[0283] ⑤ Add alkaline water, specifically, add alkaline water, the amount of alkaline water added is 1 / 3 of the alkaline solution in step ③, stir and homogenize again, and the parameters are controlled as follows: stirring time: 10 minutes, stirring speed 65 rpm-75 rpm; homogenization time: 5 minutes, 1000±100 rpm;

[0284] ⑥ Add sugar water and oligosaccharide, the amount added is 1 part of the total water volume;

[0285] ⑦ Add alkaline water, the amount of alkaline water added is the amount of alkaline solution remaining in step ③; stirring time: 10 minutes, stirring speed 65 rpm-75 rpm; homogenization time: 5 minutes, 500±50 rpm;

[0286] S5 filling is specifically: filling the configured gel into the gelator through the filling equipment, and checking whether the intermediate product after filling meets the filling quantity specified in the product technical requirements.

[0287] S6 inner packaging specifically involves: receiving inner packaging materials and intermediate products, doing preparatory work, and then automatically placing the gelator into the inner packaging materials through the machine;

[0288] S7 outer packaging is as follows: the inner packaging material is automatically placed into the outer packaging by the machine, and trial coding is performed. The process supervisor and QA will review the batch production instruction sheet and quality standard requirements, confirm that the printing quality of the printed samples meets the requirements, and start the coding production operation. During the coding process, large boxes that are missed are detected and re-printed in time; large boxes with coding that do not meet the quality requirements are picked out and placed in the specified location for unified processing; large boxes with qualified coding are neatly placed in the specified location, and the materials are marked and transferred to the box packing personnel in a unified manner;

[0289] After the packing personnel have completed the boxing acceptance, they will pack the boxes and package them uniformly after the boxing is completed.

[0290] The specific steps for S8 warehousing are as follows: after the finished product packaging inspection is passed, the process leader will fill out the "Finished Product Warehouse Entry Form" as required, hand it over to the warehouse manager, and go through the finished product warehousing procedures in accordance with the "Finished Product Warehousing, Pending Inspection, Storage, and Outbound Standard Operating Procedures". The finished product will be put into storage after being signed by the workshop director.

[0291] The weighing, preparation, filling and inner packaging processes are carried out in a Class D clean area. The temperature and humidity requirements for the clean area are: temperature 18℃~26℃, humidity 45%~65%.

[0292] The outer packaging is in the general production area, and the temperature and humidity requirements are: temperature 10℃~30℃, humidity 25%~75%.

[0293] Class D clean area means that clean clothes should cover the hair, beard and other relevant parts; suitable work clothes and shoes or shoe covers should be worn; and appropriate measures should be taken to avoid bringing in pollutants from outside the clean area.

[0294] Example 1 to Example 3 are antibacterial gel products for women obtained under different weight component formulas. In the actual treatment of cervicitis and vaginitis, 100 people were treated in each example. In a single example, 60 people had mild symptoms, 30 people had moderate symptoms, and 10 people had severe symptoms. The number of cured people is shown in the following table:

[0295]

[0296] It can be concluded from the above table that the treatment effect in Example 3 is the best. Among the 60 people with mild symptoms, 55 were cured within 1 week, and all were cured within 2 weeks. Among the 30 people with moderate symptoms, 26 were cured within 1 week, and all were cured within 2 weeks. Among the 10 people with severe symptoms, 4 were cured within 1 week, 7 were cured within 2 weeks, and all were cured within 4 weeks.

[0297] The recombinant collagen antibacterial gel for women obtained by the present invention is denser after film formation, and has stronger performance of isolating bacteria after final film formation; it not only has good film-forming property, but also has strong repairing ability, and the formula is more scientific, so the application effect of the recombinant collagen antibacterial gel for women finally prepared is better; by adding prebiotics to the formula, the microecological balance after gel formation can be effectively adjusted, the pH value environment of the cavity can be quickly restored, and the pH value is adjusted to be between 4.0 and 4.5, which is more conducive to the cavity to restore the best physiological pH, so as to achieve the purpose of quickly restoring the self-cleaning ability of the human body; while adding prebiotics to form a film, the flora is also balanced and restored to the best physiological state; by adding oligosaccharides with prebiotic characteristics, it can be metabolized and utilized by beneficial bacteria such as bifidobacteria and lactic acid bacteria, promote the proliferation of beneficial bacteria, and play a role in regulating the balance of flora in the cavity and restoring the microecological environment.

[0298] It should be noted that a membrane structure can be formed by carbomer, recombinant collagen, hydroxyethyl cellulose and isomaltooligosaccharide, the components of which are cross-linked with each other, and the carbomer molecules will open due to the electrical repulsion between the molecules. During the opening process, the recombinant collagen, hydroxyethyl cellulose and isomaltooligosaccharide molecules will penetrate into it, thereby forming a denser protective layer. At the same time, adding alkaline water multiple times during the preparation can adjust the opening angle of the carbomer molecules, so that the above molecules can fully penetrate into the gaps opened by the carbomer molecules, which can form more effective protection and better healing effect.

[0299] The clinical treatment cases of the present invention are as follows:

[0300] Case 1: Zhang, 30 years old, had mild cervicitis and vaginitis, accompanied by itching symptoms. After using the gel of the present invention, the itching disappeared on the same day and was cured in the second week;

[0301] Case 2: Li, 25 years old, had mild vaginitis, accompanied by local pain and odor. After using the gel of the present invention, the pain was relieved on the same day, and there was no pain within 3 days, and the odor was reduced. He was cured within 1 week.

[0302] Case 3: Mr. Wang, 45 years old, had moderate cervicitis and vaginitis, accompanied by local itching, strong odor, and local pain. After using the gel of the present invention, the itching was relieved within 1 week, the odor was reduced, and the disease was cured within 2 weeks.

[0303] Case 4: Cui, 43 years old, had moderate cervicitis and vaginitis, accompanied by local itching, increased leucorrhea, and strong odor. After using the gel of the present invention, the itching was relieved within 1 week, the odor was reduced, the leucorrhea was normal, and he was cured within 2 weeks.

[0304] Case 5: Tang, 38 years old, had severe cervicitis and vaginitis, local erosion, pain and itching, strong odor, abnormal leucorrhea. After using the gel of the present invention, the odor was alleviated within 1 week, there was no obvious pain, itching disappeared, leucorrhea was normal, and he was cured in the 3rd week.

[0305] Case 6: Lv, 41 years old, had severe cervicitis and vaginitis, local erosion, severe odor, unbearable pain and itching, and abnormal leucorrhea. After using the gel of the present invention, the pain was reduced within 1 week, and there was no obvious pain. The odor was reduced within 2 weeks, the pain disappeared, the odor and itching disappeared, and the patient was cured in the 4th week.

[0306] The above are only preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the protection scope of the present invention.

Claims

1. A recombinant collagen antibacterial gel for women, characterized in that: The weight percentages of the components are as follows: Carbomer 0.1-1.9; Recombinant collagen 0.8-1.1; Hydroxyethyl cellulose 1-1.5; Sodium hydroxide 0.1-0.3; Isomaltooligosaccharide 0.2-1.5; Propylene glycol 3-8; Sodium ethylparaben 0.1-1; Sodium ethylparaben 0.1-1; Purified water 80-95; It is used to treat itching, erosion, pain, and vaginal odor caused by cervicitis and vaginitis, and to reduce the increase of leucorrhea; The prepared gel is placed in a gel dispenser, and the drug is administered through the gel dispenser. When using, simply open the package and apply the product directly to the vulva or vagina, 1 to 2 times a day.

2. A method for preparing a recombinant collagen antibacterial gel for women, using the recombinant collagen antibacterial gel formula for women according to claim 1, characterized in that: The preparation method comprises the following steps: S1 Raw material acceptance inspection; S2 picks materials; S3 weighing and batching; S4 preparation; S5 filling; S6 inner packaging; S7 outer packaging; S8 storage; Among them, the S4 configuration is specifically: Pre-mixed powder: ① Mix carbomer and hydroxyethyl cellulose and set aside; ② The above materials are added into propylene glycol water through a compressed air feeding device by a five-point serpentine method for dispersion. After dispersion, stirring, homogenization and heating are performed. The parameters are controlled as follows: Stirring time: 40 minutes, stirring speed 65 rpm-75 rpm; Homogenization time: 40 minutes, 2000±100 rpm; Heating time: 40 minutes, 45℃~50℃; ③ Add alkaline water, specifically, dissolve sodium hydroxide in water that is one tenth of the total water volume of the formula, take 1 / 3 of the above solution, add it, and then stir, homogenize and heat. The parameters are controlled as follows; Stirring time: 10 minutes, stirring speed 65 rpm-75 rpm; Homogenization time: 0 min; Heating time: stop; ④Add protein water, specifically recombinant collagen water, the amount of recombinant collagen water added is 1 part of the total water volume to dissolve; ⑤ Add alkaline water, specifically, add alkaline water, the amount of alkaline water added is 1 / 3 of the alkaline solution in step ③, stir and homogenize again, and the parameters are controlled as follows: Stirring time: 10 minutes, stirring speed 65 rpm-75 rpm; Homogenization time: 5 minutes, 1000±100 rpm; ⑥ Add sugar water and oligosaccharide, the amount added is 1 part of the total water volume; ⑦ Add alkaline water, the amount of alkaline water added is the amount of alkaline solution remaining in step ③; Stirring time: 10 minutes, stirring speed 65 rpm-75 rpm; Homogenization time: 5 minutes, 500±50 rpm; S5 filling is specifically: Fill the configured gel into the gelator through the filling equipment, and check whether the intermediate product after filling meets the filling quantity specified in the product technical requirements.

3. The method for preparing the recombinant collagen antibacterial gel for women according to claim 2, characterized in that: S1 Raw material acceptance inspection is as follows: staff inspect incoming raw materials and put them into storage after inspection and acceptance; S2 material collection is as follows: the production workshop collects materials according to the production instructions and operating procedures. After collecting materials, the materials are transported to the raw material temporary storage room, packaging material temporary storage room or receiving post according to the management regulations; S3 weighing and batching are as follows: (1) The operator checks the name, batch number, quantity and other information of the recombinant collagen antibacterial gel for women to be produced according to the production instructions. If they are consistent with the production instructions, the operator takes the raw materials to the weighing and batching room; (2) The operator at the weighing and batching post shall weigh each material according to the batch production instructions; the weighed materials shall be independently reviewed by the reviewer, and cross-weighing shall not be allowed during the weighing process to prevent wrong weighing and mixing of materials.

4. The method for preparing the recombinant collagen antibacterial gel for women according to claim 3, characterized in that: S6 inner packaging specifically involves: receiving inner packaging materials and intermediate products, doing preparatory work, and then automatically placing the gelator into the inner packaging materials through the machine; S7 outer packaging is as follows: the inner packaging material is automatically placed into the outer packaging by the machine, and trial coding is performed. The process supervisor and QA will review the batch production instruction sheet and quality standard requirements, confirm that the printing quality of the printed samples meets the requirements, and start the coding production operation. During the coding process, large boxes that are missed are detected and re-printed in time; large boxes with coding that do not meet the quality requirements are picked out and placed in the specified location for unified processing; large boxes with qualified coding are neatly placed in the specified location, and the materials are marked and transferred to the box packing personnel in a unified manner; After the packing personnel have completed the boxing acceptance, they will pack the boxes and package them uniformly after the boxing is completed. The specific steps for S8 warehousing are as follows: after the finished product packaging inspection is passed, the process leader will fill out the "Finished Product Warehouse Entry Form" as required, hand it over to the warehouse manager, and go through the finished product warehousing procedures in accordance with the "Finished Product Warehousing, Pending Inspection, Storage, and Outbound Standard Operating Procedures". The finished product will be put into storage after being signed by the workshop director.

5. The method for preparing the recombinant collagen antibacterial gel for women according to claim 3, characterized in that: The weighing, preparation, filling and inner packaging processes are carried out in a Class D clean area. The temperature and humidity requirements for the clean area are: temperature 18℃~26℃, humidity 45%~65%.

6. The method for preparing the recombinant collagen antibacterial gel for women according to claim 4, characterized in that: The outer packaging is in the general production area, and the temperature and humidity requirements are: temperature 10℃~30℃, humidity 25%~75%.

7. The method for preparing the recombinant collagen antibacterial gel for women according to claim 5, characterized in that: Class D clean area means that clean clothes should cover the hair, beard and other relevant parts; suitable work clothes and shoes or shoe covers should be worn; and appropriate measures should be taken to avoid bringing in pollutants from outside the clean area.

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