CN111803624A - Skin antibacterial gel preparation containing transfer factor and preparation method thereof - Google Patents

Abstract

The invention relates to a skin antibacterial gel preparation containing transfer factors and a preparation method thereof, belonging to the technical field of disinfection. The gel preparation comprises the following raw materials in parts by weight: 1 part of traditional Chinese medicine extract, 0.4-0.8 part of transfer factor, 0.2-0.5 part of chlorhexidine acetate, 0.3-0.6 part of menthol, 0.1 part of borneol, 12-15 parts of glycerol, 12-15 parts of propylene glycol and 67-74 parts of gel matrix. The Chinese medicinal extract is prepared from six Chinese medicinal materials including cortex moutan, radix Stemonae, radix Sophorae Flavescentis, fructus Cnidii, Kochiae fructus and flos Chrysanthemi Indici by decocting, precipitating with ethanol, and decolorizing. The skin antibacterial gel preparation containing the transfer factor is beneficial to maintaining the microenvironment of the skin surface layer and promoting the recovery of skin immunity; the medicament does not contain antibiotics and hormones, is not easy to generate medicament resistance, and can be used for a long time; the antibacterial effect is obvious, no irritation is caused to the skin, and the antibacterial agent is safe and stable; is suitable for antibacterial, anti-inflammatory, cleaning and caring skin after infection.

Description

Skin antibacterial gel preparation containing transfer factor and preparation method thereof

Technical Field

The invention belongs to the technical field of disinfection, and particularly relates to a skin antibacterial gel preparation containing transfer factors and a preparation method thereof.

Background

Human skin is a natural barrier for the body to resist microbial infection in vitro. Skin is often susceptible to various skin diseases caused by infection with microorganisms such as bacteria, fungi, and viruses due to injury, immune dysfunction, and the like. The traditional skin antibacterial agent mostly adopts chemical antibacterial agents according to the composition components, such as quaternary ammonium salts (represented by benzalkonium chloride and benzalkonium bromide), guanidine disinfectants (represented by chlorhexidine and polyhexamethylene guanidine) and hydrogen peroxide, iodophor, trichloro hydroxy diphenyl ether (triclosan) and the like, and the single-component chemical disinfectant has potential safety hazard, single function, easy generation of drug resistance and no effect on drug-resistant strains. In recent years, some Chinese herbal extract compound preparations with antibacterial effect are gradually appeared, but the Chinese herbal compound preparations have slow effect and unsatisfactory antibacterial and bacteriostatic effects. For skin infection caused by allergy or immunologic dysfunction, the chemical antibacterial agent and the traditional Chinese medicine compound antibacterial preparation cannot achieve good treatment effect, hormone external skin preparations are often used for matching treatment in clinic, and repeated use of the hormone preparations can reduce local resistance, aggravate the disease condition, treat the symptoms and root causes but not cause the root causes, and cause the skin infection to have prolonged course and repeated attack. Thus, there is a need in the market for a multi-component, hormone-free, safe and effective skin antimicrobial formulation.

The transfer factor is a cytokine released by T lymphocytes in the immune response process of an organism, and can specifically transfer cellular immune information of a donor to recipient cells, thereby enhancing the immune function of the recipient. As an immunoregulation medicine, the transfer factor can enhance or inhibit humoral immunity and cellular immunity, increase the number of helper T cells, and is widely used for preventing and treating bacterial diseases, viral diseases, fungal diseases and other diseases clinically. For skin infection diseases which are difficult to control by antibiotics and antiviral drugs, clinically, a transfer factor preparation is commonly used as an auxiliary drug to be matched with antibacterial treatment. At present, the transfer factor for injection, the transfer factor capsule, the transfer factor oral liquid and other dosage forms exist, and no external transfer factor preparation exists. Therefore, a formula antibacterial preparation is clinically needed, the short-term antibacterial effect of the traditional antibacterial preparation can be exerted, the characteristics of antibiosis, inflammation diminishing, dampness clearing, itching relieving, safety and no side effect of the traditional Chinese medicine compound preparation can be reflected, the immune function of the damaged skin can be adjusted, and the purpose of treating both principal and secondary aspects of diseases is achieved.

Disclosure of Invention

The invention provides a skin antibacterial gel preparation containing transfer factors and a preparation method thereof. The purpose is as follows: solves the problems of single function and easy generation of drug resistance of chemical antibacterial agents, poor antibacterial effect of traditional Chinese medicine compound preparations and more toxic and side effects of hormone preparations, and simultaneously solves the problem that the traditional antibacterial preparations treat the symptoms and do not treat the root causes.

In order to achieve the purpose, the invention adopts the following technical scheme:

a skin antibacterial gel preparation containing transfer factors is characterized by comprising the following raw materials in parts by weight: 1 part of traditional Chinese medicine extract, 0.4-0.8 part of transfer factor, 0.2-0.5 part of chlorhexidine acetate, 0.3-0.6 part of menthol, 0.1 part of borneol, 12-15 parts of glycerol, 12-15 parts of propylene glycol and 67-74 parts of gel matrix.

The invention further adopts the technical scheme that the traditional Chinese medicine extract is prepared by extracting six traditional Chinese medicinal materials of tree peony bark, sessile stemona root, lightyellow sophora root, common cnidium fruit, belvedere fruit and wild chrysanthemum flower. The cortex moutan has effects of clearing heat, cooling blood, promoting blood circulation, and removing blood stasis (Shen nong's herbal Jing). The cortex moutan extract has antibacterial, antiinflammatory, hemostatic, analgesic, heat clearing away, and repercussive effects (modern research and application of Chinese medicinal materials). Paeonol, the main active ingredient of cortex moutan, also has the effects of inhibiting the generation of intracellular O2-free radicals, whitening skin, reducing and fading deposited pigments in skin, and has good treatment and health-care effects on color spots, skin pruritus, psoriasis, herpes zoster and eczema, and the paeonol is widely used in skin external preparations; the stemona root, radix stemonae, is a Chinese herbal medicine for treating scabies and tinea pedis, wherein the stemona root is prepared by soaking in alcohol with fire on an empty stomach, removing insect and silkworm bites, and treating scabies and tinea pedis (Bencao shiyi), and in vitro experiments show that: the radix Stemonae decoction and ethanol infusion have inhibitory effect on various bacteria, viruses and pathogenic fungi; kuh-seng has the functions of cooling blood, removing heat toxin, scabies and pus sore toxin. Treating skin pruritus, tinea, and obstinate psoriasis (Ben Cao of Yunnan); the broom cypress fruit can 'remove accumulated heat in the skin and wet and itchy except the skin' ('Ben Cao Yuan'; wild chrysanthemum can dispel wind and clear heat, and relieve swelling and remove toxicity, and is used for treating carbuncle, cellulitis, furuncle and suppuration (modern practical traditional Chinese medicine). The six traditional Chinese medicines are used together, and play the roles of resisting bacteria and diminishing inflammation, eliminating dampness and reducing swelling, relieving itching and easing pain and the like to the maximum.

The borneol and the menthol in the invention have the functions of cooling, relieving pain, promoting tissue regeneration and healing wound, and are beneficial to the repair of damaged skin.

The chlorhexidine acetate is a biguanide cationic surfactant, is a common external antibacterial disinfectant, has broad-spectrum antibacterial and bactericidal effects, and is effective on gram-positive bacteria and gram-negative bacteria. Its advantages are high effect, high safety and low by-effect. The chlorhexidine acetate and the traditional Chinese medicine extract have synergistic effect, and the antibacterial effect is further enhanced.

The transfer factor of the invention is used as an immunomodulator, can effectively correct organism allergy and regulate immunologic dysfunction, and can repair and adjust the damaged immune state of eczema, allergic dermatitis, pruritus caused by unknown reasons and virus-infected skin diseases, thereby maintaining the normal immune state of skin. Transfer factors are added in the compatibility of medicines to stabilize the antibacterial effect, and the problems of prolonged course of disease and repeated attack are further solved.

The glycerin and propylene glycol in the invention act as a solvent, a softener and a humectant, and can keep the skin soft, elastic and not dry, and prevent chapped skin.

The invention further adopts the technical scheme that the gel is adopted. The gel matrix is prepared by swelling hypromellose (or other methylcellulose derivatives) in deionized water, and the content of hypromellose is 3-5%.

The further technical scheme of the invention is that the traditional Chinese medicine extract is obtained by decocting, precipitating with ethanol and decoloring the traditional Chinese medicinal materials according to the following weight ratio. The weight ratio is as follows: 10 parts of tree peony bark, 5 parts of radix stemonae, 1 part of radix sophorae flavescentis, 1 part of fructus cnidii, 1 part of fructus kochiae and 1 part of wild chrysanthemum flower.

The technical scheme of the invention is that the transfer factor is prepared by using healthy pig or cattle spleen as a raw material, preparing a mixture solution of polypeptide, amino acid and polynucleotide with the molecular weight of less than 6kDa through fat removal, cell disruption, dialysis or ultrafiltration, and then freezing and drying. The polypeptide content should be more than 80mg/kg, and the nucleotide content should be not less than 3mg/kg calculated as D-ribose.

The invention relates to a skin antibacterial gel preparation containing transfer factors and a preparation method thereof, which is characterized in that the preparation method of the skin antibacterial gel preparation containing the transfer factors comprises the following steps:

step 1, preparation of traditional Chinese medicine extract: pulverizing the dried traditional Chinese medicine components into powder according to the weight parts of the raw materials, mixing, adding 10 times of water for decoction, extracting supernatant after decoction, concentrating, adding ethanol until the ethanol content is about 65%, dissolving with water, adding activated carbon for decolorization, adding ethanol until the ethanol content is about 65% after filtration, standing, filtering, and taking precipitate and drying to obtain the traditional Chinese medicine extract;

step 2, preparing a gel matrix: weighing hydroxypropyl methylcellulose, stirring and mixing with deionized water in a corresponding proportion to make the content of hydroxypropyl methylcellulose be 3-5%, fully swelling, and standing for 24h to obtain transparent colloid as the gel matrix;

step 3, weighing 1 part of the Chinese medicinal extract in the step 1, 0.4-0.8 part of transfer factor, 0.2-0.5 part of chlorhexidine acetate, 0.3-0.6 part of menthol, 0.1 part of borneol, 12-15 parts of glycerol and 12-15 parts of propylene glycol, and mixing and stirring to obtain a uniform mixed solution;

step 4, mixing 67-74 parts of the gel matrix in the step 2 with the mixed solution in the step 3, stirring, grinding and emulsifying to form uniform and stable viscous colloid, and standing for 24 hours to obtain the skin antibacterial gel containing the transfer factor;

step 5, filling: and (3) after the packaging container is unpacked and cleaned, sterilizing for 30min by ultraviolet rays, and quantitatively packaging to complete the preparation of the skin antibacterial gel preparation containing the transfer factor.

The further technical proposal of the invention is that the pH value of the gel is 5.0-8.0.

Compared with the prior art, the invention adopting the technical scheme has the following beneficial effects:

(1) the invention prepares gel by the compatibility of traditional Chinese medicine extract, chlorhexidine acetate, transfer factor component, menthol and borneol, and simultaneously, glycerol and propylene glycol are taken as adjuvant. Is a compound preparation combining traditional Chinese medicine and western medicine, treats both symptoms and root causes, and obviously improves the antibacterial and anti-inflammatory effects;

(2) the invention does not contain antibiotics and hormone, does not generate the problem of antibiotic drug resistance, does not have side effect generated by hormone, and is safer than antibiotic preparations and hormone preparations;

(3) the gel used by the invention has good spreadability, the effective components are uniformly dispersed, and the administration rate is improved. The protective film is easy to disperse on the surface of the skin to form, so that the effect of protecting the damaged skin is achieved, and the compliance of a user is improved;

(4) the preparation method is simple and convenient, and various raw and auxiliary materials adopted in the preparation process are easy to obtain, widely distributed and easy to control, and can be used for large-scale production.

Detailed Description

The present invention will be further illustrated below with reference to specific embodiments, which are to be understood as merely illustrative and not limitative of the scope of the present invention.

Example 1 this example of a skin antimicrobial gel formulation containing transfer factor was prepared from the following raw materials by weight: 100g of traditional Chinese medicine extract, 60g of transfer factor, 40g of chlorhexidine acetate, 50g of menthol, 10g of borneol, 1400g of glycerol, 1500g of propylene glycol and 6.8kg of gel matrix.

The preparation method of the skin antibacterial gel preparation containing the transfer factor comprises the following steps:

(1) the preparation of the traditional Chinese medicine extract comprises mixing 1kg of dried tree peony bark, 0.5kg of radix stemonae, 0.1kg of radix sophorae flavescentis, 0.1kg of fructus cnidii, 0.1kg of fructus kochiae and 0.1kg of flos chrysanthemi indici, crushing into powder, adding 19kg of water for decoction, extracting supernatant for concentration after decoction, adding ethanol until the ethanol content is about 65%, adding activated carbon for decolorization after water dissolution, adding ethanol until the ethanol content is about 65% after filtration, standing, filtering, and taking precipitate and drying to obtain the traditional Chinese medicine extract;

(2) preparing a gel matrix: weighing 300g of hydroxypropyl methylcellulose, stirring and mixing with 6500g of deionized water, swelling and standing for 24h to obtain a transparent colloid which is the gel matrix;

(3) weighing 100g of the traditional Chinese medicine extract in the step (1), weighing the glycerol, the propylene glycol, the borneol, the menthol, the chlorhexidine acetate, the transfer factor and the like in the amount, and mixing and stirring to obtain uniform mixed liquid;

(4) adding the mixed solution in the item (3) into the gel matrix in the item (2), stirring while adding, grinding and emulsifying after uniformly stirring to form uniform and stable viscous colloid, namely the skin antibacterial gel containing the transfer factor;

(5) filling: and (4) after the container is unpacked and cleaned, sterilizing the container for 30min by using ultraviolet rays, and filling the container to obtain the skin antibacterial gel preparation containing the transfer factors.

The pH was measured to be 6.7.

Example 2 the skin antibacterial gel preparation containing transfer factor of this example was prepared from the following raw materials by weight: 100g of traditional Chinese medicine extract, 40g of transfer factor, 30g of chlorhexidine acetate, 30g of menthol, 10g of borneol, 1500g of glycerol, 1300g of propylene glycol and 7.0kg of gel matrix.

The preparation method of the skin antibacterial gel preparation containing the transfer factor comprises the following steps:

(1) the preparation of the traditional Chinese medicine extract comprises mixing 1kg of dried tree peony bark, 0.5kg of radix stemonae, 0.1kg of radix sophorae flavescentis, 0.1kg of fructus cnidii, 0.1kg of fructus kochiae and 0.1kg of flos chrysanthemi indici, crushing into powder, adding 19kg of water for decoction, extracting supernatant for concentration after decoction, adding ethanol until the ethanol content is about 65%, adding activated carbon for decolorization after water dissolution, adding ethanol until the ethanol content is about 65% after filtration, standing, filtering, and taking precipitate and drying to obtain the traditional Chinese medicine extract;

(2) preparing a gel matrix: weighing 300g of hydroxypropyl methylcellulose, stirring and mixing with 6700g of deionized water, swelling and standing for 24h to obtain transparent colloid which is the gel matrix;

(3) weighing 100g of the traditional Chinese medicine extract in the step (1), weighing the above components such as glycerin, propylene glycol, borneol, menthol, chlorhexidine acetate, transfer factor and the like, and mixing and stirring to obtain a uniform mixed solution;

(4) adding the mixed solution in the item (3) into the gel matrix in the item (2), stirring while adding, grinding and emulsifying after uniformly stirring to form uniform and stable viscous colloid, namely the skin antibacterial gel containing the transfer factor;

(5) filling: and (4) after the container is unpacked and cleaned, sterilizing the container for 30min by using ultraviolet rays, and filling the container to obtain the skin antibacterial gel preparation containing the transfer factors.

The pH was measured to be 6.5.

Example 3 the skin antibacterial gel preparation containing transfer factor of this example was prepared from the following raw materials by weight: 100g of traditional Chinese medicine extract, 80g of transfer factor, 50g of chlorhexidine acetate, 40g of menthol, 10g of borneol, 1200g of glycerol, 1400g of propylene glycol and 7.1kg of gel matrix.

The preparation method of the skin antibacterial gel preparation containing the transfer factor comprises the following steps:

(1) the preparation of the traditional Chinese medicine extract comprises mixing 1kg of dried tree peony bark, 0.5kg of radix stemonae, 0.1kg of radix sophorae flavescentis, 0.1kg of fructus cnidii, 0.1kg of fructus kochiae and 0.1kg of flos chrysanthemi indici, crushing into powder, adding 19kg of water for decoction, extracting supernatant for concentration after decoction, adding ethanol until the ethanol content is about 65%, adding activated carbon for decolorization after water dissolution, adding ethanol until the ethanol content is about 65% after filtration, standing, filtering, and taking precipitate and drying to obtain the traditional Chinese medicine extract;

(2) preparing a gel matrix: weighing 350g of hydroxypropyl methylcellulose, stirring and mixing with 6750g of deionized water, swelling and standing for 24h to obtain transparent colloid which is the gel matrix;

(3) weighing 100g of the traditional Chinese medicine extract in the step (1), weighing the glycerol, the propylene glycol, the borneol, the menthol, the chlorhexidine acetate, the transfer factor and the like in the amount, and mixing and stirring to obtain uniform mixed liquid;

(4) adding the mixed solution in the item (3) into the gel matrix in the item (2), stirring while adding, grinding and emulsifying after uniformly stirring to form uniform and stable viscous colloid, namely the skin antibacterial gel containing the transfer factor;

(5) filling: and (4) after the container is unpacked and cleaned, sterilizing the container for 30min by using ultraviolet rays, and filling the container to obtain the skin antibacterial gel preparation containing the transfer factors.

The pH was measured to be 6.3.

Example 4 the skin antibacterial gel formulations containing transfer factor prepared in example 1, example 2, example 3 were tested. The data detected by the Shanxi medicine stock control group medicine research institute and the detection center of the Shanxi province health products are as follows:

1. the antibacterial effect is as follows:

the antibacterial test is carried out according to GB15979-2002 hygienic Standard for Disposable sanitary articles, the antibacterial test is a carrier test, the test temperature is 20 +/-1 ℃, and the test is repeated for three times. The action time is 10min, and the average bacteriostasis rate is shown in the following table:

as can be seen from the table, the skin antibacterial agent can achieve 100% killing rate within 10min for staphylococcus aureus, escherichia coli and candida albicans.

2. Safety:

2.1 multiple skin irritation experiments

According to the multiple skin irritation test method in the disinfection technical specification, the skin antibacterial gel preparations containing the transfer factor prepared in the examples 1, 2 and 3 have multiple skin irritation, the highest irritation index scores are all 0, and the test result is that the multiple skin irritation intensity is nonirritating according to the skin irritation intensity grading standard in the disinfection technical specification.

2.2 determination of the content of Pb, Hg and As

Measured according to the related method of technical Specification for safety of cosmetics 2015 edition. The lead, mercury and arsenic contents are shown in the following table:

3. stability:

according to the method of GB15979 hygienic Standard for Disposable sanitary articles. The samples were tested under stability test conditions (37-40 ℃, relative humidity not less than 75%, after 3 months of storage) at a test temperature of 20 + -1 ℃ and repeated three times. The action time is 10min, and the average bacteriostasis rate is shown in the following table:

as can be seen from the data in the table, the stability of the skin antimicrobial agent is good. The bactericidal or bacteriostatic action of the composite antibacterial agent can be maintained for at least two years at room temperature.

The foregoing shows and describes the general principles, essential features, and advantages of the invention. It will be understood by those skilled in the art that the present invention is not limited to the embodiments described above, which are intended to illustrate the principles of the invention, but that various changes and modifications may be made without departing from the spirit and scope of the invention, and the invention is to be limited to the embodiments described above.

Claims (7)

1. A skin antibacterial gel preparation containing transfer factors is characterized by comprising the following raw materials in parts by weight: 1 part of traditional Chinese medicine extract, 0.4-0.8 part of transfer factor, 0.2-0.5 part of chlorhexidine acetate, 0.3-0.6 part of menthol, 0.1 part of borneol, 12-15 parts of glycerol, 12-15 parts of propylene glycol and 67-74 parts of gel matrix.

2. The skin antiseptic gel formulation of claim 1 comprising a transfer factor, wherein: the traditional Chinese medicine extract is prepared by extracting six traditional Chinese medicinal materials of moutan bark, stemona root, kuh-seng, common cnidium fruit, belvedere fruit and wild chrysanthemum flower.

3. The skin antiseptic gel formulation of claim 1 comprising a transfer factor, wherein: the transfer factor is prepared by using healthy pig or cattle spleen as a raw material, preparing a mixture solution of polypeptide, amino acid and polynucleotide with the molecular weight of less than 6kDa by fat removal, cell disruption, dialysis or ultrafiltration, and freeze-drying; the polypeptide content should be more than 80mg/kg, and the nucleotide content should be not less than 3mg/kg calculated as D-ribose.

4. The skin antiseptic gel formulation of claim 1 comprising a transfer factor, wherein: the gel matrix is obtained by fully swelling hydroxypropyl methylcellulose in deionized water, and the content of the hydroxypropyl methylcellulose is 3-5%.

5. The skin antiseptic gel formulation of claim 1 comprising a transfer factor, wherein: the pH of the gel is 5.0-8.0.

6. The skin antiseptic gel formulation of claim 2 comprising a transfer factor, wherein: the traditional Chinese medicine extract is obtained by decocting, precipitating with ethanol and decolorizing the dried traditional Chinese medicinal materials in the following weight ratio; the weight ratio is as follows: tree peony bark 10: stemona root 5: 1, kuh-seng: fructus cnidii 1: kochia scoparia 1: 1 of wild chrysanthemum flower.

7. The process for preparing a skin antibacterial gel preparation containing a transfer factor according to any one of claims 1 to 6, characterized by comprising the steps of:

step 1, preparation of traditional Chinese medicine extract: pulverizing the dried traditional Chinese medicine components into powder according to the weight parts of the raw materials, mixing, adding 10 times of water for decoction, extracting supernate after decoction, concentrating, and adding ethanol until the ethanol content is about 65%; dissolving with water, adding active carbon for decolorizing, filtering, and adding ethanol until the alcohol content is about 65%; standing, filtering, and oven drying the precipitate to obtain the Chinese medicinal extract;

step 2, preparing a gel matrix: weighing hydroxypropyl methylcellulose, stirring and mixing with deionized water in a corresponding proportion to make the content of hydroxypropyl methylcellulose be 3-5%, fully swelling, and standing for 24h to obtain transparent colloid as the gel matrix;

step 3, weighing 1 part of the traditional Chinese medicine extract in the step 1, 0.4-0.8 part of transfer factor, 0.2-0.5 part of chlorhexidine acetate, 0.3-0.6 part of menthol, 0.1 part of borneol, 12-15 parts of glycerol and 12-15 parts of propylene glycol, and mixing and stirring to obtain a uniform mixed solution;

step 4, mixing 67-74 parts of the gel matrix in the step 2 with the mixed solution in the step 3, stirring, grinding and emulsifying to form uniform and stable viscous colloid, and standing for 24 hours to obtain the skin antibacterial gel containing the transfer factor;

step 5, filling: and (3) unpacking and cleaning a filling container, sterilizing by ultraviolet rays for 30min, and then quantitatively filling to finish the preparation of the skin antibacterial gel preparation containing the transfer factor.