CN111317781A - Preparation method of biological adhesive gel with insecticidal and antipruritic effects - Google Patents
Preparation method of biological adhesive gel with insecticidal and antipruritic effects Download PDFInfo
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- A—HUMAN NECESSITIES
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/489—Sophora, e.g. necklacepod or mamani
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- A61K36/15—Pinaceae (Pine family), e.g. pine or cedar
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- A61K36/18—Magnoliophyta (angiosperms)
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- A61K36/268—Asarum (wild ginger)
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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Abstract
The invention discloses a preparation process of biological adhesive gel with the functions of killing parasites and relieving itching. The process comprises extracting the raw materials respectively, mixing, adding into matrix, and making into gel. Pharmacodynamic experiments prove that the gel has the effects of clearing heat, drying dampness, killing parasites and relieving itching, and has obvious curative effects on vulvitis, nonspecific trichomonas vaginitis, gonococcal vaginitis and mycotic vaginitis.
Description
Technical Field
The invention relates to a preparation method of biological gel, in particular to a preparation method of biological adhesive gel with insecticidal and antipruritic effects, belonging to medical health.
Background
Vaginitis is a more common morbid leucorrhea disease in modern clinic, and can be subdivided into four types according to the traditional Chinese medicine symptoms: downward flow of damp-heat, spleen deficiency with excessive dampness, kidney deficiency with damp obstruction, and liver and kidney deficiency. The traditional Chinese medicine is used for treating vaginitis according to syndrome differentiation, the downward flow type of damp-heat is mainly treated by clearing heat, drying dampness, killing parasites and relieving itching, the excessive dampness type of spleen deficiency is mainly treated by strengthening spleen, drying dampness, killing parasites and relieving itching, the dampness resistance type of kidney deficiency is mainly drying dampness, and the dampness resistance type of liver and kidney deficiency is mainly nourishing liver and kidney, clearing heat and stopping leukorrhagia.
The western medicine treatment mainly comprises bacteriostasis and disinsection, nitroimidazole antibacterial drugs are commonly used for trichomonas vaginitis, and clindamycin antibacterial drugs are commonly used for bacterial vaginitis besides the nitroimidazole drugs; azole and polyene antibacterial drugs commonly used for treating candida vaginitis
The traditional Chinese medicine treats both principal and secondary aspects of diseases of vaginitis, has slow effect taking and long medication time, but has high cure rate and difficult relapse of disease.
Gels are semisolid preparations with gelling properties made of a drug and a suitable matrix, and are generally classified into water-soluble gels and organic gels (or oil-soluble gels) according to the gel matrix. The drug in the water-soluble gel can be dissolved in the water-dispersible solvent; the drug in the organogel should be soluble in the oil dispersion solvent. According to different preparation methods, the gel can be divided into environment-sensitive gel, liposome gel, micro-emulsion gel and the like, and the environment-sensitive gel such as temperature-sensitive gel, magnetic-responsive polymer gel microspheres, pH-sensitive gel and the like is prepared by utilizing different sensitivity degrees of the gel to physical environments such as temperature, magnetic field, pH and the like; mixing gel matrix with phospholipid and cholesterol to obtain liposome gel with slow release effect; the microemulsion gel capable of improving the solubility of the insoluble drug is prepared by mixing the drug with a proper water phase, an oil phase and an emulsifier according to a certain proportion. The water-soluble gel has good spreadability, no greasy feeling, easy cleaning, comfortable and convenient use, improves the compliance of patients, has better adhesiveness, can be closely contacted with an acting part, has better transdermal absorption effect, ensures that effective components in the gel slowly diffuse into mucous membrane to play pharmacological action, and is commonly used as external preparations, such as adapalene gel for treating skin acne, nano-silver antibacterial hydrogel for treating rhinitis, lomefloxacin hydrochloride ophthalmic gel for eye infection, sophora flavescens gel for treating vaginal inflammation and trichomoniasis, and the like.
The biological gel with the functions of killing insects and relieving itching is not reported before the completion of the invention.
Disclosure of Invention
The invention aims to provide a preparation method of biological adhesive gel with the effects of killing parasites and relieving itching.
The invention has the advantages that: the product is a compound preparation, organically combines the medicines in the formula together based on the comprehensive multiple medicines for treating gynecological diseases, and has the effects of clearing heat, eliminating dampness, killing parasites and relieving itching. Can be used for treating downward flow of damp-heat, yellow and thick leucorrhea, and pudendal swelling and pruritus: pharmacodynamic studies show that the gel has obvious antibacterial, anti-inflammatory and itching relieving effects, has more obvious pharmacological activity than the commercial Fujieshu lotion, and has obvious technical progress.
The object of the invention can be achieved by the following measures:
a method for preparing biological adhesive gel with parasite killing and itching relieving effects comprises
The method is characterized by comprising the following steps:
a. extracting volatile oil from herba asari with water 10-20 times for 4-8 hr, and separating the extractive solution and volatile oil;
b. reflux-extracting fructus Cnidii with 6-10 times of 65-85% ethanol for 1-3 times, each for 1-3 hr, mixing extractive solutions, filtering, and recovering ethanol from filtrate;
c. decocting the residue of fructus Cnidii extracted with ethanol and other materials with 4-8 times of water for 1-3 times, each for 1-2 hr, mixing decoctions, filtering, mixing the filtrate with the volatile oil solution of herba asari, and concentrating to relative density of 1.00-1.05 at 80 deg.C;
d. adding 2-4 times of deionized water into Alumen, heating for dissolving, mixing with above solution, filtering, and adjusting pH of the filtrate to 4.5-6.0 with ammonia water to obtain medicinal liquid;
e. dissolving salicylic acid in 3-6 times of ethanol, dissolving herba asari volatile oil in appropriate amount of ethanol, mixing ethanol solutions, mixing with above medicinal liquid, stirring, adjusting pH to 4.5-6.0, standing for 24 hr, and filtering to obtain extractive solution;
f. dissolving the matrix with 2-4 times of water, adding the extractive solution of e, stirring, and mixing to obtain gel.
The object of the invention can also be achieved by the following measures:
1. the process according to claim 1, wherein the ratio of the total weight of the extract and the matrix in step f is 1: 2-1: 4.
2. the process according to claim 1, wherein the matrix in step f is a mixture of poloxamer 188, poloxamer 407 and hydroxypropylmethyl cellulose K100.
3. The process of claim wherein the gel has a pH in the range of about 4.5 to about 6.0.
The invention overcomes the defects of short action time and poor curative effect of the lotion, the action time is prolonged after the lotion is prepared into gel, the gel can be tightly contacted with an action part, the transdermal absorption effect is better, the active ingredients in the gel are slowly diffused into mucous membrane to play pharmacological action, and the gel can better inhibit bacteria and diminish inflammation.
The inner walls of the vagina of women are provided with mucous membranes which are very fragile, the vagina mucous membranes which are natural protective barriers can be damaged by frequent washing with strong bactericidal lotion, the immunity function of the private parts is rapidly reduced once the barriers are damaged, and many women show that the private parts are more uncomfortable after the lotion is used. However, the gel well solves the problem, has mild gel effect, relieves the pain of patients, has more obvious curative effect, and has obvious practicability and outstanding contribution.
From the aspect of packaging, the gel is vacuum sterile, is disposable and convenient to carry, most of the washing liquid is bottled, air easily enters the washing liquid when the washing liquid is used for multiple times, and the washing liquid needs to be mixed with water and then is used for articles such as basins, towels and the like. Compared with lotion, the gel is more convenient to use and has stronger practicability.
The gel has the effects of sterilizing, relieving itching and resisting inflammation, has obvious curative effects on vulvitis, nonspecific trichomonas vaginitis, gonococcal vaginitis and mycotic vaginitis, and the pharmacological effects are proved by the following pharmacodynamic test examples.
The strains staphylococcus aureus, staphylococcus epidermidis, escherichia coli, proteus, pseudomonas aeruginosa, streptococcus pyogenes, neisseria gonorrhoeae, aspergillus and candida albicans are provided by the experimental center of pathogenic immune cell genetics of the basic medical department of Jilin university.
Reagent the gel of the present invention was self-made by the unit laboratory of the present invention, Fujieshu lotion (Jilin Zhenz361699, Yinnoko pharmaceutical Co., Ltd., batch No. 20180501).
1. Influence of the gel of the invention on in vitro bacteriostasis experiments
Plate emptying method: the bacteria are respectively inoculated on a common nutrient agar culture medium and a chocolate agar culture medium overnight, (Neisseria gonorrhoeae is anaerobically cultured for 48 hours). The transfer broth (serum) was activated to 9 hundred million/ml. Inoculating activated strain, inoculating 0.1ml of common agar medium and chocolate agar medium, and perforating with a perforator. The gel of the invention is diluted into five different concentrations (the drug concentration is 0.08g crude drug/ml, 0.05g crude drug/ml, 0.04g crude drug/ml, 0.02g crude drug/ml and 0.01g crude drug/ml) after being processed under high pressure, the concentration of the Fujieshu lotion administration group 1 is 0.05g crude drug/ml, the concentration of the Fujieshu lotion administration group 2 is 0.02g crude drug/ml, the two different concentrations are respectively added into the holes, 50 mul of the liquid medicine is added into each hole, and the two parallel holes are arranged for culture. The results are shown in Table 1.
And (3) judging the bacteriostatic standard: the antibacterial ring is resistant at more than 6mm, sensitive at low degree at 6-8mm, sensitive at medium degree at 8-10mm, and sensitive at high degree at more than 10.
TABLE 1 Effect of the gels of the invention on in vitro bacteriostatic experiments
The result proves that the gel has stronger bacteriostatic action on various strains, wherein the gel has the strongest bacteriostatic action on escherichia coli, candida albicans, neisseria gonorrhoeae and proteus. Compared with the Fujieshu lotion, the gel containing the same dosage of the invention has little difference in the inhibition effect on each.
2. In vivo antifungal test
0.lml Candida albicans ATCC1O231 standard bacteria liquid is injected into the pudendum of the rabbit, and pyogenic infection is formed after local application for 48 hours. The gel (0.08g crude drug/ml, 0.04g crude drug/ml) dosage group and Fujieshu lotion (0.08g crude drug/ml, 0.04g crude drug/ml) were applied 3 times per day (0.5 ml/time), and the control group was applied with the same amount of physiological saline. The secretion is taken from each point every day and cultured to observe whether the bacteria grow or not to determine the curative effect of the medicine. The results show that after the gel of the invention is used for treatment, the gel takes effect on the 2 nd day, 50 percent turns negative on the 5 th day and the gel is cured on the 8 th day; after the treatment of the Fujieshu lotion, the lotion takes effect on the 3 rd day, 50 percent of the lotion turns to negative on the 6 th day, and the lotion is cured on the 10 th day; the gel of the invention has stronger antibacterial activity than the Fujieshu lotion.
3. Test for relieving itching
After topical application of a topical composition (0. lml/foot) for 10min to the affected area of the dorsum of the right foot (with the same amount of vehicle applied to the control group) in 6 groups of 60 guinea pigs, 0.05 ml/body of 0.l% histamine phosphate was dropped onto the affected area, and the concentration was increased every 3min thereafter to give an itching based on the total amount of histamine phosphate administered when the right hind foot was licked by the guinea pigs, and the results are shown in Table 2. The gel (0.08g crude drug/ml and 0.04g crude drug/ml) of the invention is very obviously improved (P <0.01) for the guinea pig to cause itching, the dose group of 0.02g crude drug/ml is also obviously improved (P <0.05), and compared with the Fujiesu lotion group, the gel group of the invention has more obvious effect result with the same dose.
TABLE 2 Effect of gels of the invention on histamine phosphate-induced itching
Comparison with the control group: p < 0.05; p <0.01
4. Xylene induced ear swelling test in mice
60 mice were divided into 6 groups. The medicine is applied once, each ear is 0.lml, and the control group is coated with the same amount of solvent. After 1h, the mice were coated with 0.05 ml/ear xylene in the right ear and the mice were compared in the left ear. After 15min the animals were sacrificed and the ears of the same area of the ears were removed by a 6mm diameter punch, and the difference between the weight of the left and right ears was taken as the swelling degree, and the results are shown in Table 3. The gel (0.08g crude drug/ml, 0.04g crude drug/ml and 0.02g crude drug/ml) has an inhibiting effect on mouse ear swelling caused by xylene in three doses. Compared with the Fujieshu lotion, the gel of the invention has stronger activity and more obvious effect with the same dosage.
TABLE 3 Effect of the gels of the invention on ear swelling of mice caused by xylene
Comparison with the control group: p < 0.05; p <0.01
5. Egg white plantar swelling test in rats
Taking 60 mice, dividing into 6 groups, applying medicine (0.lml/100g) for 1h, injecting 0.03 ml/mouse of 1% carrageenan under tendon membrane of right hind paw of mouse, and applying equal amount of solvent to control group. And (3) killing the mouse by dislocation of cervical vertebrae after 6h after inflammation, cutting off the hind feet at two sides, weighing respectively, and calculating the weight difference between the left foot and the right foot to obtain the swelling degree. The results show that: the gel can obviously inhibit the swelling of the feet of the mice caused by the carrageenan, and the high and medium dose groups have obvious difference. Compared with the Fujieshu lotion, the gel of the invention with the same dosage has more obvious effect. See table 4.
TABLE 4 Effect of gels of the invention on carrageenan-induced foot swelling in mice
Comparison with the control group: p < 0.05; p <0.01
Detailed Description
The present invention is illustrated in detail by the following examples, which are not intended to limit the invention thereto, and the following specific embodiments are provided:
example 1
Gel prescription and preparation process
Extracting volatile oil from herba asari according to a prescription amount, wherein the amount of water is 14 times that of the herba asari for 8 hours, and separating an extracting solution and the volatile oil for later use; reflux-extracting fructus Cnidii with 8 times of 80% ethanol for 3 times, each for 2 hr, mixing the extractive solutions, filtering, and recovering ethanol from the filtrate; decocting the residue of fructus Cnidii extracted with ethanol and the rest materials with 8 times of water for 2 times, each time for 2 hr, mixing decoctions, filtering, mixing the filtrate with the volatile oil solution of herba asari, and concentrating to relative density of 1.00-1.05 (measured at 80 deg.C); adding 2 times of deionized water into Alumen, heating for dissolving, mixing with above solution, filtering, and adjusting pH of the filtrate to 4.5-6.0 with ammonia water to obtain medicinal liquid; dissolving salicylic acid in 3-6 times of ethanol, dissolving herba asari volatile oil in appropriate amount of ethanol, mixing ethanol solutions, mixing with above medicinal liquid, stirring, adjusting pH to 4.5-6.0, standing for 24 hr, and filtering to obtain extractive solution; dissolving poloxamer 407, poloxamer 188 and hydroxypropyl methylcellulose K100M with 2 times of water, adding the extractive solution of e, stirring, adding deionized water to 1000ml, and stirring to obtain gel.
Claims (4)
1. A preparation process of biological adhesive gel with the effects of killing parasites and relieving itching comprises the following raw materials in parts by weight:
the method is characterized by comprising the following steps:
a. extracting volatile oil from herba asari with water 10-20 times for 4-8 hr, and separating the extractive solution and volatile oil;
b. reflux-extracting fructus Cnidii with 6-10 times of 65-85% ethanol for 1-3 times, each for 1-3 hr, mixing extractive solutions, filtering, and recovering ethanol from filtrate;
c. decocting the residue of fructus Cnidii extracted with ethanol and other materials with 4-8 times of water for 1-3 times, each for 1-2 hr, mixing decoctions, filtering, mixing the filtrate with the volatile oil solution of herba asari, and concentrating to relative density of 1.00-1.05 at 80 deg.C;
d. adding 2-4 times of deionized water into Alumen, heating for dissolving, mixing with above solution, filtering, and adjusting pH of the filtrate to 4.5-6.0 with ammonia water to obtain medicinal liquid;
e. dissolving salicylic acid in 3-6 times of ethanol, dissolving herba asari volatile oil in appropriate amount of ethanol, mixing ethanol solutions, mixing with above medicinal liquid, stirring, adjusting pH to 4.5-6.0, standing for 24 hr, and filtering to obtain extractive solution;
f. dissolving the matrix with 2-4 times of water, adding the extractive solution of e, stirring, and mixing to obtain gel.
2. The process according to claim 1, wherein the ratio of the total weight of the extract and the matrix in step f is 1: 2-1: 4.
3. the process according to claim 1, wherein the matrix in step f is a mixture of poloxamer 188, poloxamer 407 and hydroxypropylmethyl cellulose K100.
4. The process of claim wherein the gel has a pH in the range of about 4.5 to about 6.0.
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| CN1806826A (en) * | 2005-01-18 | 2006-07-26 | 卢盛余 | Chinese medicinal suppository for treating gynecological disease |
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| CN101862400A (en) * | 2010-04-09 | 2010-10-20 | 成都天宇联盟医药科技有限责任公司 | Dehumidifying itching-relieving gels and preparation method thereof |
| CN105343717A (en) * | 2015-11-27 | 2016-02-24 | 天津雪赢世纪专利技术有限公司 | Traditional Chinese medicine bags for fumigating treatment of trichomonas vaginitis |
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