CN114748527A - Compound gentian gel for treating infantile eczema and dermatitis - Google Patents
Compound gentian gel for treating infantile eczema and dermatitis Download PDFInfo
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
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- A61K36/515—Gentiana
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- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/288—Taraxacum (dandelion)
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- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
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- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/539—Scutellaria (skullcap)
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- A61P17/00—Drugs for dermatological disorders
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- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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- A61K2236/50—Methods involving additional extraction steps
- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
Abstract
The invention discloses a compound gentian composition for treating infantile eczema and dermatitis, which is prepared from the following raw material medicines in parts by weight: 60-80 parts of gentian, 25-35 parts of scutellaria baicalensis, 25-35 parts of radix sophorae flavescentis and 25-35 parts of dandelion. The invention discloses a compound gentian gel for treating infantile eczema and dermatitis, which is prepared from the following raw material medicines in parts by weight: 60-80 parts of gentiana scabra bunge, 25-35 parts of scutellaria baicalensis, 25-35 parts of sophora flavescens, 25-35 parts of dandelion, 1-6 parts of carbomer, 5-15 parts of Transcutol P, 2-5 parts of triethanolamine, 10-30 parts of glycerol and 0.1-0.5 part of potassium sorbate. The compound gentiana gel has the effects of clearing away heat and toxic materials, diminishing inflammation and relieving itching, and clinical curative effect observation shows that the gel can effectively relieve skin inflammation and adjust skin immune function, has obvious curative effect on treating infantile eczema and dermatitis, and has no adverse reaction and toxic or side effect.
Description
Technical Field
The invention belongs to the field of medicines, and relates to a compound gentian composition for treating infantile eczema and dermatitis, and compound gentian gel for treating infantile eczema and dermatitis, which takes the composition as an effective component.
Background
Eczema and dermatitis (contact dermatitis, atopic dermatitis, self-allergic dermatitis, infectious eczematoid dermatitis and the like) are the most common skin diseases in clinic, particularly acute eczema and acute dermatitis are common, and the skin diseases are one of key subjects of clinical and basic researches of skin diseases at home and abroad. Eczema and dermatitis are the same in nature in a broad sense and are allergic skin diseases caused by various reasons, and the pathological changes of eczema and dermatitis are intercellular edema and intracellular edema in the epidermis, and capillary vessel dilatation, edema and mononuclear cell infiltration in the superficial dermis. Therefore, it is used as a synonym by many scholars clinically.
Eczema is characterized by red swelling, dryness and pruritus, and is accompanied by symptoms of blisters, chaps, oozing blood, scabbing, flaking and the like. Eczema frequently attacks repeatedly and is not cured for a long time, and great trouble and inconvenience are brought to daily life of patients. Currently, treatment of eczema includes the use of antiallergic agents such as antihistamines, glucocorticoid-like preparations, antibiotic preparations, and the like. On the premise of unclear etiology, clinical medication is often only symptomatic treatment, but is not satisfactory due to limited efficacy and major side effects.
The main treatment method of eczema in western medicine comprises the following steps: 1. removing all suspected pathogenic factors: keep skin clean and avoid various external irritations such as hot water washing and scalding, scratching with strength, excessive use of soap, inappropriate external use of medicine, etc. Avoid secondary infection, avoid overwork and mental stress, and avoid foods such as pungent, spicy, fishy and sour foods. For chronic generalized eczema patients, the focus is removed when necessary, and systemic diseases are treated. 2. Systemic treatment, comprising: (1) antihistamines such as chlorpheniramine maleate, cyproheptadine, and chlorpheniramine maleate; (2) sedative antipruritic for patients with mental disorder or poor sleep, such as chlorpromazine, perphenazine, meprobamate, 10% chloral hydrate, etc. (3) Calcium preparation, such as 10% calcium gluconate injection, is injected intravenously slowly. (4) Vein occlusion for severe itching: 10-20 ml of 0.25% procaine is added with 1-2 g of vitamin C, and the mixture is injected intravenously. (5) Vitamin drugs such as vitamin C, B, B6, etc. (6) Corticosteroid hormones are used for skin lesions with severe inflammation, which cannot be treated by the above methods, such as prednisone. (7) The histamine globulin is an injection prepared by mixing histamine hydrochloride and gamma globulin and is used for treating recurrent eczema. (8) Antibacterial drugs were used for secondary infections. (9) External application therapy (calamine lotion, etc.).
The principle of traditional Chinese medicine advocates the combination of both principal and secondary aspects and the combination of internal and external treatment, and attaches importance to the manifestations of damp-heat and the root causes of dysfunction of the spleen in transportation and transformation. In therapeutic methods, the symptoms are treated first, and when damp-heat is relieved, the spleen is strengthened to promote the transportation. (1) And (3) treatment by syndrome differentiation: the acute stage can be classified into wind-heat accumulation, wind-damp accumulation, damp-heat accumulation (damp-heat over heat, heat-heat over damp-heat, damp-heat over heat), stagnation of liver-qi and damp-obstruction, spleen-damp-stomach heat, etc. Modified to dispel wind and clear hot drink, Xiaofeng san, Qingfeishu Tang, Xiaofeng dao san, Damp-removing and itching-relieving Tang, Danzhi Xiaoyao san and Xie Huang san are respectively adopted for treatment. (2) Other treatments are as follows: is mainly prepared from Chinese medicinal lotion, application agent, liniment, acupoint injection, cupping, umbilicus application, etc.
In conclusion, the pathological factors related to eczema are unknown. Western medicines belong to syndrome treatment, for example, antihistamine medicines and local corticosteroid hormones are applied, so the treatment effect is poor, the recurrence rate is high, and certain adverse effects are caused by long-term application. The traditional Chinese medicine has definite curative effect, but has ideal curative effect in clinical deficiency and is a Chinese patent medicine preparation suitable for infants or children.
The traditional Chinese medicine is a product of the theory and practice of traditional Chinese medicine, has rich resources and long history, is a pure natural organic substance applied to human beings at the earliest, and has the advantages of small toxic and side effects, good curative effect and lasting effect in the aspect of treating diseases. Therefore, compared with the modern western medicine treatment method, the traditional Chinese medicine has the advantages of little side effect and difficult relapse when being used for treating infantile eczema and dermatitis.
Radix Gentianae Gentiana scabra Bunge, Gentianaceae, Gentiana perennial, and radix Gentianae root and rhizome. It is bitter in taste and cold in nature. It enters liver and gallbladder meridians. Clearing heat, eliminating dampness, purging liver-fire and gallbladder excess fire. Mainly treats hypertension, dizziness and tinnitus, cholecystitis, acute infectious hepatitis, pudendum pruritus due to dampness and heat, jaundice due to damp-heat, sore, furuncle, carbuncle and swelling, bitter taste in mouth, convulsion and the like, and is a good medicine for protecting liver and benefiting gallbladder.
Kuh-seng, name of traditional Chinese medicine. Is prepared from dried root of Sophora flavescens ait of Leguminosae by digging in spring and autumn, removing root head and small branch root, cleaning, drying, or slicing and drying. It is bitter and cold. Has the functions of clearing heat, drying dampness, killing parasites and promoting urination. Can be used for treating dysentery with heat, hematochezia, jaundice, anuria, leucorrhea with red and white discharge, pudendal swelling, pudendal pruritus, eczema, skin pruritus, scabies, tinea, leprosy, and trichomonas vaginitis.
The transdermal drug delivery system can avoid the first pass effect of liver and the inactivation of the drug in gastrointestinal tract, and the absorption of the drug is not influenced by the factors of the gastrointestinal tract. The sustained-release tablet maintains constant effective blood concentration or physiological effect, has long action time, avoids peak valley phenomenon of blood concentration caused by oral administration, reduces toxic and side effects, is convenient to use, and can be independently taken by patients or withdrawn at any time.
The gel has the advantages of smooth appearance, transparency, fineness, proper consistency and viscosity, easy coating and the like, so the gel has good research and development values.
Disclosure of Invention
The invention aims to provide a compound gentian composition for treating infantile eczema and dermatitis.
In order to achieve the purpose, the invention adopts the following technical scheme:
a compound gentian composition for treating infantile eczema and dermatitis is prepared from the following raw material medicines in parts by weight: 60-80 parts of gentian, 25-35 parts of scutellaria baicalensis, 25-35 parts of radix sophorae flavescentis and 25-35 parts of dandelion.
Preferably, the compound gentian composition is prepared from the following raw material medicines in parts by weight: 60-80 parts of gentian, 25-35 parts of scutellaria baicalensis, 25-35 parts of radix sophorae flavescentis and 25-35 parts of dandelion.
More preferably, the compound gentian composition is prepared from the following raw material medicines in parts by weight: 70 parts of gentian, 30 parts of scutellaria baicalensis, 30 parts of sophora flavescens and 30 parts of dandelion.
A preparation method of a compound gentian composition comprises the following steps: extracting the raw material medicines with water, filtering and concentrating to obtain clear paste with the relative density of 1.10-1.15; precipitating the fluid extract with 95% ethanol until the ethanol content is 70%, standing, filtering, and concentrating to obtain fluid extract after ethanol precipitation; collecting fluid extract after alcohol precipitation, adding water, heating, filtering with absorbent cotton while it is hot, precipitating, and concentrating to obtain compound radix Gentianae fluid extract.
Preferably, the preparation method of the gentian composition comprises the following steps:
weighing four raw material medicines, adding water, decocting and extracting for three times;
step (2), merging the decoctions, filtering, and concentrating the filtrate to obtain clear paste with the relative density of 1.10-1.15 (measured at 50 ℃);
adding 95% ethanol into the clear paste to ensure that the ethanol content is 70%, standing for 24 hours, filtering, and concentrating the filtrate under reduced pressure until no ethanol smell exists to obtain an ethanol precipitated fluid extract;
and (4) taking the fluid extract after alcohol precipitation, adding purified water, heating in a water bath at 80 ℃, filtering and precipitating with absorbent cotton while hot, and concentrating under reduced pressure to the original volume to obtain the compound gentian fluid extract.
In the step (1), the water consumption for each time of water decoction is 10 times of the total weight of the 4 raw material medicines. The first water decoction is carried out for 1 hour, the second water decoction is carried out for 45 minutes, and the third water decoction is carried out for 30 minutes.
In the step (4), the volume ratio of the alcohol precipitated fluid extract to the purified water is 1: 4.
The invention also aims to provide the application of the compound gentian composition in preparing medicines for treating infantile eczema and dermatitis.
The invention also aims to provide the compound gentian gel for treating infantile eczema and dermatitis, which takes the compound gentian composition as an effective component and is prepared by taking carbomer and Transcutol P as auxiliary materials. In order to improve the detention time of the effective components of the compound gentian liquid on the wound surface, the liquid extract is adopted to replace the existing liquid preparation, and the carbomer is taken as a gel matrix, so that the spreading performance and the high temperature resistance of the compound gentian gel are improved. The innovation points of the formula of the compound gentian gel are as follows:
1. Carbomer is selected as a water-soluble gel matrix, so that the carbomer has no stimulation to skin mucosa, no greasy feeling, good skin coupling property, good transdermal property, easy coating and good treatment effect; the glycerol is used as a wetting agent and a humectant in the formula; the pH of the carbomer-forming hydrogel is reduced when the pH is less than 3 or more than 12, so that the pH of the compound radix Gentianae gel is adjusted to 5-11.
2. Carbomers are sensitive to salts with which the commonly used quaternary ammonium salts are incompatible, otherwise precipitation may occur. Now we add surfactant Transcutol P to increase the solubility of berberine hydrochloride and disperse the extract in gentian, thus better solving the problem and leading the prepared gel to be uniform and fine.
3. Transcutol P as a novel surfactant is a better penetration enhancer and solubilizer and also a drug storage, and increases the solubility of an effective component berberine hydrochloride, thereby increasing the main drug bearing capacity of the gel.
Preferably, the compound gentian gel is prepared from the following raw material medicines in parts by weight: 60-80 parts of gentian, 25-35 parts of scutellaria baicalensis, 25-35 parts of sophora flavescens, 25-35 parts of dandelion, 1-6 parts of carbomer and 5-15 parts of Transcutol P.
More preferably, the compound gentian gel is prepared from the following raw material medicines in parts by weight: 70-80 parts of gentian, 30-35 parts of scutellaria baicalensis, 30-35 parts of sophora flavescens, 30-35 parts of dandelion, 1-3 parts of carbomer and 5-10 parts of Transcutol P.
The invention also provides a preparation method of the compound gentian gel, which comprises the following steps:
dispersing carbomer in water, standing and swelling overnight to obtain carbomer solution;
and (2) adding Transcutol P and the compound gentian fluid extract into the carbomer solution to obtain the compound gentian gel.
As a further preferable technical scheme of the compound gentian gel, the raw material medicines also comprise: one or more of a pH adjusting agent, a humectant, or a preservative.
The pH regulator is triethanolamine, sodium hydroxide, ethylenediamine, laurylamine and sodium bicarbonate, preferably triethanolamine. The compatibility of triethanolamine and the compound gentian gel is best, and the prepared gel has the most stable drug property. The pH value of the compound gentian gel is 5-11, and the gel is relatively stable.
The humectant is glycerin or propylene glycol. The glycerin has good moisturizing effect and small irritation. The propylene glycol has good transdermal absorption promoting effect, and has better solubility to drugs than glycerin, but has larger irritation than glycerin. Therefore, the humectant is preferably glycerin.
Gels made with carbomer bases typically require the addition of preservatives. The preservative is nipagin, potassium sorbate, chlorobutanol, benzyl alcohol or benzoic acid, sodium benzoate, and preferably potassium sorbate.
More preferably, the compound gentian gel is prepared from the following raw material medicines in parts by weight: 60-80 parts of gentiana scabra bunge, 25-35 parts of scutellaria baicalensis, 25-35 parts of sophora flavescens, 25-35 parts of dandelion, 1-6 parts of carbomer, 5-15 parts of Transcutol P, 2-5 parts of triethanolamine, 10-30 parts of glycerol and 0.1-0.5 part of potassium sorbate.
Most preferably, the compound gentian gel is prepared from the following raw material medicines in percentage by weight:
a preparation method of the compound gentian gel comprises the following steps:
dispersing carbomer in glycerol, adding water, standing overnight for swelling to obtain carbomer solution;
step (2), adding Transcutol P, compound gentian fluid extract and potassium sorbate into carbomer solution;
and (3) adding triethanolamine to obtain the compound gentian gel.
The invention has the beneficial effects that:
the traditional Chinese medicine composition has a reasonable formula, wherein each component is absent: gentiana scabra Bunge belongs to perennial herb, and the root and rhizome of Gentiana scabra Bunge are bitter in taste and cold in nature. It enters liver and gallbladder meridians. Clearing heat, eliminating dampness, purging excessive fire of liver and gallbladder, etc., mainly treating pudendum pruritus, jaundice due to damp-heat, sore, furuncle, carbuncle, swelling, etc., is a good medicine for protecting liver and benefiting gallbladder, and is a monarch medicine; the scutellaria is bitter in taste and cold in nature, has the effects of clearing heat, eliminating dampness, purging fire, detoxifying, stopping bleeding and the like, is mainly used for treating damp-heat yellow gallbladder, dysentery, carbuncle, furuncle, sore and other symptoms, and is used as a ministerial drug; the sophora flavescens has the functions of clearing heat and drying dampness, is used for treating heat dysentery, vulva swelling and pruritus vulvae, eczema and skin pruritus, and the dandelion is mainly used for treating furuncle pyogenic infections, damp-heat jaundice and stranguria with astringency and pain, and the sophora flavescens and the dandelion are used as adjuvant drugs. The compatibility of the four herbs promotes each other, so that not only the manifestation of damp-heat but also the root cause of spleen failure in transportation and transformation are emphasized. In therapeutic methods, the symptoms are treated first, and after damp-heat subsides, the spleen is strengthened to promote transportation to treat the root cause, and the anti-inflammatory and antipruritic effects are strengthened. Clinical curative effect observation shows that the gel can effectively relieve skin inflammation and regulate skin immune function, has obvious curative effect on treating infantile eczema and dermatitis, has no adverse reaction and toxic or side effect, has no stimulation to the skin of infants, can enhance the resistance of the skin of the infants, and plays a role in treating both principal and secondary aspects of diseases.
The traditional Chinese medicine extraction technology is organically combined with the gel preparation technology and the like, so that the active ingredients of the traditional Chinese medicine and the pharmaceutic adjuvant are organically combined, the traditional Chinese medicine has the effects of clearing away heat and toxic materials, diminishing inflammation and relieving itching, and the defects of large side effect of western medicines, unsuitability for long-term use of a large amount of infants, easy relapse after medicine withdrawal and the like are overcome.
The compound gentian gel is a semisolid or solid gel in a storage state, can be spread on an affected part by being smeared on skin when in use, and has the following advantages:
(1) the compound gentiana gel has better bioadhesion and biocompatibility, is suitable for skin, mucosa and cavities, can be applied by skin smearing, enema and other modes, has accurate administration dosage, ensures that the medicine stays for a long time at the action part, achieves the aim of slow release and ensures that the medicine effect lasts for a longer time; not only avoids the first-pass action of oral administration in gastrointestinal tract, but also can reduce the adverse reaction of the medicine.
(2) The external preparation not only has some advantages which are not available in the traditional Chinese medicine external preparation, but also can contain superfine powder, extract and the like of a traditional Chinese medicine compound, has no harsh process conditions, is suitable for the current production situation of the traditional Chinese medicine compound liniment, and is convenient to popularize and apply.
(3) Can absorb a large amount of water (more than 20 percent of the self weight) and swell, maintain the three-dimensional structure of the self, and have the structure memory function after deswelling.
(4) Generally, a transdermal absorption enhancer can be selectively added to accelerate and complete drug absorption and rapidly exert curative effects. Conversely, a matrix for delaying the release of the drug can be selected to ensure that the drug is slowly released and continuously absorbed so as to maintain the longer drug effect.
(5) Good air permeability, no pollution to clothes, durable effect, simple preparation method, comfortable use and the like.
(6) The gel can isolate the drug action part from the external environment, provide a moist environment for wound healing, and avoid infection.
(7) The high polymer material adopted by the gel preparation is degradable, and infection recurrence caused by wet dressing of gauze of the liquid preparation to the wound is avoided.
(8) Is convenient to carry and use.
Drawings
FIG. 1 is a graph showing daily changes in allergic reactions in the backs of rats.
FIG. 2 shows the daily recovery of anaphylaxis in rat backs (P < 0.05, statistically different from the model group; P < 0.01, statistically different from the model group).
FIG. 3 shows the results of ear swelling in mice induced by xylene (P < 0.05, statistically different from the model group; P < 0.01, statistically different from the model group).
FIG. 4 is a graph of the number of times the mice licked with back pruritus caused by 4-aminopyridine (P < 0.05, statistically different from the model group; P < 0.01, statistically different from the model group).
Detailed Description
The technical solution of the present invention is further described in detail by the following examples to facilitate the understanding of those skilled in the art.
The instrument comprises:
a pH meter, an electric heating constant temperature water bath, a refrigerator, an oven, an electronic balance and the like.
Materials and reagents:
gentian: perennial herb of Gentiana scabra Bunge of gentianaceae.
Flavescent sophora root: is made from Sophora flavescens Alt. of leguminous, Sophora genus herbaceous or subshrubular plants in the form of diluted shrubs.
Scutellaria baicalensis: the root of Japanese camellia and the root of Japanese ardisia herb are used as medicines, are bitter in taste and cold in nature, and have the effects of clearing heat, drying dampness, purging fire, detoxifying and the like.
Dandelion: it is mainly used for furuncle, swelling and toxin, acute mastitis, scrofula, conjunctival congestion, pharyngalgia, pulmonary abscess, intestinal abscess, jaundice due to damp-heat pathogen, stranguria with heat and pain, etc.
The medicinal materials all meet the requirements of each medicinal material item in the first part of 'Chinese pharmacopoeia' 2015 edition.
Triethanolamine and potassium sorbate are analytically pure.
The gel pharmaceutic adjuvant is in a pharmaceutical grade as follows:
sodium carboxymethylcellulose (CMC-Na): batch number: 20130906 (national drug group chemical Co., Ltd.);
hydroxypropyl methylcellulose (HPMC): batch number: 35733 (Aladdin corporation);
carbomer: batch number: 0101253033 (Lubriun corporation);
Transcutol P: batch number: 154003 (Jiafa lion (Shanghai) trade company);
triethanolamine: batch number: 20150709 (Kangde chemical Co., Ltd., Laiyang);
glycerol: batch number: 40520388-GB (Tianjin Yida chemical trade Co., Ltd.).
Example 1
A compound gentian composition is prepared by the following preparation process, and the steps are as follows:
weighing four raw material medicines in parts by weight: decocting gentian 70 parts, scutellaria baicalensis 30 parts, sophora flavescens 30 parts and dandelion 30 parts in water for three times, wherein the water consumption for each time is 10 times of the total weight of the 4 raw material medicines, and the water consumption for the first time is 1 hour, the second time is 45 minutes, and the third time is 30 minutes;
step (2), merging the decoctions, filtering, and concentrating the filtrate into clear paste with the relative density of 1.10-1.15 (measured at 50 ℃);
adding 95% ethanol into the clear paste to ensure that the ethanol content reaches 70%, standing for 24 hours, filtering, and concentrating the filtrate under reduced pressure until no ethanol smell exists to obtain an ethanol-precipitated fluid extract;
and (4) taking the fluid extract subjected to alcohol precipitation, adding purified water according to the volume ratio of the fluid extract subjected to alcohol precipitation to the purified water of 1:4, heating in a water bath at 80 ℃, filtering and precipitating with absorbent cotton while the fluid extract is hot, and concentrating under reduced pressure to the original volume of the fluid extract subjected to alcohol precipitation to obtain the compound gentian fluid extract.
Example 2
Research on compound gentian gel forming process
And (3) screening a gel matrix: the selection of the gel matrix for the topical gel requires: the appearance is smooth, transparent and fine; the consistency and viscosity are proper, and the coating is easy; the properties are stable, and the compatibility change with the main medicine is avoided; does not interfere with the normal function of the skin and has good drug release performance; good safety, no irritation to local parts, etc. After the inventors have analyzed conventional gelling agents, the focus is on three gel matrices: hydroxypropyl methylcellulose (HPMC), sodium carboxymethylcellulose (CMC-Na), and carbomer were studied for their characteristics and suitability.
(1) Weighing 1g of carbomer and 10g of glycerol, adding 70g of purified water when the carbomer is dispersed in the glycerol, uniformly stirring, swelling overnight, adding 1g of triethanolamine to adjust the pH value, and finally adding the purified water to a constant volume of 100g to form gel. The gel is observed after being placed for 24 hours, has transparent, uniform and fine appearance, can obtain a uniform and stable system, is easy to smear and has good stability.
The carbomer matrix is a common matrix of the water-based gel, and has certain tolerance to acid, alkali and alcohol; can resist low-temperature storage and high-temperature damp-heat sterilization; has good biocompatibility and no irritation to eyes and skin. The carbomer matrix is beautiful and the preparation process is simple. The best gel matrix is selected to be carbomer.
(2) Weighing 1g of HPMC, adding 5g of glycerol and 80g of purified water to fully disperse and hydrate the HPMC, and finally adding the purified water to a constant volume of 100g to form gel. The gel is opaque in appearance, is not easy to absorb when being coated, and is layered after being stored for 24 hours under the conditions of high temperature and low temperature.
Considering that HPMC has low solubility in hot water and is easy to precipitate, the gel prepared by using HPMC as a matrix is not suitable for high-temperature sterilization.
(3) And weighing 1g of CMC-Na, adding 70g of purified water, quickly stirring for 5min, adding the purified water to the volume of 100g after the CMC-Na is completely dissolved, and obtaining gel. The appearance is non-transparent, and the layering phenomenon appears after the storage for 24 hours under the conditions of high temperature and low temperature.
The viscosity of the gel prepared by using CMC-Na as the gel matrix is rapidly increased below 20 ℃, and is obviously reduced by heating for a long time above 80 ℃.
And comparing the results of the three gel matrixes to determine that the carbomer is used as the gel matrix of the compound radix gentianae gel.
Preparing a compound gentian gel:
weighing carbomer and glycerol, adding purified water into the carbomer dispersed in the glycerol, and standing the carbomer and the glycerol overnight for swelling;
weighing Transcutol P, a compound radix gentianae fluid extract (example 1) and a preservative potassium sorbate, and adding the weighed substances into a carbomer solution under the condition of stirring to ensure that the weight percentages of the Transcutol P, the compound radix gentianae fluid extract (example 1) and the potassium sorbate are 5%, 5% and 0.1% respectively;
And (3) adding triethanolamine to adjust the pH value to form the compound gentian gel.
Comprehensive evaluation standard of gel formula
The evaluation of the prescription composition of the gel by adopting a single index inevitably leads to one-sided results, and the inventor adopts a comprehensive evaluation standard of sensory indexes and experimental indexes to carry out quality evaluation on the gel prescription on the basis of referring to related documents and pre-tests so as to comprehensively and comprehensively evaluate the gel prescription. The evaluation criteria are shown in Table 1.
TABLE 1 gel evaluation criteria
Composite score-gloss + uniformity + paintability + centrifuge stability + high temperature stability + Low temperature stability
Design L with gloss, uniformity, spreadability, centrifugal stability, high temperature stability, low temperature stability as indices9(34) Orthogonal experiment, wherein carbomer, glycerol and triethyl ester are examined through the orthogonal experimentThe adding amount of alcohol amine.
TABLE 2 factor horizon
TABLE 3 orthogonal test Table
TABLE 4 analysis of comprehensive scores and variances table
As can be seen from the ANOVA table: the factor A has significance, A3> A2> A1, B3> B1> B2, C2> C1> C3 determine the optimal gel preparation process conditions to be A3B3C2, namely the adding amount of carbomer is 1.0%, the glycerol amount is 10% and the triethanolamine amount is 1.0%.
The optimal prescription of the compound gentian gel is determined as follows:
example 3
According to the optimal prescription of the compound gentian gel determined in the example 2, the compound gentian gel is prepared by the following steps:
weighing carbomer and glycerol, adding purified water when the carbomer is dispersed in the glycerol, and standing overnight at normal temperature for swelling to obtain a carbomer solution;
weighing Transcutol P, compound gentian fluid extract (example 1) and potassium sorbate, and adding the mixture into carbomer solution under the condition of stirring;
and (3) adding triethanolamine to adjust the pH value to form the compound gentian gel.
Stability test of the Compound Gentiana gel
Heat resistance test
The samples of example 3 were poured into 2 test tubes, respectively, to a level of about 10cm, each tube was stoppered with a clean cork, one tube was placed at room temperature, the other tube was placed in an electric-heated incubator previously adjusted to 40 ℃. + -. 1 ℃ and taken out after 24 hours, and the resultant was allowed to stand at room temperature and visually compared with the samples of the tubes placed at room temperature, as shown in Table 5.
TABLE 5 Heat resistance test results Table
The test result shows that: the compound gentian gel provided by the invention is placed for 24 hours at 40 +/-1 ℃, and no layering or color change phenomenon exists, which indicates that the compound gentian gel has good thermal stability.
Cold resistance test
The samples of example 3 were poured into 2 test tubes each having a liquid level of about 10cm, stoppered with a clean cork, one test tube was placed at room temperature, the other test tube was placed in a refrigerator at (-5 ℃ C. - (-10 ℃ C.) and taken out after 24 hours, and the test tubes were allowed to stand at room temperature and compared with the test samples placed in the test tubes at room temperature by visual observation, and the results are shown in Table 6.
TABLE 6 Cold resistance test results table
The test result shows that: the compound gentian gel provided by the invention is placed for 24 hours at (-5 ℃) to (-10 ℃) without layering and discoloration phenomena, which shows that the compound gentian gel has good cold resistance and stability.
Centrifugal test
The samples of example 3 according to the invention were each poured into 2 tubes (the test specimens approximately two thirds high) and stoppered with clean cork. Placing one test tube at room temperature, placing the other test tube in an electric heating constant temperature incubator pre-adjusted to 38 +/-1 ℃, preserving heat for 1h, immediately transferring into a centrifuge, centrifuging at 2000r/min for 30min, taking out and observing, wherein the results are shown in Table 7.
TABLE 7 centrifugal test results table
The test result shows that: the compound gentian gel is placed for 1 hour at the temperature of 38 +/-1 ℃, and is taken out for centrifugation without layering and color change, which shows that the compound gentian gel has good gel formula stability.
Antiallergic test
Animals: SD rats 32, SPF grade, randomly divided into 4 groups of 8 rats each, and the sex is not limited. Body weight 200 + -20 g.
Reagent: 45g of compound gentian gel, 20g of compound dexamethasone acetate cream (dermatan), 15mg of DNCB (2-4 dinitrochlorobenzene), 500ml of acetone solution, 8mm ear-punching device, straight ruler and shaver.
Setting a medicine-containing gel group: compound gentian gel, 1.0g/kg for each; positive control group: 1.0g/kg of dermatitis treating cream; model control group: distilled water, 1.0g/kg each.
The experimental steps are as follows: taking 32 healthy mice, feeding for 1 day conventionally, and then randomly dividing into 4 groups, wherein each group comprises 8 mice, namely a drug-containing gel group, a positive control group (dermatitis flat cream), a normal control group (distilled water) and a model control group. After the back of the mouse is unhaired, a drug-containing gel group, a positive control group (dermatitis treating cream) and a 2cm multiplied by 2cm skin of the back of the mouse of a model control group are smeared with a 5% DNCB acetone solution, after an eczema model is successfully established, compound gentian gel (1.0 g/kg of each drug) is smeared on the eczema skin of the back of the mouse every day in the drug-containing gel group, the dermatitis treating cream (1.0 g/kg of each drug) is smeared on the eczema skin of the back of the mouse every day in the positive control group, and distilled water (1.0 g/kg of each drug) is smeared on the eczema skin of the back of the mouse every day in the model control group. The size of the eczema area on the back of the mouse is observed every day, and the photographing record is carried out.
And (3) statistical treatment: a one-way analysis of variance was used to test that P <0.05 indicated a statistical difference and P <0.01 indicated a very significant difference.
The experimental results are shown in fig. 1 and 2: the application of the compound gentian gel on the back of a mouse has the obvious effect of improving the delayed anaphylactic reaction caused by DNCB.
Anti-inflammatory assay
Animals: 32 Kunming mice with SPF grade are randomly divided into 4 groups, each group comprises 8 mice, and the male and female are not limited. The weight is 18-22 g.
Reagent: 45g of compound gentian gel, 20g of compound dexamethasone acetate cream (dermatitis treating ointment), 15mg and 500mL of dimethylbenzene.
Electronic analytical balance, 8mm ear-beater.
Setting a blank control group; the gel group containing the medicine comprises: compound gentian gel, 1.0g/kg for each; positive control group: 1.0g/kg of dermatitis treating cream; model group: distilled water, 1.0g/kg each.
The experimental steps are as follows:
1.0g/kg of gel is uniformly smeared on auricles of right ears of mice in the gel group containing the medicine, 1.0g/kg of dermatitidis flat cream is uniformly smeared on auricles of right ears of the mice in the positive control group, 1.0g/kg of distilled water is uniformly smeared on auricles of right ears of the mice in the model group, and the mice in the blank control group are not treated; 2 times/d, continuously applying medicine for 3 days, after applying medicine for 1h on day 4, applying xylene to the right ear of the mouse, applying 20 μ L of xylene to each mouse, and keeping for 30 min; then 1.0g/kg of medicine is administered again, after 30min, purified water is used for washing away liquid medicine coated on auricles of right ears of each group of mice, the mice are killed after being wiped dry by cotton balls, double ears are cut off, round ear pieces are punched at the same parts of the double ears by a puncher with the diameter of 8mm, an electronic balance is used for weighing, the left ear is used as a control, the difference of the mass of the left ear and the right ear is the swelling degree, the swelling degree of each group is calculated, and the swelling degree of auricles is measured: the mice were sacrificed by removing the neck and the left and right ears were cut off, round ears were punched out at the same positions of the left and right ears by an 8mm punch, and the mass was immediately weighed on an analytical balance and the degree of swelling of the ears was calculated, which is the mass of the right ear-the mass of the left ear.
The results are shown in fig. 3, P <0.05 indicates statistical differences, and P <0.01 indicates very significant differences. The effect of ear swelling caused by dimethylbenzene (P is less than 0.05) can be obviously improved by smearing compound gentian gel on the ear of a mouse, and the effect is superior to that of a positive control group and a model group.
Itching relieving test
Animals: 32 Kunming mice, SPF grade, randomly divided into 4 groups, each group comprises 8 mice, and the sex is not limited. The weight is 18-22 g.
Reagent: 45g of compound gentian gel, 20g of compound dexamethasone acetate cream (dermatitis treating ointment), 15mg of 4-aminopyridine, 500ml of physiological saline and a shaver.
Setting a blank control group; the gel group containing the medicine comprises: compound gentian gel, 1.0g/kg for each; positive control group: 1.0g/kg of dermatitis treating cream; model control group: distilled water, 1.0g/kg each.
The experimental steps are as follows: an experiment for inducing allergic skin pruritus reaction of mice by using 4-aminopyridine comprises the following groups: the mouse grouping method is as above. Administration: depilating the back of mouse by 2cm × 2cm, smearing distilled water (1.0 g/kg each) on blank control group, smearing compound radix Gentianae gel (1.0 g/kg each) on medicated gel group, smearing dermatitis removing cream (1.0 g/kg each) on positive control group, smearing distilled water (1.0 g/kg each) on model control group, and continuously applying for 7 days 1 time per day. Itching: after last administration for 40min, the drug-containing gel group, the positive control group and the model control group are 1mg kg of 4-aminopyridine -1The dose of (4-aminopyridine) was injected subcutaneously in the depilatory area of the back of mice immediately followed by 1.0g/kg, and the control mice were left untreated. Observation of pruritus reaction: immediately observing the times of the body licking behaviors of the mice within 10min, wherein the body licking behaviors refer to the repeated behavior that the mice wriggle heads and lick the back parts on both sides, and the behavior that the mice continuously lick the bodies to cause transient pause is counted as 1 time of body licking. The latency time, duration and frequency of licking the body of the mouse are observed, and the inhibition rate of the response is calculated.
The inhibition rate is (number of times of body licking in the model control group-number of times of body licking in the administration group)/number of times of body licking in the model control group x 100%.
Statistical treatment: the single-factor analysis of variance is adopted for testing, P <0.05 shows that the statistical difference exists, P <0.01 shows that the very significant difference exists
The results of the experiment are shown in FIG. 4: the effect of obviously improving the itching reaction caused by 4-aminopyridine by smearing the compound gentian gel on the back of the mouse is superior to that of a positive control group and a model control group.
In conclusion, the compound gentiana gel disclosed by the invention has the effects of resisting inflammation, resisting allergy and relieving itching, has a treatment effect on eczema and dermatitis, has no side effect on skin, and can be applied to medicines for treating eczema and dermatitis.
The embodiments described above are presented to facilitate one of ordinary skill in the art to understand and use the invention. It will be readily apparent to those skilled in the art that various modifications to these embodiments may be made, and the generic principles described herein may be applied to other embodiments without the use of the inventive faculty. Therefore, the present invention is not limited to the above embodiments, and those skilled in the art should make improvements and modifications within the scope of the present invention based on the disclosure of the present invention.
Claims (10)
1. A compound gentian composition for treating infantile eczema and dermatitis is characterized in that: the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 60-80 parts of gentian, 25-35 parts of scutellaria baicalensis, 25-35 parts of radix sophorae flavescentis and 25-35 parts of dandelion.
2. The compound gentian composition of claim 1, wherein: the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 60-80 parts of gentian, 25-35 parts of scutellaria baicalensis, 25-35 parts of radix sophorae flavescentis and 25-35 parts of dandelion.
3. A method of preparing the compound gentian composition of claim 1, comprising: the method comprises the following steps: extracting the raw material medicines with water, filtering and concentrating to obtain clear paste with the relative density of 1.10-1.15; precipitating the fluid extract with 95% ethanol until the ethanol content is 70%, standing, filtering, and concentrating to obtain fluid extract after ethanol precipitation; and (3) taking the alcohol-precipitated fluid extract, adding water, heating, filtering and precipitating with absorbent cotton while the fluid extract is hot, and concentrating to obtain the compound gentian fluid extract.
4. The compound gentian gel for treating infantile eczema and dermatitis is characterized in that: the compound gentian composition of claim 1 or 2 is used as an active ingredient or a main active ingredient, and carbomer and Transcutol P are used as auxiliary materials.
5. The compound gentian gel of claim 4, wherein: the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 60-80 parts of gentian, 25-35 parts of scutellaria baicalensis, 25-35 parts of sophora flavescens, 25-35 parts of dandelion, 1-6 parts of carbomer and 5-15 parts of Transcutol P.
6. The compound gentian gel of claim 5, wherein: the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 70-80 parts of gentian, 30-35 parts of scutellaria baicalensis, 30-35 parts of sophora flavescens, 30-35 parts of dandelion, 1-3 parts of carbomer and 5-10 parts of Transcutol P.
7. A method for preparing the compound gentian gel of claim 4, wherein the method comprises the following steps: the method comprises the following steps:
dispersing carbomer in water, standing and swelling overnight to obtain carbomer solution;
and (2) adding Transcutol P and the compound gentian fluid extract into the carbomer solution to obtain the compound gentian gel.
8. The compound gentian gel of claim 4, wherein: further comprising: one or more of a pH adjuster, a humectant, or a preservative;
The pH regulator is triethanolamine, sodium hydroxide, ethylenediamine, laurylamine and sodium bicarbonate, preferably triethanolamine;
the humectant is glycerol or propylene glycol, preferably glycerol;
the antiseptic is selected from nipagin, potassium sorbate, chlorobutanol, benzyl alcohol or benzoic acid, and sodium benzoate, preferably potassium sorbate.
9. The compound gentian gel for treating infantile eczema and dermatitis is characterized in that: the compound gentian gel is prepared from the following raw material medicines in parts by weight: 60-80 parts of gentiana scabra bunge, 25-35 parts of scutellaria baicalensis, 25-35 parts of sophora flavescens, 25-35 parts of dandelion, 1-6 parts of carbomer, 5-15 parts of Transcutol P, 2-5 parts of triethanolamine, 10-30 parts of glycerol and 0.1-0.5 part of potassium sorbate.
10. A method of preparing the compound gentian gel of claim 9, comprising: the method comprises the following steps:
dispersing carbomer in glycerol, adding water, standing overnight for swelling to obtain carbomer solution;
step (2), adding Transcutol P, compound gentian fluid extract and potassium sorbate into carbomer solution;
and (3) adding triethanolamine to obtain the compound gentian gel.
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| CN107198721A (en) * | 2016-03-17 | 2017-09-26 | 山东汉方生物科技有限公司 | A kind of compound phellodendron bark gel and preparation method for treating childhood eczema |
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| CN107198721A (en) * | 2016-03-17 | 2017-09-26 | 山东汉方生物科技有限公司 | A kind of compound phellodendron bark gel and preparation method for treating childhood eczema |
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