CN114224953A - Itching relieving cream for treating anal itching and preparation method thereof - Google Patents

Itching relieving cream for treating anal itching and preparation method thereof Download PDF

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CN114224953A
CN114224953A CN202210008049.6A CN202210008049A CN114224953A CN 114224953 A CN114224953 A CN 114224953A CN 202210008049 A CN202210008049 A CN 202210008049A CN 114224953 A CN114224953 A CN 114224953A
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李成
李一兵
陈连剑
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • 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)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • 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)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/234—Cnidium (snowparsley)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • 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)
    • A61K36/75—Rutaceae (Rue family)
    • A61K36/758—Zanthoxylum, e.g. pricklyash
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/46—Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0031—Rectum, anus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/04—Antipruritics

Abstract

The invention relates to the technical field of preparation of traditional Chinese medicine compositions, in particular to an itching relieving cream for treating anal itching and a preparation method thereof. The liquid medicine is used as water phase to participate in the preparation of the cream, and the oil-in-water cream is prepared. The invention has the beneficial effects that: in the itching relieving cream for treating the pruritus ani, the traditional Chinese medicine components have synergistic effect, and compared with lotion/decoction in the prior art, the oil-in-water itching relieving cream for treating the pruritus ani is convenient to carry and use and has better treatment effect.

Description

Itching relieving cream for treating anal itching and preparation method thereof
Technical Field
The invention relates to the technical field of preparation of traditional Chinese medicine compositions, and in particular relates to an itching relieving cream for treating anal itching and a preparation method thereof.
Background
The anal pruritus refers to a skin disease with pruritus symptoms only without any primary skin damage around the anus, and the cause of the skin disease is complex. Often as a result of internal and external interactions. Internal factors such as chronic digestive system diseases, mental stress, insomnia, overfatigue, mood changes, endocrine disorders, infection, metabolic disorders, etc.; external factors such as living environment, climate change, food, etc. can affect the occurrence of eczema. External stimuli such as sunlight, cold, dryness, heat, hot water scalding, and various animal skins, plants, cosmetics, soaps, artificial fibers, etc. can be induced.
The Chinese patent with the application number of 201510485260.7 discloses an external washing medicine for treating perianal eczema, which comprises the following components in parts by mass: 1-3 parts of radix sophorae flavescentis, fructus cnidii, alum, mirabilite, pericarpium zanthoxyli, folium artemisiae argyi, herba schizonepetae and fructus kochiae respectively. However, the external washing medicine is a solution, and the affected part is soaked in the liquid medicine for 15 minutes generally, so that the external washing medicine has short action time, is inconvenient, and has unsatisfactory absorption effect and poor treatment effect.
The compound radix sophorae flavescentis and fructus cnidii hip bath liquid medicine is a pure traditional Chinese medicine external decoction of a secret recipe of a famous family in a traditional Chinese medicine anorectal hospital in Shenzhen city, and has the effects of clearing heat, drying dampness, relieving pain and itching, and resisting bacteria and astringing. The traditional Chinese medicine composition is mainly used for treating perianal eczema, perianal pruritus and various eczemas and pruritus, has a clinical basis of many years, has a good clinical curative effect, is popular with patients, and has the problem of inconvenient use. 150ml of the product is used each time, and after being diluted by about 450ml of warm water, the product is heated for hip bath for 2 times per day. The liquid medicine has large volume, is not easy to carry, has long treatment time, and needs hip bath for about 30 minutes each time. The concentration of the finally used liquid medicine is lower, and the acting time of the medicine is shorter.
Disclosure of Invention
The technical problem to be solved by the invention is as follows: provides the itching relieving cream for treating the anal itch, which has convenient use, long acting time and good absorption effect, and the preparation method thereof.
In order to solve the technical problems, the invention adopts the technical scheme that: an itching relieving cream for treating anal itching comprises the following components in parts by mass: 28-32 parts of radix sophorae flavescentis; 28-32 parts of fructus cnidii; 28-32 parts of fructus kochiae; 18-22 parts of pepper and 4-6 parts of alum.
Preferably, the itching relieving cream for treating anal itching consists of the following components in parts by mass: 10-14 parts of stearic acid; 3.5-5.5 parts of glycerin monostearate; 6-10 parts of vaseline; 6-10 parts of liquid paraffin; 0.7-1.0 part of span-60; 3.5-5.5 parts of tween-60; 0.1 part of sorbic acid; 4-6 parts of glycerol and 55-59 parts of a traditional Chinese medicine concentrated solution;
the traditional Chinese medicine concentrated solution is prepared by the following preparation method:
taking the following traditional Chinese medicine raw materials in parts by mass: 28-32 parts of radix sophorae flavescentis; 28-32 parts of fructus cnidii; 28-32 parts of fructus kochiae and 18-22 parts of pepper, adding 1000-1300 parts by mass of water, decocting, concentrating to obtain 200-300 parts by mass of decoction concentrate, and adding 4-6 parts by mass of alum.
Preferably, the itching relieving cream for treating anal itching consists of the following components: 12g of stearic acid; 4.5g of glyceryl monostearate; 8g of vaseline; 8g of liquid paraffin; 0.85g span-60; 4.5g Tween-60; 0.1g sorbic acid; 5g of glycerol and 57g of traditional Chinese medicine concentrated solution;
the traditional Chinese medicine concentrated solution is prepared by the following preparation method:
taking the following traditional Chinese medicine raw materials in parts by mass: 30g of radix sophorae flavescentis; 30g of fructus cnidii; 30g of fructus kochiae and 20g of pepper are added with 1000g of water in total and decocted for two times, filtered and concentrated by heating to obtain 200g of decocted concentrated solution, and then 5g of alum is added to prepare the traditional Chinese medicine concentrated solution.
The other technical scheme provided by the invention is as follows: provides a preparation method of an antipruritic cream for treating anal itching, which comprises the following steps:
step 1, taking the following traditional Chinese medicine raw materials in parts by mass: 28-32 parts of radix sophorae flavescentis; 28-32 parts of fructus cnidii; 28-32 parts of fructus kochiae and 18-22 parts of pepper are soaked in 800 parts by mass of water with the temperature of 600-;
adding 500 parts by mass of 400-one-step water into the left decoction dregs, boiling the decoction dregs by using a big fire, boiling the decoction dregs for 15 to 25 minutes by using a small fire, boiling the decoction dregs into 300 parts by mass of 200-one-step liquid medicine, and pouring out the liquid medicine for later use;
uniformly mixing the liquid medicines obtained in the two steps, boiling the mixture with strong fire, boiling the mixture for 15 to 25 minutes with soft fire, boiling the mixture into 300 parts by mass of concentrated liquid medicine of 200-6 parts by mass, cooling the concentrated liquid medicine, adding 4 to 6 parts by mass of alum, and stirring the mixture to dissolve the alum to obtain the traditional Chinese medicine concentrated solution;
step 2, taking the following raw materials in parts by mass: 10-14 parts of stearic acid; 3.5-5.5 parts of glycerin monostearate; 6-10 parts of vaseline; 6-10 parts of liquid paraffin; 0.7-1.0 part of span-60; heating and melting 3.5-5.5 parts of tween-60 and 0.1 part of sorbic acid as oil phases, and then keeping the temperature at 75-80 ℃; taking 4-6 parts by mass of glycerol and 55-59 parts by mass of the traditional Chinese medicine concentrated solution as a water phase, heating to 75-80 ℃, wherein the temperature of the water phase is higher than that of the oil phase, pouring the water phase into the oil phase, homogenizing and stirring for 3-5 minutes, and then stirring until the mixture is cooled and solidified to obtain the itching relieving cream for treating anal pruritus.
Preferably, the preparation method of the itching relieving cream for treating anal itching specifically comprises the following steps:
step 1, taking the following traditional Chinese medicine raw materials by mass: 30g of radix sophorae flavescentis; 30g of fructus cnidii; soaking 30g of fructus kochiae and 20g of pepper in 600 ml of water for 30 minutes, boiling with strong fire, boiling with slow fire for 20-30 minutes, boiling into 200 ml of liquid medicine, and pouring out the liquid medicine for later use;
adding 400 ml of water into the residual medicine dregs, boiling the medicine dregs with strong fire, boiling the medicine dregs with small fire for 15 to 25 minutes, boiling the medicine dregs into 200 ml of liquid medicine, and pouring out the liquid medicine for later use;
mixing the liquid medicines obtained in the two steps uniformly, boiling the mixture with strong fire, boiling the mixture for 15 to 25 minutes with small fire, boiling the mixture into 200 milliliters of concentrated liquid medicine, cooling the concentrated liquid medicine, adding 5 grams of alum, and stirring the mixture to dissolve the alum to obtain the traditional Chinese medicine concentrated solution;
step 2, taking the following raw materials by mass: 12g of stearic acid; 4.5g of glyceryl monostearate; 8g of vaseline; 8g of liquid paraffin; 0.85g span-60; heating and melting 4.5g of tween-60 and 0.1g of sorbic acid serving as oil phases, and then keeping the temperature at 75-80 ℃; taking 5g of glycerol and 57g of the traditional Chinese medicine concentrated solution as a water phase, heating to 75-80 ℃, wherein the temperature of the water phase is higher than that of the oil phase, pouring the water phase into the oil phase, homogenizing and stirring for 3-5 minutes, and then stirring until the mixture is cooled and solidified to obtain the itching relieving cream for treating anal pruritus.
The invention has the beneficial effects that: in the itching relieving cream for treating pruritus ani, the traditional Chinese medicine components have synergistic effect, and compared with lotion/decoction (solution) in the prior art, the oil-in-water (O/W) cream (semisolid) provided by the invention has the following advantages:
(1) the application mode of the cream provided by the invention is as follows: the cream is smeared on the affected part, the action time is long, the medicine is convenient to use, and the cream is easy to accept by patients;
(2) the cream adopts a nonionic emulsifier pair, and the preparation is convenient to smear and easy to clean, so that the compliance of patients is greatly improved, and the advantages of the preparation are fully exerted;
(3) the cream contains various transdermal enhancers and can promote the absorption of effective components at the affected part, and the main drug in the cream also contains pepper, so that the cream not only has the functions of anti-inflammation and analgesia, but also is a good traditional Chinese medicine transdermal enhancer and further promotes the absorption of the effective components at the affected part.
(4) The main medicines in the cream provided by the invention have the following effects and cooperate to obtain a better effect of treating pruritus ani. Wherein, kuh-seng: antiallergic and antioxidant effects. Fructus cnidii: osthole can inhibit atopic dermatitis by inhibiting thymic stromal lymphopoietin level. The preparation method comprises the following steps of (1) preparing broom cypress fruit: has obvious itching relieving effect on pruritus models. Chinese prickly ash: anesthesia, pain relief, immunosuppression and antibiosis effects, has strong inhibition and killing effects on mites of human bodies, and meanwhile, the pepper volatile oil is a good traditional Chinese medicine transdermal enhancer. Alum: it has effects of removing toxic substance, killing parasite, eliminating dampness, relieving itching, and astringing.
Drawings
FIG. 1 is a photograph of the cream droplets of formulation 1 of example 4, which were observed under a microscope;
FIG. 2 is a photograph of emulsion droplets observed under a microscope with the cream of formula 2 of example 4;
FIG. 3 is a photograph of the cream droplets of formula 3 of example 4, as observed under a microscope;
FIG. 4 is a photograph of the emulsion droplets observed under a microscope with the cream of formula 4 in example 4;
FIG. 5 is a photograph of the cream of formula 5 of example 4 as droplets observed under a microscope;
FIG. 6 is a photograph of the cream droplets of formulation 6 of example 4 observed under a microscope.
Detailed Description
In order to explain technical contents, achieved objects, and effects of the present invention in detail, the following description is made with reference to the accompanying drawings in combination with the embodiments.
The key concept of the invention is that:
research on preparation process of compound radix sophorae flavescentis and fructus cnidii itching-relieving cream (nosocomial preparation) has already been conducted in the research of the department of traditional Chinese medicine and pharmacy of Guangdong province. The application method of the original prescription is that each dose is decocted into 300ml by a conventional decoction method of traditional Chinese medicine decoction pieces, the decoction pieces are divided into two parts, and 150ml of each part is diluted by adding a proper amount of warm boiled water for 2-3 times of hip bath. The concentration of the finally used liquid medicine is lower, and the acting time of the medicine is shorter.
The invention is characterized in that a dose of traditional Chinese medicine is decocted and filtered to obtain 300ml according to the conventional decoction method of traditional Chinese medicine decoction pieces, filtrate is heated and concentrated to 150ml, and the concentrated solution is used as water phase for preparing the cream to prepare O/W type cream. The concentrated solution is about 57% in the cream, and compared with hip bath lotion, the concentration of the medicine in the cream is about 3.5 times of that in hip bath lotion. Meanwhile, the cream has certain viscosity and coating property and can act on the skin all the time, the hip bath lotion can act for only 30 minutes each time, and the acting time of the cream is greatly longer than that of the hip bath lotion. The oil phase in the cream component, the emulsifier and the pricklyash peel volatile oil in the prescription have good transdermal promoting effect, and can remarkably improve the curative effect.
The traditional Chinese medicine has complex ingredients, is easy to have physicochemical reaction with cream matrix to influence the stability of the cream, and is especially easy to react with ionic emulsifier to cause rough character, emulsion rupture and oil-water demixing. According to the invention, the nonionic compound emulsifier is selected, a large number of tests are carried out in the early stage, and the dosage of raw materials such as alum is adjusted on the premise of ensuring the clinical curative effect, so that the O/W cream for treating the pruritus ani with good effect is obtained.
Example 1
A preparation method of an antipruritic cream for treating anal itching comprises the following steps:
step 1, taking the following traditional Chinese medicine raw materials by mass: 30g of radix sophorae flavescentis; 30g of fructus cnidii; soaking 30g of fructus kochiae and 20g of pepper in 600 ml of water for 30 minutes, boiling with strong fire, boiling with slow fire for 20-30 minutes, boiling into 200 ml of liquid medicine, and pouring out the liquid medicine for later use;
adding 400 ml of water into the residual medicine dregs, boiling the medicine dregs with strong fire, boiling the medicine dregs with small fire for 15 to 25 minutes, boiling the medicine dregs into 200 ml of liquid medicine, and pouring out the liquid medicine for later use;
mixing the liquid medicines obtained in the two steps uniformly, boiling the mixture with strong fire, boiling the mixture for 15 to 25 minutes with small fire, boiling the mixture into 200 milliliters of concentrated liquid medicine, cooling the concentrated liquid medicine, adding 5 grams of alum, and stirring the mixture to dissolve the alum to obtain the traditional Chinese medicine concentrated solution;
step 2, taking the following raw materials by mass: 12g of stearic acid; 4.5g of glyceryl monostearate; 8g of vaseline; 8g of liquid paraffin; 0.85g span-60; heating and melting 4.5g of tween-60 and 0.1g of sorbic acid serving as oil phases, and then keeping the temperature at 75-80 ℃; taking 5g of glycerol and 57g of the traditional Chinese medicine concentrated solution as a water phase, heating to 75-80 ℃, wherein the temperature of the water phase is higher than that of the oil phase, pouring the water phase into the oil phase, homogenizing and stirring for 3-5 minutes, and then stirring until the mixture is cooled and solidified to obtain the itching relieving cream for treating anal pruritus.
Example 2
A preparation method of an antipruritic cream for treating anal itching comprises the following steps:
step 1, taking the following traditional Chinese medicine raw materials by mass: 28g of radix sophorae flavescentis; 28g of fructus cnidii; soaking 28g of fructus kochiae and 18g of pepper in 600 ml of water for 20 minutes, boiling with strong fire, boiling with slow fire for 20-30 minutes, boiling into 200 ml of liquid medicine, and pouring out the liquid medicine for later use;
adding 400 ml of water into the residual medicine dregs, boiling the medicine dregs with strong fire, boiling the medicine dregs with small fire for 15 to 25 minutes, boiling the medicine dregs into 200 ml of liquid medicine, and pouring out the liquid medicine for later use;
mixing the liquid medicines obtained in the two steps uniformly, boiling the mixture with strong fire, boiling the mixture for 15 to 25 minutes with small fire, boiling the mixture into 200 milliliters of concentrated liquid medicine, cooling the concentrated liquid medicine, adding 4 grams of alum, and stirring the mixture to dissolve the alum to obtain the traditional Chinese medicine concentrated solution;
step 2, taking the following raw materials by mass: 10g of stearic acid; 3.5g of glyceryl monostearate; 6g of vaseline; 6g of liquid paraffin; 0.7g span-60; heating and melting 3.5g of tween-60 and 0.1g of sorbic acid serving as oil phases, and then keeping the temperature at 75-80 ℃; taking 4g of glycerin and 55g of the traditional Chinese medicine concentrated solution as a water phase, heating to 75-80 ℃, wherein the temperature of the water phase is higher than that of the oil phase, pouring the water phase into the oil phase, homogenizing and stirring for 3-5 minutes, and then stirring until the mixture is cooled and solidified to obtain the itching relieving cream for treating anal pruritus.
Example 3
A preparation method of an antipruritic cream for treating anal itching comprises the following steps:
step 1, taking the following traditional Chinese medicine raw materials by mass: 32g of radix sophorae flavescentis; 32g of fructus cnidii; soaking 32g of fructus kochiae and 22g of pepper in 800 ml of water for 40 minutes, boiling with strong fire, turning to slow fire for 20-30 minutes, boiling into 500 ml of liquid medicine, and pouring out the liquid medicine for later use;
adding 500 ml of water into the residual medicine dregs, boiling the medicine dregs with big fire, boiling the medicine dregs with small fire for 15 to 25 minutes to obtain 250 ml of liquid medicine, and pouring out the liquid medicine for later use;
mixing the liquid medicines obtained in the two steps uniformly, boiling the mixture with strong fire, boiling the mixture for 15 to 25 minutes with small fire, boiling the mixture into 250 milliliters of concentrated liquid medicine, cooling the concentrated liquid medicine, adding 6 grams of alum, and stirring the mixture to dissolve the alum to obtain the traditional Chinese medicine concentrated solution;
step 2, taking the following raw materials by mass: 14g of stearic acid; 5.5g of glyceryl monostearate; 10g of vaseline; 10g of liquid paraffin; 1.0g span-60; heating and melting 5.5g of tween-60 and 0.1g of sorbic acid serving as oil phases, and then keeping the temperature at 75-80 ℃; taking 6g of glycerin and 55g of traditional Chinese medicine concentrated solution as a water phase, heating to 75-80 ℃, wherein the temperature of the water phase is higher than that of the oil phase, pouring the water phase into the oil phase, homogenizing and stirring for 3-5 minutes, and then stirring until the mixture is cooled and solidified to obtain the itching-relieving cream for treating anal pruritus.
Example 4 verification example of the technical solution of the present invention
In the embodiment, amine soap and lauryl sodium sulfate are used as composite ionic emulsifiers, or span-60 and tween-60 are used as composite nonionic composite emulsifiers; mixing oil phases with different components, such as fatty acid and fatty alcohol; solid, semi-solid and liquid components with different proportions are adopted, such as solid fatty acid, fatty alcohol, semi-solid vaseline, liquid paraffin and the like; the concentrate of the formulation and 5% glycerol were used as the total aqueous phase. The cream is prepared by adopting a reverse phase rapid addition method. According to the variables, comprehensively evaluating the appearance property, the emulsion drop particle size, the centrifugal test, the pH value, the heat and cold resistance test and other results of the creams prepared by different prescriptions, and designing an optimal prescription, wherein the optimal prescription is specifically as follows:
1 instruments and materials
1.1 Instrument JJ-1 precision force-increasing electric stirrer (Changzhou Onhua instruments Co., Ltd.), TG16G high-speed centrifuge (Changzhou Onhua instruments Co., Ltd.), DHG-9070A forced air drying oven (Shanghai Yuefeng instruments Co., Ltd.), S40 acidimeter (METTLER TOLEDO), LT302CT electronic balance (Changhui Meter responsibility Co., Ltd.), LEICA DMLP microscopic image system (Leica).
1.2 the compound flavescent sophora root-cnidium fruit sitz bath liquid medicine and purified water are prepared by laboratories, stearic acid, white vaseline and glycerol are medicinal grade, and the rest is analytically pure.
2 methods and results
2.1 pretreatment of the traditional Chinese medicine formula, the mass parts of the traditional Chinese medicine formula are as follows: 28-32 parts of radix sophorae flavescentis; 28-32 parts of fructus cnidii; 28-32 parts of fructus kochiae; decocting 18-22 parts of pepper and 4-6 parts of alum twice according to a conventional decoction method of traditional Chinese medicine decoction pieces, mixing liquid medicines decocted twice, filtering, heating and concentrating the filtrate to 150ml, and thus obtaining the traditional Chinese medicine concentrated solution, namely the water phase for preparing the O/W type emulsifiable paste.
2.2 prescription screening
2.2.1 preliminary screening of ionic emulsifier and nonionic emulsifier: amine soap and lauryl sodium sulfate are taken as a representative compound ionic emulsifier, span-60 and tween-60 are taken as a representative compound non-ionic emulsifier, and preliminary screening is carried out to determine the approximate type of emulsifier required for preparing the prescription liquid medicine into the O/W type emulsifiable paste. Specific ionic and non-ionic formulations are shown in table 1.
TABLE 1 Ionic and nonionic formula composition (unit: g)
Figure BDA0003457765510000071
Figure BDA0003457765510000081
The reverse phase rapid addition method is adopted. Taking stearic acid, glyceryl monostearate, vaseline, liquid paraffin, triethanolamine (or span-60 and tween-60) and ethylparaben (or sorbitol) as oil phases, heating for melting, and then keeping the temperature at 75-80 ℃; taking glycerin and the traditional Chinese medicine concentrated solution as a water phase, and heating to 75-80 ℃ which is slightly higher than the temperature of the oil phase. And (3) rapidly pouring the water phase into the oil phase at one time under stirring, rapidly homogenizing and stirring for about 3-5 minutes, and then properly and slowly stirring until the mixture is cooled and solidified to obtain the water-based oil-based paint.
As a result: the finished products of the ionic prescription 1 and the ionic prescription 2 have granular feel, are liquid and do not form cream; the final product of the non-ionic prescription is in cream shape and is applied uniformly. Therefore, the traditional Chinese medicine concentrated solution is not suitable for being compatible with ionic emulsifier and is suitable for being compatible with non-ionic emulsifier.
2.2.2 non-ionic emulsifier formulation screening: the pH of the Chinese medicinal concentrated solution is 3.1, and is acidic, and the following nonionic formula is designed based on the previous experiments, and is shown in Table 2.
TABLE 2 non-ionic prescription composition (unit: g)
Figure BDA0003457765510000082
Figure BDA0003457765510000091
(preparation method is the same as the reverse phase rapid addition method under the item of 2.2)
Prescription description: the solid oil phases of the formula 1 and the formula 2 are stearic acid, and the difference is that the dosage of the emulsifier is different, and the dosage of the emulsifier in the formula 2 is larger than that in the formula 1; the difference between the formula 3 and the formula 4 is that the solid oil phase is different, the solid oil phase of the formula 3 is stearic acid and octadecanol (namely a mixture), and the solid oil phase of the formula 4 is hexadecanol; ③ both the solid oil phase of formula 5 and the solid oil phase of formula 6 are alcohols, with the difference that formula 5 is cetyl alcohol and formula 6 is stearyl alcohol.
The purpose of prescription screening is as follows: firstly, selecting fatty acid or fatty alcohol as an oil phase solid component, or selecting a mixture; secondly, the dosage of the emulsifier is proper; ③ which of hexadecanol and octadecanol in the fatty alcohol is proper; fourthly, the dosage of the solid oil phase is proper.
2.3 evaluation standard of cream quality 6 indexes of cream such as appearance, particle size of emulsion drop, centrifugal test, heat resistance test, cold resistance test and pH suitability are inspected, the total score is 100, and the specific score is shown in Table 3.
2.3.1 appearance Properties: whether the paste is uniform, fine, smooth and beautiful; whether it is easy to coat and wash; thirdly, whether the hardness is proper or not; fourthly, whether the skin is comfortable after being smeared.
2.3.2 emulsion droplet size: taking a proper amount of emulsifiable paste, placing the emulsifiable paste on a glass slide, and observing whether the distribution of the emulsion drops is uniform and whether the diameter of the main emulsion drops reaches the standard or not under a microscope.
2.3.3 centrifugation test: taking 1.5g of cream, placing in a 1.5ml centrifuge tube, centrifuging at 4000 rpm and 8000 rpm for 15 min, and observing whether the cream is layered.
2.3.4 Heat resistance test: taking the cream, keeping the temperature at 55 ℃ for 24 hours, cooling to normal temperature, observing the appearance character under item 3.1.1 and observing whether the emulsion drops change under a microscope.
2.3.5 Heat resistance test: and (3) taking the cream, keeping the temperature of the cream at-15 ℃ for 24 hours, cooling to normal temperature, and observing the appearance character under item 3.1.1 and observing whether the emulsion drops change under a microscope.
2.3.6pH suitability: 5g of cream is completely and uniformly dispersed in 25mL of water, and whether the pH value is proper or not is determined.
TABLE 3 cream quality evaluation criteria (unit: minute)
Figure BDA0003457765510000092
Figure BDA0003457765510000101
(. the pH of the original concentrated solution was 3.1)
2.4 cream quality evaluation results 6 non-ionic prescription creams under the 2.2.2 item were subjected to quality evaluation according to the cream quality evaluation criteria of the 2.3 item Table 3, and the results are shown in Table 4. The results show that the cream obtained with formula 1 is of the best quality.
TABLE 4 nonionic cream quality evaluation results (unit: point)
Figure BDA0003457765510000111
2.4.1 appearance Properties: the 6 prescriptions can obtain the cream with good appearance and character, and have slight difference. The appearance of the prescription 1 and the prescription 2 is good in all aspects; prescription 3 has slightly hard hardness, and the rest is good; recipes 4, 5, and 6 did not achieve the best coatability, with the remainder being good.
2.4.2 emulsion droplet size: respectively placing a proper amount of cream of 6 prescriptions on a glass slide, observing and measuring the particle size and distribution uniformity under a microscope, wherein the prescription 1 is slightly superior to the prescription 2, the particle size of the emulsion drops is mainly 11 mu m, the part of the emulsion drops is 31 mu m, and the mass of the emulsion drops is first grade; formula 3, the particle size of the emulsion drop is mainly 21 μm, the part is 31 μm and 100 μm, the mass is second, etc.; formulas 5 and 6 are slightly superior to formula 4, the particle size of the emulsion drops is mainly 21 mu m, and the proportion of the emulsion drops with large particle size of 100 mu m is increased; mass third, etc. Specifically, please refer to fig. 1 to 6, which are photographs of the emulsion droplets under the microscope at various positions.
3.2.3 centrifugation test 6 formulations of cream, 1.5g each, were placed in 1.5ml centrifuge tubes and centrifuged at 4000 rpm and 8000 rpm for 15 minutes, respectively. Results 8000 rpm/min of centrifuge, 6 samples stratified evenly; centrifuge at 4000 rpm for 15 minutes, with formula 1 and formula 3 not delaminating, and the remainder slightly delaminating.
2.4.3 Heat resistance test: respectively taking 6 prescription creams, placing at the constant temperature of 55 ℃ for 24 hours, placing at the normal temperature, and observing appearance properties, wherein the appearance properties of the 6 prescriptions have no obvious change; and (3) observing under a microscope, wherein the prescriptions 1, 2 and 3 have no obvious change, and the prescriptions 4, 5 and 6 have 2-3 fuzzy-edge emulsion drops.
2.4.4 Cold resistance test: respectively taking 6 prescription creams, placing at the constant temperature of-15 ℃ for 24 hours, placing at the normal temperature, and observing appearance properties, wherein the appearance properties of the 6 prescriptions have no obvious change; and (4) observing under a microscope, wherein 1-2 fuzzy-edge emulsion drops appear in the prescription 5, and the rest prescriptions have no obvious change.
2.4.5pH suitability: 5mL of the Chinese medicinal concentrated solution and 5g of the 6 prescription emulsifiable pastes are respectively and uniformly dispersed in 25mL of water, and the pH values are measured, so that the pH values of the 6 prescription emulsifiable pastes are all close to the pH value of the concentrated solution, and the results are shown in Table 5.
TABLE 5pH of concentrate and cream
Concentrated solution Prescription 1 Prescription 2 Prescription 3 Prescription 4 Prescription 5 Prescription 6
pH value 3.1 3.3 3.4 3.3 3.5 3.5 3.6
2.5 verification test according to 2.4 evaluation results, formula 1 is the best non-ionic formula, 3 batches of formula 1 samples are prepared, evaluation is carried out according to 2.4 evaluation methods in the following table 4, and results are respectively 94, 93 and 93, which shows that the cream prepared by formula 1 has stable quality, good reproducibility and excellent cream quality.
3. Discussion of the related Art
3.1 Effect of Alum on O/W cream
3.1.1 pH Effect: the original prescription contains a certain amount of alum, and the external application mainly has the effects of detoxifying, killing parasites, eliminating dampness, relieving itching, diminishing inflammation, astringing and the like, and is one of the main components of the prescription. Alumen is crystal extracted from sulfate mineral alunite, and contains hydrous aluminum potassium sulfate KAl (SO) as main ingredient4)2·12H2O, is easily dissolved in water, the 10% aqueous solution is in an acidic reaction, the pH value is 3.0-3.5, and the pH value of the concentrated solution in the research is 3.1, which is consistent with the above. The ionic emulsifier amine soap and the lauryl sodium sulfate are alkaline and are unstable when meeting acid, and the formed emulsifiable paste cannot be obtained. The nonionic emulsifiers span and tween are neutral in pH, stable to heat, small in irritation and compatible with acid salt, and the results of the research are consistent with the results, span and tween compounds are selectedThe O/W cream with qualified quality can be prepared by combining the emulsifier.
3.1.2 influence of inorganic salts: the Alumen contains hydrous aluminum potassium sulfate KAl (SO) as main ingredient4)2·12H2And O. When a plurality of multivalent counter ions exist in the solution, the solubility of the anionic surfactant can be reduced, and a salting-out phenomenon is generated; inorganic salts have little effect on nonionic surfactants, but at high concentrations (> 0.1mol/L) can disrupt the binding of hydrophilic groups such as the surfactant polyoxyethylene to water molecules. According to the research, a large number of tests are carried out in the early stage by selecting the nonionic composite emulsifier, and the dosage of the alum is properly adjusted on the premise of ensuring the clinical curative effect, so that the alum meets the requirement, and the O/W cream with qualified quality is obtained.
3.2 selection of emulsifier and oil phase
3.2.1 selection of emulsifiers: due to the influence of alum, the formula can only select non-ionic emulsifier. And the cream prepared by the single emulsifier without the mixed emulsifier has stable quality. The mixed emulsifier can make the HLB value of the oil phase and the HLB value of the water phase closer and more uniform, and can make the oil phase and the water phase more fully connected and make the cream more stable in property. In the research, span-60 and tween-60 are selected on the basis of the early test, the HLB values are 4.7 and 14.9 respectively, good balance can be formed between a hydrophobic group and a hydrophilic group, and glyceryl monostearate is used as an auxiliary emulsifier, so that the obtained product has better quality.
3.2.2 selection of oil phase ingredients: the emulsifier is selected from span-60 and tween-60. Span-60 comprises sorbitan monostearate as chemical component, and Tween-60 comprises polyoxyethylene (20) sorbitan monostearate as chemical component. According to the principle of similarity and compatibility, the components of the solid oil phase are respectively selected from stearic acid, octadecanol and hexadecanol, and as a result, the cream obtained by selecting stearic acid has the best quality and conforms to the theory.
3.3 the selective emulsification effect of the solid oil phase and the solid-solid and semi-solid proportion of the oil phase determine the hardness of the cream. The earlier stage of the research proves that the cream prepared by selecting span-60 and tween-60 as mixed emulsifiers and the total proportion of solid oil phase such as stearic acid, octadecanol, hexadecanol, glyceryl monostearate, paraffin, bee wax and the like in the formula is 15-24% has proper hardness, and the proportion of solid components contained in the optimal formula is 17% through quality evaluation of 6 nonionic emulsifier formulas selected in the research. As a hospital preparation, the effective period is generally 6 months, and the proportion of solid components can be properly adjusted according to the selection of the emulsifying agent and different seasons, so as to obtain a product with more proper hardness.
Example 5
Through analysis and use, the best technical scheme of the invention is embodiment 1, and the using effect of the itching relieving cream for treating the pruritus ani is as follows:
the treatment method comprises the following steps: 62 cases of patients with anal pruritus are selected, cleaned of perianal affected parts, uniformly smeared with a proper amount of cream, and continuously treated for seven days 2 times a day.
Observation indexes and determination methods: it is drawn up according to the guidelines of clinical research of new Chinese medicine.
Total clinical symptom score is perianal pruritus score + perianal cutaneous area score + perianal cutaneous score.
Total clinical symptom score improvement rate ═ (pre-treatment symptom score-post-treatment symptom score)/pre-treatment symptom score 100%.
And (3) healing: the clinical symptoms and physical signs are eliminated, and the score improvement rate of the clinical symptoms is (95-100%);
the effect is shown: the pruritus is obviously improved, most of skin lesions are eliminated, and the clinical symptom score improvement rate is (70% -95%);
the method has the following advantages: partial improvement of symptoms, partial elimination of skin lesions, and improvement rate of clinical symptom scores (30% -70%);
and (4) invalidation: the clinical symptoms are not obviously improved or even worsened, and the score improvement rate of the clinical symptoms is less than 30%.
The total effective rate is (recovery + obvious effect)/the total case number is x100 percent
The statistics of the effect of 62 patients after seven days of treatment are shown in table 6, and the total effective rate reaches 91.9%.
TABLE 6
Number of examples Cure of disease Show effect Is effective Invalidation Total effective rate (%)
62 33 24 3 2 91.9
The above description is only an embodiment of the present invention, and not intended to limit the scope of the present invention, and all equivalent changes made by using the contents of the present specification and the drawings, or applied directly or indirectly to the related technical fields, are included in the scope of the present invention.

Claims (5)

1. The itching relieving cream for treating the pruritus ani is characterized by comprising the following components in parts by mass: 28-32 parts of radix sophorae flavescentis; 28-32 parts of fructus cnidii; 28-32 parts of fructus kochiae; 18-22 parts of pepper and 4-6 parts of alum.
2. The itching relieving cream for treating anal itching according to claim 1, which is characterized by comprising the following components in parts by mass: 10-14 parts of stearic acid; 3.5-5.5 parts of glycerin monostearate; 6-10 parts of vaseline; 6-10 parts of liquid paraffin; 0.7-1.0 part of span-60; 3.5-5.5 parts of tween-60; 0.1 part of sorbic acid; 4-6 parts of glycerol and 55-59 parts of a traditional Chinese medicine concentrated solution;
the traditional Chinese medicine concentrated solution is prepared by the following preparation method:
taking the following traditional Chinese medicine raw materials in parts by mass: 28-32 parts of radix sophorae flavescentis; 28-32 parts of fructus cnidii; 28-32 parts of fructus kochiae and 18-22 parts of pepper, adding 1000-1300 parts by mass of water, decocting, concentrating to obtain 200-300 parts by mass of decoction concentrate, and adding 4-6 parts by mass of alum.
3. The itching relieving cream for treating anal itching according to claim 1, which is characterized by comprising the following components in parts by mass: 12g of stearic acid; 4.5g of glyceryl monostearate; 8g of vaseline; 8g of liquid paraffin; 0.85g span-60; 4.5g Tween-60; 0.1g sorbic acid; 5g of glycerol and 57g of traditional Chinese medicine concentrated solution;
the traditional Chinese medicine concentrated solution is prepared by the following preparation method:
taking the following traditional Chinese medicine raw materials in parts by mass: 30g of radix sophorae flavescentis; 30g of fructus cnidii; 30g of fructus kochiae and 20g of pepper are added with 1000g of water in total and decocted for two times, filtered and concentrated by heating to obtain 200g of decocted concentrated solution, and then 5g of alum is added to prepare the traditional Chinese medicine concentrated solution.
4. The preparation method of the itching relieving cream for treating anal itching is characterized by comprising the following steps:
step 1, taking the following traditional Chinese medicine raw materials in parts by mass: 28-32 parts of radix sophorae flavescentis; 28-32 parts of fructus cnidii; 28-32 parts of fructus kochiae and 18-22 parts of pepper are soaked in 800 parts by mass of water with the temperature of 600-;
adding 500 parts by mass of 400-one-step water into the left decoction dregs, boiling the decoction dregs by using a big fire, boiling the decoction dregs for 15 to 25 minutes by using a small fire, boiling the decoction dregs into 300 parts by mass of 200-one-step liquid medicine, and pouring out the liquid medicine for later use;
uniformly mixing the liquid medicines obtained in the two steps, boiling the mixture with strong fire, boiling the mixture for 15 to 25 minutes with soft fire, boiling the mixture into 300 parts by mass of concentrated liquid medicine of 200-6 parts by mass, cooling the concentrated liquid medicine, adding 4 to 6 parts by mass of alum, and stirring the mixture to dissolve the alum to obtain the traditional Chinese medicine concentrated solution;
step 2, taking the following raw materials in parts by mass: 10-14 parts of stearic acid; 3.5-5.5 parts of glycerin monostearate; 6-10 parts of vaseline; 6-10 parts of liquid paraffin; 0.7-1.0 part of span-60; heating and melting 3.5-5.5 parts of tween-60 and 0.1 part of sorbic acid as oil phases, and then keeping the temperature at 75-80 ℃; taking 4-6 parts by mass of glycerol and 55-59 parts by mass of the traditional Chinese medicine concentrated solution as a water phase, heating to 75-80 ℃, wherein the temperature of the water phase is higher than that of the oil phase, pouring the water phase into the oil phase, homogenizing and stirring for 3-5 minutes, and then stirring until the mixture is cooled and solidified to obtain the itching relieving cream for treating anal pruritus.
5. The preparation method of the itching relieving cream for treating anal itching as claimed in claim 4, which is characterized by comprising the following steps:
step 1, taking the following traditional Chinese medicine raw materials by mass: 30g of radix sophorae flavescentis; 30g of fructus cnidii; soaking 30g of fructus kochiae and 20g of pepper in 600 ml of water for 30 minutes, boiling with strong fire, boiling with slow fire for 20-30 minutes, boiling into 200 ml of liquid medicine, and pouring out the liquid medicine for later use;
adding 400 ml of water into the residual medicine dregs, boiling the medicine dregs with strong fire, boiling the medicine dregs with small fire for 15 to 25 minutes, boiling the medicine dregs into 200 ml of liquid medicine, and pouring out the liquid medicine for later use;
mixing the liquid medicines obtained in the two steps uniformly, boiling the mixture with strong fire, boiling the mixture for 15 to 25 minutes with small fire, boiling the mixture into 200 milliliters of concentrated liquid medicine, cooling the concentrated liquid medicine, adding 5 grams of alum, and stirring the mixture to dissolve the alum to obtain the traditional Chinese medicine concentrated solution;
step 2, taking the following raw materials by mass: 12g of stearic acid; 4.5g of glyceryl monostearate; 8g of vaseline; 8g of liquid paraffin; 0.85g span-60; heating and melting 4.5g of tween-60 and 0.1g of sorbic acid serving as oil phases, and then keeping the temperature at 75-80 ℃; taking 5g of glycerol and 57g of the traditional Chinese medicine concentrated solution as a water phase, heating to 75-80 ℃, wherein the temperature of the water phase is higher than that of the oil phase, pouring the water phase into the oil phase, homogenizing and stirring for 3-5 minutes, and then stirring until the mixture is cooled and solidified to obtain the itching relieving cream for treating anal pruritus.
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