CN115887526A - External preparation for treating anal pruritus and preparation method thereof - Google Patents

External preparation for treating anal pruritus and preparation method thereof Download PDF

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Publication number
CN115887526A
CN115887526A CN202211377656.6A CN202211377656A CN115887526A CN 115887526 A CN115887526 A CN 115887526A CN 202211377656 A CN202211377656 A CN 202211377656A CN 115887526 A CN115887526 A CN 115887526A
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parts
weight
borneol
mint
sucrose
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王辉
卫应奇
路婧
王怀明
杨科力
黄榕康
焦燕
王盛宇
李杨
李静熹
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Sixth Affiliated Hospital of Sun Yat Sen University
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Sixth Affiliated Hospital of Sun Yat Sen University
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    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
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Abstract

The invention relates to the field of medicinal preparations, and mainly relates to an external preparation for treating anal pruritus and a preparation method thereof. Aims to solve the problems that the existing traditional Chinese medicine therapy is difficult to effectively and radically cure the pruritus ani and the western medicine therapy has great side effect when the pruritus ani is treated. One purpose of the invention is to provide an external preparation for treating pruritus ani, which comprises 70-95 parts by weight of sodium carboxymethylcellulose, 2-10 parts by weight of sucrose, 0.1-5 parts by weight of borneol and 0.1-5 parts by weight of mint. The invention also aims to provide a preparation method of the external preparation, the preparation is powder, ointment, suppository and self-fixing dressing, and the preparation method comprises the specific steps of crushing, sieving, uniformly mixing, sterilizing, packaging and the like. The invention has the effects of eliminating dampness and drying, reducing swelling and relieving pain, and relieving itching and resisting bacteria on the focus part of the anal pruritus through unique medicine preparation, particularly a laminated medicament layer structure of the self-fixing dressing.

Description

External preparation for treating anal pruritus and preparation method thereof
Technical Field
The invention relates to the field of medicinal preparations, in particular to an external preparation for treating pruritus ani and a preparation method thereof.
Background
The pruritus ani symptom refers to a skin disease with pruritus symptoms without any primary skin damage around the anus, which is mostly caused in young and middle-aged 20-40 years old, and more men than women are better than those in lack of exercise. After anorectal surgery, anal pruritus is also very common. At the time of clinical onset, pruritus is difficult to endure, or one-time onset, or continuous onset. In many cases, the patient feels more or less itching due to fluctuating mood. In addition, the itching symptoms gradually worsen in cold days and nights and in quiet environments. If the patients do not pay attention to diet contraindications, the patients can also aggravate pruritus symptoms by eating spicy and hot foods or cold and hot foods. The pruritus ani can seriously affect the quality and life of a patient, and if the patient fails to seek medical treatment in time, the pruritus ani symptom can spread day by day to cover the gluteal fold and scrotum, so that the symptom is aggravated.
At present, the treatment means aiming at the pruritus ani comprise traditional Chinese medicine dialectical therapy and western medicine therapy. The Chinese traditional treatment method comprises oral administration of Chinese medicinal preparation such as capsule for removing dampness and toxin, cleaning with calamine lotion, and hip bath with pricklyash peel water. While western medicine therapy mainly comprises means of oral administration or application of loratadine, application of antihistamine medicines such as diphenhydramine and the like, injection of hormone medicines or surgical excision of focuses and the like. Research shows that the existing traditional Chinese medicine therapy has slow effect and insignificant effect, while the western medicine therapy easily causes hormone dependence symptoms of patients due to the common use of hormone drugs, has obvious side effect and easy recurrence, and obviously cannot meet the requirement of completely curing the diseases of the patients. Therefore, there is a need to develop a safe and effective treatment for anal pruritus that is not likely to recur.
Disclosure of Invention
The invention aims at one or more defects mentioned above, and provides an external preparation for treating anal pruritus, so as to solve the problems that the existing traditional Chinese medicine therapy is difficult to effectively cure the anal pruritus and the side effect of the western medicine therapy is great.
One of the purposes of the invention is to provide an external preparation for treating anal pruritus, which comprises the following components by weight: 70-95 parts of sodium carboxymethylcellulose, 2-10 parts of sucrose, 0.1-5 parts of borneol and 0.1-5 parts of mint. Further, the composition comprises the following components in parts by weight: 75-95 parts of sodium carboxymethylcellulose, 2-10 parts of sucrose, 0.5-5 parts of borneol and 0.5-5 parts of mint. Further, the composition comprises the following components in percentage by weight: 75-95 parts of sodium carboxymethylcellulose, 2-10 parts of sucrose, 0.5-4 parts of borneol and 0.5-4 parts of mint.
Further, the external preparation for treating anal pruritus comprises the following components in percentage by weight: 70-95 parts of sodium carboxymethylcellulose, 2-10 parts of sucrose, 0.1-5 parts of borneol, 0.1-5 parts of mint, 1-5 parts of titanium dioxide and 1-5 parts of zinc oxide. Further, the paint comprises the following components in percentage by weight: 75-95 parts of sodium carboxymethylcellulose, 2-10 parts of sucrose, 0.5-5 parts of borneol, 0.5-5 parts of mint, 2-5 parts of titanium dioxide and 2-5 parts of zinc oxide; further, the composition comprises the following components in percentage by weight: 75-95 parts of sodium carboxymethylcellulose, 2-10 parts of sucrose, 0.5-4 parts of borneol, 0.5-4 parts of mint, 2-5 parts of titanium dioxide and 2-5 parts of zinc oxide.
Further, the external preparation for treating anal pruritus comprises the following components in percentage by weight: 70-95 parts of sodium carboxymethylcellulose, 2-10 parts of sucrose, 0.1-5 parts of borneol, 0.1-5 parts of mint, 1-5 parts of titanium dioxide, 1-5 parts of zinc oxide, 1-5 parts of radix sophorae flavescentis, 1-5 parts of coptis chinensis and 1-5 parts of baicalein. Further, the paint comprises the following components in percentage by weight: 75-95 parts of sodium carboxymethylcellulose, 2-10 parts of sucrose, 0.5-5 parts of borneol, 0.5-5 parts of mint, 2-5 parts of titanium dioxide, 2-5 parts of zinc oxide, 1-5 parts of radix sophorae flavescentis, 2-5 parts of coptis chinensis and 2-5 parts of baicalein.
Furthermore, the molecular weight of the sodium carboxymethylcellulose is 5-30 ten thousand.
Further, external preparations include powders, ointments, suppositories, and dressings.
The invention also aims to provide a preparation method of the external preparation for treating pruritus ani, which is used for preparing powder and specifically comprises the following steps:
s51, weighing a proper amount of sodium carboxymethylcellulose, sucrose, borneol, mint, titanium dioxide, zinc oxide, radix sophorae flavescentis, coptis chinensis and baicalein, and respectively crushing;
s52, sieving the products of the components obtained in the step S51 by using a 100-500-mesh sieve respectively;
s53, weighing 70-95 parts by weight of carboxymethyl cellulose sodium, 2-10 parts by weight of sucrose, 0.1-5 parts by weight of borneol, 0.1-5 parts by weight of mint, 1-5 parts by weight of titanium dioxide, 1-5 parts by weight of zinc oxide, 1-5 parts by weight of radix sophorae flavescentis, 1-5 parts by weight of coptis chinensis and 1-5 parts by weight of baicalein obtained in the step S52, and mixing;
and S54, sterilizing the mixed product obtained in the step S53.
The invention also aims to provide a second preparation method of the external preparation for treating pruritus ani, which is used for preparing an ointment and specifically comprises the following steps of:
s61, weighing a proper amount of sodium carboxymethylcellulose, sucrose, borneol, mint, titanium dioxide, zinc oxide, radix sophorae flavescentis, coptis chinensis and baicalein, and respectively crushing;
s62, sieving the products of the components obtained in the step S61 respectively by using a 100-500-mesh sieve;
s63, weighing 70-95 parts by weight of the carboxymethyl cellulose sodium, 2-10 parts by weight of sucrose, 0.1-5 parts by weight of borneol, 0.1-5 parts by weight of mint, 1-5 parts by weight of titanium dioxide, 1-5 parts by weight of zinc oxide, 1-5 parts by weight of radix sophorae flavescentis, 1-5 parts by weight of coptis chinensis and 1-5 parts by weight of baicalein obtained in the step S62, and mixing to obtain mixed medicinal powder;
s64, uniformly mixing the mixed medicinal powder obtained in the step S63 with a glycerol aqueous solution with the concentration of 10-70%; namely, water and glycerol are selected as main dispersing agents, wherein the water accounts for 30-90%, and the glycerol accounts for 70-10%; more preferably, 70% of water and 30% of glycerol are mixed to prepare the dispersing agent; wherein, when the materials are mixed uniformly, the weight portion of the mixed medicinal powder is 10-80, the weight portion of the dispersing agent is 90-20, preferably, the weight portion of the mixed medicinal powder is 45, and the weight portion of the dispersing agent is 55.
S65, sterilizing the product obtained in the step S64.
The invention also aims to provide a preparation method of the third external preparation for treating pruritus ani, which is used for preparing the suppository and specifically comprises the following steps:
s71, weighing a proper amount of sodium carboxymethylcellulose, sucrose, borneol, mint, titanium dioxide, zinc oxide, radix sophorae flavescentis, coptis chinensis and baicalein, and respectively crushing;
s72, respectively sieving products of the components obtained in the step S71 by using a 100-500-mesh sieve;
s73, weighing 70-95 parts by weight of the carboxymethyl cellulose sodium obtained in the step S72, 2-10 parts by weight of sucrose, 0.1-5 parts by weight of borneol, 0.1-5 parts by weight of mint, 1-5 parts by weight of titanium dioxide, 1-5 parts by weight of zinc oxide, 1-5 parts by weight of radix sophorae flavescentis, 1-5 parts by weight of coptis chinensis and 1-5 parts by weight of baicalein, and mixing to obtain mixed medicinal powder;
s74, uniformly mixing the mixed medicinal powder obtained in the step S73 with a glycerol aqueous solution with the concentration of 10-70%; namely, water and glycerol are selected as main dispersing agents, the water accounts for 30-90 percent, and the glycerol accounts for 70-10 percent; more preferably, 75% of water and 25% of glycerol are mixed to prepare the dispersing agent; wherein, when the materials are mixed uniformly, the weight portion of the mixed medicinal powder is 10-80, the weight portion of the dispersing agent is 90-20, preferably, the weight portion of the mixed medicinal powder is 55, and the weight portion of the dispersing agent is 45.
S75, preparing the product obtained in the step S74 into a suppository;
and S76, dehydrating the suppository obtained in the step S75.
The invention also aims to provide a preparation method of a fourth external preparation for treating pruritus ani, which is used for preparing a self-fixing dressing and specifically comprises the following steps:
s81, weighing a proper amount of sodium carboxymethylcellulose, sucrose, borneol, mint, titanium dioxide, zinc oxide, radix sophorae flavescentis, coptis chinensis and baicalein, and respectively crushing;
s82, sieving the products of the components obtained in the step S81 respectively by using a 100-500-mesh sieve;
s83, sterilizing the product obtained in the step S82;
s84, distributing the product obtained in the step S83 in 3 medicament layers in parts by weight: the first medicament layer comprises 2-10 parts of cane sugar, 1-5 parts of titanium dioxide, 1-5 parts of zinc oxide, 1-5 parts of radix sophorae flavescentis, 1-5 parts of coptis chinensis and 1-5 parts of baicalein; the second medicament layer comprises 0.1-5 parts of borneol and 0.1-5 parts of mint; the third medicament layer comprises 70-95 parts of sodium carboxymethyl bacterial cellulose.
S85, coating an adhesive on the periphery of the medical gauze, and arranging the medicament layers in the step S84 in the middle of the medical gauze in a stacking mode.
Further, the present invention also provides an external dressing for treating pruritus ani, comprising a base layer and a drug layer disposed on an upper surface of the base layer, wherein the drug layer is provided with the first drug layer, the second drug layer and the third drug layer in a laminated manner; the first medicament layer comprises 2-10 parts of cane sugar, 1-5 parts of titanium dioxide, 1-5 parts of zinc oxide, 1-5 parts of radix sophorae flavescentis, 1-5 parts of coptis chinensis and 1-5 parts of baicalein; the second medicament layer comprises 0.1-5 parts of borneol and 0.1-5 parts of mint; the third medicament layer comprises 70-95 parts of sodium carboxymethyl bacterial cellulose.
The invention designs 3 medicament layers in a stacking mode by adopting a single medicament layer design different from the components of the existing common plaster, and respectively realizes the effects of relieving itching and resisting bacteria, relieving swelling and pain and eliminating dampness and drying aiming at the pruritus ani, has comprehensive medicament effect, is beneficial to improving the treatment effect and shortening the treatment period. Due to the adoption of the laminated structure, when the external dressing is prepared, each layer of medicament can be independently designed and manufactured, the optimized arrangement of a production line is facilitated, and only the optimized adjustment of the components of a single medicament layer can be carried out according to the actual application condition, so that the overall production cost is reduced. Meanwhile, when the medicine is specifically applied, the arrangement of the medicine layers can be flexibly adjusted according to the conditions of different patients, so that the order of administration is optimized, and the treatment effect is improved.
Further, the first, second, and third chemical layers are stacked on the upper surface of the base layer from bottom to top. Wherein the first medicinal layer has antipruritic and antibacterial effects, the second medicinal layer has repercussive and analgesic effects, and the third medicinal layer has dampness eliminating and drying effects. In view of the fact that most patients with pruritus ani have focus positions with damp and even small amount of fluid secretion, the third medicament layer is arranged on the topmost layer of the dressing so as to be in contact with the focus position firstly, so that the aims of drying and moisture absorption are fulfilled. Furthermore, the patients with anal pruritus mostly have scratching focuses, so that inflammation and swelling and pain occur at the anus, and the second medicament layer is applied after moisture absorption, so that inflammation and swelling are effectively reduced, and the pain of the patients is relieved. Furthermore, the first medicament layer which is mainly used for radical treatment is arranged below the second medicament layer, and the first two medicament layers pretreat the focus part, so that the first medicament layer can achieve the optimal administration effect when the focus is applied, the aim of treating with twice the result of half the effort is achieved, and the medicament effect of the dressing is improved.
Further, the area of the first medicament layer is not smaller than the area of the second medicament layer; the area of the second medicament layer is not smaller than that of the third medicament layer, specifically, the second medicament layer is positioned in the area covered by the first medicament layer, and the third medicament layer is positioned in the area covered by the second medicament layer.
In this scheme, the first medicament layer that makes the stratum basale of pressing close to most has the biggest area in 3 layers of medicament layers to it is littleer to arrange up the layer area more, adopts similar pyramid structure, thereby has better stability, and the medicament layer edge is difficult for appearing collapsing the condition of mixing the powder. Simultaneously, still can paste from type paper layer after dressing preparation, from type paper layer edge and stratum basale edge bonding or compound, the activity on restriction medicament layer ensures the holistic stability of dressing product, tears during the use and can use from type paper layer.
Further, the medicament layer is arranged in the middle of the upper surface of the substrate layer, and the area of the medicament layer is smaller than that of the substrate layer; the periphery of stratum basale upper surface still is equipped with gluing portion. Since the area of the medicine layer is smaller than the area of the base layer, the periphery of the base layer has a sufficient space for providing the adhesive portion. When the dressing is used, the dressing can be adhered and fixed with the skin of a patient through the adhesive part, so that the dressing position is not obviously deviated, and the dressing is favorable for enhancing the pesticide application effect.
Further, the first medicament layer is formed by mixing various particles of cane sugar, titanium dioxide, zinc oxide, radix sophorae flavescentis and baicalein. According to the scheme, the cane sugar, the titanium dioxide and the zinc oxide have the effects of moisture absorption, itching relieving and inflammation diminishing, the radix sophorae flavescentis and the baicalein have broad-spectrum antibacterial property and histamine resisting effect, and the cooperation of the material particles can achieve the synergistic effect, so that the itching relieving and antibacterial effects of the first medicament layer are achieved.
Furthermore, the second medicament layer is formed by mixing two kinds of particles of mint and borneol. Because the mint and borneol particles have the cool characteristic, the traditional Chinese medicine considers that the mint and borneol particles have the effects of clearing heat and reducing internal heat, thereby having the effects of relieving swelling and pain on the focus of a patient and achieving the purpose of the effect of the second medicament layer.
Further, the third agent layer is formed of granules of sodium carboxymethylcellulose. The sodium carboxymethyl cellulose granules have good rapid water absorption performance, are beneficial to keeping dry environment of skin around anus, and can form a gel protective layer on the surface of the skin to destroy inflammatory infection environment, thereby rapidly improving pruritus ani symptom.
Furthermore, the particle size of the particles is less than or equal to 100 meshes. Because the tiny particles with the mesh less than or equal to 100 are adopted, the medicament layer has better skin-friendly effect on the focus, avoids uncomfortable feeling caused by larger friction force between the large particles and the skin of a patient, is favorable for the comfort of the patient after the medicament is applied, and improves the medication will of the patient.
Further, the substrate layer is a medical gauze layer. Because the medical gauze layer has the advantages of sterility, strong hygroscopicity, good skin-friendly property and the like, the medical gauze layer is favorable for improving the treatment effect when being used as the base layer of the external dressing, and the negative risk of bad materials is avoided.
Furthermore, the thicknesses of the first medicament layer, the second medicament layer and the third medicament layer are all less than or equal to 2mm. In this scheme, through designing the thinner medicament layer thickness, be favorable to the laminating of medicament layer and focus department skin, strengthen the effect of giving medicine to the poor free of charge and be favorable to improving the utilization degree of medicament, can also avoid medicament layer granule to appear the fault after packaging process or using medicine simultaneously, the unstable phenomenon of collapsing.
Compared with the prior art, the invention has the beneficial effects that:
(1) The medicines are used in a matched manner, so that the anus can be kept dry, and the medicine has the functions of relieving itching, diminishing inflammation, sterilizing and the like, can effectively treat the pruritus ani, and effectively solves the problems of slow effect and unobvious effect of the traditional Chinese medicine therapy.
(2) The external preparation of the invention is nontoxic and harmless, has no toxic or side effect, is safe and reliable, is safe for clinical use, and effectively overcomes the defect of great side effect of the existing western medicine treatment.
(3) The invention provides an external dressing for treating anal pruritus, which designs 3 medicament layers in a laminating mode, respectively realizes the effects of relieving itching and resisting bacteria, reducing swelling and relieving pain and eliminating dampness and dryness aiming at the anal pruritus and has comprehensive medicament effect. And through the effect that layering is progressive, be favorable to realizing the cooperation between the multilayer medicament, the medicament layer of contact skin in the front can not only realize corresponding drug effect, and can also realize the preliminary treatment for contacting skin medicament layer in the back, makes each medicament layer have the microenvironment that is fit for exerting the drug effect when contacting skin, is showing improvement treatment. Meanwhile, the dressing also uses medicament particles with small particle size so as to improve the skin affinity of the dressing and enhance the administration effect; and still through setting up frivolous medicament layer thickness more, ensure dressing medicament layer's stability and skin nature to help improving patient's will of giving medicine to the poor free of charge.
Drawings
FIG. 1 is a structural view of embodiment 13 of the present invention.
FIG. 2 is a cross-sectional view of example 13 of the present invention.
Fig. 3 is a structural view of embodiment 14 of the present invention.
Reference numerals: a base layer 1, 1a, a first medicament layer 2, 2a, a second medicament layer 3, 3a, a third medicament layer 4, 4a, an adhesive portion 5.
Detailed Description
It should be noted that the following detailed description is exemplary and is intended to provide further explanation of the disclosure. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs.
It is noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of example embodiments according to the present application. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, and it should be understood that when the terms "comprises" and/or "comprising" are used in this specification, they specify the presence of stated features, steps, operations, devices, components, and/or combinations thereof, unless the context clearly indicates otherwise.
The present invention will now be further described with reference to specific examples, which are intended to be illustrative only and not to be limiting. The test samples and test procedures used in the following examples include the following (generally, according to the conventional conditions or according to the conditions recommended by a reagent company if the specific conditions of the experiment not specified in the examples; reagents, consumables and the like used in the following examples are commercially available without specific description).
Example 1
Preparation of powder A
Weighing 85 parts of sodium carboxymethylcellulose, 4 parts of sucrose, 1 part of borneol, 1 part of mint, 2 parts of titanium dioxide, 2 parts of zinc oxide, 1 part of radix sophorae flavescentis, 2 parts of coptis chinensis and 2 parts of baicalein, grinding the raw materials of the components by using a freezing ball mill and a mortar, and sieving the ground materials by using a 200-mesh sieve.
Weighing raw materials according to the specified raw material proportion of each component, and fully mixing the raw materials by a vibration instrument and a mixing instrument.
And (4) performing sterilization treatment by means of ultraviolet irradiation and irradiation. Subpackaging to obtain the external powder A.
Example 2
Preparation of powder B
Weighing 70 parts of sodium carboxymethylcellulose, 2 parts of sucrose, 0.2 part of borneol, 0.2 part of mint, 5 parts of titanium dioxide, 3 parts of zinc oxide, 5 parts of radix sophorae flavescentis, 4 parts of coptis chinensis and 1.5 parts of baicalein, grinding the raw materials of the components by using a freezing ball mill and a mortar, and sieving the ground materials by using a 100-mesh sieve.
Weighing raw materials according to the specified raw material proportion of each component, and fully mixing the raw materials by a vibration instrument, a blending instrument and the like.
The sterilization treatment is performed by irradiation or the like. Subpackaging to obtain the external powder B of the invention.
Example 3
Preparation of powder C
Weighing 95 parts of sodium carboxymethylcellulose, 10 parts of sucrose, 4.5 parts of borneol, 5 parts of mint, 3 parts of titanium dioxide, 4 parts of zinc oxide, 3 parts of radix sophorae flavescentis, 5 parts of coptis chinensis and 5 parts of baicalein, grinding the raw materials of the components by using a freezing ball mill and a mortar, and sieving the ground raw materials by using a 500-mesh sieve.
Weighing raw materials according to the specified raw material proportion of each component, and fully mixing the raw materials by a vibration instrument and a mixing instrument.
And (4) performing sterilization treatment in an ultraviolet illumination mode. Subpackaging to obtain the external powder C.
Comparative example 1
Weighing 60 parts of sodium carboxymethylcellulose, 1 part of borneol, 1 part of mint, 1 part of radix sophorae flavescentis, 2 parts of coptis chinensis and 2 parts of baicalein, grinding the raw materials of the components by using a frozen ball mill and a mortar, and sieving the ground materials by using a 200-mesh sieve. Then, the components are mixed evenly to prepare the corresponding medicine mixture.
Comparative example 2
80 parts of sodium carboxymethylcellulose, 4.5 parts of borneol, 2.55 parts of mint, 3 parts of titanium dioxide, 4 parts of zinc oxide and 4 parts of coptis chinensis are weighed, and raw materials of the components are ground by a freezing ball mill and a mortar and are sieved by a 200-mesh sieve. Then, the components are mixed evenly to prepare the corresponding medicine mixture.
Comparative example 3
Weighing and weighing 0.1 part of sucrose, 7 parts of borneol, 7 parts of mint, 1 part of titanium dioxide, 1 part of zinc oxide, 3 parts of radix sophorae flavescentis, 5 parts of coptis chinensis and 5 parts of baicalein, grinding the raw materials of the components by using a freezing ball mill and a mortar, and sieving the ground materials by using a 200-mesh sieve. Then, the components are uniformly mixed to prepare the corresponding medicine mixture.
The results of the pruritus treatment experiments by using the medicines obtained in examples 1-3 and comparative examples 1-3 as samples show that the examples 1-3 can quickly and effectively relieve and treat pruritus without relapse, and the example 1 in the three examples has the best effect, while the comparative examples 1 and 2 can inhibit pruritus to a certain extent, but need longer treatment time, and once the use is stopped, pruritus is easy to relapse, and the effect of improving pruritus is limited. Comparative example 3 was inferior to examples 1 to 3 in effect during use, and was shown to cause some discomfort.
Example 4
Preparation of ointment A
Weighing 90 parts of sodium carboxymethylcellulose, 5 parts of sucrose, 2 parts of borneol, 1 part of mint, 4 parts of titanium dioxide, 2 parts of zinc oxide, 2 parts of radix sophorae flavescentis, 2 parts of coptis chinensis and 5 parts of baicalein, grinding the raw materials of the components by using a freezing ball mill and a mortar, and sieving the ground materials by using a 200-mesh sieve to obtain a medicine mixture.
55 parts of dispersing agent and 45 parts of medicinal mixture by weight are uniformly mixed by a magnetic stirrer and the like by taking 30% glycerol aqueous solution as the dispersing agent.
Sterilizing by ultraviolet irradiation or irradiation, and packaging to obtain ointment A for treating pruritus ani.
Example 5
Preparation of ointment B
Weighing 71 parts of sodium carboxymethylcellulose, 9 parts of sucrose, 0.2 part of borneol, 4.5 parts of mint, 5 parts of titanium dioxide, 3 parts of zinc oxide, 5 parts of radix sophorae flavescentis, 4 parts of coptis chinensis and 3 parts of baicalein, grinding the raw materials of the components by using a freezing ball mill and a mortar, and sieving the ground materials by using a 100-mesh sieve to obtain a medicine mixture.
The 15% glycerol aqueous solution is used as a dispersing agent, and 25 parts by weight of the dispersing agent and 75 parts by weight of the medicine mixture are uniformly mixed by a magnetic stirrer and the like.
Sterilizing by ultraviolet irradiation or irradiation, and packaging to obtain ointment B for treating pruritus ani.
Example 6
Preparation of ointment C
Weighing 95 parts of sodium carboxymethylcellulose, 2 parts of sucrose, 4.5 parts of borneol, 2.5 parts of mint, 1 part of titanium dioxide, 4 parts of zinc oxide, 3 parts of radix sophorae flavescentis, 5 parts of coptis chinensis and 1 part of baicalein, grinding the raw materials of the components by using a freezing ball mill and a mortar, and sieving the raw materials by using a 500-mesh sieve.
Taking 70% glycerin water solution as a dispersing agent, and uniformly mixing 85 parts of dispersing agent and 15 parts of medicine mixture by weight in a magnetic stirrer and the like.
Sterilizing by ultraviolet irradiation or irradiation, and packaging to obtain ointment C for treating pruritus ani.
Example 7
Preparation of suppository A
Weighing 85 parts of sodium carboxymethylcellulose, 5 parts of sucrose, 2 parts of borneol, 1 part of mint, 5 parts of titanium dioxide, 2 parts of zinc oxide, 2 parts of radix sophorae flavescentis, 2 parts of coptis chinensis and 2 parts of baicalein, grinding the raw materials of the components by using a freezing ball mill and a mortar, and sieving to obtain a medicine mixture. Wherein, the sieving is carried out by using a 200-mesh sieve.
The preparation method comprises the following steps of taking 25% glycerol aqueous solution as a dispersing agent, uniformly mixing 45 parts of the dispersing agent and 55 parts of a medicine mixture by weight in a magnetic stirrer and the like, and preparing the mixture into suppositories with different shapes according to requirements.
Dehydrating by means of freeze drier or oven to obtain suppository A.
Example 8
Preparation of suppository B
73 parts of sodium carboxymethylcellulose, 10 parts of sucrose, 0.1 part of borneol, 4.5 parts of mint, 1 part of titanium dioxide, 3 parts of zinc oxide, 5 parts of radix sophorae flavescentis, 4 parts of coptis chinensis and 3 parts of baicalein are weighed, the raw materials of the components are ground by using a freezing ball mill and a mortar, and a medicine mixture is obtained after the raw materials are sieved by a 100-mesh sieve.
The suppository is prepared by uniformly mixing 20 parts of dispersing agent and 80 parts of medicinal mixture by weight by taking 10% glycerol aqueous solution as the dispersing agent through a magnetic stirrer and the like, and preparing the suppository into different shapes according to requirements.
Dehydrating by means of a freeze drier, an oven, etc. to obtain suppository B.
Example 9
Preparation of suppository C
Weighing 95 parts of sodium carboxymethylcellulose, 3 parts of sucrose, 4.5 parts of borneol, 2.5 parts of mint, 3 parts of titanium dioxide, 4 parts of zinc oxide, 3 parts of radix sophorae flavescentis, 4 parts of coptis chinensis and 5 parts of baicalein, grinding the raw materials of the components by using a freezing ball mill and a mortar, and sieving the ground raw materials by using a 500-mesh sieve.
70% glycerin water solution is used as a dispersing agent, 90 parts of dispersing agent and 10 parts of medicine mixture are uniformly mixed in a magnetic stirrer and the like by weight, and the mixture is prepared into suppositories with different shapes according to requirements.
Dehydrating by means of a freeze drier, an oven, etc. to obtain the suppository C.
Example 10
Preparation of self-fixing dressing A
Selecting medical gauze as a substrate, and coating glue around the gauze, wherein the glue consists of one or more of polyurethane, polyacrylate and maleic gel, so that the medical gauze is better fixed around the anus skin;
the first medicament layer, the second medicament layer and the third medicament layer are sequentially arranged in the center of the medical gauze in a stacking mode. In this embodiment, the first agent layer is, by weight: 5 parts of cane sugar, 3 parts of titanium dioxide, 2 parts of zinc oxide, 1 part of radix sophorae flavescentis, 2 parts of coptis chinensis and 3 parts of baicalein; the second agent layer is: 1 part of borneol and 2 parts of mint; the third medicament layer is: 80 parts of sodium carboxymethyl bacterial cellulose.
The components are sieved and sterilized by ultraviolet irradiation, irradiation and the like, and the dressing A is obtained.
Example 11
Preparation of self-fixing dressing B
The preparation method is the same as that of example 10, except for the ratio of each component in the drug layer, and the component ratio of the drug layer in this example is as follows:
the first agent layer is, by weight: 10 parts of cane sugar, 5 parts of titanium dioxide, 3 parts of zinc oxide, 5 parts of radix sophorae flavescentis, 3 parts of coptis chinensis and 5 parts of baicalein; the second agent layer is: 2.5 parts of borneol and 4.5 parts of mint; the third medicament layer is: 75 parts of sodium carboxymethyl bacteria.
Example 12
Preparation of self-fixing dressing C
The preparation method is the same as that of example 10, except for the ratio of each component in the medicament layer, and the ratio of the components in the medicament layer in this example is as follows:
the first agent layer is, by weight: 2 parts of cane sugar, 1 part of titanium dioxide, 4 parts of zinc oxide, 3 parts of radix sophorae flavescentis, 5 parts of coptis chinensis and 2 parts of baicalein; the second medicament layer is: 4.5 parts of borneol and 2.5 parts of mint; the third medicament layer is: 95 parts of sodium carboxymethyl bacterial cellulose.
Example 13
Self-fixing dressing D
As shown in fig. 1 and fig. 2, the present embodiment provides an external self-fixing dressing D for treating pruritus ani, one side of the dressing has a substrate layer 1 with an adhesive fixing function, a first medicament layer 2 is covered on the substrate layer 1, a second medicament layer 3 is arranged on the top of the first medicament layer, and a third medicament layer 4 is arranged on the top of the second medicament layer.
Wherein, by weight, the first agent layer 2 specifically includes: 5 parts of cane sugar, 3 parts of titanium dioxide, 2 parts of zinc oxide, 1 part of radix sophorae flavescentis, 2 parts of coptis chinensis and 3 parts of baicalein. The first medicament layer synergistically inhibits pruritus symptoms of skin around the anus through sucrose, titanium dioxide and zinc oxide, disinfects and sterilizes the skin around the anus through radix sophorae flavescentis, coptis chinensis and baicalein, and further reduces infection possibility.
The second agent layer 3 includes, by weight: 1 part of borneol and 2 parts of mint. The borneol has the effects of clearing heat and relieving pain, the mint is cool in nature and has the effects of diminishing inflammation and relieving pain, and the two medicinal materials are matched according to the proportion of the embodiment and can synergistically play the effects of diminishing swelling and relieving pain on skin around an anus.
The third agent layer 4 includes, by weight: 80 parts of sodium carboxymethyl bacterial cellulose. Preferably, in this embodiment, the molecular weight of the sodium carboxymethylcellulose is between 5 and 30 ten thousand, and more preferably, the molecular weight is between 20 and 30 ten thousand.
The sodium carboxymethyl cellulose absorbs the seepage and other wet substances of the skin around the anus, so that the anus is kept dry and fresh.
The characteristics that different functions are realized to this embodiment according to different medicaments adopt the medicament layer of arranging of range upon range of mode, improve the pruritus ani treatment effect.
Aiming at the pruritus ani, the 3 independent medicament layers can respectively realize the effects of relieving itching and resisting bacteria, relieving swelling and pain and eliminating dampness and dryness after being applied to the focus part, have comprehensive medicament effect, are beneficial to improving the treatment effect and shorten the treatment period.
The base layer 1 of the external dressing of the embodiment is a medical gauze layer, so that the external dressing has better air permeability and moisture absorption, and reduces the risk of bacteria contamination of the material. Set up gluing portion in the gauze periphery, have polyurethane, polyacrylate and the wherein one or more material of maleic gum on gluing portion and coat the tie coat that forms on medical gauze layer to make better the fixing of dressing around the anus skin.
In order to enable the medicament layer to have a better skin-friendly effect on the focus and avoid discomfort caused by large friction force between coarse particles and the skin of a patient, the particle size of all medicament particles in the embodiment is small particles with the particle size being less than or equal to 100 meshes, so that the comfort degree of the patient using the dressing is greatly improved, and meanwhile, the permeability of the effective substances in the medicament layer to the skin can be improved, thereby enhancing the treatment effect of the dressing.
More specifically, in order to further improve the adhesion between the drug layer and the skin at the lesion, enhance the drug application effect and improve the drug utilization, the thicknesses of the first drug layer 2, the second drug layer 3 and the third drug layer 4 are set to be less than or equal to 2mm in this embodiment. The unstable phenomena of fault and collapse of medicament layer particles in the packaging process or after medicament administration can be avoided by the arrangement.
The specific implementation scenario of the utility model of the invention is as follows: the dressing is applied to the anus. The dressing is positionally stabilized by the adhesive layer. The third medicament layer 4 absorbs seepage and other wet substances generated by the skin around the anus, so that the dryness and the coolness around the hepatic portal are kept, and then the second medicament layer 3 is used for reducing the swelling of the skin around the anus, reducing the pain of a patient and relieving the psychological pressure of the patient. Through the first medicament layer 2, the pruritus symptom of the skin around the anus is relieved, the psychological mood of a patient is relaxed, the patient is helped to cooperate with follow-up treatment, surrounding bacteria can be killed, and the possibility of further infection is reduced. The multiple medicament layers are arranged layer by layer, and the synergistic effect is achieved, so that the effects of resisting bacteria, reducing swelling and inhibiting pruritus are achieved.
The embodiment solves the clinical symptoms of the existing pruritus ani patients, and the components used by the invention are nontoxic and harmless, have no toxic or side effect, are safe and reliable, and are safe for clinical use.
Simultaneously, this embodiment designs an external dressing for pruritus ani, can independently pack, and is lightly and conveniently carried, and is simple to use, helps improving patient's use experience and quality of life.
Example 14
Self-fixating dressing E
As shown in fig. 3, the method of providing a drug layer according to the present embodiment is the same as that of embodiment 5, and includes a base layer 1a, a first drug layer 2a, a second drug layer 3a, and a third drug layer 4a are respectively provided in a stacked manner at a central position of an upper surface of the base layer 1a, and an adhesive layer is formed on an outer periphery of the base layer 1a by coating.
The first agent layer 2a is formed by adhering various medicinal material particles of cane sugar, titanium dioxide, zinc oxide, radix sophorae flavescentis and baicalein together through natural adhesive such as natural rubber or rosin resin, and is further adhered to the substrate layer 1 a. It can be understood that because the natural adhesive is used for fixing the medicinal material particles, the medicament layer of the dressing can keep a stable layered structure in the using and storing processes, the conditions of collapse and scattering of the medicinal material particles of the medicament layer are avoided, and meanwhile, the natural adhesive also has the characteristics of low toxic and side effects and strong skin affinity, and is favorable for enhancing the medicinal effect of the external dressing.
In this embodiment, the medicinal particles of the second and third medicament layers 3a and 4a are also fixed and adhered in a manner similar to the first medicament layer 2a, which is helpful for the dressing to exert the best therapeutic effect.
In order to make the dressing more fit to the specific anatomy of the anal region in actual use, the base layer 1a of the present embodiment is formed in an elongated rectangular shape as a whole, and the base layer 1a, the first drug layer 2a, and the second drug layer 3a are also provided in a long strip shape and stacked on the middle portion of the base layer 1 a. As shown in fig. 3, in order to make the agent layer go deep into the focal site of the anus, the width of the base layer 1a of this embodiment is set to 1 to 2cm, and the adhesive parts 5 are provided at both ends of the base layer in the longitudinal direction, so that the adhesive parts 5 can be attached to the front and rear sides of the application site in actual use, the adhesive layers on the periphery of the base layer 1a are attached to two skin strands, and the agent layer provided in the middle of the base layer 1a is applied to the focal site of the anus.
This embodiment provides extra adhesive force for the dressing through setting up gluing portion 5, and simultaneously, the holistic thin and long structure of dressing accords with anus and the special human structure between two strands more to optimized the laminating mode of medicament layer with focus department, helped improving the utilization ratio on medicament layer, reached reinforcing drug effect, shortened treatment cycle's effect.
It should be understood that the above-mentioned embodiments of the present invention are only examples for clearly illustrating the technical solutions of the present invention, and are not intended to limit the specific embodiments of the present invention. Any modification, equivalent replacement, and improvement made within the spirit and principle of the present invention claims should be included in the protection scope of the present invention claims.

Claims (10)

1. An external preparation for treating pruritus ani is characterized by comprising the following components in parts by weight: 70-95 parts of sodium carboxymethylcellulose, 2-10 parts of sucrose, 0.1-5 parts of borneol and 0.1-5 parts of mint.
2. The external preparation for treating anal pruritus according to claim 1, further comprising the following components by weight: 1-5 parts of titanium dioxide and 1-5 parts of zinc oxide.
3. The external preparation for treating anal pruritus of claim 2, further comprising the following components by weight: 1-5 parts of radix sophorae flavescentis, 1-5 parts of coptis chinensis and 1-5 parts of baicalein.
4. The external preparation for treating anal pruritus according to claim 1, wherein the external preparation comprises the following components by weight: 75-95 parts of sodium carboxymethylcellulose, 2-10 parts of sucrose, 0.5-5 parts of borneol and 0.5-5 parts of mint;
or, comprises the following components: 75-95 parts of sodium carboxymethylcellulose, 2-10 parts of sucrose, 0.5-5 parts of borneol, 0.5-5 parts of mint, 2-5 parts of titanium dioxide and 2-5 parts of zinc oxide;
or, comprises the following components: 75-95 parts of sodium carboxymethylcellulose, 2-10 parts of sucrose, 0.5-5 parts of borneol, 0.5-5 parts of mint, 2-5 parts of titanium dioxide, 2-5 parts of zinc oxide, 1-5 parts of radix sophorae flavescentis, 2-5 parts of coptis chinensis and 2-5 parts of baicalein.
5. A method for preparing the external preparation according to any one of claims 1 to 4, wherein the preparation is a powder, comprising the steps of:
s51, weighing a proper amount of sodium carboxymethylcellulose, sucrose, borneol, mint, titanium dioxide, zinc oxide, radix sophorae flavescentis, coptis chinensis and baicalein, and respectively crushing;
s52, sieving the products of the components obtained in the step S51 by using a 100-500-mesh sieve respectively;
s53, weighing 70-95 parts by weight of carboxymethyl cellulose sodium, 2-10 parts by weight of sucrose, 0.1-5 parts by weight of borneol, 0.1-5 parts by weight of mint, 1-5 parts by weight of titanium dioxide, 1-5 parts by weight of zinc oxide, 1-5 parts by weight of radix sophorae flavescentis, 1-5 parts by weight of coptis chinensis and 1-5 parts by weight of baicalein obtained in the step S52, and mixing;
and S54, sterilizing the mixed product obtained in the step S53.
6. A method for preparing the external preparation according to any one of claims 1 to 4, wherein the preparation is an ointment, comprising the steps of:
s61, weighing a proper amount of sodium carboxymethylcellulose, sucrose, borneol, mint, titanium dioxide, zinc oxide, radix sophorae flavescentis, coptis chinensis and baicalein, and respectively crushing;
s62, sieving the products of the components obtained in the step S61 respectively by using a 100-500-mesh sieve;
s63, weighing 70-95 parts by weight of the carboxymethyl cellulose sodium, 2-10 parts by weight of sucrose, 0.1-5 parts by weight of borneol, 0.1-5 parts by weight of mint, 1-5 parts by weight of titanium dioxide, 1-5 parts by weight of zinc oxide, 1-5 parts by weight of radix sophorae flavescentis, 1-5 parts by weight of coptis chinensis and 1-5 parts by weight of baicalein obtained in the step S62, and mixing to obtain mixed medicinal powder;
s64, uniformly mixing the mixed medicinal powder obtained in the step S63 with a glycerol aqueous solution with the concentration of 10-70%;
s65, sterilizing the product obtained in the step S64.
7. A method for preparing the external preparation according to any one of claims 1 to 4, wherein the preparation is a suppository, comprising the steps of,
s71, weighing a proper amount of sodium carboxymethylcellulose, sucrose, borneol, mint, titanium dioxide, zinc oxide, radix sophorae flavescentis, coptis chinensis and baicalein, and respectively crushing;
s72, respectively sieving products of the components obtained in the step S71 by using a 100-500-mesh sieve;
s73, weighing 70-95 parts by weight of the carboxymethyl cellulose sodium obtained in the step S72, 2-10 parts by weight of sucrose, 0.1-5 parts by weight of borneol, 0.1-5 parts by weight of mint, 1-5 parts by weight of titanium dioxide, 1-5 parts by weight of zinc oxide, 1-5 parts by weight of radix sophorae flavescentis, 1-5 parts by weight of coptis chinensis and 1-5 parts by weight of baicalein, and mixing to obtain mixed medicinal powder;
s74, uniformly mixing the mixed medicinal powder obtained in the step S73 with a glycerol aqueous solution with the concentration of 10-70%;
s75, preparing the product obtained in the step S74 into a suppository;
s76, dehydrating the suppository obtained in the step S75.
8. A method for producing the external preparation according to any one of claims 1 to 4, wherein the preparation is a self-fixing dressing, comprising the steps of,
s81, weighing a proper amount of sodium carboxymethylcellulose, sucrose, borneol, mint, titanium dioxide, zinc oxide, radix sophorae flavescentis, coptis chinensis and baicalein, and respectively crushing;
s82, sieving the products of the components obtained in the step S81 respectively by using a 100-500-mesh sieve;
s83, sterilizing the product obtained in the step S82;
s84, distributing the product obtained in the step S83 in 3 medicament layers in parts by weight: the first medicament layer comprises 2-10 parts of cane sugar, 1-5 parts of titanium dioxide, 1-5 parts of zinc oxide, 1-5 parts of radix sophorae flavescentis, 1-5 parts of coptis chinensis and 1-5 parts of baicalein; the second medicament layer comprises 0.1-5 parts of borneol and 0.1-5 parts of mint; the third medicament layer comprises 70-95 parts of sodium carboxymethyl bacterial cellulose.
S85, coating an adhesive on the periphery of the medical gauze, and arranging the medicament layer in the step S84 in the middle of the medical gauze in a stacking manner;
the first medicament layer, the second medicament layer and the third medicament layer are arranged on the medical gauze in a stacking mode from bottom to top.
9. The external preparation obtained by the production method according to any one of claims 5 to 8.
10. The external preparation according to any one of claims 1 to 4, or the external preparation according to claim 9, for use in the treatment of anal pruritus.
CN202211377656.6A 2022-11-04 2022-11-04 External preparation for treating anal pruritus and preparation method thereof Pending CN115887526A (en)

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