CN112156225A

CN112156225A - Chitosan or and algal polysaccharide composite biological matrix liquid dressing gel preparation and preparation method thereof

Info

Publication number: CN112156225A
Application number: CN202011236367.5A
Authority: CN
Inventors: 唐长菱
Original assignee: Individual
Current assignee: Individual
Priority date: 2020-11-09
Filing date: 2020-11-09
Publication date: 2021-01-01

Abstract

A chitosan or and algal polysaccharide composite biological matrix liquid dressing gel preparation is characterized by comprising main materials and auxiliary materials, wherein the main materials comprise the following components: the content of chitosan is 0.5-5 wt%; the content of algal polysaccharide is 0.00-3.0 wt%; the concentration of the schizonepeta extract is 0-2 wt%; 0-2 wt% of sophora flavescens extract concentrated solution; the content of the hydrolyzed pearl powder is 0.5-2 wt%; borneol content of 0.05-0.5 wt%, epidermal growth factor content of 5-10 ten thousand IU; the auxiliary materials comprise a stabilizing agent and an emulsifying agent, wherein the emulsifying agent is at least one of glycerol, carbomer, EDTA, ethylene glycol, triethanolamine and benzoic acid; the invention has the characteristics of broad-spectrum antibiosis, slough removal, granulation promotion, quick repair, safety, stability, high efficiency, slow release and the like, and achieves the effects of treating anal hemorrhoids and fistula and gynecological inflammation and promoting wound healing.

Description

Chitosan or and algal polysaccharide composite biological matrix liquid dressing gel preparation and preparation method thereof

Technical Field

The invention is applicable to the field of medical treatment and health, in particular to a chitosan or and algal polysaccharide composite biological matrix liquid dressing gel preparation.

Background

Hemorrhoids and fistula are common diseases and frequently encountered diseases, and the traditional Chinese medicine has very deep knowledge on hemorrhoids and fistula in thousands of years of clinical practice, and accumulates abundant and precious clinical experience. The traditional Chinese medicine believes that the hemorrhoids are formed by disorder of spleen and stomach, downward flow of damp-heat and stagnation of qi. The fumigation and washing therapy is a precious heritage of traditional Chinese medicines, has a history of thousands of years in China, and is an indispensable treatment method for anorectal departments, namely Chinese herbal medicine decoction is used for fumigation and washing at the anus when the decoction is hot, and blood vessels of affected parts are expanded under the action of medicine power and heat power to promote local blood and lymph circulation, so that channels and collaterals are dredged, qi and blood are smooth, edema is eliminated, inflammation is absorbed, and pain is relieved and eliminated, thereby achieving the purpose of treatment. It is usually made up by using flavescent sophora root decoction and compound schizonepeta fumigant.

Schizonepeta (Nepeta cataria L.), alias: herba Schizonepetae, herba Capsellae, herba Artemisiae Annuae, and herba Stachydis Japonicae are perennial plants of genus Schizonepetae of family Labiatae. Schizonepeta tenuifolia is one of the commonly used Chinese herbs for inducing sweat and relieving fever, and can suppress phlegm,Wind dispelling deviceAnd cooling blood. [ solution ] ACompendium of compendiumA large section of: disperse wind-heat, clear head and eyes, relieve sore throat, and eliminate sores and swelling. It is indicated for stiff neck, blackish flower in eyes, sores, lingering blood, hematemesis, epistaxis, bleeding, bloody dysentery, metrorrhagia, and hemorrhoids and fistula. Treating hemorrhoids with swelling and pain: the schizonepeta is boiled and washed daily. (simple prescription);

sophora flavescens (Sophora flavescens), alternative names: sophora japonica, Japanese pagodatree twig, Japanese pagodatree seed and Japanese pagodatree are perennial plants in leguminous and sophora genus. The medicine has the effects of clearing heat and promoting diuresis, resisting bacteria and diminishing inflammation, invigorating stomach and expelling parasites, and is used for treating large intestine rectocele by being divided into lightyellow sophora root, Chinese gall, old wall soil and the like. The decoction is washed and then the powder of horsetail is applied. (& lt & ltAbstract of medical prescription & gt)

Borneol (dryobalanopronata gwaertn. f.), another name: borneolum, Borneolum Syntheticum, borneolum, Borneolum Syntheticum, and Borneolum Syntheticum. Unblocking orifices, dispelling stagnated fire, removing nebula, improving eyesight, relieving swelling and alleviating pain. The borneol has slight stimulation to sensory nerves when being locally applied, has certain pain relieving and mild antiseptic effects, and has the antibacterial and anti-inflammatory effects. Treating internal and external hemorrhoids: borneol one and two halves, shallot juice is applied. ("simple single prescription)

Hydrolyzing pearls: margarita has effects in tranquilizing mind, nourishing yin, calming endogenous wind, clearing away heat, eliminating phlegm, improving eyesight, removing toxic materials, and promoting granulation. It has astringent, granulation promoting, and healing effects. The book Ben Cao Hui Yan (materia Medica) has the effects of relieving palpitation, tranquilizing mind, relieving stranguria, removing toxic substances, eliminating malignant boil, healing ulcer, and breaking ulceration. The hydrolysis reaction pearl powder is pearl powder which can dissolve water by 100 percent, preserves original components of the pearl in detail, changes insoluble substances in the pearl components into soluble substances according to various technical characteristics, improves the digestibility, and treats the difficulty that the pearl powder is not easy to absorb.

Epidermal Growth Factor (EGF) is the earliest growth factor found and plays an important role in regulating cell growth, proliferation and differentiation. The medicine can be used for treating skin trauma, postoperative wound, bedsore, oral ulcer and gangrene, and dermatitis caused by radiotherapy. It can accelerate the healing of wound and ulcer, promote the metabolism of human skin, and reduce skin deformity.

The chitosan is a natural high-molecular polycation polysaccharide, has no immunogenicity, no toxic or side effect and good biological safety, has the functions of stopping bleeding, resisting bacteria, promoting healing and the like, and has good performance for preparing hemostatic dressings, bacteriostatic dressings and ulcer healing dressings.

The algal polysaccharide has antiviral, antitumor, antimutagenic, antiradiation and immunity enhancing effects.

In recent years, experts at home and abroad are dedicated to research on the pharmacological function and the biological activity function of algal polysaccharide, and great progress is made, but the traditional Chinese medicine hip bath medicine has the defects of short contact time, low absorption rate, inconvenient use and the like.

Disclosure of Invention

The invention aims to provide a chitosan or and algal polysaccharide composite biological matrix liquid dressing and a preparation method thereof, overcomes the defects of short contact time, low absorption rate, inconvenient use and the like of the traditional Chinese medicine hip bath medicine, overcomes the defects of single polysaccharide substance and poor antibacterial and anti-inflammatory effects, has good hydrophilic absorption property and film forming property by combining different auxiliary materials, can be widely used as a medical dressing for anus diseases and gynecological diseases, has the characteristics of broad-spectrum antibacterial property, slough removal and tissue regeneration, quick repair, safety, stability, high efficiency, slow release and the like, and achieves the effects of treating anus fistula and gynecological inflammation and promoting the healing of wounds and surgical wounds.

In order to achieve the aim, the invention provides a chitosan or and algal polysaccharide composite biological matrix liquid dressing gel preparation, which comprises main materials and auxiliary materials, wherein the main materials comprise the following components:

the chitosan content is 0.5-5 wt%

The content of the algal polysaccharide is 0.00-3.0 wt%

The concentration of the schizonepeta extract is 0-2 wt%

0-2 wt% of sophora flavescens ait extract concentrate

0.5-2 wt% of hydrolyzed pearl powder,

0.05 to 0.5 weight percent of borneol,

the content of epidermal growth factor is 5-10 ten thousand IU

The auxiliary materials comprise a stabilizing agent and an emulsifying agent, wherein the emulsifying agent is at least one of glycerol, carbomer, EDTA, ethylene glycol, triethanolamine and benzoic acid.

The main materials are a main material composition which adopts one or more than two of schizonepeta extract concentrated solution, sophora flavescens extract concentrated solution, hydrolyzed pearl powder and borneol as well as two or more than two of chitosan and algal polysaccharide as matrixes.

A preparation method of chitosan or and algal polysaccharide composite biological matrix liquid dressing gel preparation comprises the following steps:

firstly, preparing 20% concentrated liquid from schizonepeta and sophora flavescens through water extraction, filtering and standing for later use, weighing 100g of chitosan, 30g of algal polysaccharide, 8 g of carbomer 940, 150g of schizonepeta extract concentrated solution, 150g of sophora flavescens extract concentrated solution, then adding 600 g of glycerin, 30g of benzyl alcohol, 1.5 g of EDTA and a proper amount of triethanolamine, stirring to emulsify, then adding 15g of borneol, 30g of hydrolyzed pearl powder and 30mg of epidermal growth factor, gradually adding sterile water until the total amount reaches 3000 g, and then carrying out sterile subpackaging in 1000 piston type plastic guide tubes to obtain the sterile gel preparation.

A topical liquid spray comprises a composite biological matrix liquid dressing gel preparation.

A colloidal fluid comprising a composite biological matrix liquid dressing gel formulation.

Use of chitosan or and algal polysaccharide composite biological matrix liquid dressing gel preparation in preparation of medicament for treating anal diseases and gynecological diseases.

By applying the technical scheme of the invention, the traditional empirical prescription of the ancient Chinese medical science in China is taken as the leading factor, and the traditional Chinese medical science and the modern medical science are combined through the innovation of new medicine compatibility combination and administration mode, so that the aim of developing a new medicine is fulfilled. The herba schizonepetae and the radix sophorae flavescentis belong to plant extracts, have no toxic or side effect on human bodies, and the hydrolyzed pearl and the borneol are common traditional externally-applied traditional Chinese medicines, so that the safety and the effectiveness of the traditional Chinese medicines are tested by long-standing historical proved prescriptions. The medicines are traditional external medicines for treating anal diseases and gynecology, no incompatibility exists, compared with oral medicines, the external dressing can directly reach the diseased region, the dosage is less, and the composition has a synergistic effect through different combinations, so that a more obvious treatment effect is realized. The gel formed by chitosan and algal polysaccharide in the composition is used as a colloid with positive charge, can adsorb and agglutinate a large amount of germs with negative charge, and retards the metabolic activity and propagation of the germs until the composition is disintegrated; meanwhile, the chitosan has good biocompatibility, has synergistic effects of keeping effective administration concentration of herba schizonepetae, radix sophorae flavescentis and borneol, prolonging the action time of the medicine and the like, and the hydrolyzed pearls have the effects of removing the necrotic tissue and promoting granulation, provide nutrition for epidermal cells and beneficial bacteria under the promotion of epidermal growth factors, and promote self-repair and microecological balance of tissues; the borneol local application also has the effect of relieving pain, and through the compatibility and the synergy of the medicines and the innovation of the administration mode, the treatment effect is improved, and the medication comfort and the convenience are improved.

Detailed Description

While the invention will be described in detail with reference to specific embodiments thereof, the invention may be embodied in practice using conventional equipment, it being understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention thereto. The invention provides a chitosan and/or algal polysaccharide composite biological matrix liquid dressing, which comprises 0.5-5 wt% of chitosan, 0.00-3.0 wt% of algal polysaccharide, 0-2 wt% of herba schizonepetae extract concentrate, 0-2 wt% of radix sophorae flavescentis extract concentrate, 0.5-2 wt% of hydrolyzed pearl powder, 0.05-0.5 wt% of borneol and 5-10 ten thousand IU of epidermal growth factor.

Further, preferably, the contents of the schizonepeta concentrated extract, the sophora flavescens concentrated extract and the hydrolyzed pearl powder are 0.5-1 wt% of the dressing composition, the content of the borneol is 0.2-0.5 wt% of the dressing composition, the content of the epidermal growth factor is 10 ten thousand IU, the content of the chitosan is 2-5 wt% of the dressing composition, and the content of the algal polysaccharide is 0.1-1 wt%.

Further, preferably, the contents of the schizonepeta concentrated extract, the sophora flavescens concentrated extract and the hydrolyzed pearl powder are 1-2 wt% of the dressing composition, the content of the borneol is 0.05-0.1 wt% of the dressing composition, the content of the epidermal growth factor is 10 ten thousand IU, the content of the chitosan is 0.5-2 wt% of the dressing composition, and the content of the algal polysaccharide is 0.5-3 wt%.

Further, preferably, the contents of the schizonepeta concentrated extract, the sophora flavescens concentrated extract and the hydrolyzed pearl powder are 0.5-2 wt% of the dressing composition, the content of the borneol is 0.2-0.5 wt% of the dressing composition, the content of the epidermal growth factor is 10 ten thousand IU, and the content of the chitosan is 2-5 wt% of the dressing composition.

Optionally, one or more of herba Schizonepetae extract concentrate, radix Sophorae Flavescentis extract concentrate, hydrolyzed Margarita powder, and Borneolum Syntheticum, and dressing composition with two or more of chitosan and algal polysaccharide as matrix.

Furthermore, the dosage form of the pharmaceutical composition is medical gel.

Further, the medical gel is 2-4 ml of gel.

Further, in a preferred embodiment of the present invention, the gel further comprises a spray of external liquid or a colloidal fluid.

According to another aspect of the present invention, there is provided a use of the above dressing composition in the treatment of anal diseases and gynecological diseases, and a new administration mode for external application of Chinese medicine.

Further, the adjuvant of the dressing composition comprises a stabilizer and an emulsifier, wherein the stabilizer and the emulsifier can be any one of those conventional in the art, such as glycerin, carbomer, EDTA, ethylene glycol, triethanolamine or benzoic acid.

The preparation process comprises the following steps:

example 1

Firstly, preparing 20% concentrated liquid from schizonepeta and sophora flavescens through water extraction, filtering and standing for later use, weighing 100g of chitosan, 30g of algal polysaccharide, 8 g of carbomer 940, 150g of schizonepeta extract concentrated solution, 150g of sophora flavescens extract concentrated solution, then adding 600 g of glycerin, 30g of benzyl alcohol, 1.5 g of EDTA and a proper amount of triethanolamine, stirring to emulsify, then adding 15g of borneol, 30g of hydrolyzed pearl powder and 30mg of epidermal growth factor, gradually adding sterile water until the total amount reaches 3000 g, and then aseptically subpackaging into 1000 piston type plastic guide tubes to obtain the sterile gel preparation in the embodiment 1.

Example 2

Firstly, preparing 20% concentrated liquid from schizonepeta and sophora flavescens through water extraction, filtering and standing for later use, weighing 60g of chitosan, 90g of algal polysaccharide, 8 g of carbomer 940, 200g of schizonepeta extract concentrated solution, 200g of sophora flavescens extract concentrated solution, then adding 600 g of glycerin, 30g of benzyl alcohol, 1.5 g of EDTA and a proper amount of triethanolamine, stirring to emulsify, then adding 3g of borneol, 50g of hydrolyzed pearl powder and 30mg of epidermal growth factor, gradually adding sterile water until the total amount reaches 3000 g, and then aseptically subpackaging into 1000 piston type plastic guide tubes to obtain the sterile gel preparation of the embodiment 2.

Example 3

The preparation method comprises the steps of firstly preparing 20% concentrated liquid from schizonepeta and sophora flavescens through water extraction, filtering and standing for later use, weighing 150g of chitosan, 8 g of carbomer 940, 300g of schizonepeta extract concentrated solution and 300g of sophora flavescens extract concentrated solution, then adding 600 g of glycerin, 30g of benzyl alcohol, 1.5 g of EDTA and a proper amount of triethanolamine, stirring to emulsify, then adding 15g of borneol, 30g of hydrolyzed pearl powder and 30mg of epidermal growth factor, gradually adding sterile water until the total amount reaches 3000 g, and then aseptically subpackaging into 1000 piston type plastic guide tubes to obtain the sterile gel preparation in the embodiment 3.

Clinical trial

For anorectal diseases

Example 4

Clinically, 120 patients with internal hemorrhoids and mixed hemorrhoids were treated by pushing the gel preparation of example 1 into the deep part of the anus with a guide tube after cleaning the anus once a day, morning and evening, and 7 days were a treatment course, and then the treatment effect was evaluated according to the clinical grading criteria, and the evaluation results are shown in table 1.

TABLE 1 evaluation of the efficacy of two groups of patients

As can be seen from Table 1, the gel preparation of example 1 has an effective rate of 96.3% for internal hemorrhoids, 95.5% for mixed hemorrhoids, and a total effective rate of 95.8%.

Example 5

Clinically, 60 patients after hemorrhoids and anal fistula operation are randomly divided into 2 groups (an observation group and a control group), the gel preparation in the example 3 is pushed into the anus wound part by a guide tube after warm water cleaning and hip bath every day in the observation group, the gel preparation in the control group is used for hip bath after the schizonepeta and sophora flavescens empirical prescription, then the curative effect evaluation is carried out according to the healing standard, and the evaluation result is shown in the specification

Table 2.

As can be seen from table 2, the observed groups were significantly smaller than the control group for comparison of post-operative bleeding volume, pain level and incision healing time in both groups, and the difference was statistically significant (P < 0.05), indicating that the gel dressing of example 3 was used with significant efficacy.

Example 6

Clinically, 110 patients with vaginitis and cervicitis order to push the gel preparation in the embodiment 2 to the pathological change part in the vagina every night before sleep, 7 days are a treatment course, and then the curative effect evaluation is carried out according to clinical grading standards, and the evaluation results are shown in table 3.

Analysis of data in table 3 shows that the dressing composition of example 3 has an effective rate of 92.7% for treating vaginitis, 90.1% for treating cervicitis and 91.8% for total effective rate, which indicates that the dressing composition of example 3 has an obvious treatment effect on gynecological diseases.

Analysis of the above data reveals that the dressing composition of the present application exerts significant therapeutic effects in treating anorectal gynecological diseases or anorectal diseases, and the above description is only a preferred embodiment of the present invention and is not intended to limit the present invention, and various modifications and changes can be made by those skilled in the art. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A chitosan or and algal polysaccharide composite biological matrix liquid dressing gel preparation is characterized by comprising main materials and auxiliary materials, wherein the main materials comprise the following components:

the chitosan content is 0.5-5 wt%

The content of the algal polysaccharide is 0.00-3.0 wt%

The concentration of the schizonepeta extract is 0-2 wt%

0-2 wt% of sophora flavescens ait extract concentrate

0.5-2 wt% of hydrolyzed pearl powder,

0.05 to 0.5 weight percent of borneol,

the content of epidermal growth factor is 5-10 ten thousand IU;

the auxiliary materials comprise a stabilizing agent and an emulsifying agent, wherein the emulsifying agent is at least one of glycerol, carbomer, EDTA, ethylene glycol, triethanolamine and benzoic acid;

2. A method for preparing the chitosan or seaweed polysaccharide composite biological matrix liquid dressing gel preparation according to claim 1, which is characterized by comprising the following steps:

3. A liquid spray for external use characterized by containing the complex bio-matrix liquid dressing gel formulation of claim 1.

4. A colloidal fluid comprising the composite bio-matrix liquid dressing gel formulation of claim 1.

5. Use of a chitosan or and algal polysaccharide composite bio-matrix liquid dressing gel formulation according to claim 1 in the preparation of a medicament for the treatment of anal and gynecological diseases.