CN111991372B - Application of medical skin repairing paste in preparation of dermatitis treatment medicine - Google Patents
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
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- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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Abstract
The invention belongs to the technical field of biological medicines, and particularly relates to an application of a medical skin repairing paste in preparation of a medicine for treating dermatitis. The invention firstly proposes that the medical skin repairing plaster is used in the clinical treatment of various types of dermatitis, has obvious auxiliary treatment effect on the dermatitis, and has food safety, no toxic or side effect and good safety. The invention adopts multi-center and open test design, takes the EASI score and the VAS score of the face as main evaluation indexes, and observes the safety, the applicability and the effectiveness of the auxiliary treatment of the dermatitis diseases of the medical skin repairing paste. The results show that: on the 7 th day and the 14 th day of treatment, the EASI mean value and the VAS mean value are obviously reduced compared with the baseline, the EASI mean reduction rate is 80.28 percent, the VAS mean reduction rate is 87.17 percent and the total effective rate is 98.33 percent at the end of treatment (the 14 th day).
Description
Technical Field
The invention belongs to the technical field of biological medicines, and particularly relates to an application of a medical skin repairing paste in preparation of a medicine for treating dermatitis.
Background
Dermatitis is a relatively common disease in clinic, and is classified into contact dermatitis, eczema, allergic dermatitis and other types of dermatitis according to the dermatitis classification recommended by the allergic organization in the world. Among the contact dermatitis (cosmetics, diapers, and dermatitis lacquer) caused by contact with foreign substances, eczema such as atopic dermatitis, seborrheic dermatitis, stasis dermatitis, self-sensitivity dermatitis, infectious dermatitis around wound, eczema, lichen simplex chronicus, ringworm, hand dermatitis, polymorphous light eruption, etc.; eczema which cannot be further classified includes perianal eczema, crural eczema, scrotum eczema, breast eczema, external ear eczema, spring eczema, summer eczema, prurigo and the like. Dermatitis and eczema are often used synonymously to refer to an inflammation of the skin, representing the allergic reaction of the skin to a variety of substances such as chemicals, proteins, bacteria and fungi.
At present, for dermatitis treatment medicines, the western medicine mainly adopts corticoids, and antihistamines and antibiotics medicines are taken orally, wherein the antihistamines mainly play a role in calming and relieving itching, the antibiotics are used for infected skin lesions, and the medicine containing the corticoids has a remarkable curative effect on mild dermatitis when being externally applied. However, in recent years, skin damage caused by external hormone preparations has increased sharply, and adverse reactions have become a social problem of high concern. If the drug containing the corticoids is frequently or massively used for a long time, sensitive skin is caused, and the whole body of the skin can be sensitive; a large amount of external hormone can be absorbed by skin to enter blood circulation for a long time, causing diabetes and the like; abuse of antibiotics may lead to increased bacterial resistance and reduced immune function of the body, which leads to repeated and difficult recovery.
Therefore, chinese patent document CN103006686A discloses a functional preparation for adjuvant therapy of atopic dermatitis and a preparation method thereof, wherein the functional preparation comprises the following raw materials by weight: 0.2-1 part of sodium hyaluronate, 5-10 parts of emulsifying thickener, 5-10 parts of grease and 100 parts of deionized water. The patent document is a functional preparation containing sodium hyaluronate, and the mometasone furoate cream is combined to obviously improve the symptom of eczema sicca, effectively recover the barrier function of skin and reduce relapse, and the curative effect is superior to that of the mometasone furoate cream used alone; can be used for adjuvant treatment of dermatitis and eczema, with good therapeutic effect and safety, and reduced recurrence. However, this technique has an adjuvant therapeutic effect only on atopic dermatitis, and does not have universality.
Disclosure of Invention
Therefore, the technical problem to be solved by the invention is to overcome the defects that the existing preparation for adjuvant dermatitis treatment in the prior art does not have universality and the like, so that the application of the medical skin repairing paste which can reduce or eliminate the irritation and sensitization of raw material components contained in the conventional dermatitis medicament in preparing the dermatitis treatment medicament is provided.
Therefore, the invention provides the following technical scheme:
the invention provides application of a medical skin repairing paste in preparation of a medicine for treating dermatitis.
Further, the dermatitis medicines comprise medical skin repairing patches and conventional dermatitis medicines.
Further, the medical skin repairing paste comprises the following raw materials in percentage by mass:
0.1 to 0.3 percent of carboxymethyl chitosan;
1-3% of trehalose;
8-12% of glycerol;
85-90% of water.
Further, the medical skin repairing paste comprises the following raw materials in percentage by mass:
0.2 percent of carboxymethyl chitosan;
2% of trehalose;
10% of glycerol;
and 87.8 percent of water.
Further, the medical skin repairing paste is a mask agent.
Furthermore, the facial mask takes a biological cellulose membrane or non-woven fabric as a base material.
Further, the preparation method of the mask agent comprises the following steps:
and weighing the raw materials of the medical skin repairing paste according to a proportion, uniformly mixing, and flatly paving the mixture on the surface of the base material to obtain the mask agent.
Further, the conventional dermatitis medicament is a corticoid medicament, an antihistamine medicament or an antibiotic medicament.
The technical scheme of the invention has the following advantages:
1. the medical skin repairing paste provided by the invention is applied to the preparation of the medicine for treating dermatitis, is firstly proposed to be applied to the clinical treatment of various types of dermatitis, has an obvious auxiliary treatment effect on the dermatitis, and is food-safe, free of toxic and side effects and good in safety. By adopting a multi-center and open test design and taking the EASI score and the VAS score of the face as main evaluation indexes, the safety, the applicability and the effectiveness of the auxiliary treatment of the dermatitis diseases of the medical skin repairing plaster are observed. The results show that: the EASI mean value before the treatment of the experimental group is 0.48 +/-0.16, and the EASI mean value at the 7 th day and the 14 th day after the treatment is respectively reduced to 0.30 +/-0.22 and 0.12 +/-0.21. Mean reduction in EASI at the end of treatment (day 14) 80.28%; the EASI mean value of the control group before treatment is 0.47 +/-0.24, and the EASI mean values are reduced (the mean P is less than 0.0001) on the 7 th day and the 14 th day after treatment; the EASI mean value before treatment is 0.47 + -0.24, and the EASI mean values at 7 days and 14 days after treatment are respectively reduced to 0.23 + -0.19 and 0.16 + -0.17. The mean reduction in EASI at the end of treatment (day 14) was 77.85%. The VAS mean value of the experimental group before treatment is 5.27 +/-1.95, and the VAS mean values of the experimental group at 7 days and 14 days after treatment are respectively reduced to 4.52 +/-2.16 and 0.79 +/-1.14. The mean reduction in VAS at the end of treatment (day 14) was 87.17%; the VAS mean value of the control group before treatment is 5.15 +/-2.26, and the VAS mean values of the control group at 7 days and 14 days after treatment are respectively reduced to 2.35 +/-2.03 and 1.16 +/-1.57. The mean rate of VAS decline at the end of treatment (day 14) was 76.28%. The total effective rate is 98.33%.
Detailed Description
The following examples are provided to further understand the present invention, not to limit the scope of the present invention, but to provide the best mode, not to limit the content and the protection scope of the present invention, and any product similar or similar to the present invention, which is obtained by combining the present invention with other prior art features, falls within the protection scope of the present invention.
The examples do not indicate specific experimental procedures or conditions, and can be performed according to the procedures or conditions of the conventional experimental procedures described in the literature in the field. The reagents or instruments used are not indicated by manufacturers, and are all conventional reagent products which can be obtained commercially.
Example 1
The embodiment provides an application of a medical skin repairing patch in preparing a medicine for treating dermatitis, wherein the dermatitis medicine comprises the medical skin repairing patch and a conventional dermatitis medicine;
the medical skin repairing paste comprises the following raw materials in parts by weight: 0.2g of carboxymethyl chitosan; 2g of trehalose; 10g of glycerol; 87.8g of water;
the preparation method of the medical skin repairing paste comprises the following steps: and uniformly mixing the weighed components, and flatly paving the mixture on the surface of the biological cellulose membrane to obtain the medical skin repairing plaster.
The conventional dermatitis medicament is adjusted according to specific cases, wherein the pimpines are given for the sensitive dermatitis of the face, the pimpines are given for the recurrent dermatitis of the face, the triamcinolone acetonide econazole cream is given for the cosmetic dermatitis of the face, and the compound dexamethasone acetate cream is given for the recovery period of the contact dermatitis of the face.
Example 2
The embodiment provides an application of a medical skin repairing patch in preparing a medicament for treating dermatitis, wherein the dermatitis medicament comprises the medical skin repairing patch and a conventional dermatitis medicament;
the medical skin repairing plaster comprises the following raw materials in parts by weight: 0.1g of carboxymethyl chitosan; 3g of trehalose; 8g of glycerol; 88.9g of water;
the preparation method of the medical skin repairing paste comprises the following steps: and uniformly mixing the weighed components, and flatly paving the mixture on the surface of the biological cellulose membrane to obtain the medical skin repairing plaster.
The conventional dermatitis medicament is adjusted according to specific cases, wherein the pimpines are given for the sensitive dermatitis of the face, the pimpines are given for the recurrent dermatitis of the face, the triamcinolone acetonide econazole cream is given for the cosmetic dermatitis of the face, and the compound dexamethasone acetate cream is given for the recovery period of the contact dermatitis of the face.
Example 3
The embodiment provides an application of a medical skin repairing patch in preparing a medicine for treating dermatitis, wherein the dermatitis medicine comprises the medical skin repairing patch and a conventional dermatitis medicine;
the medical skin repairing paste comprises the following raw materials in parts by weight: 0.3g of carboxymethyl chitosan; 1g of trehalose; 12g of glycerol; 86.7g of water;
the preparation method of the medical skin repairing paste comprises the following steps: and uniformly mixing the weighed components, and flatly paving the mixture on the surface of the biological cellulose membrane to obtain the medical skin repairing plaster.
The conventional dermatitis medicine is adjusted according to specific cases, wherein the pimpinene is given for the sensitive dermatitis of the face, the pimecros is given for the recurrent dermatitis of the face, the triamcinolone acetonide econazole cream is given for the cosmetic dermatitis of the face, and the compound dexamethasone acetate cream is given for the recovery period of the contact dermatitis of the face.
Clinical trial
In order to further verify the clinical efficacy of the medical skin repair patch in the adjuvant therapy of the facial dermatitis diseases and verify the clinical safety, applicability and effectiveness of the medical skin repair patch in the adjuvant therapy of the facial dermatitis diseases, a multicenter and open control test was performed on 120 patients with the facial dermatitis diseases in 2018 to 12 months, and the dressing adopted was the dressing product in example 1.
1 data and method
1.1 case data
1.1.1 inclusion criteria
(1) The age is 18-60 years old, and the male and female are not limited.
(2) Facial dermatitis-like disorders including: (1) recurrent dermatitis of the face; (2) dermatitis of the face cosmetics; (3) convalescent period of facial contact dermatitis; (4) dermatitis sensitivity of the face.
1.1.2 exclusion criteria
(1) Those allergic to this type of product (query for medical history);
(2) Taking steroid hormone medicine, glycyrrhizin, and other steroid hormone medicine one week before test;
(3) Patients with other skin conditions that may affect the experimental observations, such as psoriasis;
(4) Severe infection at the skin lesion, other severe complications and systemic infection;
(5) In the acute stage of skin inflammation, symptoms are severe, blisters appear, and exudation is obvious;
(6) A woman who is nursing or preparing for pregnancy;
(7) Those with unclear consciousness, or those with mental disease and those who cannot express the disease clearly;
(8) Patients with blood coagulation insufficiency, such as hemophilia and thrombocytopenia.
1.2 methods
1.2.1 methods of treatment
An auxiliary treatment scheme: each center carries out conventional treatment on patients with facial dermatitis according to the skin damage condition of the patients. Patients meeting the inclusion criteria are randomly assigned to a test group and a control group, the test group adopts the conventional medicament treatment auxiliary medical skin repairing plaster, and the control group only adopts the conventional medicament treatment. The medical skin patch (the medical skin patch provided in example 1) was applied 1 day at night on days 1-7, and 1 patch every other day on days 8-14 for 14 consecutive days. The dressing used must not be changed during observation, and other similar products are forbidden.
The medication standard of the conventional dermatitis medicament is as follows: the ointment is prepared by adding paresone for the sensitive dermatitis of the face, fumeisong for the recurrent dermatitis of the face, triamcinolone acetonide econazole ointment for the cosmetic dermatitis of the face and compound dexamethasone acetate ointment for the recovery period of the contact dermatitis of the face.
1.2.2 Observation indicators
The facial skin damage, itching degree and the like of the patients at weekly double visits before and after treatment are observed and recorded, and comprehensive scoring is carried out according to the Eczema Area and Severity Index (EASI) and the Visual Analogue Scale (VAS). The above indexes are observed and recorded on the 7 th day after treatment before treatment and 14 days after treatment.
(1) EASI scoring: the skin damage severity is divided into four terms, namely: erythema (E), edema/infiltration/papulation (I), scaling (Ex), lichenification (L). The severity of each clinical presentation was scored from 0-3 points, 0= none, 1= light, 2= medium, 3= heavy. The score for each symptom may be scored halfway, i.e., 0.5. The proportion of adult head and neck in the whole body is 10%. Therefore, the head and neck (face) EASI score is (E + I + Ex + L). Times.10%.
(2) VAS scoring: a moving ruler with the length of 10cm is adopted, 0 is divided into no itching feeling, and 10 is divided into unbearable itching feeling. When scoring, the non-scale side of the moving scale faces the patient, and the patient marks the pruritus degree on the moving scale according to the pruritus feeling. 0-2 is divided into excellent; 3-5 points are good; 6-8 are divided into middle; a difference of 9-10.
(3)
1.2.3 treatment efficacy assessment
The primary evaluation index was the degree of improvement before and after treatment of the facial EASI and VAS values at enrollment and termination.
EASI reduction rate = (pre-treatment EASI value-post-treatment EASI value)/pre-treatment EASI value × 100%;
VAS reduction rate = (pre-treatment VAS value-post-treatment VAS value)/pre-treatment VAS value × 100%;
efficacy index = (total integral before treatment-total integral after treatment) × 100%;
the therapeutic effect judgment standard is as follows: the healing is as follows: the curative effect index is more than or equal to 95 percent; the obvious effect is as follows: the curative effect index is more than or equal to 70 percent and less than 95 percent; the method is as follows: the curative effect index is more than or equal to 30 percent and less than 70 percent; the invalidity is: the curative effect index is less than 30%. Recovery rate = number of recovery cases/total cases × 100%; effective rate = (cure + significant effect + improvement) cases/total cases × 100%.
1.2.4 safety assessment
At each visit, the investigator inquires whether the patient has adverse reaction, and performs vital sign examination and physical examination 1 time before and after treatment. If the adverse events are found, the occurrence time, the performance, the outcome and the like of the adverse events are recorded, the adverse events are treated, the test is withdrawn, and the causal analysis is carried out.
1.3 statistical methods
After all research data are recorded and locked, carrying out statistical analysis strictly according to a statistical analysis plan, and carrying out data analysis processing by using SPSS18.0 software. T test is used for measuring data, x is used for counting data 2 The test shows that P is less than 0.05, and the statistical significance is considered.
2. Results
2.1 general data
In the clinical observation, 120 subjects are selected in 6 centers, all cases are signed with informed consent, the classification index sex is tested by a chi-square method, and the continuous indexes (age, weight, height, body temperature and course of disease) are tested by a t test to compare the difference of the basic indexes of the population of a test group and a control group.
TABLE 1 Baseline demographic indicator comparison
TABLE 2 Baseline Vital sign comparison
| Test group | Control group | P | |
| Age (year of old) | 31.28±13.17 | 29.36±21.00 | ＞0.05 |
| Body weight (Kg) | 52.74±16.55 | 57.23±21.06 | ＞0.05 |
| Height (cm) | 154.32±29.12 | 151.65±25.26 | ＞0.05 |
| Body temperature (. Degree. C.) | 36.48±0.20 | 36.50±0.17 | ＞0.05 |
| Heart rate (times/minutes) | 70.20±6.05 | 71.73±4.98 | ＞0.05 |
| Respiration (times/minutes) | 18.68±4.51 | 18.70±4.31 | ＞0.05 |
| Systolic pressure (mmHg) | 110.65±6.09 | 109.78±11.08 | ＞0.05 |
| Diastolic blood pressure (mmHg) | 70.31±8.10 | 72.86±9.05 | ＞0.05 |
The test results show that the baseline demographic indicators are compared, the difference between the test group and the control group is not statistically significant (P > 0.05), see Table 1, the baseline vital signs are compared, the difference between the test group and the control group is not statistically significant (P > 0.05), see Table 2, and the results suggest that the two groups of cases randomly entered into the group have good comparability on the baseline.
2.2 therapeutic results
TABLE 3 clinical therapeutic effects
After 14 days, 16 cases are cured, 31 cases are obviously effective, 12 cases are improved and 1 case is ineffective, and the total effective rate is 98.33%; after the control group is treated for 14 days, 21 cases are cured, 19 cases with obvious effect, 11 cases with improvement and 9 cases with ineffectiveness are treated, the total effective rate is 85.00 percent, P is less than 0.05, and the difference has statistical significance, namely the effect of the test group is better than that of the control group.
2.2.1 post-treatment comparison with baseline the degree of EASI improvement (Main evaluation index)
TABLE 4 EASI case
| Test group | Control group | |
| Before treatment | 0.48±0.16 | 0.47±0.24 |
| Mean 7 days post treatment | 0.30±0.22 | 0.23±0.19 |
| 7 days after treatment decline rate | 34.76％ | 56.91％ |
| Mean 14 days after treatment | 0.12±0.21 | 0.16±0.17 |
| 14 days after treatment decline rate | 80.28％ | 77.85％ |
On the 7 th day and the 14 th day after the test group is added with the medical skin repairing paste for assisting in treating the facial dermatitis diseases, the EASI mean value is reduced compared with that before treatment (the mean P is less than 0.0001); the EASI mean value before treatment is 0.48 +/-0.16, and the EASI mean values at 7 days and 14 days after treatment are respectively reduced to 0.30 +/-0.22 and 0.12 +/-0.21. The mean rate of decline of EASI at the end of treatment (day 14) was 80.28%; the EASI mean value of the control group before treatment is 0.47 +/-0.24, and the EASI mean values are reduced (the mean P is less than 0.0001) on the 7 th day and the 14 th day after treatment; the EASI mean value before treatment is 0.47 + -0.24, and the EASI mean values at 7 days and 14 days after treatment are respectively reduced to 0.23 + -0.19 and 0.16 + -0.17. The mean rate of decline of EASI at the end of treatment (day 14) was 77.85%.
2.2.2 degree of VAS value improvement compared to baseline after treatment
TABLE 5 VAS Scoring
| Test group | Control group | |
| Before treatment | 5.27±1.95 | 5.15±2.26 |
| Mean 7 days after treatment | 4.52±2.16 | 2.35±2.03 |
| 7 days after treatment decline rate | 29.95％ | 57.38％ |
| Mean 14 days after treatment | 0.79±1.14 | 1.16±1.57 |
| 14 days after treatment decline rate | 87.17％ | 76.28％ |
The VAS itching self-evaluation average value of the test group on the 7 th day and the 14 th day after the medical skin repairing patch is added for assisting in treating the facial dermatitis diseases is obviously reduced (P is less than 0.05) compared with that before treatment; the VAS mean value before treatment is 5.27 +/-1.95, and the VAS mean values at 7 days and 14 days after treatment are respectively reduced to 4.52 +/-2.16 and 0.79 +/-1.14. The mean reduction in VAS at the end of treatment (day 14) was 87.17%; the VAS mean value of the control group before treatment is 5.15 +/-2.26, and the VAS mean values of the control group at 7 days and 14 days after treatment are respectively reduced to 2.35 +/-2.03 and 1.16 +/-1.57. The mean rate of VAS decline at the end of treatment (day 14) was 76.28%.
During the study, all subjects showed no adverse reactions, confirming their clinically good safety.
The invention adopts a multi-center and open control test design, takes the EASI score and the VAS score of the face as main evaluation indexes, and observes the safety, the applicability and the effectiveness of the auxiliary treatment of dermatitis diseases of the medical skin repair patch. The results show that: on the 7 th day and the 14 th day of treatment, the EASI mean value and the VAS mean value are obviously reduced compared with the baseline, the EASI mean reduction rate is 80.28 percent, the VAS mean reduction rate is 87.17 percent and the total effective rate is 98.33 percent at the end of treatment (the 14 th day).
In a word, the test results show that the medical skin repair patch for the auxiliary treatment of the facial dermatitis diseases has good clinical safety, has auxiliary treatment effects on various types of facial dermatitis, has universality and definite curative effect, can be used as an auxiliary treatment means to greatly improve the skin discomfort symptoms of patients, avoids the irritation and sensitization of raw material components contained in the conventional dermatitis medicaments, and further improves the clinical curative effect.
In addition, in clinical tests, the longest use period of the conventional hormonal dermatitis drugs is 14 days, so the clinical test is only carried out for 14 days. However, all the raw materials of the medical skin repairing paste provided by the invention are food safety grade, the paste can be used for a long time, the treatment effect after long-term use is more obvious, and the dependence of patients on conventional hormone medicines is avoided, so that the repeated attack of the disease condition is further avoided. In addition, children, pregnant women or lactating women can also be used by the applicable people.
The medical skin repairing patch provided by the invention can also be independently used for treating dermatitis, and can achieve the effect of healing after being used for a long time.
It should be understood that the above examples are only for clarity of illustration and are not intended to limit the embodiments. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. This need not be, nor should it be exhaustive of all embodiments. And obvious variations or modifications of the invention may be made without departing from the spirit or scope of the invention.
Claims (5)
1. The application of the medical skin repairing paste in the separate preparation of the medicine for treating dermatitis is characterized in that the medical skin repairing paste comprises the following raw materials in percentage by mass:
0.1 to 0.3 percent of carboxymethyl chitosan;
1-3% of trehalose;
8-12% of glycerol;
85-90% of water.
2. The application of the medical skin repairing patch in the separate preparation of the medicine for treating dermatitis as claimed in claim 1, wherein the medical skin repairing patch comprises the following raw materials in percentage by mass:
0.2 percent of carboxymethyl chitosan;
2% of trehalose;
10% of glycerol;
and (5) 87.8 percent of water.
3. The use of the medical skin patch according to claim 1 or 2 in the separate preparation of a medicament for treating dermatitis, wherein the medical skin patch is a facial mask.
4. The application of the medical skin patch in the separate preparation of the dermatitis treatment drug according to claim 3, wherein the facial mask agent takes a biological cellulose membrane or a non-woven fabric as a base material.
5. The application of the medical skin repairing patch in the separate preparation of the dermatitis treatment drug according to claim 4, wherein the preparation method of the mask agent comprises the following steps:
and weighing the raw materials of the medical skin repairing plaster in proportion, uniformly mixing, and flatly paving the mixture on the surface of the base material to obtain the mask agent.
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