CN106924443B - External oil for treating senile cutaneous pruritus and preparation method thereof - Google Patents

Abstract

The invention relates to an external oil composition for treating senile skin pruritus and a preparation method thereof. The external oil is mainly prepared from 1-35 parts by weight of agilawood essential oil, 1-25 parts by weight of cassia leaf essential oil, 1-20 parts by weight of peony seed oil, 1-20 parts by weight of walnut oil, 1-20 parts by weight of coriander seed oil, 1-15 parts by weight of hemp seed oil, 1-15 parts by weight of white sesame oil, 1-10 parts by weight of pine needle essential oil, 1-10 parts by weight of cactus seed oil, 1-10 parts by weight of frangipani essential oil, 1-10 parts by weight of citric oil and 0.5-10 parts by weight of mint oil. Clinical experiments prove that the product has the total effective rate of 97%, the cure rate of 74.7%, the recurrence rate of 2.8%, no side effect, obvious curative effect of treating senile cutaneous pruritus, less side effect, low recurrence rate, short treatment course, convenient administration, low cost, simple preparation method and the like.

Description

External oil for treating senile cutaneous pruritus and preparation method thereof

Technical Field

The invention relates to an external oil composition for treating senile skin pruritus and a preparation method thereof.

Background

Senile pruritus is a common skin disease of old people, which is mostly seen above 60 years old, and more men than women have pruritus symptoms in clinical manifestation without primary skin damage. The senile pruritus has a lingering course and is difficult to heal, the old pruritus is often itching and cannot be tolerated, an effective treatment means is lacked, the physical and mental health of the old patients is seriously affected, the life quality of the old patients is reduced, most of the old patients are accompanied by depression, anxiety, dysphoria or unstable mood, and the itching feeling is aggravated by the bad mood. Alcohol consumption, mood changes, cold and hot stimuli, and even certain cues can induce or exacerbate itching. According to statistics, senile pruritus is the most common pruritus disease of the elderly, and the incidence rate is about 40.7%. With the trend of aging of the population in China, the senile pruritus causes more and more attention of people, and the treatment of the senile pruritus is a serious challenge for the clinical doctors in China, particularly dermatologists.

The pathogenesis of the senile pruritus is complex and is not completely clear at present. The etiology of the disease comprises physiological factors and pathological factors, wherein the physiological factors mainly comprise degenerative change of the skin structure and function of the old people, change of the skin immune function and change of the endocrine level; pathological factors are related to systemic diseases such as diabetes, habitual constipation, thyroid disorders and neurasthenia. Belongs to the categories of wind itch, wind itch and the like in the traditional Chinese medicine. According to the traditional Chinese medicine, the causes of the disease can be divided into internal causes and external causes, the internal causes are mostly related to qi and blood of viscera, and the external causes are usually related to wind, dampness, heat and insects. For the treatment of senile pruritus, an effective treatment method is not available at present. In clinical treatment, most of patients with senile pruritus are usually treated locally by taking antihistamine, glucocorticoid, endogenous marijuana and the like as main medicines, and for stubborn patients, the patients are usually required to be treated systemically by taking antihistamine, immunosuppressant, antidepressant and the like. Although western medicine treatment takes effect quickly, it is easy to recur, and it is easy to be tolerated and side effects are easy to occur if it is used for a long time, thus limiting its clinical application.

Disclosure of Invention

In order to overcome the defects, the invention provides the external oil for treating the senile pruritus.

The external oil is mainly prepared from the following raw materials in parts by weight: 1-35 parts of agilawood essential oil, 1-25 parts of cassia leaf essential oil, 1-20 parts of peony seed oil, 1-20 parts of walnut oil, 1-20 parts of coriander seed oil, 1-15 parts of hemp seed oil, 1-15 parts of white sesame oil, 1-10 parts of pine needle essential oil, 1-10 parts of cactus seed oil, 1-10 parts of frangipani essential oil, 1-10 parts of citric oil and 0.5-10 parts of mint oil.

The preferable formula is as follows: 5-20 parts of agilawood essential oil, 5-15 parts of cassia leaf essential oil, 10-20 parts of peony seed oil, 10-15 parts of walnut oil, 10-20 parts of coriander seed oil, 5-10 parts of hemp seed oil, 7.5-10 parts of white sesame oil, 5-8 parts of pine needle essential oil, 5-8 parts of cactus seed oil, 2.5-4 parts of frangipani essential oil, 2-4 parts of citric oil and 0.5-2.5 parts of mint oil.

The optimal formula is as follows: 20 parts of agilawood essential oil, 15 parts of cassia leaf essential oil, 10 parts of peony seed oil, 10 parts of walnut oil, 10 parts of coriander seed oil, 10 parts of hemp seed oil, 7.5 parts of white sesame oil, 5 parts of pine needle essential oil, 5 parts of cactus seed oil, 5 parts of frangipani essential oil, 2 parts of citric oil and 0.5 part of mint oil.

The external oil can also comprise a proper amount of auxiliary material base oil. The auxiliary material base oil is preferably camellia seed oil.

The preparation method of the external oil comprises the following steps:

(1) mixing the raw materials according to a ratio, and uniformly stirring to obtain mixture oil;

(2) and (2) adding 10-60 parts of an appropriate amount of auxiliary material base oil into the mixture oil obtained in the step (1), homogenizing at 35-42 ℃ for 30-60 minutes, and subpackaging.

The invention is based on the understanding and the treatment rules of the traditional Chinese medicine and the modern medicine on the senile pruritus, utilizes the characteristics of quick response and strong permeability of the traditional Chinese medicine or the natural plant oil, adopts twelve kinds of essential oil of the traditional Chinese medicine or the natural plant, and is prepared according to the formula of the traditional Chinese medicine theory and the modern medicine theory and a certain proportion. Clinical experiments prove that: the total effective rate is 97%, the cure rate is 74.7%, the recurrence rate is 2.8%, and no side effect is caused. The external oil has the advantages of obvious curative effect on senile pruritus, less side effect, low recurrence rate, short treatment course, convenient administration, low cost, simple preparation method and the like.

Detailed Description

The present invention will be further described with reference to the following specific examples.

Firstly, preparation of experimental sample

Sample one recipe: 20 parts of agilawood essential oil, 15 parts of cassia leaf essential oil, 10 parts of peony seed oil, 10 parts of walnut oil, 10 parts of coriander seed oil, 10 parts of hemp seed oil, 7.5 parts of white sesame oil, 5 parts of pine needle essential oil, 5 parts of cactus seed oil, 5 parts of frangipani essential oil, 2 parts of citric oil and 0.5 part of mint oil.

(II) sample II formula: 15 parts of agilawood essential oil, 10 parts of cassia leaf essential oil, 15 parts of peony seed oil, 15 parts of walnut oil, 12 parts of coriander seed oil, 8 parts of hemp seed oil, 8 parts of white sesame oil, 5 parts of pine needle essential oil, 5 parts of cactus seed oil, 2.5 parts of frangipani essential oil, 2 parts of citric oil and 2.5 parts of mint oil.

(III) sample III formula: 5 parts of agilawood essential oil, 5 parts of cassia leaf essential oil, 20 parts of peony seed oil, 10 parts of walnut oil, 20 parts of coriander seed oil, 5 parts of hemp seed oil, 10 parts of white sesame oil, 8 parts of pine needle essential oil, 8 parts of cactus seed oil, 4 parts of frangipani essential oil, 4 parts of citric oil and 1 part of mint oil.

(IV) sample four recipe: 35 parts of agilawood essential oil, 25 parts of cassia leaf essential oil, 1 part of peony seed oil, 1 part of walnut oil, 1 part of coriander seed oil, 15 parts of hemp seed oil, 15 parts of white sesame oil, 1 part of pine needle essential oil, 1 part of cactus seed oil, 10 parts of frangipani essential oil, 10 parts of citric oil and 10 parts of mint oil.

The preparation method comprises the following steps: mixing the raw materials according to the formula, uniformly stirring to obtain a vegetable oil mixture, adding 10-60 parts of medicinal camellia seed oil, homogenizing at 35-42 ℃ for 30-60 minutes, and subpackaging for external use.

(VI) the sources of the components of the formula are as follows:

the lignum Aquilariae Resinatum essential oil is extracted from resin-containing wood of Aquilaria sinensis (L our.) of Aquilaria sinensis of Thymelaeaceae, and is prepared by selecting lignum Aquilariae Resinatum, cleaning, sun drying, pulverizing, and extracting with supercritical carbon dioxide extraction device.

Sweet Osmanthus essential oil is extracted from leaves of L output of Osmanthus fragrans (Thunb.) of Oleaceae, and is prepared by selecting sweet Osmanthus, cleaning, sun drying, and extracting with supercritical carbon dioxide extraction device to obtain sweet Osmanthus essential oil.

And (3) peony seed oil: is oil extracted from seeds of Paeonia suffruticosa Andr of Ranunculaceae. The preparation method comprises the following steps: selecting peony seeds, drying in the sun, and extracting by using a supercritical carbon dioxide extraction complete device to obtain peony seed oil.

The walnut oil is extracted from dried mature kernel of Juglans regia L of Juglandaceae, and is prepared by selecting walnut kernel, sun drying, and extracting with supercritical carbon dioxide extraction equipment.

The coriander seed oil is oil extracted from mature seed of coriander coriandem sativum L of Coriandrum of Umbelliferae, and is prepared by selecting coriander seed, sun drying, and extracting with supercritical carbon dioxide extraction complete equipment to obtain coriander seed oil.

The fructus Cannabis oil is extracted from dried mature fruit of Cannabis sativa L of Moraceae, and is prepared by selecting fructus Cannabis, sun drying, and extracting with supercritical carbon dioxide extraction complete equipment to obtain fructus Cannabis oil.

The white sesame oil is oil extracted from seeds of Sesamum indicum L belonging to Sesamum of Pedaliaceae, and its preparation method comprises selecting white sesame, sun drying, and extracting with supercritical carbon dioxide extraction equipment to obtain white sesame oil.

The pine needle essential oil is extracted from needle leaves of Pinus armandi Franch, Pinus pinaster Hayata, Pinus massoniana L amb, Pinus thunbergii, Pinus tabularis Carri re, Pinus yunnanensis, Pinus koraiensis Sieb.

The semen Opuntiae Dillenii seed oil is extracted from seed of Opuntia strictica (Haw.) Haw.var.dillenii (Ker-Gawl.) Benso of Opuntia of Cactaceae. The preparation method comprises the following steps: selecting cactus seeds, drying in the sun, and extracting by using a complete set of supercritical carbon dioxide extraction device to obtain the cactus seed oil.

The flos Plumeriae Acutifoliae essential oil is extracted from flos Plumeria rubra L of Apocynaceae, and is prepared by selecting flos Plumeriae Acutifoliae, cleaning, sun drying, and extracting with supercritical carbon dioxide extraction device to obtain flos Plumeriae Acutifoliae essential oil.

The lemon oil is extracted from fresh whole fruit or pericarp of Citrus limon (L.) Burm of Rutaceae, and is prepared by extracting fresh whole fruit or pericarp of Citrus limon with supercritical carbon dioxide.

Peppermint oil is volatile oil extracted from fresh stem and leaf of Mentha haplocalyx Briq. of Labiatae by steam distillation, freezing, and partial delectation.

Second, clinical efficacy test

General data

The invention treats 75 patients with senile pruritus. The youngest is 60 years, the biggest is 85 years, and the average age is 71.5 years; the shortest disease course is half a year, and the longest disease course is 24 years. Among them, 5 cases within 1 year of the disease course, 25 cases within 1 to 5 years, and 45 cases above 5 years.

(II) case selection

1. Diagnostic criteria: the western medicine diagnosis standard is drawn according to the relevant standard in clinical dermatology, the systemic skin itch is severe, primary skin damage does not exist, and the skin can generate scratch marks, blood crusts, pigmentation and other secondary damage after repeated scratching due to itch; it is common in autumn and winter and common in the elderly. The traditional Chinese medicine diagnosis standard is drawn up according to the diagnosis standard related to 'wind itch' in 'new-compiled Chinese medicine dermatology', and only itch but no primary rash appears after onset; severe itching, often paroxysmal, especially at night; repeated and frequent scratching can result in secondary scratches, blood crusts, pigmentation, pachylosis, lichenification and other rashes.

2. And (3) inclusion standard: the patients who meet the above-mentioned diagnostic standards of Western medicine and traditional Chinese medicine are 60-85 years old.

3. Exclusion criteria: those who do not meet the criteria of Western and Chinese medicine diagnosis of senile pruritus; skin pruritus caused by severe internal diseases such as severe heart, kidney, liver disease, diabetes, autoimmune disease, etc.; other skin diseases such as neurodermatitis and eczema; the corticosteroid hormone is taken within 1 month before treatment, and any antihistamine is taken within 1 week; the treatment method and the drug are optionally stopped or replaced during the treatment period.

(III) methods of treatment

The external oil is directly applied to the skin itch part, the oil is permeated to the epidermis and the subcutaneous tissue of the skin in a massage mode, 1 time is respectively carried out in the morning and at the evening of each day, 4 weeks are 1 treatment course, the rest is carried out for 1 day in the treatment course, and the treatment effect evaluation is carried out after 2 treatment courses are continuously carried out.

(IV) therapeutic efficacy judgment criteria

1. The observation indexes of the curative effect are as follows:

a4-grade scoring method is adopted to evaluate symptoms and signs, ① pruritus is rated 0 when no pruritus occurs, patients with mild pruritus can tolerate the itching without influencing daily life and rated 3 when moderate pruritus can tolerate the itching and sometimes influence the daily life and rated 6 when the severe pruritus can be rated 6, patients with severe pruritus cannot tolerate the itching by self and obviously influence the daily life and rated 9, ② scratches and scabs are rated 0 when no scratches and scabs occur, a small number of scratches and scabs are rated 1 when the scratches and scabs are distributed on multiple places, scratches and scabs are distributed on multiple places and rated 2 when the scratches and scabs are distributed on the whole body, ③ skin dryness degree is rated 0 when no scales and no dryness, mild dryness is rated 1 when the skin is scratched with few scales, the skin is relatively dry and has tight feeling, the scales are graded 2 when the scales are flaky, the skin is very dry and has severe pain and even chapped, the score is 3 when the scales are obviously removed, ④ skin is rated 3 when the scale score is not rated 0 when the skin is changed, the scales are relatively thick, the scale is not graded and rated 1 when the scale is changed, and the scale is changed, the score is increased, and the score is rated 18 when the scale is treated before the scale is increased, and the score is rated 3 when the scale score is increased.

2. Criteria for evaluating therapeutic effects

The medicine is made according to the clinical research guiding principle and curative effect judgment standard of new traditional Chinese medicine for treating the wind pruritus and related documents. And (3) healing: the systemic pruritus symptom is completely disappeared, the skin lesions such as secondary dryness, desquamation, lichen varietality, blood crust and the like are subsided, and the integral reduction index of the symptom is more than or equal to 90 percent; the effect is shown: the subjective systemic pruritus is obviously relieved, most of skin lesions such as secondary dryness, desquamation, moss-like change, blood crusts and the like are obviously relieved, and the integral reduction index of symptoms is more than or equal to 70 percent but less than 90 percent; the method has the following advantages: the subjective itching symptom is relieved, the local secondary skin damage is improved, and the integral reduction index of the symptom is more than or equal to 30 percent but less than 70 percent; and (4) invalidation: the subjective itching is not obviously improved, the local secondary skin damage is not changed, and the integral reduction index of the symptom is less than 30 percent.

(V) adverse reactions and prognosis

Clinical adverse reactions of patients during treatment were recorded. And follow-up 1 year after treatment and telephone visit to observe patient prognosis.

(VI) therapeutic results

1. Treatment outcome of sample one

After 75 patients with senile pruritus are treated by applying the external oil composition sample according to the treatment method for 2 treatment courses, the pruritus symptoms and secondary skin damage symptoms such as dryness, desquamation, lichenification, scratch, blood crust and the like of 72 patients are obviously relieved. Wherein, 56 cases of cure (the cure rate is 74.7%), 10 cases of significant effect (the significant efficiency is 13.3%), 6 cases of effective case (the effective rate is 8%), 3 cases of ineffective case (the ineffective rate is 4%) and the total effective rate is 97%. The integral of pruritus and symptom skin lesion before and after treatment is reduced from 15.83 +/-1.01 before treatment to 0.91 +/-0.22 (the P is less than 0.01 through statistics, and the difference is significant). After 1 year of treatment in 2 courses, 2 recovery cases recur, 1 effective case has pruritus symptom and secondary skin lesion symptoms such as dryness, desquamation, lichenification, scratch, blood crust and the like aggravation, the recurrence rate is 2.8%, but the pruritus symptom after recurrence and the secondary skin lesion symptoms such as dryness, desquamation, lichenification, scratch, blood crust and the like are obviously relieved compared with the degree before treatment, and the symptom after continuous medication can be quickly relieved or disappeared. In addition, patients did not experience the clinical adverse effects associated with the present invention throughout the treatment.

Attached: typical cases

Liza, male, 77 years old. The treatment of the invention is applied between 10 and 15 days 2015 and 12 and 15 days 2015.

The main complaints are: the skin of the trunk and the limbs is repeatedly itched for more than 5 years. Itching worsens when exposed to heat or bathing with hot water in winter and at night, and seriously affects sleep and mental status. The senile pruritus is diagnosed in hospitals for a plurality of times in 2010, and wind-dispelling and itching-relieving traditional Chinese medicines, levocetirizine hydrochloride tablets and the like are taken once, so that the pruritus is slightly relieved after the taking of the traditional Chinese medicines, but the pruritus is repeated after about one week. Patients also use external preparations such as calamine lotion, corticosteroid ointment and the like, which are effective initially, but after one or two weeks, the curative effect is remarkably reduced or even ineffective.

Physical examination: the skin of trunk and limbs of the patient has no primary skin damage, but has obvious scratch, blood crust and local rough and thickened skin. The system check and the auxiliary check have no obvious exception.

And (3) diagnosis: the western medicine diagnoses senile pruritus; the Chinese medicine diagnoses the pruritus due to wind.

Treatment: the external oil is directly applied to the skin itch part, the oil is permeated to the epidermis and the subcutaneous tissue of the skin in a massage mode, 1 time is respectively carried out in the morning and at the evening of each day, 4 weeks are 1 treatment course, the rest is carried out for 1 day in the treatment course, and the treatment effect evaluation is carried out after 2 treatment courses are continuously carried out.

As a result: after 3 days of treatment, the pruritus is obviously relieved; after 2 weeks of treatment, scratch and blood crust partially subsided; after 1 treatment course, secondary skin lesion symptoms such as dryness, desquamation, lichen varietation, scratch, blood crust and the like are basically eliminated, systemic pruritus is basically eliminated, and sleeping and mental conditions are obviously improved; after 2 treatment courses, secondary skin lesion symptoms such as dryness, desquamation, lichen varietation, scratch, blood crust and the like are completely removed, systemic pruritus is completely eliminated, and sleeping and mental conditions are restored to normal. No recurrence is seen in half a year of follow-up; after 1 year of follow-up, when the weather is hot and dry, the local skin has slight pruritus for 1 time, and the symptoms completely disappear after the medicine is continuously applied for 2 days.

2. Treatment results for sample two

After 65 patients with senile pruritus are treated by the external oil composition sample two according to the treatment method for 2 courses, the pruritus symptoms and secondary skin damage symptoms such as dryness, desquamation, lichenification, scratch, blood crust and the like of 60 patients are obviously relieved. Wherein, 47 cases of cure (the cure rate is 72.31%), 8 cases of significant effect (the significant efficiency is 12.31%), 5 cases of effective case (the effective rate is 7.69%), 5 cases of ineffective case (the ineffective rate is 7.69%) and the total effective rate is 92.31%. The integral of pruritus and symptom skin lesion before and after treatment is reduced from 16.34 +/-2.32 before treatment to 1.52 +/-0.35 (the P is less than 0.01 through statistics, and the difference is significant). After 1 year of treatment for 2 courses, 3 cases recur, the recurrence rate is 4.2%, but the degree of pruritus symptom after recurrence and secondary skin lesion symptoms such as dryness, desquamation, lichenification, scratch, blood crust and the like is obviously reduced compared with the degree before treatment, and the symptom after continuous administration can be quickly relieved or disappeared. In addition, patients did not experience the clinical adverse effects associated with the present invention throughout the treatment.

3. Treatment results for sample three

After 82 patients with senile pruritus are treated by three external oil composition samples according to the treatment method for 2 courses, the pruritus symptoms and secondary skin damage symptoms such as dryness, desquamation, lichenification, scratch, blood crust and the like of 72 patients are obviously relieved. Wherein, 55 cases of cure (the cure rate is 67.07%), 12 cases of significant effect (the significant efficiency is 14.63%), 5 cases of effective case (the effective rate is 4.87%), 5 cases of ineffective case (the ineffective rate is 7.69%) and the total effective rate is 87.80%. The integral of pruritus and symptom skin lesion before and after treatment is reduced from 14.98 +/-1.52 before treatment to 2.91 +/-0.32 (the P is less than 0.01 through statistics, and the difference is significant). After 1 year of treatment for 2 courses, 6 cases recur, the recurrence rate is 8.33%, but the degree of pruritus symptom after recurrence and secondary skin lesion symptoms such as dryness, desquamation, lichenification, scratch, blood crust and the like is obviously reduced compared with the degree before treatment, and the symptom can be quickly relieved or disappeared after continuous medication. In addition, patients did not experience the clinical adverse effects associated with the present invention throughout the treatment.

4. Treatment results for sample four

After 34 patients with senile pruritus are treated by four external oil composition samples according to the treatment method for 2 courses, the pruritus symptoms and secondary skin damage symptoms such as dryness, desquamation, lichenification, scratch, blood crust and the like of 28 patients are obviously relieved. Wherein, 20 cases of cure (the cure rate is 58.82%), 2 cases of significant effect (the significant efficiency is 5.9%), 6 cases of effective case (the effective rate is 17.64%), 6 cases of ineffective case (the ineffective rate is 17.64%) and the total effective rate is 82.36%. The integral of pruritus and symptom skin lesion before and after treatment is reduced from 14.33 +/-1.52 before treatment to 3.51 +/-0.86 (by statistics, P is less than 0.01, and the difference is significant). After 1 year of treatment for 2 courses, 4 cases recur, the recurrence rate is 14.28%, but the degree of pruritus symptom after recurrence and secondary skin lesion symptoms such as dryness, desquamation, lichenification, scratch, blood crust and the like is obviously reduced compared with the degree before treatment, and the symptom after continuous administration can be quickly relieved or disappeared. In addition, patients did not experience the clinical adverse effects associated with the present invention throughout the treatment.

Claims (6)

1. The external oil for treating senile skin pruritus is characterized by mainly being prepared from the following raw materials in parts by weight: 1-35 parts of agilawood essential oil, 1-25 parts of cassia leaf essential oil, 1-20 parts of peony seed oil, 1-20 parts of walnut oil, 1-20 parts of coriander seed oil, 1-15 parts of hemp seed oil, 1-15 parts of white sesame oil, 1-10 parts of pine needle essential oil, 1-10 parts of cactus seed oil, 1-10 parts of frangipani essential oil, 1-10 parts of citric oil and 0.5-10 parts of mint oil.

2. The external oil according to claim 1, which is mainly prepared from the following raw materials in parts by weight: 5-20 parts of agilawood essential oil, 5-15 parts of cassia leaf essential oil, 10-20 parts of peony seed oil, 10-15 parts of walnut oil, 10-20 parts of coriander seed oil, 5-10 parts of hemp seed oil, 7.5-10 parts of white sesame oil, 5-8 parts of pine needle essential oil, 5-8 parts of cactus seed oil, 2.5-4 parts of frangipani essential oil, 2-4 parts of citric oil and 0.5-2.5 parts of mint oil.

3. The external oil according to claim 1, which is mainly prepared from the following raw materials in parts by weight: 20 parts of agilawood essential oil, 15 parts of cassia leaf essential oil, 10 parts of peony seed oil, 10 parts of walnut oil, 10 parts of coriander seed oil, 10 parts of hemp seed oil, 7.5 parts of white sesame oil, 5 parts of pine needle essential oil, 5 parts of cactus seed oil, 5 parts of frangipani essential oil, 2 parts of citric oil and 0.5 part of mint oil.

4. The external oil according to any one of claims 1 to 3, wherein: the external oil also comprises a proper amount of auxiliary material base oil.

5. The topical oil according to claim 4, characterized in that: the auxiliary material base oil is camellia seed oil.

6. The method for producing external oil according to claim 1, characterized by comprising the steps of:

(1) mixing the raw materials according to a ratio, and uniformly stirring to obtain mixture oil;

(2) and (2) adding 10-60 parts of medicinal camellia seed oil into the mixture oil obtained in the step (1), homogenizing at 35-42 ℃ for 30-60 minutes, and subpackaging.