CN107617010B - External traditional Chinese medicine composition for treating skin rash as well as preparation method and application thereof - Google Patents
External traditional Chinese medicine composition for treating skin rash as well as preparation method and application thereof Download PDFInfo
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Abstract
The invention provides a traditional Chinese medicine composition for treating skin rash by external use, which comprises the following raw material medicines: 10-50 parts of scutellaria baicalensis, 10-60 parts of purslane, 10-60 parts of dittany bark, 10-50 parts of radix sophorae flavescentis and 10-60 parts of dandelion. The traditional Chinese medicine composition has obvious effect on improving the EGFRis-related acneiform skin rash and the itching degree, and has no obvious adverse reaction.
Description
Technical Field
The invention relates to a traditional Chinese medicine composition, a preparation method and application thereof, in particular to a traditional Chinese medicine composition for treating skin rash by external application, a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicines.
Background
In recent years, the clinical application of tumor targeted therapy is increasing year by year, and the therapeutic effect is increasing day by day, which will become a promising tumor therapy mode in the 21 st century. Currently, the most widely used drugs in clinical applications are epidermal growth factor receptor (epidermal growth factor receptor) antagonists, which are favored by doctors and patients due to their outstanding clinical effects. However, adverse reactions are diverse and rashes (mainly manifested as acne/acneiform rashes) are among the most common. Acne/acneiform skin rash not only affects the quality of life of patients, but also may cause treatment failure and seriously affect the treatment effect of tumors. Acne/acneiform skin rash has limited the use of egfr is class drugs to some extent. Western medicine usually adopts antibiotics, external hormones and other methods for treatment, and the effect is not obvious.
Since the work of the inventor, the inventor has engaged in the clinical work of diagnosis and treatment of tumors by combining traditional Chinese medicine and western medicine, and has made many researches on the treatment of EGFRis-related adverse skin reactions in the process of tumor targeted treatment; in the aspect of treating EGFRis-related skin adverse reactions by traditional Chinese medicines, an inventor publishes a traditional Chinese medicine prescription 'antipruritic skin smoothing liquid' in 2012 to treat 20 cases of skin rash related to epidermal growth factor receptor antagonist, and observes [ J ]. published by Zhongri friendly Hospital, 2012,26(02):97-98+102, wherein the traditional Chinese medicine prescription 'antipruritic skin smoothing liquid' is scutellaria baicalensis, sophora flavescens, dittany bark, purslane and the like; 120 clinical studies on treating epidermal growth factor receptor antagonist-related skin rash by using external heat-clearing and dampness-removing traditional Chinese medicines are published in 2013, the university of Beijing Chinese medicine is reported (clinical version of traditional Chinese medicine), 2013,20(04) is 14-17, wherein the external heat-clearing and dampness-removing traditional Chinese medicines comprise: scutellaria, purslane, sophora flavescens, dittany bark and the like; in 2015, a Chinese patent CN105079186A was filed, and a Chinese medicinal composition comprising radix Scutellariae, herba Portulacae, cortex Dictamni, radix Sophorae Flavescentis, herba Taraxaci, radix Paeoniae Rubra, and herba Menthae is provided for treating EGFRIS-related skin rash; in 2016, the meta-analysis of the rash related to the Chinese herbal medicine intervening epidermal growth factor receptor inhibitor was published, and the study showed that: the traditional Chinese medicine intervention can obviously relieve the rash related to EGFRis, obviously relieve the clinical symptoms of the traditional Chinese medicine, improve the life quality of patients and does not influence the anti-tumor effect of EGFRis; the inventor always researches the treatment effect of the traditional Chinese medicine composition on the relevant rash for many years, and continuously improves the traditional Chinese medicine formula and the preparation method so as to prepare the traditional Chinese medicine composition with simple formula, convenient preparation and good curative effect; aiming at the problems of single function, complex components, general drug effect and the like in the existing scheme, the invention provides a multifunctional traditional Chinese medicine composition for treating rash grading, skin pruritus, dry skin and the like, which has the advantages of simple formula, convenient preparation and good curative effect.
Disclosure of Invention
The invention aims to provide a traditional Chinese medicine composition for treating rash by external application;
the other purpose of the invention is to provide a preparation method of the traditional Chinese medicine composition;
the third purpose of the invention is to provide the application of the traditional Chinese medicine composition in preparing externally applied medicines for treating the rash.
The fourth purpose of the invention is to provide the application of the traditional Chinese medicine composition in preparing a medicine for treating the EGFRis-related rash by external application.
The purpose of the invention is realized by the following technical scheme:
a traditional Chinese medicine composition for external use for treating skin rash comprises the following raw medicines: scutellariae radix, herba Portulacae, cortex Dictamni Radicis, radix Sophorae Flavescentis and herba Taraxaci;
wherein, the content of baicalin in the scutellaria baicalensis is 0.2-4.5%, the content of total flavonoids in the purslane is 0.5-2.5%, the content of total flavonoids in the dittany bark is 0.1-2.5%, the content of matrine in the sophora flavescens is 1-10%, and the content of total flavonoids in the dandelion is 0.1-2.2%.
Further, the content ratio of baicalin in scutellaria baicalensis, total flavonoids in purslane, total flavonoids in dittany bark, matrine in sophora flavescens and total flavonoids in dandelion in the raw material medicaments of the traditional Chinese medicine composition is as follows: 2:1.5:2:2:1.9.
The production area and harvesting season of the raw material medicine can influence the content of active ingredients in the medicinal materials, the traditional Chinese medicine composition is a complex system formed by multiple ingredients and multiple factors, and no sound evaluation method and standard exist at present, but through a large number of experimental researches, when the content of baicalin in the scutellaria baicalensis is 0.2-4.5%, the content of total flavone in the purslane is 0.5-2.5%, the content of total flavone in the cortex dictamni is 0.1-2.5%, the content of matrine in the sophora flavescens is 1-10%, the content of total flavone in the dandelion is 0.1-2.2%, and the content ratios of the baicalin in the scutellaria baicalensis, the total flavone in the purslane, the total flavone in the cortex dictamni, the matrine in the sophora flavescens and the total flavone in the dandelion are as follows: the traditional Chinese medicine composition has better effect when the ratio is 2:1.5:2:2: 1.9.
Furthermore, the traditional Chinese medicine composition comprises the following raw medicines: 10-50 parts of scutellaria baicalensis, 10-60 parts of purslane, 10-60 parts of dittany bark, 10-50 parts of radix sophorae flavescentis and 10-60 parts of dandelion.
Furthermore, the traditional Chinese medicine composition comprises the following raw medicines: 20 parts of scutellaria baicalensis, 30 parts of purslane, 30 parts of dittany bark, 20 parts of radix sophorae flavescentis and 30 parts of dandelion;
or 25 parts of scutellaria baicalensis, 40 parts of purslane, 35 parts of dittany bark, 30 parts of radix sophorae flavescentis and 35 parts of dandelion;
or 30 parts of scutellaria baicalensis, 35 parts of purslane, 40 parts of dittany bark, 25 parts of radix sophorae flavescentis and 40 parts of dandelion.
The preparation method of the traditional Chinese medicine composition comprises the following steps:
the raw materials are taken according to a certain proportion, extracted by water or an organic solvent according to a conventional extraction method, and prepared into an external preparation according to a conventional preparation process.
The conventional extraction method comprises any one of reflux extraction, immersion extraction, ultrasonic extraction or percolation extraction, or the combination of different extraction methods; the organic solvent is one or more of methanol, 20-95% ethanol solution and acetone. The external preparation comprises patch, cataplasma, ointment, plaster, gel, liniment, lotion, plastics, etc.
According to one embodiment of the application, the preparation method comprises the following steps:
a) screening scutellaria baicalensis with the baicalin content of 0.2-4.5%, purslane with the total flavone content of 0.5-2.5%, radix sophorae flavescentis with the matrine content of 1-10%, dittany bark with the total flavone content of 0.1-2.5% and dandelion with the total flavone content of 0.1-2.2%, wherein the contents of the baicalin in the scutellaria baicalensis, the total flavone in the purslane, the total flavone in the dittany bark, the matrine in the sophora flavescens and the total flavone in the dandelion are in proportion as follows: weighing the raw material medicines at a ratio of 2:1.5:2:2:1.9, and removing impurities for later use;
b) pretreatment: steaming Scutellariae radix for half an hour, drying, and pulverizing; drying herba Portulacae, cortex Dictamni Radicis, radix Sophorae Flavescentis, and herba Taraxaci, and pulverizing;
c) mixing Scutellariae radix and radix Sophorae Flavescentis, heating and refluxing for 2 times, with the water amount of 6-8 times of the medicinal materials respectively, and extracting for 0.5-2 hr;
d) mixing herba Portulacae, cortex Dictamni Radicis and herba Taraxaci, adding 15-20 times of 70% ethanol, soaking at 60-70 deg.C for 4 hr, and reflux extracting for 1-2 hr;
e) mixing the filter residues obtained in the steps c) and d), and performing supercritical extraction;
f) mixing the above filtrates, concentrating to obtain extract with relative density of 1.0-1.2, adding adjuvants, and making into external preparation.
Further, the external preparation comprises a patch, a cataplasm, an ointment, a plaster, a gel, a liniment, a lotion and a film coating agent.
In the pretreatment process, the scutellaria baicalensis is steamed for half an hour, and the method is mainly used for directly and rapidly denaturing and killing the enzyme for decomposing the baicalin and protecting the baicalin from being damaged; the enzymes are not inactivated at room temperature and in the initial stage of cold water extraction, and can hydrolyze baicalin and reduce the content of active ingredients. Firstly, extracting scutellaria and sophora flavescens by adopting a water extraction method, wherein the middle part of filtrate is easily extracted, and in the invention, the active ingredients playing a main role in purslane, dittany bark and dandelion are total flavonoids, so that the three are mixed, and the easily extracted ingredients are firstly extracted by adopting an ethanol immersion method; then mixing the filter residues of the five medicinal materials, and further extracting active ingredients of the raw material medicaments by adopting supercritical extraction;
preferably, the entrainer of the supercritical extraction is absolute ethyl alcohol, the extraction pressure is 15-20MPa, the extraction temperature is 55-60 ℃, and the extraction time is 2-4 h.
The traditional Chinese medicine composition can be prepared by adding the extracts (effective parts) of the raw medicinal materials except the raw medicinal materials of scutellaria baicalensis, purslane, dittany bark, radix sophorae flavescentis and dandelion, so that the invention further discloses the traditional Chinese medicine composition for treating the rash by external application:
a traditional Chinese medicine composition for external use for treating skin rash is composed of the following raw material medicines: 10-50 parts of scutellaria baicalensis extract, 10-60 parts of purslane extract, 10-60 parts of dittany bark extract, 10-50 parts of sophora flavescens extract and 10-60 parts of dandelion extract.
The above crude drug extract can be water extract, organic solvent extract, or refined extract obtained by further refining and purifying water extract/organic solvent extract.
The organic solvent is selected from one or more of methanol, 20-95% ethanol solution and acetone;
the extraction method for preparing the extract comprises any one of reflux extraction, immersion extraction, ultrasonic extraction or percolation extraction, or the combination of different extraction methods.
According to one embodiment of the present application, the preparation method of the Chinese medicinal composition comprises the following steps:
a) screening out a plurality of weight parts of bulk drugs of scutellaria baicalensis, purslane, dittany bark, radix sophorae flavescentis and dandelion which accord with the record of 2015 Chinese pharmacopoeia, and removing impurities for later use;
b) pretreatment: drying Scutellariae radix, herba Portulacae, cortex Dictamni Radicis, radix Sophorae Flavescentis, and herba Taraxaci, and pulverizing;
c) extracting baicalin from the scutellaria baicalensis by adopting a water extraction and acid precipitation method, wherein the content of the baicalin in the scutellaria baicalensis extract is 75-85%; preferably, the water extraction is carried out by boiling water decoction;
d) extracting flavone from herba Portulacae with organic solvent under reflux, wherein the content of total flavone in herba Portulacae extract is 20-30%; preferably, the organic solvent is refluxed with 70% ethanol;
e) extracting flavone from cortex Dictamni Radicis under reflux with organic solvent, wherein the total flavone content in cortex Dictamni Radicis is 4.0-6.0%; preferably, 95% ethanol is adopted for reflux extraction;
f) extracting matrine from radix Sophorae Flavescentis by organic solvent impregnation and macroporous resin purification, wherein the content of matrine in radix Sophorae Flavescentis extract is 15-20%; preferably, methanol is adopted for immersion extraction; preferably, the macroporous resin is a polystyrene column;
g) extracting flavones from the dandelion by adopting organic solvent ultrasound and macroporous resin adsorption, wherein the content of total flavones in the dandelion extract is 60% -70%; preferably, ultrasonic extraction is performed by using acetone; preferably, the macroporous resin is a polyamide column;
h) mixing Scutellariae radix extract, herba Portulacae extract, cortex Dictamni Radicis extract, radix Sophorae Flavescentis extract and herba Taraxaci extract at a certain ratio, adding adjuvants, and making into external preparation;
preferably, the ratio of scutellaria baicalensis extract, purslane extract, dittany bark extract, sophora flavescens extract and dandelion extract is (1-2): (3-5): (5-12): (5-8): (1-3) the effect is best when mixed.
Because the components of the traditional Chinese medicine extract are not single and different extraction methods are adopted, the efficacy of the extract obtained by extracting the solvent is greatly different; the inventor finds that when the traditional Chinese medicine composition is prepared from traditional Chinese medicine extracts, the extraction methods of different extracts have obvious influence on the drug effect of the final composition, and finally determines that the best effect is achieved when the scutellaria baicalensis is extracted with water and the purslane, the dittany bark, the sophora flavescens and the dandelion are extracted with alcohol.
The invention also provides application of the traditional Chinese medicine composition in preparing a medicine for externally treating the rash and application in preparing a medicine for externally treating the rash related to EGFRis.
Clinical test research results show that the effective rates of the traditional Chinese medicine composition prepared by the conventional method, namely the scutellaria baicalensis, the purslane, the dittany bark, the radix sophorae flavescentis and the dandelion for treating skin rash grading, skin pruritus and skin dryness are respectively 90.1%, 57.9% and 57.9%; the effective rates of the traditional Chinese medicine composition prepared by the method for treating rash grading, skin pruritus and skin dryness are 97.2%, 77.8% and 63.3% respectively; the effective rates of the traditional Chinese medicine composition of scutellaria baicalensis extract, purslane extract, dittany bark extract, radix sophorae flavescentis extract and dandelion extract for treating rash grading, skin pruritus and skin dryness are respectively 90.0%, 63.3% and 70.0%; the control groups were 12.9%, 28.6%, 1.6%, respectively. The difference between the two groups compared with the classification of rash, skin itch and dry skin is statistically significant.
Drawings
FIG. 1 shows the change of rash in one week before and after administration
FIG. 1A shows before administration and FIG. 1B shows after administration
Detailed Description
The beneficial effects of the drug of the present invention are further illustrated by the following experimental examples.
Experimental example 1 clinical Effect of the composition of the present invention on EGFRis-related rashes
A total of 251 clinical observations were completed in 273 patients with egfr is enrolled from month 1 of 2013 to month 1 of 2016. All are patients who have confirmed diagnosis of malignant tumor in the department of oncology in Zhongri friendly Hospital, general Hospital oncology in Jiefang Hospital, department of oncology in Beijing thoracic Hospital, and Indocoration in Kogyang Hospital or in ward cases. Wherein, the experiment group of the Zhongri friendly hospital is 92 cases, and the contrast group is 35 cases; 54 cases of the general hospital experimental group of the liberation force and 18 cases of the control group; 51 experimental groups of Beijing thoracic hospital and 15 control groups of Beijing thoracic hospital; the yang-ward hospital was used in 6 cases, and the control group was used in 2 cases.
1. Diagnostic criteria:
patients with malignant tumors, which are clearly pathologically diagnosed, develop acneiform skin rash after EGFRIs administration.
2. Standard for grading acneiform rash
Severity of acneiform skin rash was assessed using MASCC grading criteria specifically used by the american cooperative skin toxicity management group for evaluation of egfr-related skin reactions, as shown in table 1:
TABLE 1MASCC Classification Standard
The interval between rashes is 2 points which are more than or equal to 2 cm.
3. Skin itch, dry skin grading applied NCI-CTCAE standard (version 3.0), see table 2. TABLE 2 EGFRis-related adverse skin reactions NCI-CTCAE Standard (version 3.0)
4. Group entry criteria
Firstly, there are malignant tumor patients with definite pathological diagnosis; ② people who are undergoing EGFRis treatment and have acne-like rash; or those exhibiting similar appearance to EGFR-related skin lesions when administered with other molecularly targeted drugs; ③ the functions of the heart, the liver and the kidney are not seriously hindered; fourthly, the age is 18 to 80 years; no intellectual and mental disorder, normal language expression ability; sixthly, understanding and receiving the treatment and signing an informed consent.
5. Exclusion criteria
(ii) those who have stopped treating EGFRis and other molecular targeted drugs. ② those without acne-like rash. ③ other types of skin reactions, such as dry skin, paronychia and onychoschisis. Fourthly, allergic constitution patients.
6. The treatment method comprises the following steps:
experimental groups:
experimental group 1 the formulation prepared according to the method of example 1 was applied for 7-14 consecutive days.
The using method comprises the following steps: face part: the preparation of example 1 was made into facial mask for 30 minutes each time, 2-3 times daily, and washed with clean water after completion.
Head rash: the preparation of example 1 was applied directly to the rash area for 30 minutes each time, 2-3 times daily, and then washed with clean water. Do not strongly clear the secretions.
Other parts: the preparation of example 1 was applied directly to the rash area for 30 minutes each time, 2-3 times daily, and then washed with clean water.
If the rash is extensive, the preparation can be added into bath water and soaked and washed for 30 minutes before sleep.
Experimental group 2 the formulation prepared according to the method of example 3 was applied for 7-14 consecutive days.
The using method comprises the following steps: face part: the preparation of example 3 was made into facial mask for 30 minutes each time, 2-3 times daily, and washed with clean water after completion.
Head rash: the preparation of example 3 was applied directly to the rash area, 30 minutes each time, 2-3 times daily, and washed with clean water after completion. Do not strongly clear the secretions.
Other parts: the preparation of example 3 was applied directly to the rash area, 30 minutes each time, 2-3 times daily, and washed with clean water after completion.
If the rash is extensive, the preparation can be added into bath water and soaked and washed for 30 minutes before sleep.
Experimental group 3 the formulation prepared according to the method of example 11 was applied for 7-14 consecutive days.
The using method comprises the following steps: face part: the preparation of example 11 was prepared into a mask, each time for 30 minutes, 2-3 times daily, and washed with clean water after completion.
Head rash: the preparation of example 11 was applied topically directly to the rash area for 30 minutes each time, 2-3 times daily, and washed with clear water after completion. Do not strongly clear the secretions.
Other parts: the preparation of example 11 was applied topically directly to the rash area for 30 minutes each time, 2-3 times daily, and washed with clear water after completion.
If the rash is extensive, the preparation can be added into bath water and soaked and washed for 30 minutes before sleep.
Control group: erythromycin cream for external use for mild rash, diphenhydramine cream for pruritus patients (provided by Zhongri friendly hospital preparation room); for moderate rash erythromycin cream was given for external use and milbemycin was given 100mg orally 2 times a day; the treatment of severe rash is the same as that of severe rash, for example, cefuroxime 250mg is orally taken 2 times per day when combined infection is given, and if the skin symptoms can not be relieved continuously, EGFRIS medicines are reduced and even stopped.
Simultaneously administering placebo facial mask and topical medicinal liquid for 7-14 days
7. The evaluation standard of the curative effect is as follows:
and (3) healing: the rash disappears, no subjective symptoms and no infection symptoms exist, and the life and the work are normal.
Improvement: the grade of the skin toxicity is reduced by one grade or more (including the obvious reduction of rash or the wide change of the rash into local distribution, the reduction or disappearance of subjective symptoms and the obvious improvement of life quality).
And (4) invalidation: those with unchanged rash or with grade-up toxicity (including marked increase of rash or change from local to general distribution, subjective symptoms or aggravation, and marked deterioration of quality of life).
The total effective rate (%) - (cure + improvement)/total cases (x 100%)
8. Test results
8.1 Graded Change in skin rash before and after treatment: experiment group 1 is effective for 109 cases, stable for 10 cases and ineffective for 2 cases; experiment group 2 had 35 cases of effectiveness, 1 case of stability, and 0 case of ineffectiveness; experiment group 3 had 27 cases of effectiveness, 3 cases of stability, and 0 case of ineffectiveness; the control group had 9 cases of effectiveness, 40 cases of stability and 15 cases of ineffectiveness. Through statistical test, the change of the experimental group rash grade after being treated for 14 days is statistically significant, and the effective rates are respectively 90.1%, 97.2% and 90.0%; the control group had a 14 day change in rash grade after treatment which was insignificant. The efficacy of the experimental group in improving the classification of rash was better than that of the control group (see table 3).
TABLE 3 comparison of the efficacy of the experimental and control groups before and after the fractionated treatment of skin rash
| Rash grading | n | Is effective | Stabilization | Invalidation | Chi-square value | P |
| Experimental group 1 | 121 | 109 | 10 | 2 | - | - |
| Experimental group 2 | 36 | 35 | 1 | 0 | - | - |
| Experimental group 3 | 30 | 27 | 3 | 0 | - | - |
| Control group | 64 | 9 | 40 | 15 | 105.1022 | <0.0001 |
Through non-parameter test, the curative effect comparison P of the skin rash grading of the experimental group and the control group after 14 days of treatment is less than 0.05, and the difference has statistical significance. The curative effect of the experimental group is better than that of the control group.
8.2 cutaneous pruritus graduation changes before and after treatment: experiment group 1 had 70 cases of effectiveness, 46 cases of stability and 5 cases of ineffectiveness; experiment group 2 had 28 cases of effectiveness, 7 cases of stability and 1 case of ineffectiveness; experiment group 3 had 19 cases of effectiveness, 10 cases of stability and 1 case of ineffectiveness; the control group had 4 cases of efficacy, 35 cases of stability and 18 cases of ineffectiveness. Through statistical examination, the change of the experimental group of skin pruritus after 14 days of treatment is significant, and the effective rates are 57.9%, 77.8% and 63.3% respectively; the control group had no changes in skin itch over the 14 days of treatment. The curative effect of the experimental group on improving the skin itch is better than that of the control group (see table 4).
TABLE 4 comparison of the therapeutic effects before and after treatment of skin pruritus between the experimental group and the control group
| Itching (pruritus) | n | Is effective | Stabilization | Invalidation | Chi-square value | P |
| Experimental group 1 | 121 | 70 | 46 | 5 | - | - |
| Experimental group 2 | 36 | 28 | 7 | 1 | ||
| Experimental group 3 | 30 | 19 | 10 | 1 | ||
| Control group | 64 | 4 | 35 | 18 | 51.3312 | <0.0001 |
Through non-parameter test, after the experimental group and the control group are treated for 14 days, the curative effect comparison P of the skin itch is less than 0.05, and the difference has statistical significance. The curative effect of the experimental group is better than that of the control group.
(3) Cutaneous dryness scale changes before and after treatment: experiment group 1 had 70 cases of effectiveness, 46 cases of stability and 5 cases of ineffectiveness; experiment group 2 had 25 cases of effectiveness, 10 cases of stability and 1 case of ineffectiveness; experiment group 3 had 21 cases of effectiveness, 9 cases of stability and 0 case of ineffectiveness; the control group had 1 effective, 40 stable and 17 ineffective. Through statistical examination, the change of the experimental group skin dryness after 14 days of treatment is significant, and the effective rates are 57.9%, 63.3% and 70.0% respectively; the control group had dry skin and the change was insignificant for 14 days of treatment. The effect of the experimental group on improving the dry skin is better than that of the control group (see table 5).
TABLE 5 comparison of the effectiveness of the skin dryness treatment in the test and control groups before and after scaling
| Drying | n | Is effective | Stabilization | Invalidation | Chi-square value | P |
| Experimental group 1 | 121 | 70 | 46 | 5 | - | - |
| Experimental group 2 | 36 | 25 | 10 | 1 | ||
| Experimental group 3 | 30 | 21 | 9 | 0 | ||
| Control group | 64 | 1 | 40 | 17 | 59.1777 | <0.0001 |
Through non-parameter test, the curative effect comparison P of the skin dryness is less than 0.05 after the experimental group and the control group are treated for 14 days, and the difference has statistical significance. The curative effect of the experimental group is better than that of the control group.
The group 273 cases, 251 cases, 14 cases of the test group and 8 cases of the control group are subjected to clinical observation. The effective rates of the experimental group 1 for treating the rash grading, the skin pruritus and the dry skin are respectively 90.1%, 57.9% and 57.9%; the control groups were 12.9%, 28.6%, 1.6%, respectively. The difference between the two groups in comparison of rash grade, skin itch and dry skin is statistically significant (chi)2105.1022, 51.3312, 59.1777, respectively, P < 0.05). The clinical observation process has no serious adverse events related to the medicine, the safety is better, and the satisfaction degrees of the experimental group 1 and the control group are 95.40% and 65.50% respectively. No statistical significance was observed for the difference in progression-free survival between the two groups (χ)2＝2.006，P＞0.05)。
After the patient Jia is cured, male and lung adenocarcinoma takes erlotinib for 1 week, facial rash, breast rash and back rash appear, and figure 1 shows the change condition of one week before and after the drug is taken, the pustule is collapsed after one week after the drug is taken, the rash is reduced, the skin color is obviously improved, and the pruritus is relieved.
The following examples further illustrate the Chinese medicinal composition and the preparation method thereof.
Example 1
The formula is as follows: 20g of scutellaria baicalensis, 30g of purslane, 30g of dittany bark, 20g of radix sophorae flavescentis and 30g of dandelion;
the content of baicalin in the scutellaria baicalensis is 2.5%, the content of total flavonoids in the purslane is 2%, the content of total flavonoids in the dittany bark is 2%, the content of matrine in the sophora flavescens is 2%, and the content of total flavonoids in the dandelion is 1.8%. The content measurement methods of the components are respectively referred to the content measurement methods under the items of scutellaria baicalensis, purslane, dittany bark, radix sophorae flavescentis and dandelion in the 'Chinese pharmacopoeia' 2015 version.
The preparation method comprises the following steps: taking the raw materials according to a certain proportion, decocting the raw materials with water twice, combining extracting solutions, filtering, concentrating under reduced pressure until the density is 1.10(60 ℃), centrifuging at high speed, and taking supernatant; according to the supernatant fluid: glycerol: adding auxiliary materials according to the proportion of 2.2:1:2, and preparing the external preparation.
Homogenizing by using a homogenizing tank: rated pressure is 0-100Mpa, rated flow is 30 kg/min, and rated temperature is lower than 60 ℃.
The use method comprises the following steps: directly applying on rash part or making into facial mask for application on face.
Example 2
The formula is as follows: 25g of scutellaria baicalensis, 40g of purslane, 35g of dittany bark, 30g of radix sophorae flavescentis and 35g of dandelion;
the preparation method comprises the following steps: taking the raw materials according to a certain proportion, carrying out reflux extraction twice by 50% ethanol, combining the extracting solutions, filtering, recovering ethanol, adding water for dissolution, concentrating under reduced pressure until the density is 1.10(60 ℃), carrying out high-speed centrifugation, and taking the supernatant; according to the supernatant fluid: glycerol: adding auxiliary materials according to the proportion of 2.2:1:2, and preparing the external preparation.
The use method comprises the following steps: directly applying on rash part or making into facial mask for application on face.
Example 3
The formula is as follows: 25g of scutellaria baicalensis, 20.38g of purslane, 32.89g of dittany bark, 20.83g of radix sophorae flavescentis and 29.69g of dandelion;
the content of baicalin in the scutellaria baicalensis is 2.5%, the content of total flavonoids in the purslane is 2.3%, the content of total flavonoids in the dittany bark is 1.9%, the content of matrine in the radix sophorae flavescentis is 3%, and the content of total flavonoids in the dandelion is 2.0%. The content measurement methods of the components are respectively referred to the content measurement methods under the items of scutellaria baicalensis, purslane, dittany bark, radix sophorae flavescentis and dandelion in the 'Chinese pharmacopoeia' 2015 version. The content ratio of baicalin in scutellaria baicalensis, total flavone in purslane, total flavone in dittany bark, matrine in sophora flavescens and total flavone in dandelion in the raw material medicaments is as follows: 2:1.5:2:2:1.9.
The preparation method comprises the following steps:
a) screening scutellaria baicalensis with the baicalin content of 0.2-4.5%, purslane with the total flavone content of 0.5-2.5%, radix sophorae flavescentis with the matrine content of 1-10%, dittany bark with the total flavone content of 0.1-2.5% and dandelion with the total flavone content of 0.1-2.2%, wherein the contents of the baicalin in the scutellaria baicalensis, the total flavone in the purslane, the total flavone in the dittany bark, the matrine in the sophora flavescens and the total flavone in the dandelion are in proportion as follows: weighing the raw material medicines at a ratio of 2:1.5:2:2:1.9, and removing impurities for later use;
b) pretreatment: steaming Scutellariae radix for half an hour, drying, and pulverizing; drying herba Portulacae, cortex Dictamni Radicis, radix Sophorae Flavescentis, and herba Taraxaci, and pulverizing;
c) mixing Scutellariae radix and radix Sophorae Flavescentis, heating and refluxing for 2 times, with water amount of 8 and 6 times of the medicinal materials respectively, and extracting for 2 hr and 1 hr;
d) mixing herba Portulacae, cortex Dictamni Radicis and herba Taraxaci, adding 70% ethanol 20 times of the total weight, soaking at 70 deg.C for 4 hr, and reflux extracting for 1.5 hr;
e) mixing the filter residues obtained in the steps c) and d), and performing supercritical extraction, wherein the entrainer for the critical extraction is 95% absolute ethyl alcohol, the extraction pressure is 20MPa, the extraction temperature is 55 ℃, the extraction time is 4 hours, and the using amount of the entrainer absolute ethyl alcohol is 2.5 mL/g;
f) filtering the above filtrates, mixing, concentrating at 60 deg.C under reduced pressure to obtain extract with relative density of 1.2, mixing the above filtrates: adding auxiliary materials in a ratio of 1:1 to prepare the external preparation.
Homogenizing by using a homogenizing tank: rated pressure is 0-100Mpa, rated flow is 30 kg/min, and rated temperature is lower than 60 ℃.
Example 4
The formula is as follows: 15g of scutellaria baicalensis, 50g of purslane, 20g of dittany bark, 40g of radix sophorae flavescentis and 20g of dandelion.
Example 5
The formula is as follows: 40g of scutellaria baicalensis, 20g of purslane, 50g of dittany bark, 15g of radix sophorae flavescentis and 50g of dandelion.
Example 6
The formula is as follows: 10g of scutellaria baicalensis, 60g of purslane, 10g of dittany bark, 50g of radix sophorae flavescentis and 10g of dandelion.
Example 7
The formula is as follows: 50g of scutellaria baicalensis, 10g of purslane, 60g of dittany bark, 10g of radix sophorae flavescentis and 60g of dandelion.
Example 8
The formula is as follows: 20g of scutellaria baicalensis extract, 30g of purslane extract, 30g of dittany bark extract, 20g of sophora flavescens extract and 30g of dandelion extract;
the extracts are respectively water extracts obtained by extracting the raw material medicines with water.
Example 9
The formula is as follows: 25g of scutellaria baicalensis extract, 40g of purslane extract, 35g of dittany bark extract, 30g of sophora flavescens extract and 35g of dandelion extract;
the extracts are respectively ethanol extracts obtained by extracting the raw material medicines by 50% ethanol solution.
Example 10
The formula is as follows: 30g of scutellaria baicalensis extract, 35g of purslane extract, 40g of dittany bark extract, 25g of sophora flavescens extract and 40g of dandelion extract.
The extracts are respectively water extracts obtained by extracting the raw material medicines with water.
Example 11
The formula is as follows: 10g of scutellaria baicalensis extract, 30g of purslane extract, 60g of dittany bark extract, 50g of sophora flavescens extract and 20g of dandelion extract;
the baicalin content of the scutellaria baicalensis extract obtained by the experiment is 80%, the purslane total flavone content of the purslane extract is 27%, the dittany bark total flavone content of the dittany bark extract is 4.3%, the matrine content of the sophora flavescens extract is 17.5%, and the dandelion total flavone content of the dandelion extract is 68%. The content measurement methods of the components are respectively referred to the content measurement methods under the items of scutellaria baicalensis, purslane, dittany bark, radix sophorae flavescentis and dandelion in the 'Chinese pharmacopoeia' 2015 version.
The preparation method comprises the following steps:
a) screening out a plurality of weight parts of bulk drugs of scutellaria baicalensis, purslane, dittany bark, radix sophorae flavescentis and dandelion which accord with the record of 2015 Chinese pharmacopoeia, and removing impurities for later use;
b) pretreatment: drying Scutellariae radix, herba Portulacae, cortex Dictamni Radicis, radix Sophorae Flavescentis, and herba Taraxaci, and pulverizing;
c) extracting baicalin from Scutellariae radix by water extraction and acid precipitation, adding boiling water, decocting for 3 times, each time for 45min, mixing the 3 filtrates, heating to 80 deg.C, adding hydrochloric acid to adjust pH to 1.5, keeping the temperature for 30min, standing until precipitate is completely separated out, centrifuging, removing supernatant, adding 9 times of water into the precipitate, adding sodium hydroxide to adjust pH to 7, stirring until precipitate is not dissolved, adding equal volume of 70% ethanol into supernatant, and drying at low temperature to obtain Scutellariae radix extract;
d) extracting flavone from herba Portulacae with organic solvent under reflux, soaking 12 times of the raw materials in 70% ethanol at 70 deg.C for 3 hr, and extracting 5 times of the raw materials with 70% ethanol under reflux at 75 deg.C for 2 times, each for 1.5 hr; mixing the filtrates, and concentrating under reduced pressure;
e) extracting flavone from cortex Dictamni Radicis under reflux with 8 times of 95% ethanol at 55 deg.C for 3 times, each for 1 hr; mixing the filtrates, and concentrating under reduced pressure;
f) adopting organic solvent impregnation and macroporous resin purification to extract matrine from sophora flavescens, wherein the ratio of material to liquid is 1: 9 (g. mL)-1) Leaching with methanol at 60 deg.C for 3 times, each for 3 hr; filtering the filtrate with low-polarity polystyrene macroporous resin;
g) adopting organic solvent ultrasound and macroporous resin adsorption to extract flavone in the dandelion, wherein the ratio of material to liquid is 1: 15 (g. mL)-1) Ultrasonic extracting at 60 deg.C for 2 times, each for 20min, and passing the extractive solution through polyamide column;
h) mixing Scutellariae radix extract, herba Portulacae extract, cortex Dictamni Radicis extract, radix Sophorae Flavescentis extract and herba Taraxaci extract, adding adjuvants, and making into external preparation;
homogenizing by using a homogenizing tank: rated pressure is 0-100Mpa, rated flow is 30 kg/min, and rated temperature is lower than 60 ℃.
Example 12
The formula is as follows: 20g of scutellaria baicalensis, 30g of purslane, 30g of dittany bark, 20g of radix sophorae flavescentis, 30g of dandelion, 15g of red paeony root and 5g of mint;
the preparation method comprises the following steps: taking the raw materials according to a certain proportion, decocting the raw materials with water twice, combining extracting solutions, filtering, concentrating under reduced pressure until the density is 1.10(60 ℃), centrifuging at high speed, and taking supernatant; according to the supernatant fluid: glycerol: 2.2:1:2, adding auxiliary materials in the proportion to prepare the external preparation.
Homogenizing by using a homogenizing tank: rated pressure is 0-100Mpa, rated flow is 30 kg/min, and rated temperature is lower than 60 ℃.
The use method comprises the following steps: directly applying on rash part or making into facial mask for application on face.
Comparing the clinical effects of the formulations prepared in example 1 and example 11 on EGFR-related rashes
Experimental group 1: the formulation prepared in example 11;
experimental group 2: the formulation prepared in example 1;
121 patients with 3 degrees of rash were included in each group (see table 1 for grading criteria), and the change in grade of rash after 14 days of treatment is shown in table 6.
TABLE 6 two groups of formulations treat EGFRis-associated rashes after 14 days
| Group of | 1A | 1B | 2A | 2B | 3A | 3B | Chi-square value | P |
| Experimental group 1 | 3 | 9 | 21 | 32 | 31 | 25 | - | —— |
| Experimental group 2 | 8 | 16 | 47 | 22 | 26 | 2 | 7.2808 | 0.007 |
By the chi-square test, the classification change P of the rash after 14 days of treatment of the two groups is less than 0.05, and the difference has statistical significance. The effect of the group formula in the embodiment 1 is obviously better than that of the group formula in the embodiment 11.
Example 13
The formula is as follows: 10g of scutellaria baicalensis extract, 30g of purslane extract, 60g of dittany bark extract, 50g of sophora flavescens extract and 20g of dandelion extract;
the preparation method comprises the following steps: taking the raw materials according to a certain proportion, decocting the raw materials with water twice, combining extracting solutions, filtering, concentrating under reduced pressure until the density is 1.10(60 ℃), centrifuging at high speed, and taking supernatant; according to the supernatant fluid: glycerol: 2.2:1:2, adding auxiliary materials in the proportion to prepare the external preparation.
Homogenizing by using a homogenizing tank: rated pressure is 0-100Mpa, rated flow is 30 kg/min, and rated temperature is lower than 60 ℃.
The use method comprises the following steps: directly applying on rash part or making into facial mask for application on face.
Comparative example 13 and example 11 clinical effects of formulations prepared according to different preparation methods on EGFR-related skin rash
Experimental group 1: the formulation prepared in example 13;
experimental group 2: the formulation prepared in example 11;
the two groups included 30 patients with 3 degrees of rash (see table 1 for grading criteria), and the change in the grade of the rash after 14 days of treatment is shown in table 7.
TABLE 7 two groups of formulations treat EGFRis-associated rashes after 14 days
By the chi-square test, the classification change P of the rash after 14 days of treatment of the two groups is less than 0.05, and the difference has statistical significance. The formula in the example 11 is obviously better than the formula in the example 13.
Claims (4)
1. The traditional Chinese medicine composition for treating the skin rash is characterized by comprising the following raw material medicines: 25g of scutellaria baicalensis, 20.38g of purslane, 32.89g of dittany bark, 20.83g of radix sophorae flavescentis and 29.69g of dandelion;
the content of baicalin in the scutellaria baicalensis is 2.5%, the content of total flavonoids in the purslane is 2.3%, the content of total flavonoids in the cortex dictamni is 1.9%, the content of matrine in the radix sophorae flavescentis is 3%, and the content of total flavonoids in the dandelion is 2.0%, and the content determination methods of the components are determined by respectively referring to the content determination methods under the items of scutellaria baicalensis, purslane, cortex dictamni, radix sophorae flavescentis and dandelion in the 'Chinese pharmacopoeia' 2015 edition; the content ratio of baicalin in scutellaria baicalensis, total flavone in purslane, total flavone in dittany bark, matrine in sophora flavescens and total flavone in dandelion in the raw material medicaments is as follows: 2:1.5:2:2: 1.9;
the preparation method comprises the following steps:
a) screening scutellaria baicalensis with the baicalin content of 0.2-4.5%, purslane with the total flavone content of 0.5-2.5%, radix sophorae flavescentis with the matrine content of 1-10%, dittany bark with the total flavone content of 0.1-2.5% and dandelion with the total flavone content of 0.1-2.2%, wherein the contents of the baicalin in the scutellaria baicalensis, the total flavone in the purslane, the total flavone in the dittany bark, the matrine in the sophora flavescens and the total flavone in the dandelion are in proportion as follows: weighing the raw material medicines at a ratio of 2:1.5:2:2:1.9, and removing impurities for later use;
b) pretreatment: steaming Scutellariae radix for half an hour, drying, and pulverizing; drying herba Portulacae, cortex Dictamni Radicis, radix Sophorae Flavescentis, and herba Taraxaci, and pulverizing;
c) mixing Scutellariae radix and radix Sophorae Flavescentis, heating and refluxing for 2 times, with water amount of 8 and 6 times of the medicinal materials respectively, and extracting for 2 hr and 1 hr;
d) mixing herba Portulacae, cortex Dictamni Radicis and herba Taraxaci, adding 70% ethanol 20 times of the total weight, soaking at 70 deg.C for 4 hr, and reflux extracting for 1.5 hr;
e) mixing the filter residues obtained in the steps c) and d), and performing supercritical extraction, wherein the entrainer for the critical extraction is 95% absolute ethyl alcohol, the extraction pressure is 20MPa, the extraction temperature is 55 ℃, the extraction time is 4 hours, and the using amount of the entrainer absolute ethyl alcohol is 2.5 mL/g;
f) filtering the filtrate, mixing, concentrating at 60 deg.C under reduced pressure to obtain extract with relative density of 1.2, mixing the above extracts: adding auxiliary materials in a ratio of 1:1 to prepare an external preparation;
homogenizing by using a homogenizing tank: rated pressure 0-100Mpa, rated flow 30 kg/min, rated temperature lower than 60 deg.C.
2. The Chinese medicinal composition of claim 1, wherein the external preparation comprises a patch, a cataplasm, an ointment, a plaster, a gel, a liniment, a lotion and a coating agent.
3. The use of the composition of claim 1 in the preparation of a topical medicament for the treatment of skin rash.
4. The use of the composition of claim 1 in the preparation of a topical medicament for the treatment of skin rash associated with an epidermal growth factor receptor antagonist.
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