CN105168538B - A kind of Chinese medicine composition and preparation method thereof for treating xerosis - Google Patents
A kind of Chinese medicine composition and preparation method thereof for treating xerosis Download PDFInfo
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Abstract
The present invention provides a kind of Chinese medicine composition for treating xerosis, and the bulk pharmaceutical chemicals group of the Chinese medicine composition becomes：8~100 parts by weight of Radix Angelicae Sinensis, 6~80 parts by weight of radix rehmanniae preparata, 3~50 parts by weight of radix scutellariae, 3~50 parts by weight of bark of ash, windproof 3~50 parts by weight.Chinese medicine composition of the present invention dry symptom significant effect caused by improving EGFRIs, and without obvious adverse reaction.
Description
Technical field
The present invention relates to a kind of Chinese medicine compositions and its preparation method and application, and in particular to a kind of to treat in xerosis
Drug composition and its preparation method and application belongs to technical field of Chinese medicine.
Background technology
In recent years, the targeted therapy of tumour increases year by year in clinical application, and the therapeutic effect of performance also increasingly increases, i.e.,
The 21 century promising oncotherapy mode of tool will be become.Most commonly used clinical application at present is that EGF-R ELISA is short of money
Anti-agent (epidermal growth factor receptor inhibitors, EGFRIs) class drug, such medicine are protruded with it
Clinical efficacy and receive the favor of doctor and patient.But dermal toxicity caused by EGFRIs significantly affects its matter of living
Amount, reduces the compliance for the treatment of.
Dry skin furfur caused by EGFRIs mostly occurs the time after relatively, it is reported that [Guttman-Yassky
E,Nograles KE,Krueger JG.Contrasting pathogenesis of atopic dermatitis and
psoriasis--part II:immune cell subsets and therapeutic concepts[J].J Allergy
Clin Immunol,2011,127(6):1420-32] using the patient of EGFRIs, dry skin incidence 4%-35%.And mesh
The preceding processing to dry skin is not paid close attention to too much.For dry skin, emphasizes that early stage just takes measures, carry out necessary life
Nursing and prevention, mild skin adverse reaction can first observe a period of time, or use topical remedy；Middle severe need to be in part
Oral drugs are coordinated even to reduce once used amount or the drug withdrawal of EGFRIs while treatment.
For having dry skin the treatment of furfur caused by EGFRIs, external application moisturizer haves the shortcomings that effective time is short, often
It needs multiple medication, and patient burden is heavier, and cannot improve other drying symptoms of patient, as dry, dry throat, nasal cavity dryness, eye are dry
Etc.；Its mechanism of action of recombinant human epidermal growth factor spray, vitamin K is related to the blocking of EGFR downstream signals, if meeting
The therapeutic effect for influencing EGFRIs is not confirmed.Therefore EGFRIs class drugs decrement or deactivated event often have hair caused by
It is raw, seriously limit the clinical application of such drug.Therefore, exploration one kind is novel, can improve whole body drying symptom, is effective
The drug for the treatment of EGFRIs related dermals drying seems very necessary.
Invention content
The purpose of the present invention is to provide a kind of Chinese medicine compositions for treating xerosis；
It is another object of the present invention to provide the preparation methods of the Chinese medicine composition；
Third object of the present invention is that providing the Chinese medicine composition is preparing the application in treating dry disease drug.
Fourth object of the present invention is that providing the Chinese medicine composition is preparing treatment EGFRIs correlations drying symptom medicine
Application in object.
The purpose of the present invention is what is be achieved through the following technical solutions：
The bulk pharmaceutical chemicals composition of a kind of Chinese medicine composition for treating xerosis, the Chinese medicine composition includes Radix Angelicae Sinensis, radix rehmanniae preparata, Huang
It is a kind of reed mentioned in ancient books, bark of ash, windproof.
Further, the bulk pharmaceutical chemicals group of the Chinese medicine composition becomes：
It is 8~100 parts by weight of Radix Angelicae Sinensis, 6~80 parts by weight of radix rehmanniae preparata, 3~50 parts by weight of radix scutellariae, 3~50 parts by weight of bark of ash, windproof
3~50 parts by weight；
Further, the bulk pharmaceutical chemicals group of the Chinese medicine composition becomes：
It is 10~80 parts by weight of Radix Angelicae Sinensis, 8~60 parts by weight of radix rehmanniae preparata, 4~40 parts by weight of radix scutellariae, 4~40 parts by weight of bark of ash, windproof
4~40 parts by weight；
Further, the bulk pharmaceutical chemicals group of the Chinese medicine composition becomes：
12~60 parts by weight of Radix Angelicae Sinensis, 5~30 parts by weight of radix scutellariae, 5~30 parts by weight of bark of ash, are prevented at 10~40 parts by weight of radix rehmanniae preparata
5~30 parts by weight of wind；
Further, the bulk pharmaceutical chemicals group of the Chinese medicine composition becomes：
15~40 parts by weight of Radix Angelicae Sinensis, 7~20 parts by weight of radix scutellariae, 7~20 parts by weight of bark of ash, are prevented at 12~30 parts by weight of radix rehmanniae preparata
7~20 parts by weight of wind；
Further, the bulk pharmaceutical chemicals group of the Chinese medicine composition becomes：
20 parts by weight of Radix Angelicae Sinensis, 15 parts by weight of radix rehmanniae preparata, 10 parts by weight of radix scutellariae, 10 parts by weight of bark of ash, windproof 10 parts by weight；
Or, 18 parts by weight of Radix Angelicae Sinensis, 25 parts by weight of radix rehmanniae preparata, 8 parts by weight of radix scutellariae, 18 parts by weight of bark of ash, windproof 8 parts by weight；
35 parts by weight of Radix Angelicae Sinensis, 13 parts by weight of radix rehmanniae preparata, 18 parts by weight of radix scutellariae, 8 parts by weight of bark of ash, windproof 18 parts by weight.
The preparation method of Chinese medicine composition of the present invention is：
Each bulk pharmaceutical chemicals are taken in proportion, and with water or organic solvent, routinely extracting method is extracted, and routinely preparation process system
For at conventional oral dosage formulations.
Above-mentioned general extraction methods include decocting in extraction, refluxing extraction, Soakage extraction, ultrasonic extraction or seepage pressure effects
The combination of any one mode or Different Extraction Method；The ethanol solution that the organic solvent is 20~95%.The routine
Peroral dosage form includes granule, tablet, powder, capsule, oral solution, pill etc..
To enable dosage form of the present invention to realize, pharmaceutically acceptable auxiliary material, example need to be added when preparing these dosage forms
Such as：Filler, disintegrant, lubricant, suspending agent, adhesive, sweetener, corrigent, preservative, matrix etc..Filler includes：
Starch, pregelatinized starch, lactose, mannitol, chitin, microcrystalline cellulose, sucrose etc.；Disintegrant includes：Starch, pregelatinated form sediment
Powder, microcrystalline cellulose, sodium carboxymethyl starch, crosslinked polyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, cross-linked carboxymethyl fiber
Plain sodium etc.；Lubricant includes：Magnesium stearate, lauryl sodium sulfate, talcum powder, silica etc.；Suspending agent includes：Polyethylene
Pyrrolidones, microcrystalline cellulose, sucrose, agar, hydroxypropyl methyl cellulose etc.；Adhesive includes：Starch slurry, polyvinyl pyrrole
Alkanone, hydroxypropyl methyl cellulose etc.；Sweetener includes：Saccharin sodium, aspartame, sucrose, honey element, enoxolone etc.；It rectifys
Taste agent includes：Sweetener and various essence；Preservative includes：Parabens, benzoic acid, sodium benzoate, sorbic acid and its esters,
Fixed, eucalyptus oil of benzalkonium bromide, acetic acid chloroethene etc.；Matrix includes：PEG6000, PEG4000, insect wax etc..To enable above-mentioned dosage form
It realizes pharmacy of Chinese materia medica, pharmaceutically acceptable other auxiliary material (Fan Biting need to be added when preparing these dosage forms《Pharmacy of Chinese materia medica》,
The auxiliary material that each dosage form is recorded in Shanghai Science Press December the 1st edition in 1997).
Other than Chinese medicine composition of the present invention by Radix Angelicae Sinensis, radix rehmanniae preparata, radix scutellariae, bark of ash, windproof crude drug in the form of being fed intake, also
It may be used in the form of the extract of above-mentioned crude drug (active component) feeds intake, therefore the present invention further discloses one kind to control
Treat the Chinese medicine composition of xerosis：
The bulk pharmaceutical chemicals group of a kind of Chinese medicine composition for treating xerosis, the Chinese medicine composition becomes：
8~100 parts by weight of angelica extract, 6~80 parts by weight of radix rehmanniae preparata extract, 3~50 parts by weight of Baical Skullcap root P.E, the Qin
3~50 parts by weight of Macrophylla extract, 3~50 parts by weight of Radix Saposhnikoviae extract；
Further, the bulk pharmaceutical chemicals group of the Chinese medicine composition becomes：
10~80 parts by weight of angelica extract, 8~60 parts by weight of radix rehmanniae preparata extract, 4~40 parts by weight of Baical Skullcap root P.E, the Qin
4~40 parts by weight of Macrophylla extract, 4~40 parts by weight of Radix Saposhnikoviae extract；
Further, the bulk pharmaceutical chemicals group of the Chinese medicine composition becomes：
12~60 parts by weight of angelica extract, 10~40 parts by weight of radix rehmanniae preparata extract, 5~30 parts by weight of Baical Skullcap root P.E,
5~30 parts by weight of Radix Gentianae Macrophyllae extract, 5~30 parts by weight of Radix Saposhnikoviae extract；
Further, the bulk pharmaceutical chemicals group of the Chinese medicine composition becomes：
15~40 parts by weight of angelica extract, 12~30 parts by weight of radix rehmanniae preparata extract, 7~20 parts by weight of Baical Skullcap root P.E,
7~20 parts by weight of Radix Gentianae Macrophyllae extract, 7~20 parts by weight of Radix Saposhnikoviae extract；
Further, the bulk pharmaceutical chemicals group of the Chinese medicine composition becomes：
20 parts by weight of angelica extract, 15 parts by weight of radix rehmanniae preparata extract, 10 parts by weight of Baical Skullcap root P.E, Radix Gentianae Macrophyllae extract 10
Parts by weight, 10 parts by weight of Radix Saposhnikoviae extract；
Or, 18 parts by weight of angelica extract, 25 parts by weight of radix rehmanniae preparata extract, 8 parts by weight of Baical Skullcap root P.E, Radix Gentianae Macrophyllae extract
18 parts by weight, 8 parts by weight of Radix Saposhnikoviae extract；
35 parts by weight of angelica extract, 13 parts by weight of radix rehmanniae preparata extract, 18 parts by weight of Baical Skullcap root P.E, Radix Gentianae Macrophyllae extract 8
Parts by weight, 18 parts by weight of Radix Saposhnikoviae extract.
Above-mentioned raw materials medicament extract can be the water extract or extractive with organic solvent or water extract/organic of each bulk pharmaceutical chemicals
Solvent extractable matter passes through the refined substance that further polishing purification technique obtains.
The organic solvent is selected from one or more of methanol, 20~95% ethanol solutions, acetone；
Prepare said extracted object used in extracting method include decoct extraction, refluxing extraction, Soakage extraction, ultrasonic extraction or
The combination of any one mode or Different Extraction Method in seepage pressure effects；The polishing purification technique includes alcohol precipitation, extraction
It takes, silica gel chromatograph post separation, macroreticular resin post separation etc..
The present invention also provides the Chinese medicine compositions in the application prepared in treating dry disease drug and to prepare treatment
EGFRIs correlations dry the application in symptom drug.
The experimental example present composition dries EGFRIs correlations the clinical effectiveness of symptom
Case inclusion criteria：1. there is the malignant tumor patient of clear pathological diagnosis；2. carrying out EGFRIs treatments；3. going out
Now with the relevant dry skin symptoms of EGFRIs；4. the heart, Liver and kidney function are without serious hindrance 5. age 18-80 Sui；6. without intelligence and
Phrenoblabia, ability of language expression are normal；7. understanding and receiving this treatment, informed consent form is signed.Case is randomly divided into
Treatment group 48 and control group 48.
Case exclusion criteria：1. research in patient cannot medication as requested, medication be less than 14d person；2. conditions of patients into
Exhibition, observation 14d is interior to be stopped applying EGFRIs person；3. allergic constitution person.
Observation index and Syndrome Scale standard：Using the desquamation of skin as MAIN OUTCOME MEASURES, adjoint itch is as auxiliary
Observation index.Pruitus, furfur hierarchical application NCI-CTCAE standards (3.0 editions), are shown in Table 1.
1 Syndrome Scale standard of table
Experimental drug：Chinese medicine composition (being prepared by 1 method of embodiment) of the present invention；
Control drug：Radix Angelicae Sinensis 20g, Radix Rehmanniae 15g, radix rehmanniae preparata 15g, Radix Paeoniae Alba 15g, bark of ash 10g, radix scutellariae 10g, windproof 10g, Radix Glycyrrhizae
9g；The preparation method is the same as that of Example 1.
Therapy：Treatment group and control group take orally experimental drug and control drug, continuous application 14d respectively.Observation is controlled
Treat front and back two groups of patient's itch and furfur variation.
Experimental result：It is shown in Table 2.
2 pretherapy and post-treatment patient stratification's situation of table
By carrying out Wilcoxon rank sum tests to data before and after two groups of medications, P is respectively less than 0.05, shows that two groups of patients use
Medicine is front and back to have significant difference in number of cases distribution.It can be seen that two kinds of drugs are for the desquamation of skin and adjoint itch
Symptom improves significantly.Data carry out Wilcoxon rank sum tests after two groups of medications, and P is all higher than 0.05, shows two groups
Without significant difference.It can be seen that two prescriptions change the desquamation of skin and adjoint pruritis after medication
Kind apparent, Chinese medicine composition of the present invention is suitable with control drug effect on the basis of reducing bulk pharmaceutical chemicals.
Specific implementation mode
1 granule of embodiment
Radix Angelicae Sinensis 20g radix rehmanniae preparata 15g radix scutellariaes 10g
The windproof 10g of bark of ash 10g
Bulk pharmaceutical chemicals are taken in proportion, are added water to cook twice, 1.5 hours every time, collecting decoction filtered, and concentration is dried under reduced pressure,
Using dextrin as excipient, compare 3 by medicine is auxiliary:1 is mixed, and particle is made in mixing.
In addition, the granule drug-induced to EGFRIs classes other drying symptom such as dry, dry throat, nasal cavity dryness, eyes are dry
There is good remission effect.Clinical trial is observed simultaneously using occurring having dry skin and occurring dry, dry throat, nose after EGFRIs
Dry, xerophthalmia shape each 10 of malignant tumor patient, gives the Granules in Treating 14 days, with remission for effective standard.It sees
Examine other clinical effectiveness that experimental example patient takes, effective percentage point of the granule for dry, dry throat, nasal cavity dryness, xerophthalmia shape
It is not：80%, 70%, 50%, 60%, show that its other drying symptom drug-induced to EGFRIs classes also has good effect
Fruit.
2 granule of embodiment
Radix Angelicae Sinensis 35g radix rehmanniae preparata 13g radix scutellariaes 18g
The windproof 18g of bark of ash 8g
Bulk pharmaceutical chemicals are taken in proportion, and the extraction of 70% EtOH Sonicate is secondary, and 1 hour for the first time, second 0.5 hour, merging carried
Liquid is taken, is filtered, is concentrated under reduced pressure, extract compares 3 using dextrin as excipient, by medicine is auxiliary:1 is mixed, and particle is made in mixing, is done
It is dry, both.
3 granule of embodiment
Radix Angelicae Sinensis 15g radix rehmanniae preparata 30g radix scutellariaes 7g
The windproof 7g of bark of ash 20g
Bulk pharmaceutical chemicals are taken in proportion, add water refluxing extraction secondary, and 1.5 hours every time, collecting decoction filtered, and concentrates, and is added
60% ethanol solution alcohol precipitation is stood, and is filtered, and concentration is dried under reduced pressure, using dextrin as excipient, compares 3 by medicine is auxiliary:1 is mixed,
Particle is made in mixing, dry, both.
4 tablet of embodiment
Radix Angelicae Sinensis 40g radix rehmanniae preparata 12g radix scutellariaes 20g
The windproof 20g of bark of ash 7g
Bulk pharmaceutical chemicals are taken in proportion, and the extraction of 70% EtOH Sonicate is secondary, and 1 hour for the first time, second 0.5 hour, merging carried
Liquid is taken, is filtered, is concentrated under reduced pressure, D101 macroporous resin purifications on concentrate first use 2BV water elutions, then molten with 50% ethyl alcohol of 5BV
Liquid elutes, and collects 50% ethanol eluate, recycles ethyl alcohol, and extract is added customary adjuvant, tablet is made by common process.
5 oral solution of embodiment
Radix Angelicae Sinensis 12g radix rehmanniae preparata 40g radix scutellariaes 5g
The windproof 5g of bark of ash 30g
Take bulk pharmaceutical chemicals in proportion, add water to cook it is secondary, 1.5 hours every time, collecting decoction, filtration, routinely technique is made
Oral solution.
6 capsule of embodiment
Radix Angelicae Sinensis 60g radix rehmanniae preparata 10g radix scutellariaes 30g
The windproof 30g of bark of ash 5g
Bulk pharmaceutical chemicals, 50% alcohol reflux are taken to extract three times in proportion, 1.5 hours for the first time, second 1 hour, third time 1
Hour, merge extracting solution, filtration, filtrate decompression concentration；Capsule is conventionally made in extract.
7 oral solution of embodiment
Radix Angelicae Sinensis 10g radix rehmanniae preparata 60g radix scutellariaes 4g
The windproof 4g of bark of ash 40g
Bulk pharmaceutical chemicals are taken in proportion, and 6 times of 75% alcohol refluxs of amount is added to extract 2 times, every time 1.5 hours；Merge extracting solution, filter
It crosses, customary adjuvant is added, oral solution is made.
8 powder of embodiment
Radix Angelicae Sinensis 80g radix rehmanniae preparata 8g radix scutellariaes 40g
The windproof 40g of bark of ash 4g
Bulk pharmaceutical chemicals are taken in proportion, are crushed, and customary adjuvant are added, powder is made.
Embodiment 9
Radix Angelicae Sinensis 30g radix rehmanniae preparata 14g radix scutellariaes 16g
The windproof 17g of bark of ash 9g
Bulk pharmaceutical chemicals, water are taken to decoct twice in proportion, 1 hour every time；Collecting decoction, filtration, being concentrated into relative density is
The thick paste of 1.30~1.34 (50 DEG C of surveys)；Thick paste routinely technique is taken, customary adjuvant is added, pill is made.
Embodiment 10
Angelica extract 20g radix rehmanniae preparata extract 15g Baical Skullcap root P.Es 10g
Radix Gentianae Macrophyllae extract 10g Radix Saposhnikoviae extracts 10g
The extract is respectively the water extract that bulk pharmaceutical chemicals are extracted through water, and each bulk pharmaceutical chemicals Aqueous extracts are merged, filtration,
Routinely oral solution is made in technique.
Embodiment 11
Angelica extract 35g radix rehmanniae preparata extract 13g Baical Skullcap root P.Es 18g
Radix Gentianae Macrophyllae extract 8g Radix Saposhnikoviae extracts 18g
The extract is respectively the ethanol extract that bulk pharmaceutical chemicals are extracted through 50% ethanol solution；By each bulk pharmaceutical chemicals alcohol
Extract concentrates, and is uniformly mixed after being dried under reduced pressure, using dextrin as excipient, compares 3 by medicine is auxiliary:1 is mixed, and particle is made in mixing,
Tablet is made in tabletting.
Claims (9)
1. a kind of Chinese medicine composition for treating xerosis, which is characterized in that the bulk pharmaceutical chemicals group of the Chinese medicine composition becomes：Radix Angelicae Sinensis
15~40 parts by weight, 12~30 parts by weight of radix rehmanniae preparata, 7~20 parts by weight of radix scutellariae, 7~20 parts by weight of bark of ash, windproof 7~20 weight
Part.
2. Chinese medicine composition as described in claim 1, which is characterized in that the bulk pharmaceutical chemicals group of the Chinese medicine composition becomes：When
Return 20 parts by weight, 15 parts by weight of radix rehmanniae preparata, 10 parts by weight of radix scutellariae, 10 parts by weight of bark of ash, windproof 10 parts by weight.
3. Chinese medicine composition as described in claim 1, which is characterized in that the bulk pharmaceutical chemicals group of the Chinese medicine composition becomes：When
Return 18 parts by weight, 25 parts by weight of radix rehmanniae preparata, 8 parts by weight of radix scutellariae, 18 parts by weight of bark of ash, windproof 8 parts by weight.
4. Chinese medicine composition as described in claim 1, which is characterized in that the bulk pharmaceutical chemicals group of the Chinese medicine composition becomes：When
Return 35 parts by weight, 13 parts by weight of radix rehmanniae preparata, 18 parts by weight of radix scutellariae, 8 parts by weight of bark of ash, windproof 18 parts by weight.
5. the preparation method of Chinese medicine composition as described in claim any one of 1-4, which is characterized in that the preparation method is：It presses
Ratio takes each bulk pharmaceutical chemicals, and with water or organic solvent, routinely extracting method is extracted, and routinely preparation process is prepared into conventional mouth
Oral dosage form.
6. preparation method as claimed in claim 5, which is characterized in that the conventional oral dosage formulations are granule, tablet, dissipate
Agent, capsule, oral solution, pill.
7. a kind of Chinese medicine composition for treating xerosis, which is characterized in that the Chinese medicine composition is made of the following raw material medicine：When
Return 15~40 parts by weight of extract, 12~30 parts by weight of radix rehmanniae preparata extract, 7~20 parts by weight of Baical Skullcap root P.E, Radix Gentianae Macrophyllae extract 7
~20 parts by weight, 7~20 parts by weight of Radix Saposhnikoviae extract.
8. Chinese medicine composition is preparing answering in treating dry disease drug as described in claim 1-4 or any one of claim 7
With.
9. Chinese medicine composition is preparing treatment EGF-R ELISA as described in claim 1-4 or any one of claim 7
Application in the drug of the drug-induced related dry symptom of antagonist class.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101757419A (en) * | 2008-11-20 | 2010-06-30 | 杨汝静 | Blood-nourishing skin lotion |
| CN104173714A (en) * | 2013-05-21 | 2014-12-03 | 余桥生 | Traditional Chinese medicinal composition for treating dry and rough skins |
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2015
- 2015-09-14 CN CN201510583614.1A patent/CN105168538B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101757419A (en) * | 2008-11-20 | 2010-06-30 | 杨汝静 | Blood-nourishing skin lotion |
| CN104173714A (en) * | 2013-05-21 | 2014-12-03 | 余桥生 | Traditional Chinese medicinal composition for treating dry and rough skins |
Non-Patent Citations (1)
| Title |
|---|
| 滋燥养荣汤加味治疗干燥综合征30例;郭亮;《内蒙古中医药》;20100831(第16期);第3-4页 * |
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