CN104784441B - A kind of pharmaceutical composition of prevention nasopharyngeal carcinoma radiotherapy infectious-related complication - Google Patents
A kind of pharmaceutical composition of prevention nasopharyngeal carcinoma radiotherapy infectious-related complication Download PDFInfo
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- CN104784441B CN104784441B CN201510194259.9A CN201510194259A CN104784441B CN 104784441 B CN104784441 B CN 104784441B CN 201510194259 A CN201510194259 A CN 201510194259A CN 104784441 B CN104784441 B CN 104784441B
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Abstract
The invention discloses a kind of pharmaceutical compositions of prevention nasopharyngeal carcinoma radiotherapy infectious-related complication, the pharmaceutical composition is prepared by traditional Chinese medicinal material raw materials, by weight, the traditional Chinese medicinal material raw materials include 30-45 parts of Semen Benincasae, 9-18 parts of peach leaf, 21-30 parts of Sculellaria barbata, 21-30 parts of cucumber stem, 6-9 parts of semen allii tuberosi, 9-15 parts of folium isatidis, 6-9 parts of birthwort, 6-9 parts of blackberry lily, 6-9 parts of schizonepeta.The pharmaceutical composition of the present invention can promote ciliary movement, improve eustachian tube function, caused secretory otitis media after effective preventive radiotherapy, to reach reduce radiotherapy after secretory otitis media incidence.
Description
Technical field
The invention belongs to technical field of Chinese medicine, in particular to a kind of medicine of prevention nasopharyngeal carcinoma radiotherapy infectious-related complication
Compositions.
Background technology
Nasopharyngeal carcinoma ranks first in hals,Nasen und Ohrenheilkunde tumor incidence, and therapeutic modality first choice radiotherapy, secretory otitis media is nose
Common complication after pharynx cancer radiotherapy.Because in radiotherapy, middle ear Eustachian tube is in high dose area, inevitably by
Radiation insult leads to the generation of secretory otitis media.It is mainly shown as that the symptoms such as tinnitus, ear muffle, Hearing, many scholars are recognized
It is all related with eustachian tube function damage for secretory otitis media occurs after nasopharyngeal carcinoma radiotherapy.
The purpose of secretory otitis media treatment is to remove middle ear effusion, improvement and recovery middle ear normal ventilation and Eustachian tube
Function.In order to reduce the exposure dose of ear, the scholars such as Lu Taixiang are studied, but effect is not obvious (Lu Taixiang, sieve
Big, Zhao fills；Nasopharyngeal carcinoma low melting-point alloy lead face neck joint open country sets discussion [J] cancers of wild method, 2000,19 (12)：930-
931).Secretory otitis media mostly uses grommet insertion at present after radiotherapy, easily leads to intractable otorrhea auditory function damage even at a specified future date
Evil (Zhou Yong, Tang Anzhou；Progress [J] oncology magazines of secretory otitis media in patients with nasopharyngeal carcinoma after radiotherapy, 2002,8 (1)：49-
49).Foreign countries have research to confirm that intractable otorrhea incidence is up to 68%.
The generation of secretory otitis media and Eustachian tube disfunction (YAFFE in close relations after numerous studies show radiotherapy
K, HAAN M, BYERS A, et a l.Estrogenuse, APOE, and cognitive decline：evidence of
Gene environment interaction [J] .Neurology, 2000,109：1949-1954), various clinics are controlled at present
It is not satisfied to treat curative effect, therefore how simply and effectively for the generation of secretory otitis media is particularly important after preventive radiotherapy.
Invention content
In view of the deficiencies in the prior art, the purpose of the present invention is to provide a kind of curative for effect, few side effects and price it is low
The pharmaceutical composition of honest and clean prevention nasopharyngeal carcinoma radiotherapy infectious-related complication and its application.
The object of the present invention is achieved like this：
A kind of pharmaceutical composition of prevention nasopharyngeal carcinoma radiotherapy infectious-related complication, is prepared, by weight by traditional Chinese medicinal material raw materials
Meter, the traditional Chinese medicinal material raw materials include：30-45 parts of Semen Benincasae, 9-18 parts of peach leaf, 21-30 parts of Sculellaria barbata, 21-30 parts of cucumber stem,
6-9 parts of semen allii tuberosi, 9-15 parts of folium isatidis, 6-9 parts of birthwort, 6-9 parts of blackberry lily, 6-9 parts of schizonepeta.
Preferably, the pharmaceutical composition for preventing nasopharyngeal carcinoma radiotherapy infectious-related complication as described above, by weight, in described
Medicinal raw material by 36-38 parts of Semen Benincasae, 11-15 parts of peach leaf, 24-26 parts of Sculellaria barbata, 24-26 parts of cucumber stem, 7-8 parts of semen allii tuberosi,
7-8 parts of 11-13 parts of folium isatidis, 7-8 parts of birthwort, 7-8 parts of blackberry lily and schizonepeta compositions.
In the most preferred embodiment of the present invention, the medicine group of nasopharyngeal carcinoma radiotherapy infectious-related complication is prevented as described above
Close object, by weight, the traditional Chinese medicinal material raw materials by 37 parts of Semen Benincasae, 13 parts of peach leaf, 25 parts of Sculellaria barbata, 25 parts of cucumber stem,
8 parts of 8 parts of semen allii tuberosi, 12 parts of folium isatidis, 8 parts of birthwort, 8 parts of blackberry lily and schizonepeta compositions.
It is Peroral solid dosage form it is further preferred that preventing the pharmaceutical composition of nasopharyngeal carcinoma radiotherapy infectious-related complication as described above
Preparation, preferably granule, oral solution, tablet, capsule.
By the preparation method of the compound granule of above-mentioned each Chinese medicine manufacturing cost invention, include the following steps：By prescription
Amount weighs 30-45 parts of Semen Benincasae, 9-18 parts of peach leaf, 21-30 parts of Sculellaria barbata, 21-30 parts of cucumber stem, 6-9 parts of semen allii tuberosi, folium isatidis
6-9 parts of 9-15 parts, 6-9 parts of birthwort, 6-9 parts of blackberry lily and schizonepeta merge, add water to cook twice, and for the first time plus water is medicinal material weight
10-12 times of amount is measured, and 1-2h is decocted, and it is that 8-10 times of medicinal material weight is measured to add water for the second time, decoction 1-2h, collecting decoction,
The medicinal extract that relative density is 1.15 when being concentrated under reduced pressure into 65 DEG C at 0.07MPa, 60-70 DEG C, adds 95% (v/v) ethyl alcohol to make alcohol content
Up to 75% (v/v), stirring stands 24 hours, filtering, and filtrate is concentrated under reduced pressure under the conditions of 0.07MPa, 65 DEG C to 65 DEG C of phases
It is 1.25 to density, and recycles ethyl alcohol, obtain concentrate, (condition is that inlet air temperature is 100 DEG C, outlet air by concentrate spray drying
Temperature is 80 DEG C, and temperature of charge is 80 DEG C, and atomizing pressure is 0.2 megapascal, spray velocity 5ml/s.), 80 mesh sieve is crushed, is obtained
To clear cream powder；According to clear cream powder: the weight ratio of dextrin 1: 3~5 weighs clear cream powder, dextrin, clear cream powder and dextrin are put into groove profile
It in mixing machine, stirs 20 minutes, is slowly added into 55% ethyl alcohol while stirring, until softwood is made, is sieved and pelletized with 12 mesh stainless steels, 65
~75 DEG C of dryings 2 hours are taken out, and are cooled up to the granule.
It should be noted that traditional Chinese medicinal material raw materials used by the pharmaceutical composition of the present invention have following source：Semen Benincasae
Select the dry seed of cucurbitaceous plant wax gourd Benincasa hispida (Thunb.) Cogn..Peach leaf selects rosaceous plant
The dried leaf of peach Prunuspersica (L.) Batsch.Sculellaria barbata selects labiate Sculellaria barbata Scutellaria
The drying herb of barbata Don [S.rivularis Wall].Cucumber stem selects cucurbitaceous plant cucumber Cucumis
The drying rattan of sativus L..Semen allii tuberosi selects being dried to for liliaceous plant leek Allium tuberosum Rottl.
Ripe seed.Folium isatidis selects the dried leaf of cruciferae isatis Isatis indigotica Fort..Birthwort selects horse
The dry mature fruit of Dou Ling sections plant birthwort Aristolochia debilis Sieb.et Zucc..Blackberry lily selects iris
The dry rhizome of section plant blackberry lily Belamcanda chinensis (L.) DC..Schizonepeta selects labiate schizonepeta
The dry aerial parts of Schizonepeta tenuifolia Briq..
Compared with prior art, pharmaceutical composition of the invention can promote ciliary movement, improve eustachian tube function, effectively pre-
Caused secretory otitis media after anti-radiotherapy, to reach reduce radiotherapy after secretory otitis media incidence.In addition, this hair
Bright preparation method is simple, at low cost, drug safety, convenient, has no adverse reaction, and is provided for Patients with Nasopharyngeal Carcinoma in Radiation Therapy a kind of anti-
Control economy, the effective ways of irradiation complication.
Specific implementation mode
The following is specific embodiments of the present invention, and technical scheme of the present invention is further described, but of the invention
Protection domain be not limited to these examples.It is every to be included in this hair without departing substantially from the change of present inventive concept or equivalent substitute
Within bright protection domain.
The preparation of 1 Chinese herbal granules of embodiment
Crude drug prescription：It is Semen Benincasae 3.7kg, peach leaf 1.3kg, Sculellaria barbata 2.5kg, cucumber stem 2.5kg, semen allii tuberosi 0.8kg, big
Leafiness 1.2kg, birthwort 0.8kg, blackberry lily 0.8kg, schizonepeta 0.8kg.
Preparation process：Above-mentioned traditional Chinese medicinal material raw materials are weighed by recipe quantity, merges, adds water to cook twice, for the first time plus water is medicine
12 times of amounts of material weight, decoction 1.5h add water for 10 times of amounts of medicinal material weight for the second time, decoction 1.5h, collecting decoction,
The medicinal extract that relative density is 1.15 when being concentrated under reduced pressure into 65 DEG C at 0.07MPa, 60-70 DEG C, adds 95% (v/v) ethyl alcohol to make alcohol content
Up to 75% (v/v), stirring stands 24 hours, filtering, and filtrate is concentrated under reduced pressure under the conditions of 0.07MPa, 65 DEG C to 65 DEG C of phases
It is 1.25 to density, and recycles ethyl alcohol, obtain concentrate, (condition is that inlet air temperature is 100 DEG C, outlet air by concentrate spray drying
Temperature is 80 DEG C, and temperature of charge is 80 DEG C, and atomizing pressure is 0.2 megapascal, spray velocity 5ml/s.), 80 mesh sieve is crushed, is obtained
To clear cream powder；According to clear cream powder: clear cream powder and dextrin input groove profile are mixed in dextrin=1: 4 weight ratio weighs clear cream powder, dextrin
In conjunction machine, stirs 20 minutes, the ethyl alcohol of appropriate volume a concentration of 55% is slowly added into while stirring, until softwood is made, with 12 mesh
Stainless steel sieve granulation, 65~75 DEG C of drying 2 hours are taken out, and are cooled up to granule, by every bag of 15g packaging.
The preparation of 2 Chinese herbal granules of embodiment
Crude drug prescription：It is Semen Benincasae 4.0kg, peach leaf 1.8kg, Sculellaria barbata 3.0kg, cucumber stem 2.5kg, semen allii tuberosi 0.9kg, big
Leafiness 1.5kg, birthwort 0.8kg, blackberry lily 0.9kg, schizonepeta 0.7kg.
Preparation process：Above-mentioned traditional Chinese medicinal material raw materials are weighed by recipe quantity, merges, adds water to cook twice, for the first time plus water is medicine
10 times of amounts of material weight, decoction 1.5h add water for 8 times of amounts of medicinal material weight for the second time, decoction 1.5h, collecting decoction,
The medicinal extract that relative density is 1.15 when being concentrated under reduced pressure into 65 DEG C at 0.07MPa, 60-70 DEG C, adds 95% (v/v) ethyl alcohol to make alcohol content
Up to 75% (v/v), stirring stands 24 hours, filtering, and filtrate is concentrated under reduced pressure under the conditions of 0.07MPa, 65 DEG C to 65 DEG C of phases
It is 1.25 to density, and recycles ethyl alcohol, obtain concentrate, (condition is that inlet air temperature is 100 DEG C, outlet air by concentrate spray drying
Temperature is 80 DEG C, and temperature of charge is 80 DEG C, and atomizing pressure is 0.2 megapascal, spray velocity 5ml/s.), 80 mesh sieve is crushed,
Obtain clear cream powder；According to clear cream powder: clear cream powder and dextrin are put into groove profile by dextrin=1: 4 weight ratio weighs clear cream powder, dextrin
In mixing machine, stirs 20 minutes, the ethyl alcohol of appropriate volume a concentration of 55% is slowly added into while stirring, until softwood is made, with 12
The sieve granulation of mesh stainless steel, 65~75 DEG C of drying 2 hours are taken out, and are cooled up to granule, by every bag of 15g packaging.
The preparation of 3 Chinese herbal granules of embodiment
Crude drug prescription：It is Semen Benincasae 3.0kg, peach leaf 1.5kg, Sculellaria barbata 3.0kg, cucumber stem 3.0kg, semen allii tuberosi 0.8kg, big
Leafiness 1.0kg, birthwort 0.6kg, blackberry lily 0.8kg, schizonepeta 0.9kg.
Preparation process：Above-mentioned traditional Chinese medicinal material raw materials are weighed by recipe quantity, merges, adds water to cook twice, for the first time plus water is medicine
10 times of amounts of material weight, decoction 1.5h add water for 8 times of amounts of medicinal material weight for the second time, decoction 1.5h, collecting decoction,
The medicinal extract that relative density is 1.15 when being concentrated under reduced pressure into 65 DEG C at 0.07MPa, 60-70 DEG C, adds 95% (v/v) ethyl alcohol to make alcohol content
Up to 75% (v/v), stirring stands 24 hours, filtering, and filtrate is concentrated under reduced pressure under the conditions of 0.07MPa, 65 DEG C to 65 DEG C of phases
It is 1.25 to density, and recycles ethyl alcohol, obtain concentrate, (condition is that inlet air temperature is 100 DEG C, outlet air by concentrate spray drying
Temperature is 80 DEG C, and temperature of charge is 80 DEG C, and atomizing pressure is 0.2 megapascal, spray velocity 5ml/s.), 80 mesh sieve is crushed, is obtained
To clear cream powder；According to clear cream powder: clear cream powder and dextrin input groove profile are mixed in dextrin=1: 4 weight ratio weighs clear cream powder, dextrin
In conjunction machine, stirs 20 minutes, the ethyl alcohol of appropriate volume a concentration of 55% is slowly added into while stirring, until softwood is made, with 12 mesh
Stainless steel sieve granulation, 65~75 DEG C of drying 2 hours are taken out, and are cooled up to granule, by every bag of 15g packaging.
The prevention of 4 Chinese herbal granules of embodiment prevents the lanqin oral solutions of secretory otitis media in patients with nasopharyngeal carcinoma after radiotherapy
Nasopharyngeal Carcinoma Patients 48, make a definite diagnosis after pathological biopsy, wherein man 43, female 5；It is 41~77 years old age, average
49.5 ± 6.2 years old.It is randomly divided into test group and each 24 of control group, the differences such as age, gender, pathological staging of two groups of cases are equal
It is not statistically significant, it is comparable.In addition, test group and control group patient take monaural it has been observed that being checked before radiotherapy equal
Without secretory otitis media, it is all made of three-dimensional suitable row intensity-modulated radiation therapy, Radiotherapy dosimetry is 60~70Gy.
After radiotherapy starts, test group (is prepared, every bag using Chinese herbal granules of taking after mixing it with water by the formulation and technology of embodiment 1
15g), 1 bag/time, 3 times/d, oral drugs 1 month, control group is without any processing.Follow-up in 3 months after radiotherapy is observed simultaneously respectively
Record following situations：1. ear's symptom, including tinnitus, the sense of ear muffle plug and hearing loss etc.；2. eardrum inspection；3. pure tone test；
4. Tympanometry；5. eustachian tube function inspection.Tympanometry tympanogram is Type B or c-type, pure tone test are conductibility
Or mixed type deafness, otoscopy have hydrotympanum person are diagnosed as secretory otitis media.
Curative effect determinate standard：1. secretory otitis media does not occur after radiotherapy：Subjective symptom (feel in ear, under hearing by occlusion
Drop), without apparent subjective symptom；Ear examination, eardrum mark is clear, without apparent invagination and hydrops.Pure tone test (0.5,1.0 and
The Pure-tone averages of tri- class frequencys of 2.0kHz), moral character is led within range of normal value.Acoustic immittance (buckle line by tympanum
Figure), tympanogram is A type curves.2. secretory otitis media after radiotherapy：Subjective symptom has different degrees of tinnitus, ear's resistance
The symptoms such as plug sense or bored swollen sense, Hearing.Otoscopy：Eardrum have it is different degrees of invaginate, muddy or chronic congestion, or
There is hydrotympanum sign.Pure tone test shows：Different degrees of conduction deafness or mixed deafness, Tympanometry tympanogram are Type B.
Compared by symptom after the radiotherapy of table 1 as can be seen that secretory otitis media 15 (17 ear) occurs for control group, and tries
Test a group generation secretory otitis media 4 (4 ear)；There is syrigmus in control group 15 (15 ear), test group 4 (4 ear)；Control group 18
5 example (18 ear), test group 5 ears) there is ear muffle plug sense.Obviously, the symptom of test group is considerably lighter, this illustrates Chinese herbal granules
Prophylactic can reduce the incidence of secretory otitis media after radiotherapy.
Symptom compares [example (ear)] after 1 two groups of Patients Treated by Radiotherapy of table
It can be seen that by the experiment measurement result of table 2 and treat the not statistically significant difference of preceding two groups of air conduction hearing threshold mean values
Different (P > 0.05), the air conduction hearing threshold mean value after treatment have pole significant difference (P < 0.01), this further illustrates Chinese medicine
Granula prophylactic can reduce the incidence of secretory otitis media after radiotherapy.
Air conduction hearing threshold mean value compares (dB HL) before and after 2 two groups of Patients Treated by Radiotherapy of table
Compared with the control group, * P < 0.01.
Claims (3)
1. a kind of application of pharmaceutical composition in the drug for preparing prevention secretory otitis media in patients with nasopharyngeal carcinoma after radiotherapy, feature exist
In：The pharmaceutical composition is prepared by following traditional Chinese medicinal material raw materials by weight：30-45 parts of Semen Benincasae, 9-18 parts of peach leaf,
21-30 parts of Sculellaria barbata, 21-30 parts of cucumber stem, 6-9 parts of semen allii tuberosi, 9-15 parts of folium isatidis, 6-9 parts of birthwort, 6-9 parts of blackberry lily, chaste tree
6-9 parts of mustard；
The preparation method of the pharmaceutical composition, includes the following steps：By recipe quantity weigh 30-45 parts of Semen Benincasae, 9-18 parts of peach leaf,
21-30 parts of Sculellaria barbata, 21-30 parts of cucumber stem, 6-9 parts of semen allii tuberosi, 9-15 parts of folium isatidis, 6-9 parts of birthwort, 6-9 parts of blackberry lily and
6-9 parts of schizonepeta, merging, adds water to cook twice, and first time adds water to be that 10-12 times of medicinal material weight is measured, and decocts 1-2h, adds for the second time
Water is that 8-10 times of medicinal material weight is measured, decoction 1-2h, collecting decoction, and 65 DEG C of phases are concentrated under reduced pressure at 0.07MPa, 60-70 DEG C
The medicinal extract for being 1.15 to density adds 95% ethyl alcohol of v/v that alcohol content is made to reach v/v 75%, and stirring stands 24 hours, filtering, filtrate
It is 1.25 that relative density when to 65 DEG C is concentrated under reduced pressure under the conditions of 0.07MPa, 65 DEG C, and recycles ethyl alcohol, obtains concentrate, will be dense
Contracting liquid is spray-dried, and be crushed 80 mesh sieve, is obtained clear cream powder；According to clear cream powder: the weight ratio of dextrin 1: 3~5 weigh clear cream powder,
Dextrin stirs 20 minutes by clear cream powder and dextrin input trough type mixing machine, is slowly added into 55% ethyl alcohol while stirring, until system
It at softwood, is sieved and is pelletized with 12 mesh stainless steels, 65~75 DEG C of drying 2 hours take out, cool granule to obtain the final product.
2. application according to claim 1, it is characterised in that：By weight, the traditional Chinese medicinal material raw materials are by Semen Benincasae
36-38 parts, 11-15 parts of peach leaf, 24-26 parts of Sculellaria barbata, 24-26 parts of cucumber stem, 7-8 parts of semen allii tuberosi, 11-13 parts of folium isatidis, horse
7-8 parts of 7-8 parts of pocket bell, 7-8 parts of blackberry lily and schizonepeta compositions.
3. application according to claim 2, it is characterised in that：By weight, the traditional Chinese medicinal material raw materials are by Semen Benincasae
37 parts, 13 parts of peach leaf, 25 parts of Sculellaria barbata, 25 parts of cucumber stem, 8 parts of semen allii tuberosi, 12 parts of folium isatidis, 8 parts of birthwort, 8 parts of blackberry lily and
8 parts of compositions of schizonepeta.
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101104031A (en) * | 2007-06-29 | 2008-01-16 | 李文 | Internal-applied traditional Chinese medicine composition for treating nasopharyngeal cancer |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| EP3508197A1 (en) * | 2009-10-21 | 2019-07-10 | Otonomy, Inc. | Modulation of gel temperature of poloxamer-containing formulations |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101104031A (en) * | 2007-06-29 | 2008-01-16 | 李文 | Internal-applied traditional Chinese medicine composition for treating nasopharyngeal cancer |
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| Title |
|---|
| 中医药治疗鼻咽癌放射后毒副反应;方基水等;《安徽中医临床杂志》;19961231;第8卷(第5期);第218页，尤其是左栏2放疗毒副反应的治疗原则，3常用中药 * |
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