CN104784441A - Pharmaceutical composition for preventing and treating complications after nasopharynx cancer radiation treatment - Google Patents

Pharmaceutical composition for preventing and treating complications after nasopharynx cancer radiation treatment Download PDF

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CN104784441A
CN104784441A CN201510194259.9A CN201510194259A CN104784441A CN 104784441 A CN104784441 A CN 104784441A CN 201510194259 A CN201510194259 A CN 201510194259A CN 104784441 A CN104784441 A CN 104784441A
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parts
pharmaceutical composition
nasopharyngeal carcinoma
raw materials
traditional chinese
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CN104784441B (en
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侯立泳
谭作华
邵纬
傅雪茜
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TRADITIONAL CHINESE MEDICAL Co.
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侯立泳
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Abstract

The invention discloses a pharmaceutical composition for preventing and treating complications after rhinopharynx cancer radiation treatment. The medicine composition is prepared from traditional Chinese medicinal raw materials in parts by weight: 30 to 45 parts of wax gourd seeds, 9 to 18 parts of peach leaves, 21 to 30 parts of barbed skullcap herbs, 21 to 30 parts of cucumber stems, 6 to 9 parts of semen allii tuberosi, 9 to 15 parts of folium isatidis, 6 to 9 parts of pipevine, 6 to 9 parts of pardanthus, and 6 to 9 parts of herba schizonepetae. The pharmaceutical composition provided by the invention can promote ciliary motion, improve otosalpinx functions, and can effectively preventing secretory otitis media caused by radiation treatment, thereby achieving the purpose of lowering the generating rate of secretory otitis media after radiation treatment.

Description

A kind of pharmaceutical composition preventing and treating nasopharyngeal carcinoma radiotherapy infectious-related complication
Technical field
The invention belongs to technical field of Chinese medicine, in particular to a kind of pharmaceutical composition preventing and treating nasopharyngeal carcinoma radiotherapy infectious-related complication.
Background technology
Nasopharyngeal carcinoma ranks first at hals,Nasen und Ohrenheilkunde tumor incidence, and the first-selected radiotherapy of therapeutic modality, secretory otitis media is the common complication after nasopharyngeal carcinoma radiotherapy.Because in radiotherapy, middle ear pharyngotympanic tube is in high dose area, is inevitably subject to radiation injury, causes the generation of secretory otitis media.Main manifestations is the symptoms such as tinnitus, ear are vexed, auditory dysesthesia, and a lot of scholar thinks that secretory otitis media occurring after nasopharyngeal carcinoma radiotherapy all damages relevant with eustachian tube function.
The object of secretory otitis media treatment removes middle ear effusion, improvement and recovery middle ear normal ventilation and salpingian function.In order to reduce the exposure dose of ear, the scholars such as Lu Taixiang are studied, but effect not obvious (Lu Taixiang, Luo Wei, Zhao Chong etc.; The wild discussion [J] of establishing wild method of nasopharyngeal carcinoma low melting-point alloy lead face neck associating. cancer, 2000,19 (12): 930-931).After radiotherapy, secretory otitis media at present more adopts grommet insertion, easily causes the auditory function infringement even at a specified future date of intractable otorrhea (Zhou Yong, Tang Anzhou; The progress [J] of secretory otitis media in patients with nasopharyngeal carcinoma after radiotherapy. oncology's magazine, 2002,8 (1): 49-49).Intractable otorrhea incidence rate is up to 68% to have research to confirm abroad.
The generation of secretory otitis media after radiotherapy and Eustachian tube disfunction (YAFFE K in close relations is shown through large quantity research, HAAN M, BYERS A, et a l.Estrogenuse, APOE, and cognitive decline:evidence of gene environment interaction [J] .Neurology, 2000,109:1949-1954), current various clinical treatment curative effect is not satisfied, and therefore how simply and effectively for, after preventive radiotherapy, the generation of secretory otitis media is particularly important.
Summary of the invention
In view of the deficiencies in the prior art, the object of the present invention is to provide a kind of determined curative effect, few side effects and the pharmaceutical composition of cheap control nasopharyngeal carcinoma radiotherapy infectious-related complication and application thereof.
The object of the present invention is achieved like this:
A kind of pharmaceutical composition preventing and treating nasopharyngeal carcinoma radiotherapy infectious-related complication, be prepared from by traditional Chinese medicinal material raw materials, by weight, described traditional Chinese medicinal material raw materials comprises: Semen Benincasae 30-45 part, Folium Persicae 9-18 part, Herba Scutellariae Barbatae 21-30 part, Caulis Cucumidis sativiv 21-30 part, Semen Allii Tuberosi 6-9 part, Folium Isatidis 9-15 part, Fructus Aristolochiae 6-9 part, Rhizoma Belamcandae 6-9 part, Herba Schizonepetae 6-9 part.
Preferably, the pharmaceutical composition of control nasopharyngeal carcinoma radiotherapy infectious-related complication described above, by weight, described traditional Chinese medicinal material raw materials is made up of Semen Benincasae 36-38 part, Folium Persicae 11-15 part, Herba Scutellariae Barbatae 24-26 part, Caulis Cucumidis sativiv 24-26 part, Semen Allii Tuberosi 7-8 part, Folium Isatidis 11-13 part, Fructus Aristolochiae 7-8 part, Rhizoma Belamcandae 7-8 part and Herba Schizonepetae 7-8 part.
In a most preferred embodiment of the present invention, the pharmaceutical composition of control nasopharyngeal carcinoma radiotherapy infectious-related complication described above, by weight, described traditional Chinese medicinal material raw materials is made up of Semen Benincasae 37 parts, Folium Persicae 13 parts, Herba Scutellariae Barbatae 25 parts, Caulis Cucumidis sativiv 25 parts, Semen Allii Tuberosi 8 parts, Folium Isatidis 12 parts, Fructus Aristolochiae 8 parts, Rhizoma Belamcandae 8 parts and Herba Schizonepetae 8 parts.
Further preferably, the pharmaceutical composition of control nasopharyngeal carcinoma radiotherapy infectious-related complication as mentioned above, it is solid orally ingestible, is preferably granule, oral liquid, tablet, capsule.
Above-mentioned each Chinese crude drug is prepared into the preparation method of compound granule of the present invention, comprise the steps: to take Semen Benincasae 30-45 part by recipe quantity, Folium Persicae 9-18 part, Herba Scutellariae Barbatae 21-30 part, Caulis Cucumidis sativiv 21-30 part, Semen Allii Tuberosi 6-9 part, Folium Isatidis 9-15 part, Fructus Aristolochiae 6-9 part, Rhizoma Belamcandae 6-9 part and Herba Schizonepetae 6-9 part, merge, decoct with water twice, first time adds water as the 10-12 times amount of medical material weight, decoct 1-2h, second time adds water as the 8-10 times amount of medical material weight, decoct 1-2h, collecting decoction, 0.07MPa, when being evaporated to 65 DEG C at 60-70 DEG C, relative density is the extractum of 1.15, adding 95% (v/v) ethanol makes alcohol content reach 75% (v/v), stir, leave standstill 24 hours, filter, filtrate is at 0.07MPa, under 65 DEG C of conditions, concentrating under reduced pressure one-tenth is 1.25 to relative density when 65 DEG C, and reclaim ethanol, obtain concentrated solution, by concentrated solution spraying dry, (condition is inlet temperature is 100 DEG C, leaving air temp is 80 DEG C, temperature of charge is 80 DEG C, atomizing pressure is 0.2 MPa, spray velocity is 5ml/s.), pulverize 80 mesh sieves, obtain clear paste powder; According to clear paste powder: the weight ratio of dextrin 1: 3 ~ 5 takes clear paste powder, dextrin, clear paste powder and dextrin are dropped in trough type mixing machine, stir 20 minutes, slowly add 55% ethanol while stirring, to making soft material, granulate with 12 order stainless steel sifts, 65 ~ 75 DEG C of dryings 2 hours, take out, cool and obtain described granule.
It should be noted that, the traditional Chinese medicinal material raw materials that pharmaceutical composition of the present invention adopts has following source: Semen Benincasae selects the dry seed of cucurbitaceous plant Fructus Benincasae Benincasa hispida (Thunb.) Cogn..Folium Persicae selects the dried leaves of rosaceous plant Fructus Persicae Prunuspersica (L.) Batsch.Herba Scutellariae Barbatae selects the dry herb of labiate Herba Scutellariae Barbatae Scutellaria barbata Don [S.rivularis Wall].Caulis Cucumidis sativiv selects the dry rattan of cucurbitaceous plant Fructus Cucumidis sativi Cucumis sativus L..Semen Allii Tuberosi selects the dry mature seed of liliaceous plant Folium Allii tuberosi Allium tuberosum Rottl..Folium Isatidis selects the dried leaves of cruciferae isatis Isatis indigotica Fort..The dry mature fruit of aristolochiaceae plant Fructus Aristolochiae Aristolochia debilis Sieb.et Zucc. selected by Fructus Aristolochiae.Rhizoma Belamcandae selects the dry rhizome of irides Rhizoma Belamcandae Belamcanda chinensis (L.) DC..Herba Schizonepetae selects the dry aerial parts of labiate Herba Schizonepetae Schizonepeta tenuifolia Briq..
Compared with prior art, pharmaceutical composition of the present invention can promote ciliary movement, improves eustachian tube function, the secretory otitis media caused after effective preventive radiotherapy, thus reaches the incidence rate reducing secretory otitis media after radiotherapy.In addition, preparation method of the present invention is simple, and cost is low, drug safety, convenient, has no adverse reaction, for Patients with Nasopharyngeal Carcinoma in Radiation Therapy provides a kind of economy, the effective ways of preventing and treating irradiation complication.
Detailed description of the invention
Be below specific embodiments of the invention, technical scheme of the present invention is done to describing further, but protection scope of the present invention be not limited to these embodiments.Every do not deviate from the present invention's design change or equivalent substituting include within protection scope of the present invention.
The preparation of embodiment 1 Chinese medicine granules
Crude drug prescription: Semen Benincasae 3.7kg, Folium Persicae 1.3kg, Herba Scutellariae Barbatae 2.5kg, Caulis Cucumidis sativiv 2.5kg, Semen Allii Tuberosi 0.8kg, Folium Isatidis 1.2kg, Fructus Aristolochiae 0.8kg, Rhizoma Belamcandae 0.8kg, Herba Schizonepetae 0.8kg.
Preparation technology: take above-mentioned traditional Chinese medicinal material raw materials by recipe quantity, merge, decoct with water twice, first time adds water as 12 times amount of medical material weight, decoct 1.5h, second time adds water as 10 times amount of medical material weight, decoct 1.5h, collecting decoction, 0.07MPa, when being evaporated to 65 DEG C at 60-70 DEG C, relative density is the extractum of 1.15, adding 95% (v/v) ethanol makes alcohol content reach 75% (v/v), stir, leave standstill 24 hours, filter, filtrate is at 0.07MPa, under 65 DEG C of conditions, concentrating under reduced pressure one-tenth is 1.25 to relative density when 65 DEG C, and reclaim ethanol, obtain concentrated solution, by concentrated solution spraying dry, (condition is inlet temperature is 100 DEG C, leaving air temp is 80 DEG C, temperature of charge is 80 DEG C, atomizing pressure is 0.2 MPa, spray velocity is 5ml/s.), pulverize 80 mesh sieves, obtain clear paste powder; According to clear paste powder: dextrin=1: the weight ratio of 4 takes clear paste powder, dextrin, clear paste powder and dextrin are dropped in trough type mixing machine, stir 20 minutes, slowly adding the ethanol that appropriate volume concentration is 55% while stirring, to making soft material, granulating with 12 order stainless steel sifts, 65 ~ 75 DEG C of dryings 2 hours, take out, cool and obtain granule, by every bag of 15g packaging.
The preparation of embodiment 2 Chinese medicine granules
Crude drug prescription: Semen Benincasae 4.0kg, Folium Persicae 1.8kg, Herba Scutellariae Barbatae 3.0kg, Caulis Cucumidis sativiv 2.5kg, Semen Allii Tuberosi 0.9kg, Folium Isatidis 1.5kg, Fructus Aristolochiae 0.8kg, Rhizoma Belamcandae 0.9kg, Herba Schizonepetae 0.7kg.
Preparation technology: take above-mentioned traditional Chinese medicinal material raw materials by recipe quantity, merge, decoct with water twice, first time adds water as 10 times amount of medical material weight, decoct 1.5h, second time adds water as 8 times amount of medical material weight, decoct 1.5h, collecting decoction, 0.07MPa, when being evaporated to 65 DEG C at 60-70 DEG C, relative density is the extractum of 1.15, adding 95% (v/v) ethanol makes alcohol content reach 75% (v/v), stir, leave standstill 24 hours, filter, filtrate is at 0.07MPa, under 65 DEG C of conditions, concentrating under reduced pressure one-tenth is 1.25 to relative density when 65 DEG C, and reclaim ethanol, obtain concentrated solution, by concentrated solution spraying dry, (condition is inlet temperature is 100 DEG C, leaving air temp is 80 DEG C, temperature of charge is 80 DEG C, atomizing pressure is 0.2 MPa, spray velocity is 5ml/s.), pulverize 80 mesh sieves, obtain clear paste powder; According to clear paste powder: dextrin=1: the weight ratio of 4 takes clear paste powder, dextrin, clear paste powder and dextrin are dropped in trough type mixing machine, stir 20 minutes, slowly adding the ethanol that appropriate volume concentration is 55% while stirring, to making soft material, granulating with 12 order stainless steel sifts, 65 ~ 75 DEG C of dryings 2 hours, take out, cool and obtain granule, by every bag of 15g packaging.
The preparation of embodiment 3 Chinese medicine granules
Crude drug prescription: Semen Benincasae 3.0kg, Folium Persicae 1.5kg, Herba Scutellariae Barbatae 3.0kg, Caulis Cucumidis sativiv 3.0kg, Semen Allii Tuberosi 0.8kg, Folium Isatidis 1.0kg, Fructus Aristolochiae 0.6kg, Rhizoma Belamcandae 0.8kg, Herba Schizonepetae 0.9kg.
Preparation technology: take above-mentioned traditional Chinese medicinal material raw materials by recipe quantity, merge, decoct with water twice, first time adds water as 10 times amount of medical material weight, decoct 1.5h, second time adds water as 8 times amount of medical material weight, decoct 1.5h, collecting decoction, 0.07MPa, when being evaporated to 65 DEG C at 60-70 DEG C, relative density is the extractum of 1.15, adding 95% (v/v) ethanol makes alcohol content reach 75% (v/v), stir, leave standstill 24 hours, filter, filtrate is at 0.07MPa, under 65 DEG C of conditions, concentrating under reduced pressure one-tenth is 1.25 to relative density when 65 DEG C, and reclaim ethanol, obtain concentrated solution, by concentrated solution spraying dry, (condition is inlet temperature is 100 DEG C, leaving air temp is 80 DEG C, temperature of charge is 80 DEG C, atomizing pressure is 0.2 MPa, spray velocity is 5ml/s.), pulverize 80 mesh sieves, obtain clear paste powder; According to clear paste powder: dextrin=1: the weight ratio of 4 takes clear paste powder, dextrin, clear paste powder and dextrin are dropped in trough type mixing machine, stir 20 minutes, slowly adding the ethanol that appropriate volume concentration is 55% while stirring, to making soft material, granulating with 12 order stainless steel sifts, 65 ~ 75 DEG C of dryings 2 hours, take out, cool and obtain granule, by every bag of 15g packaging.
The lanqin oral solutions of embodiment 4 Chinese medicine granules control prevention secretory otitis media in patients with nasopharyngeal carcinoma after radiotherapy
Nasopharyngeal Carcinoma Patients 48 example, makes a definite diagnosis after pathological biopsy, wherein man 43 example, female 5 example; 41 ~ 77 years old age, average 49.5 ± 6.2 years old.Be divided into test group and each 24 examples of matched group at random, the equal not statistically significant of difference such as age, sex, pathological staging of two groups of cases, has comparability.In addition, test group and matched group patient all get monaural and observe discovery, check all without secretory otitis media before radiotherapy, and all employing is three-dimensional fits row Intensity Modulation Radiated Therapy (IMRT), and Radiotherapy dosimetry is 60 ~ 70Gy.
After radiotherapy starts, test group adopts Chinese medicine granules (being prepared from by the formulation and technology of embodiment 1, every bag of 15g) of taking after mixing it with water, and 1 bag/time, 3 times/d, oral drugs 1 month, matched group is left intact.After radiotherapy 3 months with examining, observe respectively and record following situations: 1. ear's symptom, comprising the vexed plug sense of tinnitus, ear and hearing loss etc.; 2. tympanum inspection; 3. pure tone test; 4. Tympanometry; 5. eustachian tube function inspection.Tympanometry tympanogram is Type B or C type, pure tone test is conductivity or mixed type deafness, otoscopy have hydrotympanum person is diagnosed as secretory otitis media.
Curative effect determinate standard: 1. after radiotherapy, secretory otitis media does not occur: subjective symptom (sense of in ear obturation, auditory dysesthesia), without obvious subjective symptom; Ear examination, tympanum mark is clear, without obviously caving in and hydrops.The pure tone test Pure-tone averages of 2.0kHz tri-class frequency (0.5,1.0 and), moral character is led all within range of normal value.Acoustic immitance (tympanum buckle line chart), tympanogram is A type curve.2. secretory otitis media after radiotherapy: subjective symptom has tinnitus in various degree, ear blocks the symptoms such as sense or vexed swollen sense, auditory dysesthesia.Otoscopy: tympanum all has caving in various degree, muddy or chronic congestion, or has hydrotympanum to levy.Pure tone test shows: conductive deafness in various degree or mixed deafness, and Tympanometry tympanogram is Type B.
Relatively can be found out by symptom after the radiotherapy of table 1, matched group generation secretory otitis media 15 example (17 ear), and test group generation secretory otitis media 4 example (4 ear); Matched group 15 example (15 ear), test group 4 example (4 ear) occur ear toot; Matched group 18 example (18 ear), test group 5 example 5 ear) there is the vexed plug sense of ear.Obviously, the symptom of test group is obviously comparatively light, and this illustrates that Chinese medicine granules prophylactic can reduce the incidence rate of secretory otitis media after radiotherapy.
After table 1 liang group Patients Treated by Radiotherapy, symptom compares [example (ear)]
Can be found out by the test determination result of table 2, treat the difference (P > 0.05) of front two groups of air conduction hearing threshold average not statistically significants, air conduction hearing threshold average after treatment has pole significant difference (P < 0.01), and this further illustrates the incidence rate that Chinese medicine granules prophylactic can reduce secretory otitis media after radiotherapy.
Air conduction hearing threshold Average value compare (dB HL) before and after table 2 liang group Patients Treated by Radiotherapy
Compared with matched group, * P < 0.01.

Claims (6)

1. prevent and treat the pharmaceutical composition of nasopharyngeal carcinoma radiotherapy infectious-related complication for one kind, it is characterized in that: this pharmaceutical composition is prepared from by traditional Chinese medicinal material raw materials, by weight, described traditional Chinese medicinal material raw materials comprises: Semen Benincasae 30-45 part, Folium Persicae 9-18 part, Herba Scutellariae Barbatae 21-30 part, Caulis Cucumidis sativiv 21-30 part, Semen Allii Tuberosi 6-9 part, Folium Isatidis 9-15 part, Fructus Aristolochiae 6-9 part, Rhizoma Belamcandae 6-9 part, Herba Schizonepetae 6-9 part.
2. prevent and treat the pharmaceutical composition of nasopharyngeal carcinoma radiotherapy infectious-related complication according to claim 1, it is characterized in that: by weight, described traditional Chinese medicinal material raw materials is made up of Semen Benincasae 36-38 part, Folium Persicae 11-15 part, Herba Scutellariae Barbatae 24-26 part, Caulis Cucumidis sativiv 24-26 part, Semen Allii Tuberosi 7-8 part, Folium Isatidis 11-13 part, Fructus Aristolochiae 7-8 part, Rhizoma Belamcandae 7-8 part and Herba Schizonepetae 7-8 part.
3. prevent and treat the pharmaceutical composition of nasopharyngeal carcinoma radiotherapy infectious-related complication according to claim 2, it is characterized in that: by weight, described traditional Chinese medicinal material raw materials is made up of Semen Benincasae 37 parts, Folium Persicae 13 parts, Herba Scutellariae Barbatae 25 parts, Caulis Cucumidis sativiv 25 parts, Semen Allii Tuberosi 8 parts, Folium Isatidis 12 parts, Fructus Aristolochiae 8 parts, Rhizoma Belamcandae 8 parts and Herba Schizonepetae 8 parts.
4. claim 1 or the medicinal raw material compositions described in 2 or 3 application in the medicine of preparation control nasopharyngeal carcinoma radiotherapy infectious-related complication.
5. application according to claim 4, is characterized in that, described medicine is oral formulations, comprises oral liquid, granule, tablet, capsule.
6. application according to claim 4, is characterized in that, described nasopharyngeal carcinoma radiotherapy infectious-related complication is secretory otitis media.
CN201510194259.9A 2015-04-23 2015-04-23 A kind of pharmaceutical composition of prevention nasopharyngeal carcinoma radiotherapy infectious-related complication Expired - Fee Related CN104784441B (en)

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Citations (2)

* Cited by examiner, † Cited by third party
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
WO2011049958A2 (en) * 2009-10-21 2011-04-28 Otonomy, Inc. Modulation of gel temperature of poloxamer-containing formulations

Patent Citations (2)

* Cited by examiner, † Cited by third party
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
WO2011049958A2 (en) * 2009-10-21 2011-04-28 Otonomy, Inc. Modulation of gel temperature of poloxamer-containing formulations

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
孙永章: "《中医药防治肿瘤特技集成》", 31 January 1997, 北京科学技术出版社 *
方基水等: "中医药治疗鼻咽癌放射后毒副反应", 《安徽中医临床杂志》 *

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