CN100542597C - A kind of Chinese medicine preparation technology who treats vocal nodule, polyp of vocal cord symptom and uses thereof - Google Patents
A kind of Chinese medicine preparation technology who treats vocal nodule, polyp of vocal cord symptom and uses thereof Download PDFInfo
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Abstract
The present invention relates to preparation technology of a kind of Chinese medicine preparation and uses thereof, particularly relate to a kind of Chinese medicine preparation technology who treats vocal nodule, polyp of vocal cord symptom and uses thereof.The object of the invention is to provide a kind of preparation technology who treats the Chinese medicine preparation of vocal nodule, polyp of vocal cord symptom.Another purpose of the present invention is to be provided at the application in the medicine for the treatment of vocal nodule, polyp of vocal cord.Its process stabilizing of preparation technology of the present invention, feasible, the chlorogenic acid content of finished product has improved utilization ratio of raw materials, extraction ratio of effective constituents than former technology height; The present invention has the activating blood circulation to dissipate blood stasis function, can reduce whole blood viscosity, plasma viscosity, whole blood reduced viscosity, fibrinogen content and the attached rate of platelet; Inhibited to the chronic inflammatory disease granulation tissue hyperplasia.
Description
Technical field:
The present invention relates to preparation technology of a kind of Chinese medicine preparation and uses thereof, particularly relate to a kind of Chinese medicine preparation technology who treats vocal nodule, polyp of vocal cord symptom and uses thereof.
Background technology:
Throat disease is common clinical, frequently-occurring disease, sickness rate has growth trend in China in recent years, the ill crowd of China's throat disease constantly increases at present, according to relevant clinical medicine report, suffer from various acute and chronic laryngopharyngeal diseases patient and be about 12% of domestic total number of persons, the height of sickness rate will cause medical circle and compatriots' attention.
The at present domestic pure Chinese medicinal preparation medicine that is used for the treatment of throat disease is few in number, and it is almost very little especially to treat chronic hoarseness pure herbal species such as (vocal nodule, polyp of vocal cord, vocal cord thickening).Clinical common method is a western medical treatment, takes sound not to use the antibiotic control or the excision of performing a surgical operation, and the traditional Chinese medical science is except that the medication of clinical diagnosis and treatment plus-minus prescription, and the Chinese medicine preparation prescription that forms determined curative effect, determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs, treating both the principal and secondary aspects of a disease is still rare.
CN1544077A discloses a kind of " Chinese medicine of treatment throat chronic hoarseness symptom ", the preparation technology of its tablet, capsule loses more in the concentration process of raw material, spissated extractum density is unfavorable for mixing, be difficult for dry, take a lot of work, time-consuming, and utilization ratio of raw materials, extraction ratio of effective constituents are not high.In commercial production, how to guarantee that the every batch of finished product total amount produced that feeds intake can keep stable in the amplitude of the permission that national drug is managed, stable by every data of national legal drug inspection and result simultaneously, the favorable reproducibility of experiment is an important techniques key point.Therefore it is stable, efficient to seek to study finished product, and the medicine series of the various laryngopharyngeal diseasess of long-acting treatment has important practical sense.
Summary of the invention:
The object of the invention is to provide a kind of preparation technology who treats the Chinese medicine preparation of vocal nodule, polyp of vocal cord symptom.
Another purpose of the present invention is to be provided at the application in the medicine for the treatment of vocal nodule, polyp of vocal cord.
The present invention seeks to be achieved through the following technical solutions:
Get Flos Lonicerae, Bulbus Fritillariae Thunbergii, the Flos Carthami of recipe quantity 40%-60%, the Lasiosphaera Seu Calvatia of recipe quantity 10%-30% is ground into fine powder, sieve, and mixing, standby; With Rhizoma Curcumae, Semen Persicae, Radix Scrophulariae, rhizoma sparganic, Radix Salviae Miltiorrhizae, Radix Isatidis, Radix Ophiopogonis, Rhizoma Alismatis, Endothelium Corneum Gigeriae Galli, Periostracum Cicadae, Semen Oroxyli, Herba Taraxaci and Flos Lonicerae, Bulbus Fritillariae Thunbergii, Flos Carthami, surplus adds 8-12 doubly after the pulverizing of Lasiosphaera Seu Calvatia four Chinese medicine, 6-10 times of decocting boils secondary, each 1-3 hour, collecting decoction, filter, filtrate is concentrated into the thick paste that relative density is 1.28～1.32 (60 ℃), adding 90%-100% ethanol makes the alcohol amount of containing reach 50-70%, stir, left standstill 12-36 hour, filter, filtrate recycling ethanol, being evaporated to relative density is the clear paste of 1.38～1.40 (60 ℃); The fine powder and the appropriate amount of auxiliary materials mixing that add preparation, drying is pulverized, and makes fine particle, promptly.
Its process stabilizing of preparation technology of the present invention, feasible, the chlorogenic acid content of finished product has improved utilization ratio of raw materials, extraction ratio of effective constituents than former technology height; The present invention has the activating blood circulation to dissipate blood stasis function, can reduce whole blood viscosity, plasma viscosity, whole blood reduced viscosity, fibrinogen content and the attached rate of platelet; Inhibited to the chronic inflammatory disease granulation tissue hyperplasia.The finished product treatment vocal nodule of extraction process by water preparation, total effective rate 56.67%, the treatment polyp of vocal cord, total effective rate is 36.67%; The finished product treatment vocal nodule of aqueous extraction-alcohol precipitation technology preparation, total effective rate 90.00%, treatment polyp of vocal cord, total effective rate 86.67%; Thereby improved the clinical efficacy for the treatment of vocal nodule, polyp of vocal cord disease.
The specific embodiment
Following experimental example is used to further specify the present invention.
Experimental example 1 extraction process by water is preferred
According to the extraction process by water analysis of influential factors, select amount of water, decocting time, decoction number of times as principal element, use orthogonal experiment, serve as the investigation index with the rate of transform of dried cream amount and chlorogenic acid, filter out optimum process condition.
1, the investigation of medical material water absorption:
In above-mentioned prescription ratio, take by weighing water and carry part medical material 149.3g altogether, add 10 times of water gagings and be dipped to the heart, filter, recording average water absorption rate is 208%.
2, Orthogonal Experiment and Design
Through factors such as the related extraction time of extraction process, extraction time, amount of water are analyzed contrast, each designs 3 levels, and the design factor water-glass sees Table 1.
Table 1 water is carried orthogonal test factor level table
Annotate:
*Be respectively amount of water in the bracket the 2nd, 3 time
3, test method
In above-mentioned recipe quantity ratio, take by weighing water and carry part medical material 149.3g, totally 9 parts, according to L
9(3
4) test (table 2) of orthogonal table design, decoct with water, filter, measure filtrate volume.Measure the paste-forming rate and the chlorogenic acid rate of transform, the results are shown in Table 2, table 3.
The calculating of dried cream amount: the accurate subsequent filtrate 25ml that draws, put in the evaporating dish that is dried to constant weight, water bath method, 105 ℃ of dryings 3 hours were put in the exsiccator cooling 30 minutes, weighed rapidly, calculated dried cream amount.
The mensuration of chlorogenic acid content:
Chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; Acetonitrile-0.4% phosphoric acid solution (10:90) is a mobile phase; The detection wavelength is 327nm.Number of theoretical plate calculates by the chlorogenic acid peak should be not less than 2500.
It is an amount of that the preparation precision of reference substance solution takes by weighing the chlorogenic acid reference substance, puts in the brown volumetric flask, adds 50% methanol and make the solution that every 1ml contains 10 μ g, promptly.
The preparation precision of need testing solution is measured above-mentioned filtrate 10ml and is put in the 25ml measuring bottle, adds 50% methanol 10ml, and supersound process 30 minutes is put coldly, adds 50% methanol to scale, shakes up, promptly.
Accurate respectively reference substance solution and each the 5 μ l of need testing solution of drawing of algoscopy inject chromatograph of liquid, measure, promptly.
Table 2 L
9(3)
4The orthogonal experiments table
Table 3 The results of analysis of variance
F
0.05(2，2)＝19.00 F
0.01(2，2)＝99.00
According to intuitive analysis in conjunction with variance analysis, it is A that water is carried optimum process condition
2B
2C
3, but C
2With C
3Very approaching, from saving the energy and man-hour, the optimum extraction process condition is A
2B
2C
2, promptly decocting boils secondary, adds 10 times of water gagings for the first time, adds 8 times of water gagings, each 2 hours for the second time.
4. the checking of extraction process by water
In above-mentioned recipe quantity ratio, take by weighing water and carry part medical material 149.3g, totally 3 parts, decoct with water secondary, add 10 times of water gagings for the first time, add 8 times of water gagings, each 2 hours for the second time.Filter, measure the paste-forming rate and the chlorogenic acid rate of transform, the results are shown in Table 4
Table 4 extraction process by water checking result
As seen from Table 5, checking result and orthogonal experiments basically identical.Illustrate that this technology is rationally feasible.So determine that decocting boils secondary, add 10 times of water gagings for the first time, add 8 times of water gagings, each 2 hours for the second time.
Experimental example 2 alcohol precipitation processes are preferred
1, the screening of precipitate with ethanol condition
The water extract of medical material is because of the easy moisture absorption of abstract and impurity are bigger, so in preparation process, tackle it and carry out alcohol and handle, to keep effective ingredient, remove impurity, reduce dose, therefore, to the total paste volume and the chlorogenic acid content of variable concentrations alcohol post precipitation, investigate.Starch, mucilaginous decocting liquid will be arranged by the alcohol deposition method purification process.After the precipitate with ethanol influence factor analyzed, select alcohol precipitation concentration (A), relative density of medicine liquid (B), time of repose (C), press L9 (3) 4 and design orthogonal tests, carry out analysis-by-synthesis as evaluation index with the rate of transform of dried cream amount and chlorogenic acid.The design factor water-glass sees Table 5.
Table 54 factors 3 are horizontally shown
Annotate: 60 ℃ of surveys of relative density.
Experimental technique: in the prescription ratio, each 1/2 amount of Flos Lonicerae, Bulbus Fritillariae Thunbergii, Flos Carthami that takes by weighing is beaten powder, the Lasiosphaera Seu Calvatia sieve is got outside the 6.7g fine powder, take by weighing the surplus 1493.1g of all the other 12 flavors and above-mentioned four Chinese medicine material, decoct with water twice, each 2 hours, amount of water was respectively 10 times, 8 times of medical material total amount, merging filtrate is operated by the requirement of orthogonal test scheme then.The results are shown in Table 6,7.
Table 6 L
9(3)
4The orthogonal experiments table
The comprehensive grading standard: regulation chlorogenic acid rate of transform Y full marks 60 minutes, put forward the test gained rate of transform according to water, regulation is full marks with the rate of transform 40%, and per 1% is 1.5 minutes, and scoring is Y * 1.5; Paste-forming rate X full marks 40 minutes stipulate that according to the mobility scale of paste-forming rate 10% is 0 minute, and 6% is 40 minutes, and every increase by 1% deducts 40/ (10-6) and divides, and scoring is [40-40/4 (X-6)]; Binomial index total points 100 minutes, overall score are counted Y * 1.5+[40-40/4 (X-6)].
Table 7 The results of analysis of variance
F
0.05(2，2)＝19.00 F
0.01(2，2)＝99.00
In conjunction with variance analysis, the A factor influences the tool significance to the chlorogenic acid rate of transform and the rate of extract according to intuitive analysis, reduces the ethanol consumption and shortens the production cycle in considering to produce, and determines A
2B
3C
1Be optimum extraction process.
Experimental example 3 aqueous extraction-alcohol precipitation technologies and extraction process by water are preferred
The parameter of determining according to above-mentioned extraction process by water and aqueous extraction-alcohol precipitation technology feeds intake by 10 times of amounts of prescription and to carry out middle trial production, shaped granule is investigated, relatively two kinds of technology similarities and differences.
1. three batches of pilot product result of the tests relatively
Three batches of pilot product result of the tests see Table 8.
Three batches of pilot product result of the tests of table 8 different process
* A is an extraction process by water, and B is an aqueous extraction-alcohol precipitation technology
As can be seen from the above table, extraction process by water extracts the extractum amount and dried cream amount is all more, differing greatly between batch, and the technology instability, dried cream amount is many, does not reach the purpose that reduces dose.Aqueous extraction-alcohol precipitation technology has effectively been removed dis-medicinal part, has kept effective ingredient, and parameter stability between the technology, dose meet national drug consumption regulation.
2. granule draws moist investigation
Take by weighing each about 100g of shaped granule that this product aqueous extraction-alcohol precipitation technology and extraction process by water are made respectively, be positioned over (35 ℃ of temperature, relative humidity 70%) under the natural conditions, surveyed its water absorption rate once, and the results are shown in Table 9 in per 24 hours.
Table 9 different process draws moist test
* A is an extraction process by water, and B is an aqueous extraction-alcohol precipitation technology
By last table result as can be seen, its average water absorption rate of the finished product of aqueous extraction-alcohol precipitation technology preparation changes little, and stability of sample is better.
3. mobility of particle is investigated
The flowability of the shaped granule of this product aqueous extraction-alcohol precipitation technology and extraction process by water being made with self-control " funnel " method is checked, the results are shown in Table 10,11.
Table 10 different process fluidity testing
* A is an extraction process by water, and B is an aqueous extraction-alcohol precipitation technology
Table 11 different process content measurement result angle of repose
* A is an extraction process by water, and B is an aqueous extraction-alcohol precipitation technology
By last table result as can be seen, the finished particle of aqueous extraction-alcohol precipitation technology preparation is better mobile, is easy to particulate filling and packing, is fit to large-scale production.
4. product quality analysis
The shaped granule that aqueous extraction-alcohol precipitation technology and extraction process by water are made detects according to the quality standard of working out, and investigates the influence of different process to product quality, thereby determines rational production technology.Experimental result sees Table 12.
Three batches of different process product quality analysis of table 12
* A is an extraction process by water, and B is an aqueous extraction-alcohol precipitation technology
By the result of last table as can be seen, the non-medicinal component that extraction process by water proposes is more, has disturbed the detection to drug standard, can not accurately control drug quality, the technology instability; The sample of aqueous extraction-alcohol precipitation technology differentiates that Xiang Junneng detects, and chlorogenic acid content is higher, and the diversity of content is little, shows that the technology stability behind the precipitate with ethanol is good.
5. product stability analysis
Capsule to aqueous extraction-alcohol precipitation technology and extraction process by water are made carries out accelerated test, in temperature (40 ± 2) ℃, placed six months under the condition of relative humidity (70 ± 5) %, sampling in every month detects once, detects by stable high spot reviews project, the results are shown in Table 13,14.
Table 13 extraction process by water is made finished product stability and is detected
Table 14 aqueous extraction-alcohol precipitation technology is made finished product stability and is detected
* A is an extraction process by water, and B is an aqueous extraction-alcohol precipitation technology
By table 10,11 as can be seen, the sample of extraction process by water has disturbed the detection to drug standard because the non-medicinal component that proposes is more, and the content difference opposite sex is big and hygroscopicity is big; The sample of aqueous extraction-alcohol precipitation technology detects according to the quality standard of working out, and differentiates that Xiang Junneng detects, and content of hesperidin is higher, and the diversity of content is little, shows that the technology stability behind the precipitate with ethanol is good.
The research of experimental example 4 antiinflammatory actions
Anti-chronic inflammatory disease test (rat cotton balls hypodermic implantation)
Be subjected to the reagent thing:
Title: Jinsangsanjie capsule
Character: content is tan granule and powder; Feeble QI, mildly bitter flavor.
The unit of providing: the Forest of Steles in Xi'an pharmaceutical factory of traditional Chinese medicine
Lot number: water extract-alcohol precipitation extract capsule 940303; Water extract capsule 940301
Content: water extract-alcohol precipitation extract capsule 940303 0.4g/ grains
Water extract capsule 940301 0.4g/ grains
Contrast medicine and main agents method: prednisone sheet [accurate word (1993) is defended No. 000532 in Shan], Xi'an pharmaceutical factory produces, lot number 9303145; FUFANG DANSHEN PIAN [ZZ-0253-Austria defends the accurate word (1996) of medicine No. 132170], White Cloud Mountain, Guangzhou pharmaceutical factory produces, lot number: 94021436.
Instrument LG-III type rotation cartridge type blood viscosity tester, Sensitive Technology Co. of the Chinese Academy of Sciences produces; 9103-B platelet adhesion instrument, Sensitive Technology Co. of the Chinese Academy of Sciences produces; 3F-3 type high speed microcentrifuge, wheel company of Huaxing produces; Reading microscope, Changchun No.1 optical Instrument Plant production; The JA1003 electronic balance, Shanghai Precision Scientific Apparatus Co., Ltd produces.
Animal subject SD strain rat, body constitution amount: 200-250g ♂ ♀ half and half.The moving card of Shan doctor word 08-005 number is provided by Xian Medical Univ's Experimental Animal Center.
Experiment room temperature: 20-26 ℃ relative humidity: 42-76%.
Experimental technique and result
Get 80 of rats, male and female half and half are divided into 8 groups at random, 10 every group.First group is the blank group, gives the isometric(al) normal saline; Second group of positive matched group (prednisone sheet 8mg/kg); 3rd, 4,5 groups is Jinsangsanjie water extract Capsules group (0.2142g, 0.4284g, 0.8568g/kg crude drug); 6th, 7,8 groups is Jinsangsanjie water extract-alcohol precipitation extract capsule group (0.2142g, 0.4284g, 0.8568g/kg crude drug).Under the shallow fiber crops of ether, the cropping sterilization.The sterile working, in hypogastric region medisection skin, it is subcutaneous that the sterilization cotton balls of heavy 50mg is implanted the both sides groin, and skin suture is sterilized then.Begin the ig administration from the preceding 3d that performs the operation, 2ml/100g, 1 time/day, continuous 10d.D11 puts to death rat, carefully peels off the granulation tissue of taking out cotton balls and parcel, weighs behind 60 ℃ of dry 12h, deducts the raw cotton ball weight and is granulation tissue weight, represents with the contained granulation tissue weight of 100g body weight (bilateral).Check through t.The results are shown in Table 15.
Two kinds of Jinsangsanjie capsules of table 15 are to the influence of rat chronic hypertrophy inflammation (X ± S)
Compare * P＜0.05 * * P＜0.01 with the blank group
By table 15 as seen, Jinsangsanjie water extract-alcohol precipitation extract capsule and water extract capsule suppress the swollen hamartoplasia of rat granuloma, alleviate granulation tissue weight and blank group relatively, all have significant difference (P＜0.01); The result shows that the Jinsangsanjie capsule of two kinds of different process productions all has inhibitory action to rat chronic cotton balls proliferative inflammation, but Jinsangsanjie water extract-alcohol precipitation extract capsule drug effect is better than the water extract capsule.
The research of experimental example 5 function of promoting blood circulation to disperse blood clots
Influence to stasis syndrome model of a syndrome hemorheology of rat
Be subjected to the reagent thing:
Title: Jinsangsanjie capsule
Character: content is tan granule and powder; Feeble QI, mildly bitter flavor.
The unit of providing: the Forest of Steles in Xi'an pharmaceutical factory of traditional Chinese medicine
Lot number: water extract-alcohol precipitation extract capsule 940303; Water extract capsule 940301
Content: water extract-alcohol precipitation extract capsule 940303 0.4g/ grains
Water extract capsule 940301 0.4g/ grains
90 of rats, male and female half and half are divided into 9 groups at random, 10 every group.First group is the blank group, gives the isometric(al) normal saline; Second group is model control group, gives the isometric(al) normal saline; The 3rd group of positive matched group given FUFANG DANSHEN PIAN 0.6g/kg; 4th, 5,6 groups is Jinsangsanjie water extract group (0.2142g, 0.4284g, 0.8568g/kg crude drug); 7th, 8,9 groups is Jinsangsanjie water extract-alcohol precipitation extract group (0.2142g, 0.4284g, 0.8568g/kg crude drug).The ig administration waits capacity 2ml/100g, and 1 time/day, continuous 7d.D8 is except that the blank group in test, and all the other each groups are all duplicated the stasis syndrome model of a syndrome by literature method.Every rat Sc epinephrine 8 μ g/kg immerse 5min in 0 ℃ of frozen water with rat behind the 2h, Sc equivalent epinephrine for the second time behind 2h.Fasting then, carotid artery blood sampling under the etherization behind the 12h, anticoagulant heparin is used to measure the whole blood height and cuts (200S
-1) and the low viscosity (40S that cuts
-1), erythrocyte sedimentation rate, packed cell volume and calculate the whole blood reduced viscosity; Measure the blood fibrinogen content with thermal precipitator method; Taking heparin anticoagulation centrifugal separation plasma is measured plasma viscosity in addition; Get the sodium citrate anticoagulation again, be used to measure platelet adhesion rate.Check through t.The results are shown in Table 16, table 17.
Two kinds of Jinsangsanjie capsules of table 16 are to the influence of stasis syndrome card rat blood viscosity (X ± S)
Compare * * P＜0.01 with the normal control group; Compare * P＜0.05, * * P＜0.01 with model control group
Two kinds of Jinsangsanjie capsules of table 17 are to the influence of stasis syndrome card rat serum fibrinogen content, erythrocyte sedimentation rate, platelet adhesion rate and cell pack (X ± S)
Compare * * P＜0.01 with the normal control group; Compare * P＜0.05, * * P＜0.01 with model control group
By table 16 and table 17 as seen, high shear of stasis syndrome model of a syndrome rat whole blood and low shear rate viscosity, plasma viscosity and whole blood reduced viscosity obviously increase, and the blood Fibrinogen increases, and platelet adhesion rate raises, compare with the normal control group, statistics has significant difference (P＜0.01).Compare with model control group, two kinds of Jinsangsanjie capsules all reduce the stasis syndrome card high shear of rat whole blood and low shear rate viscosity, plasma viscosity and whole blood reduced viscosity, reduce the blood fibrinogen content, in, heavy dose of group has significant difference (P＜0.05 or P＜0.01); And Jinsangsanjie water extract-alcohol precipitation extract capsule is better than the water extract capsule.Erythrocyte sedimentation rate and packed cell volume then there is not obvious influence.
Experimental example 6 Jinsangsanjie capsule for treating vocal nodulees, polyp of vocal cord clinical research
One, clinical trial
Test method
(1) experimental design
Random contrast clinical trial.Test group A organizes 60 examples, and B organizes 60 examples, determines best preparation technology.
(2) Therapeutic Method
A group: aqueous extraction-alcohol precipitation technology is produced the Jinsangsanjie capsule, specification: every dress 0.4g, every contains primary dose 2.5g, usage and dosage: oral, one time 3,2 times on the one.
B group: extraction process by water is produced the Jinsangsanjie capsule, specification: every dress 0.4g, every contains primary dose 1.25g, usage and dosage: oral, one time 6,2 times on the one.
Two groups day takes the crude drug amount and is 15g, has comparability.
The course of treatment: one month.
(3) observational technique
Before clinical trial begins, the clinicist who participates in test is unified training, make it sufficient understanding and unified understanding be arranged, guarantee every index consistency of observation testing program.
1. variable factor is controlled in the patient medical history strictness.
2. form is observed in unified design.
3. all case history choice criteria that meets are classified object of observation person as, all fill in symptom and sign and relevant every check result by the requirement of observation plan and observation table.
4. the doctor who participates in clinical trial must provide the details of relevant clinical trial to the experimenter, comprise test objective, test character, possible is benefited and dangerous, can be for other treatment side of selecting for use and meet the experimenter's that Declaration of Helsinki stipulates rights and duties etc., after being understood, the experimenter agrees.
Observation index:
1. safety observation: general physical examination.
2. health giving quality is observed: related symptoms and toposcopy.
3. observation lime light:
Related symptoms and sign: treat each observation in back 14 days, 30 days once.
Curative effect determinate standard:
1. clinical recovery: vocal nodule, polyp of vocal cord disappear transference cure.
2. produce effects: vocal nodule, polyp of vocal cord, symptom reduce by 2/3 above person.
3. effective: vocal nodule, polyp of vocal cord, symptom reduce by 1/3 above person.
4. invalid: vocal nodule, polyp of vocal cord, symptom do not have the change or the person of increasing the weight of.
The safety evaluatio standard:
1 grade: safety, there is not any untoward reaction.
2 grades: compare safety,, need not do any processing and can continue administration if any untoward reaction.
3 grades: safety issue is arranged, moderate untoward reaction is arranged, can continue administration after processing.
4 grades: because of test is ended in untoward reaction.
Two, case data
Sex: two groups of patient's sexes distribute relatively, see Table 1.
Two groups of vocal nodule patients of table 1-1 sex distributes relatively
The A group compares with the B group: X
2=0.625, P〉0.05, not statistically significant.
Two groups of polyp of vocal cord patients of table 1-2 sex distributes relatively
The A group compares with the B group: X
2=1.674, P〉0.05, not statistically significant.
Age: two groups of patient ages distribute relatively, see Table 2.
Two groups of vocal nodule patient ages distributions of table 2-1 comparison (year)
The A group compares with the B group: X2=4.132, P〉0.05, not statistically significant.
Two groups of polyp of vocal cord patient ages distributions of table 2-2 comparison (year)
The A group compares with the B group: X
2=0.552, P〉0.05, not statistically significant.
The course of disease: two groups of patient's courses of disease distribute relatively, see Table 3.
Two groups of vocal nodule patients of table 3-1 course of disease distributes relatively (moon)
The A group compares with the B group: X
2=0.119, P〉0.05, not statistically significant.
Two groups of polyp of vocal cord patients of table 3-2 course of disease distributes relatively (moon)
The A group has comparison: X with the B group
2=3.005, P〉0.05, not statistically significant.
The state of an illness: two groups of conditions of patients relatively see Table 4.
Two groups of vocal nodule conditions of patients of table 4-1 relatively
The A group compares with the B group: X
2=2.767, P〉0.05, not statistically significant.
Two groups of polyp of vocal cord conditions of patients of table 4-2 relatively
The A group compares with the B group: X
2=4.571, P〉0.05, not statistically significant.
Three, therapeutic outcome
Two groups of patient's clinical efficacies relatively see Table 5.
Two groups of vocal nodule patients of table 5-1 clinical efficacy relatively
The A group compares with the B group: U=2.1317, there is significant difference P＜0.01.
Two groups of polyp of vocal cord patients of table 5-2 clinical efficacy relatively
The A group compares with the B group: U=2.5938, there is significant difference P＜0.01.
Every symptom curative effect relatively sees Table 6 behind two groups of patient treatments.
Every symptom curative effect relatively behind two groups of vocal nodule patient treatments of table 6-1
Every symptom all has clear improvement behind two groups of vocal nodule patient treatments, and relatively, hoarseness, dry pharynx are＜0.05, and significant difference is arranged between group; Language fatigue is P＜0.01, has utmost point significance poor, and itching throat is P〉0.05, there was no significant difference.
Every symptom curative effect relatively behind two groups of polyp of vocal cord patient treatments of table 6-2
Every symptom all has clear improvement behind two groups of polyp of vocal cord patient treatments, and relatively, hoarseness, dry pharynx are＜0.05, and significant difference is arranged between group; Itching throat, language fatigue are P〉0.05, there was no significant difference.Untoward reaction: during the clinical verification, have no adverse reaction.
Four, experiment conclusion
Jinsangsanjie capsule for treating vocal nodule, polyp of vocal cord test are observed case 120 examples altogether, polyp of vocal cord 60 examples wherein, vocal nodule 60 examples.Clinical observation result: Jinsangsanjie capsule (A group) the treatment vocal nodule that aqueous extraction-alcohol precipitation technology is produced, 7 examples of wherein fully recovering, produce effects 12 examples, effective 18 examples, invalid 3 examples, total effective rate 90.00%; Jinsangsanjie capsule (B group) the treatment vocal nodule that extraction process by water is produced, 3 examples of wherein fully recovering, produce effects 4 examples, effective 10 examples, invalid 13 examples, total effective rate 56.67%.Jinsangsanjie capsule (A group) the treatment polyp of vocal cord that aqueous extraction-alcohol precipitation technology is produced, 3 examples of wherein fully recovering, produce effects 13 examples, effective 10 examples, invalid 4 examples, total effective rate 86.67%, Jinsangsanjie capsule (B group) the treatment polyp of vocal cord that extraction process by water is produced, 0 example of wherein fully recovering, produce effects 2 examples, effective 9 examples, invalid 19 examples, total effective rate 36.67%.Every tcm symptom all has clear improvement before and after the treatment.
Prescription: Lasiosphaera Seu Calvatia 25g, Rhizoma Curcumae (vinegar stir-fry) 50g, Flos Lonicerae 125g, Semen Persicae 50g, Radix Scrophulariae 125g, rhizoma sparganic (vinegar stir-fry) 50g, Flos Carthami 50g, Radix Salviae Miltiorrhizae 75g, Radix Isatidis 125g, Radix Ophiopogonis 100g, Bulbus Fritillariae Thunbergii 75g, Rhizoma Alismatis 75g, Periostracum Cicadae 75g, Endothelium Corneum Gigeriae Galli (stir-fry) 50g, Semen Oroxyli 75g, Herba Taraxaci 125g;
The processing step of specific embodiment 1 preparation tablet is as follows:
Get Flos Lonicerae, Bulbus Fritillariae Thunbergii, the Flos Carthami of recipe quantity 50%, the Lasiosphaera Seu Calvatia of recipe quantity 2% is ground into fine powder, sieve, and mixing, standby; Surplus after the pulverizing of Rhizoma Curcumae, Semen Persicae, Radix Scrophulariae, rhizoma sparganic, Radix Salviae Miltiorrhizae, Radix Isatidis, Radix Ophiopogonis, Rhizoma Alismatis, Endothelium Corneum Gigeriae Galli, Periostracum Cicadae, Semen Oroxyli, Herba Taraxaci and Flos Lonicerae, Bulbus Fritillariae Thunbergii, Flos Carthami, Lasiosphaera Seu Calvatia four Chinese medicine is added 10 times, 8 times decoctings boil secondary, each 2 hours, collecting decoction, filter, filtrate is concentrated into the thick paste that relative density is 1.28～1.32 (60 ℃), adding 95% ethanol makes and contains alcohol amount and reach 60%, stir, left standstill 24 hours, filter, filtrate recycling ethanol, being evaporated to relative density is the clear paste of 1.38～1.40 (60 ℃); The fine powder and the appropriate amount of auxiliary materials mixing that add preparation, compacting wrap film-coat, promptly in flakes.
The processing step of embodiment 2 preparation capsules is as follows:
Get Flos Lonicerae, Bulbus Fritillariae Thunbergii, the Flos Carthami of recipe quantity 50%, the Lasiosphaera Seu Calvatia of recipe quantity 2% is ground into fine powder, sieve, and mixing, standby; Surplus after the pulverizing of Rhizoma Curcumae, Semen Persicae, Radix Scrophulariae, rhizoma sparganic, Radix Salviae Miltiorrhizae, Radix Isatidis, Radix Ophiopogonis, Rhizoma Alismatis, Endothelium Corneum Gigeriae Galli, Periostracum Cicadae, Semen Oroxyli, Herba Taraxaci and Flos Lonicerae, Bulbus Fritillariae Thunbergii, Flos Carthami, Lasiosphaera Seu Calvatia four Chinese medicine is added 10 times, 8 times decoctings boil secondary, each 2 hours, collecting decoction, filter, filtrate is concentrated into the thick paste that relative density is 1.28～1.32 (60 ℃), adding 95% ethanol makes and contains alcohol amount and reach 60%, stir, left standstill 24 hours, filter, filtrate recycling ethanol, being evaporated to relative density is the clear paste of 1.38～1.40 (60 ℃); The fine powder and the appropriate amount of auxiliary materials mixing that add preparation, drying is pulverized, and makes fine particle, incapsulates, promptly.
The processing step of embodiment 3 preparation granules is as follows:
Get Flos Lonicerae, Bulbus Fritillariae Thunbergii, the Flos Carthami of recipe quantity 50%, the Lasiosphaera Seu Calvatia of recipe quantity 2% is ground into fine powder, sieve, and mixing, standby; Surplus after the pulverizing of Rhizoma Curcumae, Semen Persicae, Radix Scrophulariae, rhizoma sparganic, Radix Salviae Miltiorrhizae, Radix Isatidis, Radix Ophiopogonis, Rhizoma Alismatis, Endothelium Corneum Gigeriae Galli, Periostracum Cicadae, Semen Oroxyli, Herba Taraxaci and Flos Lonicerae, Bulbus Fritillariae Thunbergii, Flos Carthami, Lasiosphaera Seu Calvatia four Chinese medicine is added 10 times, 8 times decoctings boil secondary, each 2 hours, collecting decoction, filter, filtrate is concentrated into the thick paste that relative density is 1.28～1.32 (60 ℃), adding 95% ethanol makes and contains alcohol amount and reach 60%, stir, left standstill 24 hours, filter, filtrate recycling ethanol, being evaporated to relative density is the clear paste of 1.38～1.40 (60 ℃); The fine powder that adds preparation, mixing, drying is pulverized, and makes fine particle, and packing is promptly.
The processing step of embodiment 4 preparation soft capsules is as follows:
Get Flos Lonicerae, Bulbus Fritillariae Thunbergii, the Flos Carthami of recipe quantity 50%, the Lasiosphaera Seu Calvatia of recipe quantity 2% is ground into fine powder, sieve, and mixing, standby; Surplus after the pulverizing of Rhizoma Curcumae, Semen Persicae, Radix Scrophulariae, rhizoma sparganic, Radix Salviae Miltiorrhizae, Radix Isatidis, Radix Ophiopogonis, Rhizoma Alismatis, Endothelium Corneum Gigeriae Galli, Periostracum Cicadae, Semen Oroxyli, Herba Taraxaci and Flos Lonicerae, Bulbus Fritillariae Thunbergii, Flos Carthami, Lasiosphaera Seu Calvatia four Chinese medicine is added 10 times, 8 times decoctings boil secondary, each 2 hours, collecting decoction, filter, filtrate is concentrated into the thick paste that relative density is 1.28～1.32 (60 ℃), adding 95% ethanol makes and contains alcohol amount and reach 60%, stir, left standstill 24 hours, filter, filtrate recycling ethanol, being evaporated to relative density is the clear paste of 1.38～1.40 (60 ℃); The fine powder and the appropriate amount of auxiliary materials mixing that add preparation, drying is pulverized, and makes fine particle, adds vegetable oil, makes soft capsule, promptly.
Embodiment 5 should invention treat vocal nodule, the application in the medicine of polyp of vocal cord disease
Lasiosphaera Seu Calvatia 25g, Rhizoma Curcumae (vinegar stir-fry) 50g, Flos Lonicerae 125g, Semen Persicae 50g, Radix Scrophulariae 125g, rhizoma sparganic (vinegar stir-fry) 50g, Flos Carthami 50g, Radix Salviae Miltiorrhizae 75g, Radix Isatidis 125g, Radix Ophiopogonis 100g, Bulbus Fritillariae Thunbergii 75g, Rhizoma Alismatis 75g, Periostracum Cicadae 75g, Endothelium Corneum Gigeriae Galli (stir-fry) 50g, Semen Oroxyli 75g, Herba Taraxaci 125g, make 1000, the 0.4g/ grain is suffered from vocal nodule, the patient of polyp of vocal cord, oral, each 2-4 grain, every day 2 times.
Claims (4)
1, a kind of preparation technology who treats the Chinese medicine of vocal nodule, polyp of vocal cord symptom is characterized in that this preparation technology is:
The prescription: Lasiosphaera Seu Calvatia 25g, Rhizoma Curcumae 50g, Flos Lonicerae 125g, Semen Persicae 50g, Radix Scrophulariae 125g, rhizoma sparganic 50g, Flos Carthami 50g, Radix Salviae Miltiorrhizae 75g, Radix Isatidis 125g, Radix Ophiopogonis 100g, Bulbus Fritillariae Thunbergii 75g, Rhizoma Alismatis 75g, Periostracum Cicadae 75g, Endothelium Corneum Gigeriae Galli 50g, Semen Oroxyli 75g, Herba Taraxaci 125g;
Get Flos Lonicerae, Bulbus Fritillariae Thunbergii, the Flos Carthami of recipe quantity 40%-60%, the Lasiosphaera Seu Calvatia of recipe quantity 10%-30% is ground into fine powder, sieve, and mixing, standby; With Rhizoma Curcumae, Semen Persicae, Radix Scrophulariae, rhizoma sparganic, Radix Salviae Miltiorrhizae, Radix Isatidis, Radix Ophiopogonis, Rhizoma Alismatis, Endothelium Corneum Gigeriae Galli, Periostracum Cicadae, Semen Oroxyli, Herba Taraxaci and Flos Lonicerae, Bulbus Fritillariae Thunbergii, Flos Carthami, surplus adds 8-12 doubly after the pulverizing of Lasiosphaera Seu Calvatia four Chinese medicine, 6-10 times of decocting boils secondary, each 1-3 hour, collecting decoction, filter, in the time of 50-70 ℃, it is 1.28～1.32 thick paste that filtrate is concentrated into relative density, adding 90%-100% ethanol makes the alcohol amount of containing reach 50-70%, stir, left standstill 12-36 hour, and filtered filtrate recycling ethanol, in the time of 50-70 ℃, be evaporated to relative density and be 1.38～1.40 clear paste; The fine powder and the appropriate amount of auxiliary materials mixing that add preparation, drying is pulverized, and makes fine particle, promptly.
2, a kind of preparation technology who treats the Chinese medicine of vocal nodule, polyp of vocal cord symptom as claimed in claim 1 is characterized in that this preparation technology is:
The prescription: Lasiosphaera Seu Calvatia 25g, Rhizoma Curcumae 50g, Flos Lonicerae 125g, Semen Persicae 50g, Radix Scrophulariae 125g, rhizoma sparganic 50g, Flos Carthami 50g, Radix Salviae Miltiorrhizae 75g, Radix Isatidis 125g, Radix Ophiopogonis 100g, Bulbus Fritillariae Thunbergii 75g, Rhizoma Alismatis 75g, Periostracum Cicadae 75g, Endothelium Corneum Gigeriae Galli 50g, Semen Oroxyli 75g, Herba Taraxaci 125g;
Get Flos Lonicerae, Bulbus Fritillariae Thunbergii, the Flos Carthami of recipe quantity 50%, the Lasiosphaera Seu Calvatia of recipe quantity 20% is ground into fine powder, sieve, and mixing, standby; Surplus after the pulverizing of Rhizoma Curcumae, Semen Persicae, Radix Scrophulariae, rhizoma sparganic, Radix Salviae Miltiorrhizae, Radix Isatidis, Radix Ophiopogonis, Rhizoma Alismatis, Endothelium Corneum Gigeriae Galli, Periostracum Cicadae, Semen Oroxyli, Herba Taraxaci and Flos Lonicerae, Bulbus Fritillariae Thunbergii, Flos Carthami, Lasiosphaera Seu Calvatia four Chinese medicine is added 10 times, 8 times decoctings boil secondary, each 2 hours, collecting decoction, filter, in the time of 60 ℃, it is 1.28～1.32 thick paste that filtrate is concentrated into relative density, adding 95% ethanol makes and contains alcohol amount and reach 60%, stir, left standstill 24 hours, and filtered filtrate recycling ethanol, in the time of 60 ℃, be evaporated to relative density and be 1.38～1.40 clear paste; The fine powder and the appropriate amount of auxiliary materials mixing that add preparation, drying is pulverized, and makes fine particle, promptly.
3, Chinese medicine as claimed in claim 1 or 2 is in the application of the medicine of preparation treatment vocal nodule, polyp of vocal cord symptom, it is characterized in that: this medicine has the activating blood circulation to dissipate blood stasis function, can reduce whole blood viscosity, plasma viscosity, whole blood reduced viscosity, fibrinogen content and the attached rate of platelet; Inhibited to the chronic inflammatory disease granulation tissue hyperplasia.
4, Chinese medicine as claimed in claim 1 or 2 is characterized in that in the application of the medicine of preparation treatment vocal nodule, polyp of vocal cord symptom: this medicine is any in tablet, capsule, the granule.
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| CN102363018B (en) * | 2011-10-26 | 2013-04-03 | 西安碑林药业股份有限公司 | Throat stagnation eliminating Chinese medicinal composition and preparation method thereof |
| CN102363017B (en) * | 2011-10-26 | 2013-04-03 | 西安碑林药业股份有限公司 | Chinese medicinal composition having effects of clearing away heat and toxic materials, promoting blood circulation by removing blood stasis, removing dampness through diuresis and reducing phlegm and preparation method thereof |
| CN108042698A (en) * | 2018-01-19 | 2018-05-18 | 范鹏程 | A kind of Chinese medicine composition for being used to treat polyp of vocal cord |
| CN109820988A (en) * | 2019-04-03 | 2019-05-31 | 李瑞玉 | It is a kind of to treat the swollen object Chinese medicine composition of vocal cords and preparation method |
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Non-Patent Citations (2)
| Title |
|---|
| 金嗓散结丸药理研究、药效分析和临床观察. 傅彬.中国中西医结合耳鼻咽喉科杂志，第5卷第1期. 1997 |
| 金嗓散结丸药理研究、药效分析和临床观察. 傅彬.中国中西医结合耳鼻咽喉科杂志，第5卷第1期. 1997 * |
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