CN1223139A - Yanminling nose-spraying agent and preparation process - Google Patents

Yanminling nose-spraying agent and preparation process Download PDF

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Publication number
CN1223139A
CN1223139A CN98122221A CN98122221A CN1223139A CN 1223139 A CN1223139 A CN 1223139A CN 98122221 A CN98122221 A CN 98122221A CN 98122221 A CN98122221 A CN 98122221A CN 1223139 A CN1223139 A CN 1223139A
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yanminling
kilograms
nasal spray
desirable
filtrate
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CN1065766C (en
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黄意
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Lin Zhanchao
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Lin Zhanchao
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Abstract

The present invention relates to a nasal spray Yanbiling and its preparation process. It is characterized by that the preparation of 30 kg of said nasal spray requires 1.95-2.05 kg of aloe, 7-8kg of magnolia liliflora, 7-8 kg of xanthium fruit, 14.5-15.5 kg of (dried) Herba centipedae, 4.5-5.5 kg of mint and 9-11g of musk, and its preparation process includes the following steps: steam distillation of Herba centipedae, magnolia liliflora and mint, collecting distillates, decocting the medicine residue and xanthium fruit twice, for 2 hr every time; combining decoctions, filtering, concentrating filtrate, using 75% alcohol to resolve aloe and combining that with the concentrated filtrate, adding 65% alcohol to make precipitation for 24 hr, taking out supernatant fluid, recovering alcohol, adding musk in the obtained liquid medicine, filtering, adding the obtained filtrate into the above-mentioned distillate and adding a proper quantity of distilled water so as to obtain the invented product.

Description

Yanminling nasal spray and manufacturing process thereof
The present invention relates to a kind of prescription and manufacturing process thereof, particularly a kind of Yanminling nasal spray and manufacturing process thereof.
" the spray nose therapeutic agent " that has gone on the market at present nearly all contains the composition of vasoconstrictor, and be different just different to the size of nasal mucosa vessels contraction intensity and lasting time length; Because of having the side effect of knock-on property blood vessel dilating, vasoconstrictor is known as the medicine of " curing the symptoms, not the disease " by the medical worker; The patient is dripped with behind this class medicine, and nose can obtain ventilation soon, but after the property of medicine, blood vessel is the expansion of knock-on property, and the nasal mucosa congestion and edema more very causes the ventilation drain of nose worse, and nasal obstruction more very.The patient is dripped repeatedly with this class medicine, cause the nasal mucosa pipe one to contract and one relax repeatedly, for a long time it, blood vessel elasticity forfeiture causes vicious cycle, medicine that at first can very fast acquisition BITONG gas, gradually, nasal conchae hypertrophy or nasal polyp have occurred, this medicine drips to such an extent that how also can't improve BITONG gas again, has to go for the rhinologist at last part concha nasalis inferior or nasal polyp excision are just obtained BITONG gas preferably.
Chronic sinusitis, polypous etiology are very complicated, patient's part and general immunity situation, the participation of allergy factor, the problem of special infection, anatomical abnormalities or the like all has close dependency with typing (by stages) and cure rate, the success of nasal endoscope operation has only solved anatomical unusual ventilation drainage problem that reaches nasal sinuses, in addition the problems referred to above also need rely on and postoperatively follow up a case by regular visits to, the processing in art chamber, the more important thing is local and the raising of general immunity function, the elimination of allergy factor and the control of special infection.
The object of the present invention is to provide a kind of ventilation drain that improves nose by antiinflammatory, detumescence and microcirculation improvement, and, thereby can eliminate allergy factor, the special infection of control and improve the Yanminling nasal spray and the manufacturing process thereof of patient's immunologic function with nasal endoscope operation back partner treatment.
Purpose of the present invention can reach by following measure: the present invention makes 30 kilograms of nasal sprays needs Aloe 1.95-2.05 kilogram, Flos Magnoliae 7-8 kilogram, Fructus Xanthii 7-8 kilogram, Herba Centipedae (doing) 14.5-15.5 kilogram, Herba Menthae 4.5-5.5 kilogram, Moschus 9-11 gram.The manufacturing process of nasal spray is: get Herba Centipedae, Flos Magnoliae, Herba Menthae are used steam distillation, collect distillate, again its medicinal residues and Fructus Xanthii are decocted with water twice, each two hours, collecting decoction, filter, filtrate is concentrated in right amount, merge with 75% ethanol dissolving Aloe and concentrated filtrate, add 65% alcohol precipitation 24 hours, and got supernatant, recovered alcohol, the gained medicinal liquid adds Moschus, filter, add above-mentioned distillate, add an amount of distilled water promptly to get filtrate.
Purpose of the present invention can also reach by following measure: desirable 2 kilograms of Aloe of the present invention, desirable 7.5 kilograms of Flos Magnoliae, desirable 7.5 kilograms of Fructus Xanthii, desirable 15 kilograms of Herba Centipedae (doing), desirable 5 kilograms of Herba Menthae, desirable 10 grams of Moschus.
The present invention will now be further detailed embodiment:
Embodiment one
Get 14.5 kilograms of Herba Centipedae (doing), 8 kilograms of Flos Magnoliae, Herba Menthae and use steam distillation for 4.5 kilograms, collect distillate, again its medicinal residues and Fructus Xanthii are decocted with water twice for 8 kilograms, each two hours, collecting decoction, filtration is concentrated into filtrate in right amount.Merge with 2.05 kilograms of 75% ethanol dissolving Aloes and concentrated filtrate; Added 65% alcohol precipitation 24 hours, and got supernatant, recovered alcohol, gained medicinal liquid add Moschus 9 grams, filter.Gained filtrate adds above-mentioned distillate, adds about 30,000 milliliters of an amount of distilled water, promptly obtains 30 kilograms of nasal spray solution of the present invention.
Embodiment two
Get 15.5 kilograms of Herba Centipedae (doing), 7 kilograms of Flos Magnoliae, Herba Menthae and use steam distillation for 5.5 kilograms, collect distillate, again its medicinal residues and Fructus Xanthii are decocted with water twice for 7 kilograms, each two hours, collecting decoction, filtration is concentrated into filtrate in right amount.Merge with 1.95 kilograms of 75% ethanol dissolving Aloes and concentrated filtrate; Added 65% alcohol precipitation 24 hours, and got supernatant, recovered alcohol, gained medicinal liquid add Moschus 11 grams, filter.Gained filtrate adds above-mentioned distillate, adds about 30,000 milliliters of an amount of distilled water, promptly obtains 30 kilograms of nasal spray solution of the present invention.
Embodiment three
Get 15 kilograms of Herba Centipedae (doing), 7.5 kilograms of Flos Magnoliae, Herba Menthae and use steam distillation for 2 kilograms, collect distillate, again its medicinal residues and Fructus Xanthii are decocted with water twice for 7.5 kilograms, each two hours, collecting decoction, filtration is concentrated into filtrate in right amount.Merge with 2 kilograms of 75% ethanol dissolving Aloes and concentrated filtrate; Added 65% alcohol precipitation 24 hours, and got supernatant, recovered alcohol, gained medicinal liquid add Moschus 10 grams, filter.Gained filtrate adds above-mentioned distillate, adds about 30,000 milliliters of an amount of distilled water, promptly obtains 30 kilograms of nasal spray solution of the present invention.
The present invention has following advantage compared to existing technology:
1, improve the ventilation drain of nose by antiinflammatory, detumescence and microcirculation improvement, not knock-on property blood vessel dilating effect, it is good more to reach more the collunarium ventilation, the final purpose that obtains recovery from illness.
2, can the allergy of elimination factor be arranged at nasal endoscope operation back partner treatment, the effect of controlling special infection and improving patient's immunologic function has further improved cure rate.
The present invention is with " Yanminling syrup (being made up of medicines such as the Radix Astragali, Mahonia fortunei (Lindl.) Fedde, flea body, Herba Scutellariae Barbatae, Radix Trichosanthis, Polyporus, Spina Gleditsiae, Rhizoma Chuanxiong, Flos Magnoliae) is used, and its effect is more obvious with a series of.See Yanminling oral agents and the report of Yanminling nasal spray pharmacodynamic experiment done in following Guangdong Pharmaceutical University scientific research place for details:
One, gets given the test agent Yanminling oral agents concentrated extract (10g crude drug/ml) and Yanminling nasal spray (0.8g crude drug/ml).And Kunming mouse, male and female dual-purpose, body weight 18-22g; The SD rat, male and female dual-purpose, body weight 770-210g.
Two, method and result
The hexichol first is caused the inhibitory action of mice ear
Get 60 of mices, male and female half and half, be divided into 6 groups at random, it is matched group, the aspirin group, Yanminling oral agents (high dose group, low dose group), Yanminling nasal spray (high dose group, low dose group), oral administration 3 days, matched group is given the normal saline with volume, 30min after last administration in the 3rd day, cause inflammation outside being applied to 0.05ml dimethylbenzene in each mouse right ear, put to death animal behind the 1h, clip left and right sides auricle, getting the ears sheet with diameter 9mm card punch weighs respectively, about the difference of two auricle weight be the swelling degree, the result shows (table 1), Yanminling oral agents and Yanminling nasal spray xylol cause mice ear the obvious suppression effect.Table 1. Yanminling oral agents and Yanminling nasal spray are right
The inhibitory action of mice caused by dimethylbenzene xylene ear swelling
Dosage (g/kg) Poor (mg) of left and right sides ear weight
Matched group aspirin Yanminling oral agents Yanminling nasal spray ????0.1 ????20 ????10 ????20 ????10 ????21.0±2.9 ????8.9±2.4** ????13.6±3.3** ????15.9±3.6* ????14.7±3.5** ????18.1±3.2*
* p<0.01, * p<0.05 and matched group relatively cause 60 of the inhibitory action rats of rat paw edema to Ovum Gallus domesticus album, male and female half and half random packet is the same, successive administration 7 days, with capillary tube measurement by magnification method survey respectively cause scorching before and after 30min and 1,3, the right back sufficient sole of the foot volume of 6h, obtain its swelling rate by following formula, swelling rate (%)=(Vt-Vn)/Vn, Vn wherein, Vt represents respectively and causes the sufficient sole of the foot volumetric values in scorching front and back, and rat is 30min after the last administration, and 100% fresh Ovum Gallus domesticus album (0.1ml/ only) is caused inflammation in right back sufficient plantar subcutaneous injection, the result shows (table 2), and Yanminling oral agents and Yanminling nasal spray cause rat paw edema to Ovum Gallus domesticus album the obvious suppression effect.Table 2. Yanminling oral agents and Yanminling nasal spray cause the inhibitory action of rat paw edema to Ovum Gallus domesticus album
Group dosage (g/kg) Pedal swelling rate (%)
????30min ????1h ????3h ????6h
Matched group aspirin 0.1 Yanminling oral agents 20 10 Yanminling nasal sprays 20 10 45.9±12.4 28.6±12.3** 25.3±10.8** 34.3±11.1** 30.7±10.5* 33.4±14.8* 60.6±13.9 30.7±11.2** 36.9±13.4** 42.6±15.8** 35.5±13.2** 47.6±12.1* 58.g±11.9 29.9±10.2** 33.8±12.3** 40.6±10.7** 35.2±12.4** 44.9±11.5* 59.4±13.8 31.4±12.8** 36.2±10.3** 39.7±11.7** 36.3±18.3** 47.9±12.5
* p<0.01, compare with matched group * p<0.05
To the bullate influence of rat granuloma
Rat male and female half and half random packet is as table, routine disinfection left and right sides armpit, skin incision 0.5cm, to be dipped in 0.1mg ampicillin dry sterilization cotton balls (20mg/) sews up in the posting port respectively, administration 7 days, dosage is the same, put to death animal in the 8th day, open otch, peel off granuloma induced by implantation of cotton pellets, 2h in 60 ℃ of baking ovens, weighing respectively deducts the former weight of cotton balls, clear granuloma weight, and the result shows, heavy dose of Yanminling oral agents and Yanminling nasal spray form performance the obvious suppression effect are arranged rat granuloma is swollen, and low dose of Yanminling oral agents and Yanminling nasal spray to rat granuloma swollen form to show inhibiting trend (table 3) is arranged.Table 3. Yanminling oral agents and Yanminling nasal spray are to rat
The influence of granuloma induced by implantation of cotton pellets
Dosage (g/kg) the internal bud dry weight (mg) that swells
Control group 44.8 ± 9.8 aspirin 0.1 32.7 ± 11.2* Yanminling oral agents 20 35.4 ± 9.3* 10 36.8 ± 9.5 Yanminling nasal sprays 20 34.5 ± 10.2* 10 37.4 ± 8.4
* compare with matched group p<0.05
Determination of acute toxicity
30 of mices are divided into 2 groups at random, respectively oral Yanminling oral agents 200g/kg and Yanminling nasal spray 24g/kg (disposable oral administration), observed 7 days, 2 groups of mice behaviors as a result are active, and the water inlet feed is normal, hair is smooth, none is only dead, said preparation concentration, and volume has reached maximum, can not survey LD50, real genus is safe in utilization, because people's consumption of Yanminling oral agents is 0.25g/kg every day.
The Yanminling nasal spray is to the nasal membrane irritant test
20 of Cavia porcelluss, body weight 200-250g, male and female half and half are divided into two groups at random: i.e. matched group, Yanminling nasal spray group.Click and enter concentration 0.8g crude drug/ml Yanminling nasal spray 0.5ml in the every 10min of administration group Cavia porcellus nasal cavity; Matched group Cavia porcellus nasal cavity is clicked and entered with the volume aquae destillata, continuity point medicine 5h, in the some medicine process, all animals all occur choking and cough physiological reaction, in the rest point process, all animal activities freely, hair color is smooth, no hogback, perpendicular hairs etc. are symptom unusually.The 24h overall health of patients is no abnormal after observing all animal subject administrations, each group is got 5 sacrifice of animal, anatomical isolation goes out nasal mucosa, and larynx mucosa, tunica mucosa tracheae, bronchial mucosa, lung tissue are done pathology histology procuratorial work, as a result all tested animals above-mentioned organize no abnormal.Each group residue animal was observed 7 days, and diet drinking-water is normal, all animal activities freely, hair color is smooth.
The skin irritation test
4 of male rabbits of white, body weight 2.0-2.5kg, injured skin with the depilation of rabbit back vertebra both sides and not before the experiment, the depilation area is both sides 5 * 10cm.A depilation district makes the normal skin irritant test, is divided into administration district and check plot.Smear Yanminling nasal spray (0.8g/ml) 0.2ml check plot and smear the equivalent tap water in the administration district, cover with the two-layer gauze of one deck oilpaper, the reuse immobilization with adhesive tape, another piece depilation district makes the injured skin irritant test, abrade in depilation zoning # type with syringe needle before the administration, diameter 2cm is to stab wound epidermis, do not hinder corium, have slight oozing of blood to be degree.The coating method is the same, and opposite side compares.24h after the administration cleans medicinal liquid with wet gauze, writes down the situation that erythema and edema appear in 1,24,48 and 72 medicine-feeding parts respectively, according to the form below scoring stimulus intensity.
Skin irritation extent of reaction standards of grading
Erythema Integration Edema Integration
The obvious erythema moderate of the inadequate erythema of no erythema is to severe erythema purple erythema and eschar ????0 ????1 ????2 ????3 ????4 The reluctantly visible cutaneous protuberance profile of no edema knows that edema swells about 1 and expanded range ????0 ????1 ????2 ????3
This is tested and observes the Yanminling nasal spray normal skin and injured skin are had zest.
To Immune Effects
(1) the mice carbon granule is cleaned up the influence of function
Get 50 of mices and be divided into 5 groups at random, be respectively matched group, scorching Hou spirit oral agents group (20,10g/kg) and Yanminling nasal spray group (20,10g/kg).Every day, mouth was raised administration, and contrast is given with the volume normal saline, successive administration 7 days, and 1h is by tail vein injection carbon ink 0.1ml/kg after the last administration.Then 2, draw 0.020ml blood at mice eye rear vein beard with sharp mouth suction pipe (use in advance heparin moistening) during 10min, add aquae destillata 4ml, shake up, measure absorbance (0D) value at wavelength 600nm place, calculate phagocytic index K by following formula with 721 type spectrophotometers. K = log 0 D 2 - log 0 D 10 t 10 - t 2 Matched group K value is 0.0109 ± 0.0026 as a result, and Yanminling oral agents high and low dose group is respectively 0.0135 ± 0.0037 (compare with matched group P<0.05) and 0.0122 ± 0.0028 (compare with matched group P>0.05); Yanminling nasal spray high and low dose group 0.0130 ± 0.0038 and 0.0126 ± 0.00292, relatively not have significance poor with matched group.
(2) to the influence of delayed hypersensitivity reaction due to the dinitrofluorobenzene (DNFB)
Get 50 of mices and be divided into 5 groups at random, the grouping administration is the same.Sensitization began administration, successive administration 7 days the same day.Preceding 3 days of sensitization, mouse back is stuck with paste depilation with sodium sulfide and is cleaned up, only on depilation portion skin, dripped 1%DNFB acetone soln 100 μ L/ to the 3rd day, 1h reuse 1%DNFB acetone soln 50 μ L attack outside being applied in the mouse right ear portion after the last administration, put to death animal behind the 24h, clip left and right sides ear is got left and right sides ear weighing with diameter 9mm card punch, and the difference of the two weight is the swelling degree.The difference of matched group left and right sides ear weight is 18.7 ± 3.9mg as a result; Yanminling oral agents high and low dose group is respectively 20.5 ± 3.9 and 19.1 ± 3.1, and Yanminling nasal spray high and low dose group is respectively 19.5 ± 4.1 and 16.9 ± 2.4, compares there was no significant difference with matched group.
Three, conclusion
Yanminling oral agents and Yanminling nasal spray have antiinflammatory action, show xylol cause the mice ear inhibitory action, to Ovum Gallus domesticus album cause the inhibitory action of rat paw edema, to the bullate inhibitory action of rat granuloma.
Little to Immune Effects, high dose Yanminling oral agents can promote the mice carbon granule to clean up function, and Yanminling oral agents and Yanminling nasal spray do not have tangible influence to delayed hypersensitivity reaction due to the dinitrofluorobenzene (DNFB).
Yanminling oral agents and Yanminling nasal spray oral toxicity are very little, and skin is had no stimulation.The Yanminling nasal spray to nasal membrane, larynx mucosa, tunica mucosa tracheae, bronchial mucosa, lung tissue is non-stimulated and damaging action.Effect safety.

Claims (3)

1, a kind of Yanminling nasal spray and manufacturing process thereof is characterized in that: making 30 kilograms of nasal sprays needs Aloe 1.95-2.05 kilogram, Flos Magnoliae 7-8 kilogram, Fructus Xanthii 7-8 kilogram, Herba Centipedae (doing) 14.5-15.5 kilogram, Herba Menthae 4.5-5.5 kilogram, Moschus 9-11 gram.
2, nasal spray according to claim 1 and manufacturing process thereof is characterized in that: desirable 2 kilograms of described Aloe, desirable 7.5 kilograms of Flos Magnoliae, desirable 7.5 kilograms of Fructus Xanthii, desirable 15 kilograms of Herba Centipedae (doing), desirable 5 kilograms of Herba Menthae, desirable 10 grams of Moschus.
3, a kind of Yanminling nasal spray and manufacturing process thereof, it is characterized in that: the manufacturing process of nasal spray is: get Herba Centipedae, Flos Magnoliae, Herba Menthae are used steam distillation, collect distillate, again its medicinal residues and Fructus Xanthii are decocted with water twice, each two hours, collecting decoction, filter, filtrate is concentrated in right amount, merges, added 65% alcohol precipitation 24 hours with 75% ethanol dissolving Aloe and concentrated filtrate, get supernatant, recovered alcohol, the gained medicinal liquid adds Moschus, filters, add above-mentioned distillate to get filtrate, add an amount of distilled water promptly.
CN98122221A 1998-11-24 1998-11-24 Yanminling nose-spraying agent and preparation process Expired - Fee Related CN1065766C (en)

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004060382A1 (en) * 2003-01-06 2004-07-22 Linlin Yao A method and device for preparing liquid
CN101554403B (en) * 2009-05-26 2011-06-01 曹书光 Medicament for treating rhinitis and preparation method thereof
CN101306090B (en) * 2008-06-10 2011-09-21 叶明伟 Nasal fumigation medicaments for treating chronic simple rhinitis
CN106389631A (en) * 2016-01-16 2017-02-15 谢宁 External nasal patch for purifying dirty air and treating rhinitis
CN107625874A (en) * 2017-09-25 2018-01-26 佛山市佛禅健康管理有限公司 A kind of rhinitis mist fumigant and preparation method thereof

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CN101474256B (en) * 2008-12-31 2011-11-30 四川禾邦阳光制药股份有限公司 Siberian cocklebur fruit soft capsule preparation for treating rhinitis and preparation method thereof
CN101474255B (en) * 2008-12-31 2011-11-30 四川禾邦阳光制药股份有限公司 Detection method of siberian cocklebur fruit capsule for treating rhinitis

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004060382A1 (en) * 2003-01-06 2004-07-22 Linlin Yao A method and device for preparing liquid
US7770511B2 (en) 2003-01-06 2010-08-10 Shenzhen Zofu Technology Co., Ltd. Method and device for preparing liquid
US8021520B2 (en) 2003-01-06 2011-09-20 Shenzhen Zofu Technology Co., Ltd Method and device for preparing liquid
CN101306090B (en) * 2008-06-10 2011-09-21 叶明伟 Nasal fumigation medicaments for treating chronic simple rhinitis
CN101554403B (en) * 2009-05-26 2011-06-01 曹书光 Medicament for treating rhinitis and preparation method thereof
CN106389631A (en) * 2016-01-16 2017-02-15 谢宁 External nasal patch for purifying dirty air and treating rhinitis
CN107625874A (en) * 2017-09-25 2018-01-26 佛山市佛禅健康管理有限公司 A kind of rhinitis mist fumigant and preparation method thereof

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