CN105560372A - Traditional Chinese medicine spray for treating rhinitis and preparation method thereof - Google Patents
Traditional Chinese medicine spray for treating rhinitis and preparation method thereof Download PDFInfo
- Publication number
- CN105560372A CN105560372A CN201610164286.6A CN201610164286A CN105560372A CN 105560372 A CN105560372 A CN 105560372A CN 201610164286 A CN201610164286 A CN 201610164286A CN 105560372 A CN105560372 A CN 105560372A
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- water
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- rhinitis
- chinese medicine
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Abstract
本发明公开了一种治疗鼻炎的中药喷雾剂及其制备方法，属于中药技术领域。制备1000mL喷雾剂由以下的中药原料组成:炮制苍耳子300～400g、黄芩200～400g、鹅不食草100～300g、细辛30～100g、儿茶100～200g、黄芪100～300g、冰片1～15g。本方中苍耳子和细辛通窍宣散，使肺气升降通畅，冰片辅助通窍宣散。黄芩清肺热，儿茶、鹅不食草佐苍耳子宣肺气，调升降。黄芪补气固表、敛疮生肌，使诸药疗效更强。其优势在于不仅苍耳子、细辛和冰片通窍，可缓解症状，而且苍耳子、黄芩杀菌及黄芪修复受损鼻腔粘膜、提高免疫力，可实现祛邪扶正、标本兼治。另外，制剂组成还有增溶剂、防腐剂和增稠剂。喷雾剂使用方便，药物直接到达作用部位，且分散程度大，利于提高疗效。可用于治疗慢性鼻炎、过敏性鼻炎和急性鼻炎，特别是对慢性鼻炎具有显著疗效。The invention discloses a traditional Chinese medicine spray for treating rhinitis and a preparation method thereof, belonging to the technical field of traditional Chinese medicines. The preparation of 1000mL spray is composed of the following traditional Chinese medicine raw materials: 300-400g of processed cocklebur, 200-400g of Scutellaria baicalensis, 100-300g of goose herb, 30-100g of asarum, 100-200g of catechu, 100-300g of astragalus, borneol 1~15g. In this prescription, cocklebur and asarum are used to open and disperse the lung qi, and the borneol assists the opening and dispersing of the lung qi. Scutellaria baicalensis clears lung-heat, catechu and goose herb are used as cocklebur to disperse lung-qi, regulate ascending and descending. Astragalus tonifies qi and solidifies the surface, suppresses sores and promotes granulation, making the curative effects of all medicines stronger. Its advantage is that not only cocklebur, asarum and borneol can relieve symptoms, but also cocklebur, scutellaria baicalensis and astragalus can repair damaged nasal mucosa and improve immunity, which can eliminate evil and strengthen the body, and treat both symptoms and root causes. In addition, the composition of the formulation also includes solubilizers, preservatives and thickeners. The spray is easy to use, and the medicine can directly reach the action site, and the degree of dispersion is large, which is beneficial to improve the curative effect. It can be used to treat chronic rhinitis, allergic rhinitis and acute rhinitis, especially for chronic rhinitis.
Description
Technical field
The invention belongs to technical field of Chinese medicines, relate to pharmaceutical dosage form, technology of preparing and application thereof, specifically a kind of medicinal herb spray for the treatment of rhinitis and preparation method thereof.
Background technology
The present invention relates to a kind of formula and the preparation technology that treat the medicinal herb spray of rhinitis.
Rhinitis also known as nasal sinusitis, the traditional Chinese medical science have in clinical syndrome differentiation deficiency and excess point, its cause of disease is outer wind, wet, heat three is evil in suffering from, no matter diseases caused by exogenous pathogenic factor or internal injury, all based on heat symptom-complex.Chronic person's deficiency complicated with excess; Rheumatism pyretic toxicity, follows through upper criminal, gathers in nose, and hole key of burning, then rhinorrhea with turbid discharge also.Modern study is thought, rhinitis be nasal mucosa or sub-mucosal tissues because viral infection, courses of infection, stimulus object stimulation etc., cause nasal mucosa or sub-mucosal tissues impaired, the acute or chronic inflammatory disease caused.Clinical manifestation is turbid nasal discharge, nasal obstruction, hyposmia, headache, and corresponding to nasal sinuses district shows as red swelling of the skin, tenderness.Shown by survey data, at present the rhinitis sickness rate of China is up to 37%, meanwhile, just has 1-3 people to suffer from allergic rhinitis in various degree in every 10 people.Rhinitis causes stuffiness of having a stuffy nose, dyspnea, causes sleep apnea syndrome, serious caused cerebral infarction, sudden heart disease etc.
The with a long history of rhinitis controlled by Chinese medicine, the drying and ripening band involucre fruit that Fructus Xanthii (FructusXanthii) is feverfew Herba Xanthii (XanthiumsibiricumPatr.), up women's head-ornaments, kind clearing the nasal passage, in Shennong's Herbal, just record effect that it has dispel the wind loose evil dehumidifying, clearing the nasal passage, be often the monarch drug of traditional Chinese medicine therapy rhinitis.Pathological experiment research is thought, the Etiological of rhinitis, sinusitis is that organism infection pathogenic bacteria and Abwehrkraft des Koepers reduce, modern pharmacological research has confirmed that Fructus Xanthii extract all has stronger inhibitory action to the multiple Grain-positives such as escherichia coli, bacillus pyocyaneus, staphylococcus aureus and gram-negative bacteria, thus plays the effect for the treatment of rhinitis.
Radix Scutellariae is labiate Radix Scutellariae (ScutellariabaicalensisGeorsi) dry root, has the effects such as heat clearing and damp drying, eliminating fire and detoxication, cooling blood for hemostasis, is one of the key agents for the treatment of by Chinese herbs rhinitis.The principle active component of Radix Scutellariae is flavonoid, and what wherein content was higher is baicalin.Modern pharmacological research shows that baicalin has broad spectrum antibiotic activity, has inhibitory action to gram positive bacterias such as staphylococcus aureus, Hemolytic streptococcus, lung inflammatory streptococcus.
Herba Centipedae is the wounded in the battle herb of Compositae Herba Hydrocotyles platymiscium Myriogyne minuta, and acrid in the mouth is warm in nature, returns lung meridian, have dispel the wind, effect of cold expelling, stuffy nose relieving plug, be used for the treatment of obstructed, the nasal sinusitis watery nasal discharge of nasal obstruction.Compendium of Material Medica: " Herba Centipedae reaches brains, stuffy nose relieving gas and the flat meat that falls; Inside reach lung meridian and control intermittent fever due to phlegm, loose skin ulcer swells; It is except the merit of nebula, outstanding aobvious wonderful.”
Herba Asari is Aristolochiales, the dry root welding technology of Aristolochiaceae Asarum Herba Asari, GUIXIN, lung, kidney channel, dispel the wind, cold expelling, Hang Shui, the effect such as to have one's ideas straightened out, be treatment nasal sinusitis common drug." medicineization justice ": " Herba Asari if in cold-evil enters, and yin channel person, is held out from interior with this.Assistant Notoptreygium Decoction of Nine Ingredients, disperses cold-evil fast, because of the pungent perfume (or spice) of its abnormal smells from the patient, therefore can rise.Enter the pungent soup of rhizome of chuanxiong, after treating ophthalmalgia, photophobia fears day, and hidden puckery difficulty is opened.Close sensible soup, loose lung qi and clearing the nasal passage.Assistant stomach-clearing decoction, gastric heat of dispelling and only having a toothache.This medicine of a warm nature enters cold agent, lid negate with assistant justice also.”
Catechu is pulse family sallee catechu heartwood or the fried powdered extract of peeling branch, and nature and flavor are pained, is slightly cold, returns lung, heart channel, have sensible removing toxic substances, effect that granulation promoting holds back wound, can be used for the treatment of rhinitis." nasal sinusitis flowing water: my child's tea dust, blows it, good in " herbal measures and weights " record." extracorporeal bacteria inhibitor test shows, catechu has inhibitory action to staphylococcus aureus, Staphylococcus albus, beta hemolytic streptococcus, bacillus pyocyaneus, diphtheria corynebacterium, Bacillus proteus etc., also has remarkable inhibitory action to virus and some fungus.
The Radix Astragali is the root of leguminous plant Radix Astagali or Radix Astragali, and nature and flavor are sweet, tepor, returns lung, spleen, liver, kidney channel.There is effect of invigorating QI to consolidate the body surface resistance, expelling pus and promoting granulation, inducing diuresis to remove edema." book on Chinese herbal medicine converges and says " carries " real arresting sweating is defended in the Radix Astragali, tonifying the lung spleen invigorating, and the medicine of wind dispelling fortune poison also ... "." book on Chinese herbal medicine meets former " carry " all void of Radix Astragali energy tonifying five ZANG-organs, controls stringy pulse spontaneous perspiration, rushes down YIN-fire, remove lung-heat, lossless, sends out, and has antiperspirant then to stop." " herbal classic " record: " main carbuncle, loses skin ulcer for a long time, evacuation of pus pain relieving.Tonify deficiency, children's's all kinds of diseases and ailments." modern study proves, Radix Astragali main component is astragalus polysaccharides, flavone compound etc., has the effect of enhancing human body immunity function.In the Chinese medicine preparation for the treatment of chronic rhinitis, the Radix Astragali becomes important Chinese medicine simply.
Borneolum Syntheticum is the crystallization obtained in the resin of Borneolum Syntheticum and volatile oil, and nature and flavor are pungent, bitter, are slightly cold, and return lung, the heart, spleen channel.Logical all keys, loose stagnated fire, removing nebula improving eyesight, reducing swelling and alleviating pain.Compendium of Material Medica: " treat sore throat, headache, breath, toothache, typhoid fever protrusion of the tongue, children's's pox falls into, logical all keys, loose pathogenic fire." " Bencao Jingshu " claim Borneolum Syntheticum " property is apt to away key, without toward does not reach ".Modern study result shows, Borneolum Syntheticum is intimate pure dextro Borneolum Syntheticum, by blood brain barrier, for its effect of having one's ideas straightened out provides foundation.When concentration is greater than 0.5% to the antibacterial such as staphylococcus, streptococcus and fungus inhibited.
Fructus Xanthii and sensible a surname of Herba Asari fall apart, and lung qi are elevated unobstructed, and Borneolum Syntheticum assists sensible a surname to fall apart.Radix Scutellariae clearing away lung-heat, catechu, Herba Centipedae assistant Fructus Xanthii lung qi dispersing gas, increase and fall, embody the marrow that Chinese medicine cacorhinia is controlled from lung.Radix Astragali invigorating QI to consolidate the body surface resistance, expelling pus and promoting granulation, make all medications imitate stronger.It is advantageous that not only Fructus Xanthii, Herba Asari and Borneolum Syntheticum are sensible, can relief of symptoms, and Fructus Xanthii, Radix Scutellariae and catechu have bactericidal action, the Radix Astragali can be repaired impaired nasal membrane, improve immunity, thus in the treatment of rhinitis, realize the effect of eliminating pathogenic factor for supporting vital QI, treating both the principal and secondary aspects of a disease.
The treatment mainly dosage form such as tablet or the oral liquid oral administration of rhinitis, side effect is large, and onset is slow.Although nasal drop is nasal-cavity administration, little with mucosal contact area, be easy to flow out, be unfavorable for the performance of curative effect of medication.
Spray is with the form administration of spraying, and easy to use, medicine directly arrives site of action, and degree of scatter is large, significantly increases the contact with mucosa, is beneficial to raising curative effect.Add thickening agent water-soluble chitosan in the formulation, reduced liquid fluidity, be conducive to the holdup time of prolong drug at nasal mucosa, improve curative effect.The chlorhexidine acetate added in preparation is on the one hand as antiseptic, and anti-bacteria increases; On the other hand, play antiinflammatory action, kill two birds with one stone.
Spray of the present invention can be used for treating chronic rhinitis, allergic rhinitis and acute rhinitis, particularly has significant curative effect to chronic rhinitis.Have and both can alleviate Rhinitis Symptoms, can therapeutical effect be realized again, and the advantage such as easy to use.
Summary of the invention
The invention provides a kind of medicinal herb spray for the treatment of rhinitis easy to use, by antiinflammatory, antiviral, detumescence, the impaired mucosa of reparation with improve the effects such as microcirculation, thus alleviate Rhinitis Symptoms and play therapeutical effect.
The technical measures adopted are:
A kind of medicinal herb spray 1000mL treating rhinitis by concocting Fructus Xanthii 200 ~ 400g, Radix Scutellariae 200 ~ 400g, Herba Centipedae 100 ~ 300g, Herba Asari 30 ~ 100g, catechu 100 ~ 200g, the Radix Astragali 100 ~ 300g, Borneolum Syntheticum 1 ~ 15g, water-soluble chitosan 1.0 ~ 3.0g, chlorhexidine acetate 1.0 ~ 2.0g, tween 80 10 ~ 50g be prepared from.
Preparation technology for: process of preparing Chinese medicine Fructus Xanthii 200 ~ 400g, the Herba Centipedae 100 ~ 300g and the Herba Asari 50 ~ 100g that get weight described in claim 1, add 6 times of water gagings, soak 2h, vapor distillation 3h extract volatile oil, for subsequent use.Get Radix Scutellariae 200 ~ 400g and the Radix Astragali 100 ~ 300g, first time adds 10 times of water gagings, soaks 2h, decocts 2h; Second time adds 8 times of water gagings, decocts 1h.By decoction liquor merge, filter, be condensed into relative density be at 60 DEG C be 1.20 clear paste.Add 95% ethanol and reach 70% to alcohol content, leave standstill, filter, decompression recycling ethanol, by for subsequent use for gained medicinal liquid.Water-soluble chitosan 1 ~ 3g injects and dissolves with water 200mL, adds catechu 100 ~ 200g and above-mentioned Radix Scutellariae, Herba Asari and Radix Astragali medicinal liquid, stirs, mixing.Get the volatile oil of said extracted, add the tween 80 of 10 ~ 50g, mix homogeneously, dissolve, inject with water 50mL dilution, merge with above-mentioned medicinal liquid.Get chlorhexidine acetate 1 ~ 2g and Borneolum Syntheticum 1 ~ 15g and add ethanol in proper amount dissolving, add in above-mentioned mixed liquor, mixing, injecting with water adjustment cumulative volume is 1000mL, and adjust pH 5.0 ~ 7.5, filters, and divides to be filled to spray in bottle, and every bottle of 100mL, to obtain final product.
Medicinal herb spray of the present invention is inhibited to staphylococcus aureus.Show the effect experiment result of Cavia porcellus allergic rhinitis caused by egg protein, the spray for treating rhinitis of preparation can obviously alleviate the symptoms such as Cavia porcellus rhinocnesmus, sneeze, watery nasal discharge, breathing, and the scoring of administration group is significantly lower than model group.Be that object of study carries out irritation on mucous membrane experiment with rat, give spray to rats with bilateral nasal cavity, each spray three times, continuous use 1 week, gets nasal mucosa and does tissue slice inspection, and mucosa, without pathological change, shows that routine dose is to nasal mucosa nonirritant.By patients with rhinitis's clinical practice spray for treating rhinitis, 4 times on the one, use 14 days continuously, effectively can eliminate or improve the Rhinitis Symptoms such as rhinocnesmus, nasal obstruction, sneeze.
This spray for treating rhinitis prescription analysis:
Fructus Xanthii and sensible a surname of Herba Asari fall apart, and lung qi are elevated unobstructed, and Borneolum Syntheticum assists sensible a surname to fall apart.Radix Scutellariae clearing away lung-heat, catechu, Herba Centipedae assistant Fructus Xanthii lung qi dispersing gas, increase and fall, embody the marrow that Chinese medicine cacorhinia is controlled from lung.Radix Astragali invigorating QI to consolidate the body surface resistance, expelling pus and promoting granulation, make all medications imitate stronger.It is advantageous that not only Fructus Xanthii, Herba Asari and Borneolum Syntheticum are sensible, can alleviate the obstructed symptom of rhinitis snuffles, and Radix Scutellariae clearing away lung-heat, accumulate accumulated heat poison in nose key, Herba Centipedae expelling wind and cold, loose skin ulcer swell, and have and improve microcirculatory effect.Fructus Xanthii, Radix Scutellariae and catechu have sterilization antiinflammatory action, and the Radix Astragali can be repaired impaired nasal membrane, improve immunity, thus in the treatment of rhinitis, realize the effect of eliminating pathogenic factor for supporting vital QI, treating both the principal and secondary aspects of a disease.The effective ingredient of Fructus Xanthii and Herba Centipedae is volatile oil, and adding solubilizing agent tween 80 can increase the dissolving of volatile oil in water.Thickening agent water-soluble chitosan, reduces liquid fluidity, is conducive to the holdup time of prolong drug at nasal mucosa, improves curative effect.The chlorhexidine acetate added in preparation is on the one hand as antiseptic, and anti-bacteria increases; Play antiinflammatory action on the other hand, kill two birds with one stone.
Function cures mainly: expelling wind and cold, heat clearing away are sensible.Be used for the treatment of chronic rhinitis, allergic rhinitis and acute rhinitis.
Usage and dosage: external bilateral spray nose, 3 ~ 6 times on the one, each every side 2 ~ 4 is pressed.
Advantage of the present invention:
1, nasal spray administration is easy to use, and medication compliance is good;
2, medicinal liquid directly arrives nasal membrane after atomization, rapid-action, can improve rapidly and eliminate nasal obstruction symptom;
3, medicinal liquid is with fine droplet dispersion after atomization, and large with mucosal contact area, under the effect of chitosan, viscosity increases, and adds the holdup time of medicine at mucosa, is all beneficial to the absorption increasing medicine, improves curative effect;
4, not by means of only improving microcirculation, antiinflammatory and detumescence to improve and to eliminate nasal obstruction symptom, being built up one's resistance to disease by antiinflammatory and the impaired mucosa of reparation simultaneously and playing healing effect, thus reaching the effect for the treatment of both the principal and secondary aspects of a disease.
Detailed description of the invention
Below in conjunction with specific embodiment, the present invention is set forth:
Embodiment 1:
(1) Fructus Xanthii 306g, Radix Scutellariae 225g, Herba Centipedae 160g, Herba Asari 56g, catechu 108g, Radix Astragali 270g, Borneolum Syntheticum 2g, water-soluble chitosan 2g, chlorhexidine acetate 1.2g and tween 80 10g, water for injection is to 1000mL;
(2) get process of preparing Chinese medicine Fructus Xanthii 306g, Herba Centipedae 160g and the Herba Asari 56g of weight described in claim 1, add 6 times of water gagings, soak 2h, vapor distillation 3h and extract volatile oil, for subsequent use.Get Radix Scutellariae 225g and Radix Astragali 270g, first time adds 10 times of water gagings, soaks 2h, decocts 2h; Second time adds 8 times of water gagings, decocts 1h.By decoction liquor merge, filter, be condensed into relative density be at 60 DEG C be 1.20 clear paste.Add 95% ethanol and reach 70% to alcohol content, leave standstill, filter, decompression recycling ethanol, by for subsequent use for gained medicinal liquid.Water-soluble chitosan 2g injects and dissolves with water 200mL, adds catechu 108g and above-mentioned Radix Scutellariae, Herba Asari and Radix Astragali medicinal liquid, stirs, mixing.Get the volatile oil of said extracted, add the tween 80 of 10g, mix homogeneously, dissolve, inject with water 50mL dilution, merge with above-mentioned medicinal liquid.Get chlorhexidine acetate 1.2g and Borneolum Syntheticum 2g and add ethanol in proper amount dissolving, add in above-mentioned mixed liquor, mixing, injecting with water adjustment cumulative volume is 1000mL, and adjust pH 6.8, filters, and divides to be filled to spray in bottle, and every bottle of 100mL, to obtain final product.
Embodiment 2:
(1) Fructus Xanthii 330g, Radix Scutellariae 210g, Herba Centipedae 150g, Herba Asari 45g, catechu 120g, Radix Astragali 270g, Borneolum Syntheticum 3g, water-soluble chitosan 1.5g, chlorhexidine acetate 1.2g and tween 80 12g, water for injection is to 1000mL;
(2) get process of preparing Chinese medicine Fructus Xanthii 330g, Herba Centipedae 150g and the Herba Asari 45g of weight described in claim 1, add 6 times of water gagings, soak 2h, vapor distillation 3h and extract volatile oil, for subsequent use.Get Radix Scutellariae 210g and Radix Astragali 270g, first time adds 10 times of water gagings, soaks 2h, decocts 2h; Second time adds 8 times of water gagings, decocts 1h.By decoction liquor merge, filter, be condensed into relative density be at 60 DEG C be 1.20 clear paste.Add 95% ethanol and reach 70% to alcohol content, leave standstill, filter, decompression recycling ethanol, by for subsequent use for gained medicinal liquid.Water-soluble chitosan 1.5g injects and dissolves with water 200mL, adds catechu 120g and above-mentioned Radix Scutellariae, Herba Asari and Radix Astragali medicinal liquid, stirs, mixing.Get the volatile oil of said extracted, add the tween 80 of 12g, mix homogeneously, dissolve, inject with water 50mL dilution, merge with above-mentioned medicinal liquid.Get chlorhexidine acetate 1 ~ 2g and Borneolum Syntheticum 1 ~ 15g and add ethanol in proper amount dissolving, add in above-mentioned mixed liquor, mixing, injecting with water adjustment cumulative volume is 1000mL, and adjust pH 6.8, filters, and divides to be filled to spray in bottle, and every bottle of 100mL, to obtain final product.
Embodiment 3:
(1) Fructus Xanthii 270g, Radix Scutellariae 252g, Herba Centipedae 180g, Herba Asari 60g, catechu 126g, Radix Astragali 297g, Borneolum Syntheticum 3g, water-soluble chitosan 2.7g, chlorhexidine acetate 1.5g and tween 80 18g, water for injection is to 1000mL;
(2) get process of preparing Chinese medicine Fructus Xanthii 270g, Herba Centipedae 180g and the Herba Asari 60g of weight described in claim 1, add 6 times of water gagings, soak 2h, vapor distillation 3h and extract volatile oil, for subsequent use.Get Radix Scutellariae 252g and Radix Astragali 297g, first time adds 10 times of water gagings, soaks 2h, decocts 2h; Second time adds 8 times of water gagings, decocts 1h.By decoction liquor merge, filter, be condensed into relative density be at 60 DEG C be 1.20 clear paste.Add 95% ethanol and reach 70% to alcohol content, leave standstill, filter, decompression recycling ethanol, by for subsequent use for gained medicinal liquid.Water-soluble chitosan 2.7g injects and dissolves with water 200mL, adds catechu 126g and above-mentioned Radix Scutellariae, Herba Asari and Radix Astragali medicinal liquid, stirs, mixing.Get the volatile oil of said extracted, add 18g tween 80, mix homogeneously, dissolve, inject with water 50mL dilution, merge with above-mentioned medicinal liquid.Get chlorhexidine acetate 1.5g and Borneolum Syntheticum 3g and add ethanol in proper amount dissolving, add in above-mentioned mixed liquor, mixing, injecting with water adjustment cumulative volume is 1000mL, and adjust pH 6.8, filters, and divides to be filled to spray in bottle, and every bottle of 100mL, to obtain final product.
Embodiment 4:
(1) Fructus Xanthii 261g, Radix Scutellariae 300g, Herba Centipedae 153g, Herba Asari 63g, catechu 135g, Radix Astragali 240g, Borneolum Syntheticum 4g, water-soluble chitosan 2g, chlorhexidine acetate 1.8g and tween 80 15g, water for injection is to 1000mL;
(2) process of preparing Chinese medicine Fructus Xanthii 261g, Herba Centipedae 153g and the Herba Asari 63g of weight described in claim 1 is got, and Herba Centipedae 153g, add 6 times of water gagings, soak 2h, vapor distillation 3h and extract volatile oil, for subsequent use.Get Radix Scutellariae 300g and Radix Astragali 240g, first time adds 10 times of water gagings, soaks 2h, decocts 2h; Second time adds 8 times of water gagings, decocts 1h.By decoction liquor merge, filter, be condensed into relative density be at 60 DEG C be 1.20 clear paste.Add 95% ethanol and reach 70% to alcohol content, leave standstill, filter, decompression recycling ethanol, by for subsequent use for gained medicinal liquid.Water-soluble chitosan 2g injects and dissolves with water 200mL, adds catechu 135g and above-mentioned Radix Scutellariae, Herba Asari and Radix Astragali medicinal liquid, stirs, mixing.Get the volatile oil of said extracted, add the tween 80 of 15g, mix homogeneously, dissolve, inject with water 50mL dilution, merge with above-mentioned medicinal liquid.Get chlorhexidine acetate 1.8g and Borneolum Syntheticum 4g and add ethanol in proper amount dissolving, add in above-mentioned mixed liquor, mixing, injecting with water adjustment cumulative volume is 1000mL, and adjust pH 6.8, filters, and divides to be filled to spray in bottle, and every bottle of 100mL, to obtain final product.
Embodiment 5:
(1) Fructus Xanthii 360g, Radix Scutellariae 210g, Herba Centipedae 126g, Herba Asari 39g, catechu 162g, Radix Astragali 288g, Borneolum Syntheticum 3.2g, water-soluble chitosan 2.2g, chlorhexidine acetate 1.6g and tween 80 16g, water for injection is to 1000mL;
(2) process of preparing Chinese medicine Fructus Xanthii 360g, Herba Centipedae 126g and the Herba Asari 39g of weight described in claim 1 is got, and Herba Centipedae 126g, add 6 times of water gagings, soak 2h, vapor distillation 3h and extract volatile oil, for subsequent use.Get Radix Scutellariae 210g and Radix Astragali 288g, first time adds 10 times of water gagings, soaks 2h, decocts 2h; Second time adds 8 times of water gagings, decocts 1h.By decoction liquor merge, filter, be condensed into relative density be at 60 DEG C be 1.20 clear paste.Add 95% ethanol and reach 70% to alcohol content, leave standstill, filter, decompression recycling ethanol, by for subsequent use for gained medicinal liquid.Water-soluble chitosan 2.2g injects and dissolves with water 200mL, adds catechu 162g and above-mentioned Radix Scutellariae, Herba Asari and Radix Astragali medicinal liquid, stirs, mixing.Get the volatile oil of said extracted, add the tween 80 of 16g, mix homogeneously, dissolve, inject with water 50mL dilution, merge with above-mentioned medicinal liquid.Get chlorhexidine acetate 1.6g and Borneolum Syntheticum 3.2g and add ethanol in proper amount dissolving, add in above-mentioned mixed liquor, mixing, injecting with water adjustment cumulative volume is 1000mL, and adjust pH 6.8, filters, and divides to be filled to spray in bottle, and every bottle of 100mL, to obtain final product.
Experimentation of the present invention is as follows:
Experimental example 1: the extraction of volatile oil
Concoct Fructus Xanthii in we, the effective ingredient of Herba Centipedae and Herba Asari is volatile oil, adopt steam distillation to extract.Process of preparing Chinese medicine Fructus Xanthii, Herba Centipedae and Herba Asari are pulverized respectively, get process of preparing Chinese medicine Fructus Xanthii 200 ~ 400g, Herba Centipedae 100 ~ 300g and Herba Asari 50 ~ 100g after pulverizing and put into volatile oil extractor, add water, soak 2h, vapor distillation extracts volatile oil.Get according to 4:2:1 proportioning and concoct Fructus Xanthii, Herba Centipedae and Herba Asari 100g altogether, amount of water is respectively 5,10,15 times of quality of medicinal material, extraction time 3h, and single factor exploration solid-liquid ratio (amount of water), on the impact of extracted amount, the results are shown in Table 1.
Table 1 solid-liquid ratio is on the impact (n=3) of volatile oil is drawn amount
From table 1, extraction time is longer, and solid-liquid ratio is larger, and volatile oil is drawn amount is larger.But extracted amount is close when solid-liquid ratio is 1:10 and 1:15, consider the impact on the impact of stability and following purification of cost, high temperature, solid-liquid ratio is defined as 1:10.
Get according to 4:2:1 proportioning and concoct Fructus Xanthii, Herba Centipedae and Herba Asari 100g altogether, amount of water is 10 times (1000g) of quality of medicinal material, extract 1.5 respectively, 3,4.5h, single factor test extraction time, on the impact of extracted amount, the results are shown in Table 2.
Table 2 extraction time is on the impact (n=3) of volatile oil is drawn amount
From table 2, extraction time is longer, and volatile oil is drawn amount is larger.But extracted amount is close when being 3h and 4.5h upon extracting, consider that cost and high temperature are on the impact of stability, extraction time is defined as 3h.
Experimental example 2: decocting method process optimization
Decocting method is adopted to extract the principle active component baicalin in Radix Scutellariae and the principle active component such as the astragaloside in the Radix Astragali and astragalus polysaccharides.Get Radix Scutellariae 200 ~ 400g and the Radix Astragali 100 ~ 300g, soak, decoct.By decoction liquor merge, filter, be condensed into relative density be at 60 DEG C be 1.20 clear paste.Add 95% ethanol and reach 70% to alcohol content, leave standstill, filter, decompression recycling ethanol, by for subsequent use for gained medicinal liquid.
Get Radix Scutellariae 30g, Radix Astragali 20g, soak 2h, decoct 2 times, by decoction liquor merge, filter, be condensed into relative density be at 60 DEG C be 1.20 clear paste.Add 95% ethanol and reach 70% to alcohol content, leave standstill, filter, decompression recycling ethanol, gained medicinal liquid HPLC method is measured content of baicalin.Chromatographic condition: chromatographic column: DiamonsilC
18post (4.6mm × 250mm, 5 μm); Mobile phase: methanol-water (50:50); Determined wavelength: 277nm; Flow velocity: 1.0mLmin
-1; Column temperature: room temperature; Sample size: 20 μ L.Adopt L
9(3
4) Orthogonal Experiment and Design investigate extraction time (A), solid-liquid ratio (B), extraction time (C) on the impact of baicalin extracted amount, Optimized Extraction Process.Factor level in table 3, testing program and the results are shown in Table 4.
Table 3 factor and level
Table 4 orthogonal test scheme and result
From table 4, with baicalin extracted amount for inspection target, the influence degree of each factor to extraction effect is followed successively by A>B>C.The optimum level that intuitive analysis obtains each factor is combined as A
3b
3c
2, namely extraction time is 60min, and solid-liquid ratio is 1:10, and extraction time is 2 times.Consider the routine operation of decocting for Chinese herbal medicine and extract rear concentrated efficiency and cost, extraction process is defined as: get Radix Scutellariae 200 ~ 400g and the Radix Astragali 100 ~ 300g, and first time adds 10 times of water gagings, soaks 2h, decocts 2h; Second time adds 8 times of water gagings, decocts 1h.By decoction liquor merge, filter, be condensed into relative density be at 60 DEG C be 1.20 clear paste.Add 95% ethanol and reach 70% to alcohol content, leave standstill, filter, decompression recycling ethanol, by for subsequent use for gained medicinal liquid.
Experimental example 3: to the inhibitory action of staphylococcus aureus
Adopt the inhibition zone of paper disk method working sample.By the strain inoculation of staphylococcus aureus in plain agar culture medium, aseptically punch in culture medium with sterilizing card punch, get aerosol fluid respectively with suction pipe and DMSO contrast is appropriate, inject agar hole.Culture dish is placed in 37 DEG C of incubator 48h, measures antibacterial circle diameter.Found that, sample antibacterial circle diameter is 1.35cm, and contrast is without inhibition zone.
Adopt the absorbance adding bacterium liquid after aerosol fluid under turbidimetry for Determination 600nm, calculate bacteriostasis rate.Sample thief 650 μ L, with 5%DMSO in contrast, adds the golden yellow staphylococcus liquid of 3.350mL culture fluid and 54 μ L, mixing, and sealing, cultivates 48h under 37 DEG C of conditions, measures the absorbance under 600nm.According to formula:
Bacteriostasis rate %=(A
blank group-A
test group)/A
blank group* 100%
Calculate bacteriostasis rate, the bacteriostasis rate of this spray is 65.8%, shows staphylococcus aureus inhibited.
Experimental example 4: xylol causes the antiinflammatory action of mice auricle swelling
Auricle edema method investigates the antiinflammatory action of sample.
Laboratory animal: Kunming mouse, male and female half and half, body weight (20 ± 3) g, is provided by Taishan Hospital's Experimental Animal Center, the quality certification number: Shandong kinoplaszm word 020103.
Medicine: medicine prepares gained by embodiment 3 method, lot number is 20150912; Dexamethasone sodium phosphate injection (Shandong Lukang Cisen Pharmaceutical Co., Ltd); Dimethylbenzene (Tianjin BASF Chemical Co., Ltd.).
Grouping and administration: get 40 mices, be divided into 5 groups at random, often organize 8, be respectively: saline control group, 20150912 groups (0.02mL/g, 0.015mL/g, 0.01mL/g), dexamethasone matched group 3mg/Kg, intraperitoneal injection, successive administration 1 week.After last 1 administration 30min, left ear auricle drips 20 dimethylbenzene, each 10 μ L of positive and negative.Put to death mice to after dimethylbenzene 45min, cut ears, alignment, lays auricle with 9mm card punch, weighs, and calculates swelling and inhibitory rate of intumesce, the results are shown in Table 5.
Inhibitory rate of intumesce %=(administration group swelling-matched group swelling)/matched group swelling swelling * 100%
Table 5 medicine xylol cause mice auricle swelling impact (
± s)
| Group | Auricle swelling degree (mg) | Inhibitory rate of intumesce (%) |
| Normal saline group | 12.61 ± 7.65 | |
| High dose group | 3.79 ± 5.91 | 69.94 |
| Middle dosage group | 5.66 ± 6.40 | 55.11 |
| Low dose group | 8.92 ± 8.26 | 29.26 |
| Dexamethasone group | 3.01 ± 2.68 | 76.13 |
By the difference between t test and judge medicine group and matched group, result shows, high dose group is compared with blank group, and auricle swelling degree significantly reduces (p<0.01); Compared with Dexamethasone group, there was no significant difference (p>0.05), illustrates that medicine has obvious antiinflammatory action.
Experimental example 6: to the effect of Cavia porcellus allergic rhinitis
Laboratory animal: healthy guinea pig, male and female are regardless of, body weight 350 ~ 400g, are provided, the quality certification number by meter Xie Er biological product company limited of Shandong Province: Shandong kinoplaszm word D20120608.
Medicine: medicine prepares gained by embodiment 3 method, lot number is 20150912; Cangyi nose drops agent (Foshan Dezhong Pharmaceutical Co., Ltd.); Toluene-2,4-diisocyanate, 4-vulcabond (sigma, lot number: SHBD198V); Olive oil (chemical reagents corporation of traditional Chinese medicines group).
Grouping and administration: get 40 healthy guinea pigs, be divided at random blank group, model group, medicine group and positive controls (Cangyi nose drops agent) 4 groups, often organize 8.Cavia porcellus bilateral nostril is all instilled 6% Toluene-2,4-diisocyanate, 4-vulcabond olive oil solution (TDI) 5 μ L, every day 1 time, continuous 7d, sets up allergic rhinitis guinea pig model.Administration period TDI be two days 1 inferior to 1h collunarium after administration.Blank group Cavia porcellus bilateral nostril instillation equivalent olive oil.Blank group, each bilateral nostril of model group respectively instill normal saline 5 μ L, and each bilateral nostril of positive controls respectively instills Cangyi nose drops agent 5 μ L, and each bilateral nostril of medicine group respectively instills spray 5 μ L, every day 2 times, continuous 14d.Grab the number of times of nose, sneeze after stimulating with TDI before recording each group of Cavia porcellus administration in 15min, the results are shown in Table 6.
Table 6 medicine on allergic rhinitis guinea pig model grab nose and sneeze number of times impact (
± s)
Note: compare with blank group, a:p<0.01; Compare with model group, b:p<0.01
Show the effect experiment result causing Cavia porcellus allergic rhinitis, administration group grabs nose number of times and sneeze significantly lower than model group, and the spray for treating rhinitis of preparation obviously can alleviate Cavia porcellus rhinocnesmus, sneeze symptom.
Experimental example 5: toxicology test
Laboratory animal: Wistar rat, male and female half and half, body weight 200 ~ 250g, is provided by Taishan Hospital's Experimental Animal Center.
Medicine: medicine prepares gained by embodiment 3 method, lot number is 20150912;
1, acute toxicity test
Grouping and administration: get 30 rats, be divided into blank group, adjuvant matched group and spray group at random, often organize 10, male and female half and half.Bilateral spray nasal administration, every side 1 is pressed, and observes the diet of rat, behavior, body weight, excretion, abnormal response and death condition after administration in 14 days.After observation terminates, will remain rat and dissect, whether observation nasal cavity, larynx, trachea-bronchial epithelial cell mucosa there is pathological changes.
Result shows, after administration, in 14 days, rat diet, behavior, body weight and excretion situation and matched group are without obvious difference, and nothing is dead.Observe nasal cavity after dissection, the change such as redness, hyperemia do not appear in larynx, trachea-bronchial epithelial cell mucosa, fester.
2, long term toxicity test
Grouping and administration: get 50 rats, be divided into blank group, adjuvant matched group and spray high dose group (clinical 4 times of concentration), middle dosage group (clinical 2 times of concentration) and low dose group at random, often organize 10, male and female half and half.Bilateral spray nasal administration, every side 1 is pressed, every day 4 times, continuous 3 months.The diet of rat, behavior, body weight, excretion, abnormal response and death condition is observed during administration.After observation terminates, will remain rat and dissect, and carry out histological examination, whether observation nasal cavity, larynx, trachea-bronchial epithelial cell mucosa there is pathological changes.Result shows, rat diet, behavior, body weight and excretion situation are normal, without dead.Observe nasal cavity after dissection, the change such as redness, hyperemia do not appear in larynx, trachea-bronchial epithelial cell mucosa, fester.
3, Local irritation study
Grouping and administration: get 30 rats, be divided into blank group, adjuvant matched group and spray group at random, often organize 10, male and female half and half.Bilateral spray nasal administration, each 1 presses, continuous use 1 week.After last administration, 24h puts to death, and gets nasal mucosa and does tissue slice inspection.Result shows, mucosa, without pathological change, shows that routine dose is to nasal mucosa nonirritant.
Experimental example 6: clinical practice
With 66 routine patients with rhinitis for object of study carries out clinical application research, patient suffers from chronic rhinitis.Patient is divided into 2 groups at random, and matched group uses Cangyi nose drops agent, and experimental group uses spray for treating rhinitis, bilateral spray nose, 4 times on the one, and each every side 2 ~ 4 is pressed, and uses 14d continuously.The sign that observes the symptoms change score, score standard is in table 7, and score the results are shown in Table 8.
Table 7 symptom score standard
Front and back scores treated by table 8
Note: compare with before organizing administration, a:p<0.01
Table 8 result shows, spray for treating rhinitis obviously can be eliminated or improve the Rhinitis Symptoms such as rhinocnesmus, nasal obstruction, sneeze, effect and matched group close.
Claims (10)
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Cited By (7)
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| CN105943609A (en) * | 2016-06-20 | 2016-09-21 | 东莞市乐堂医疗投资有限公司 | A kind of traditional Chinese medicinal preparation for treating rhinitis and preparation method thereof |
| CN108042692A (en) * | 2017-12-25 | 2018-05-18 | 闫光鑫 | Chinese herb medicine powder for rhinitis |
| CN111588747A (en) * | 2020-07-13 | 2020-08-28 | 彭爱辉 | Pharmaceutical composition for treating allergic rhinitis and preparation method thereof |
| CN112057609A (en) * | 2020-09-28 | 2020-12-11 | 浙江丽能生物医药科技有限公司 | MOA lysozyme nasal spray preparation and preparation method thereof |
| CN112136838A (en) * | 2020-08-27 | 2020-12-29 | 东莞市泰赛特汽车用品科技有限公司 | Mild and nontoxic sterilization disinfectant, preparation method and application thereof |
| CN112843091A (en) * | 2021-01-11 | 2021-05-28 | 云南中翼鼎东生物医疗科技有限公司 | Rhinitis antibacterial spray containing lignite extract and preparation method and application thereof |
| CN115282207A (en) * | 2022-08-13 | 2022-11-04 | 上海纳米技术及应用国家工程研究中心有限公司 | Spray for treating rhinitis and preparation process thereof |
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| CN112843091A (en) * | 2021-01-11 | 2021-05-28 | 云南中翼鼎东生物医疗科技有限公司 | Rhinitis antibacterial spray containing lignite extract and preparation method and application thereof |
| CN112843091B (en) * | 2021-01-11 | 2022-10-18 | 云南中翼鼎东生物医疗科技有限公司 | Rhinitis antibacterial spray containing lignite extract and preparation method and application thereof |
| CN115282207A (en) * | 2022-08-13 | 2022-11-04 | 上海纳米技术及应用国家工程研究中心有限公司 | Spray for treating rhinitis and preparation process thereof |
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Application publication date: 20160511 |