CN1272044C - Houttuynia cordata nasal preparation and its production process - Google Patents
Houttuynia cordata nasal preparation and its production process Download PDFInfo
- Publication number
- CN1272044C CN1272044C CN 200310111552 CN200310111552A CN1272044C CN 1272044 C CN1272044 C CN 1272044C CN 200310111552 CN200310111552 CN 200310111552 CN 200310111552 A CN200310111552 A CN 200310111552A CN 1272044 C CN1272044 C CN 1272044C
- Authority
- CN
- China
- Prior art keywords
- herba houttuyniae
- parts
- distillate
- weight
- nasal
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
Links
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 12
- 238000002360 preparation method Methods 0.000 title abstract description 10
- 240000000691 Houttuynia cordata Species 0.000 title abstract description 5
- 235000013719 Houttuynia cordata Nutrition 0.000 title abstract description 4
- UAJTZZNRJCKXJN-UHFFFAOYSA-M sodium;2-dodecoxy-2-oxoethanesulfonate Chemical compound [Na+].CCCCCCCCCCCCOC(=O)CS([O-])(=O)=O UAJTZZNRJCKXJN-UHFFFAOYSA-M 0.000 claims abstract description 58
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 26
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims abstract description 18
- 239000011780 sodium chloride Substances 0.000 claims abstract description 9
- 239000012528 membrane Substances 0.000 claims abstract description 7
- 238000002156 mixing Methods 0.000 claims abstract description 7
- 238000001256 steam distillation Methods 0.000 claims abstract description 7
- 230000001954 sterilising effect Effects 0.000 claims abstract description 7
- 239000008213 purified water Substances 0.000 claims abstract description 5
- 238000009472 formulation Methods 0.000 claims description 26
- 239000000203 mixture Substances 0.000 claims description 26
- 239000003814 drug Substances 0.000 claims description 22
- XJLDYKIEURAVBW-UHFFFAOYSA-N 3-decanone Chemical compound CCCCCCCC(=O)CC XJLDYKIEURAVBW-UHFFFAOYSA-N 0.000 claims description 12
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 12
- 229940079593 drug Drugs 0.000 claims description 10
- 238000005516 engineering process Methods 0.000 claims description 10
- 239000007788 liquid Substances 0.000 claims description 8
- 235000010265 sodium sulphite Nutrition 0.000 claims description 8
- 239000007921 spray Substances 0.000 claims description 8
- 239000000243 solution Substances 0.000 claims description 7
- 230000002421 anti-septic effect Effects 0.000 claims description 6
- 238000004659 sterilization and disinfection Methods 0.000 claims description 6
- LXCFILQKKLGQFO-UHFFFAOYSA-N methylparaben Chemical compound COC(=O)C1=CC=C(O)C=C1 LXCFILQKKLGQFO-UHFFFAOYSA-N 0.000 claims description 4
- 125000001436 propyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])[H] 0.000 claims description 4
- 239000002994 raw material Substances 0.000 claims description 4
- 239000001509 sodium citrate Substances 0.000 claims description 4
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims description 4
- RTKIYNMVFMVABJ-UHFFFAOYSA-L thimerosal Chemical compound [Na+].CC[Hg]SC1=CC=CC=C1C([O-])=O RTKIYNMVFMVABJ-UHFFFAOYSA-L 0.000 claims description 3
- 229940033663 thimerosal Drugs 0.000 claims description 3
- 239000008215 water for injection Substances 0.000 claims description 2
- 206010039083 rhinitis Diseases 0.000 abstract description 27
- 201000009890 sinusitis Diseases 0.000 abstract description 15
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 abstract description 10
- 230000001154 acute effect Effects 0.000 abstract description 9
- 201000009151 chronic rhinitis Diseases 0.000 abstract description 5
- 208000015181 infectious disease Diseases 0.000 abstract description 5
- 201000009240 nasopharyngitis Diseases 0.000 abstract description 5
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 abstract description 5
- 229920000053 polysorbate 80 Polymers 0.000 abstract description 5
- 201000008283 Atrophic Rhinitis Diseases 0.000 abstract description 3
- 206010039088 Rhinitis atrophic Diseases 0.000 abstract description 3
- 239000002671 adjuvant Substances 0.000 abstract description 3
- 241000712461 unidentified influenza virus Species 0.000 abstract description 3
- 241000709661 Enterovirus Species 0.000 abstract description 2
- 241000191940 Staphylococcus Species 0.000 abstract description 2
- 241000194017 Streptococcus Species 0.000 abstract description 2
- 230000002401 inhibitory effect Effects 0.000 abstract description 2
- 239000003755 preservative agent Substances 0.000 abstract description 2
- 241000606768 Haemophilus influenzae Species 0.000 abstract 1
- 206010028741 Nasal inflammation Diseases 0.000 abstract 1
- DWAQJAXMDSEUJJ-UHFFFAOYSA-M Sodium bisulfite Chemical compound [Na+].OS([O-])=O DWAQJAXMDSEUJJ-UHFFFAOYSA-M 0.000 abstract 1
- 238000001914 filtration Methods 0.000 abstract 1
- 244000005700 microbiome Species 0.000 abstract 1
- 238000004806 packaging method and process Methods 0.000 abstract 1
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 abstract 1
- 229940068968 polysorbate 80 Drugs 0.000 abstract 1
- 230000002335 preservative effect Effects 0.000 abstract 1
- 235000010267 sodium hydrogen sulphite Nutrition 0.000 abstract 1
- 238000011282 treatment Methods 0.000 description 15
- 238000002347 injection Methods 0.000 description 13
- 239000007924 injection Substances 0.000 description 13
- 210000001331 nose Anatomy 0.000 description 11
- 230000000694 effects Effects 0.000 description 8
- GEHJYWRUCIMESM-UHFFFAOYSA-L sodium sulfite Chemical compound [Na+].[Na+].[O-]S([O-])=O GEHJYWRUCIMESM-UHFFFAOYSA-L 0.000 description 8
- 206010061218 Inflammation Diseases 0.000 description 7
- 201000010099 disease Diseases 0.000 description 7
- 230000004054 inflammatory process Effects 0.000 description 7
- 239000007923 nasal drop Substances 0.000 description 5
- KWGRBVOPPLSCSI-WPRPVWTQSA-N (-)-ephedrine Chemical compound CN[C@@H](C)[C@H](O)C1=CC=CC=C1 KWGRBVOPPLSCSI-WPRPVWTQSA-N 0.000 description 4
- 239000004480 active ingredient Substances 0.000 description 4
- 239000012467 final product Substances 0.000 description 4
- 206010028748 Nasal obstruction Diseases 0.000 description 3
- 239000002552 dosage form Substances 0.000 description 3
- 239000000796 flavoring agent Substances 0.000 description 3
- 235000019634 flavors Nutrition 0.000 description 3
- 210000004072 lung Anatomy 0.000 description 3
- 230000010534 mechanism of action Effects 0.000 description 3
- 238000000034 method Methods 0.000 description 3
- 210000002850 nasal mucosa Anatomy 0.000 description 3
- CNIIGCLFLJGOGP-UHFFFAOYSA-N 2-(1-naphthalenylmethyl)-4,5-dihydro-1H-imidazole Chemical compound C=1C=CC2=CC=CC=C2C=1CC1=NCCN1 CNIIGCLFLJGOGP-UHFFFAOYSA-N 0.000 description 2
- 206010062717 Increased upper airway secretion Diseases 0.000 description 2
- 208000004880 Polyuria Diseases 0.000 description 2
- 206010057190 Respiratory tract infections Diseases 0.000 description 2
- 208000033809 Suppuration Diseases 0.000 description 2
- 230000000844 anti-bacterial effect Effects 0.000 description 2
- 230000003115 biocidal effect Effects 0.000 description 2
- 206010006451 bronchitis Diseases 0.000 description 2
- 150000001875 compounds Chemical class 0.000 description 2
- KWGRBVOPPLSCSI-UHFFFAOYSA-N d-ephedrine Natural products CNC(C)C(O)C1=CC=CC=C1 KWGRBVOPPLSCSI-UHFFFAOYSA-N 0.000 description 2
- 230000002950 deficient Effects 0.000 description 2
- 230000035619 diuresis Effects 0.000 description 2
- 239000006196 drop Substances 0.000 description 2
- 230000000857 drug effect Effects 0.000 description 2
- 229960002179 ephedrine Drugs 0.000 description 2
- 238000011169 microbiological contamination Methods 0.000 description 2
- 210000003928 nasal cavity Anatomy 0.000 description 2
- 210000003695 paranasal sinus Anatomy 0.000 description 2
- 230000000144 pharmacologic effect Effects 0.000 description 2
- 208000026435 phlegm Diseases 0.000 description 2
- 239000000047 product Substances 0.000 description 2
- 238000003908 quality control method Methods 0.000 description 2
- 238000007910 systemic administration Methods 0.000 description 2
- XLYLQUQHYUOPIW-UHFFFAOYSA-N 3-oxo-Tetradecanal Chemical compound CCCCCCCCCCCC(=O)CC=O XLYLQUQHYUOPIW-UHFFFAOYSA-N 0.000 description 1
- 206010002653 Anosmia Diseases 0.000 description 1
- 206010006458 Bronchitis chronic Diseases 0.000 description 1
- 206010007247 Carbuncle Diseases 0.000 description 1
- 208000017667 Chronic Disease Diseases 0.000 description 1
- 206010011224 Cough Diseases 0.000 description 1
- QBDCOUHKEVYWLO-UHFFFAOYSA-N Decanoylacetaldehyde Natural products CCCCCCCCCC(=O)CC=O QBDCOUHKEVYWLO-UHFFFAOYSA-N 0.000 description 1
- 206010015943 Eye inflammation Diseases 0.000 description 1
- 206010019233 Headaches Diseases 0.000 description 1
- 206010020565 Hyperaemia Diseases 0.000 description 1
- 206010050515 Hyposmia Diseases 0.000 description 1
- 208000002193 Pain Diseases 0.000 description 1
- 235000003140 Panax quinquefolius Nutrition 0.000 description 1
- 240000005373 Panax quinquefolius Species 0.000 description 1
- 206010035664 Pneumonia Diseases 0.000 description 1
- 241000725643 Respiratory syncytial virus Species 0.000 description 1
- 206010039101 Rhinorrhoea Diseases 0.000 description 1
- 201000002014 Suppurative Otitis Media Diseases 0.000 description 1
- 206010046306 Upper respiratory tract infection Diseases 0.000 description 1
- 241000700605 Viruses Species 0.000 description 1
- 206010047700 Vomiting Diseases 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 239000003708 ampul Substances 0.000 description 1
- 230000000954 anitussive effect Effects 0.000 description 1
- 230000003266 anti-allergic effect Effects 0.000 description 1
- 230000003110 anti-inflammatory effect Effects 0.000 description 1
- 230000003097 anti-respiratory effect Effects 0.000 description 1
- 229940124584 antitussives Drugs 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 210000001367 artery Anatomy 0.000 description 1
- 208000006673 asthma Diseases 0.000 description 1
- 230000001580 bacterial effect Effects 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 208000007451 chronic bronchitis Diseases 0.000 description 1
- 230000001684 chronic effect Effects 0.000 description 1
- ZZVUWRFHKOJYTH-UHFFFAOYSA-N diphenhydramine Chemical compound C=1C=CC=CC=1C(OCCN(C)C)C1=CC=CC=C1 ZZVUWRFHKOJYTH-UHFFFAOYSA-N 0.000 description 1
- 238000004821 distillation Methods 0.000 description 1
- 208000002173 dizziness Diseases 0.000 description 1
- 239000000839 emulsion Substances 0.000 description 1
- 230000002708 enhancing effect Effects 0.000 description 1
- 208000001780 epistaxis Diseases 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 239000003172 expectorant agent Substances 0.000 description 1
- 230000003419 expectorant effect Effects 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- 238000011049 filling Methods 0.000 description 1
- 238000011010 flushing procedure Methods 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 231100000869 headache Toxicity 0.000 description 1
- 229940088597 hormone Drugs 0.000 description 1
- 239000005556 hormone Substances 0.000 description 1
- 235000019559 hyposmia Nutrition 0.000 description 1
- 230000036737 immune function Effects 0.000 description 1
- 230000001939 inductive effect Effects 0.000 description 1
- 230000001524 infective effect Effects 0.000 description 1
- 206010022000 influenza Diseases 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 238000001990 intravenous administration Methods 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 201000003453 lung abscess Diseases 0.000 description 1
- 206010025482 malaise Diseases 0.000 description 1
- 230000003340 mental effect Effects 0.000 description 1
- 244000000010 microbial pathogen Species 0.000 description 1
- 229960005016 naphazoline Drugs 0.000 description 1
- 208000010753 nasal discharge Diseases 0.000 description 1
- 231100000957 no side effect Toxicity 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 230000001717 pathogenic effect Effects 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 231100000614 poison Toxicity 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 230000029058 respiratory gaseous exchange Effects 0.000 description 1
- 210000000952 spleen Anatomy 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 208000011580 syndromic disease Diseases 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
- 239000003440 toxic substance Substances 0.000 description 1
- 230000000472 traumatic effect Effects 0.000 description 1
- 210000003462 vein Anatomy 0.000 description 1
- 238000009423 ventilation Methods 0.000 description 1
- 210000001835 viscera Anatomy 0.000 description 1
- 239000000341 volatile oil Substances 0.000 description 1
- 230000008673 vomiting Effects 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
The invention discloses a houttuynia cordata nasal preparation and a production process thereof. The preparation is prepared from 5000 parts by weight of fresh houttuynia cordata distillate, 10-50 parts by weight of polysorbate-80, 15-20 parts by weight of sodium bisulfite, 1-12 parts by weight of preservative, 80-90 parts by weight of sodium chloride, 4700-4900 parts by weight of purified water and a pH value regulator, wherein the pH value of the preparation is 5.5-7.0. The preparation is prepared from fresh or dried herba Houttuyniae by extracting effective components by steam distillation, mixing with above adjuvants, filtering with filter membrane, sterilizing with flowing steam, and packaging. The preparation has strong inhibiting effect on nasal common infection microorganism streptococcus, staphylococcus, influenza bacillus, influenza virus and rhinovirus, has simple medicinal taste, low cost and convenient use, and is mainly used for treating nasal inflammation diseases such as acute and chronic rhinitis, sinusitis, rhinitis sicca, atrophic rhinitis and the like.
Description
Technical field
The present invention relates to be used for the treatment of nosal inflammation diseases such as acute and chronic rhinitis, sinusitis, rhinitis sicca, atrophic rhinitis, epistaxis, or the medicine that behind nasal surgery, uses, refer to a kind of Herba Houttuyniae nasal formulations and production technology thereof particularly.
Background technology
Rhinitis, sinusitis are a kind of commonly encountered diseases, frequently-occurring disease and difficult disease of hals,Nasen und Ohrenheilkunde, are to be involved and a kind of infective inflammation of causing by virus or bacterial nasal cavity local patholoic change or nasal cavity adjacent organs infection focus.Traditional Chinese medical theory is called acute or chronic rhinitis " nasal obstruction ", " stuffy nose ".Because of be jammed lung system of the heresy of wind and cold or wind heat, violate and the nose key due to be " cold nasal obstruction ", " cold nasal obstruction " surplus heresy is unclear, is detained the nose key, course of disease delay forms " stuffy nose ", it is dirty with lung, spleen two and the Yangming Channel arteries and veins is lacked of proper care or blood stasis expectorant is turbid relevant.Sinusitis then is called " nasal sinusitis ", is to attack because of six climate exopathogens, and pathogenic heat is stopped up Sheng, steam the nose key that burns, or internal organs is deficient, and heresy stagnates due to the nasal sinuses.Rhinitis, the concrete clinical manifestation of sinusitis are that chronic disease acute attack, nasal mucosa hyperemia, nasal discharge increase, have a stuffy nose, and make the external respiration ventilation not smooth, the influence sleep, even cause headache, dizziness, hyposmia etc., the patient suffering is unbearably.The child suffers from rhinitis, sinusitis, can cause hypomnesis, and intelligence descends, and also may bring out serious diseases such as asthma; The adult suffers from rhinitis, sinusitis, and is more unhealthful, if obstinate can increase the probability of rhinocarcinoma greatly.
At present, can be divided into expectant treatment and operative treatment to the treatment of rhinitis, sinusitis, the Therapeutic Principle has three: eradicate the cause of disease; The assurance drain is unobstructed; Control infection and complication prevention.Expectant treatment generally is to use the sensitive antibiotic control infection, and is local with ephedrine solution collunarium, shrinks the nasal mucosa relief of symptoms.If the expectant treatment curative effect is not good enough, then operative treatments of using more.Though above method has certain effect, but also there are some problems, poor as systemic administration because of nasal sinuses portion blood circulation, often be difficult to reach effective bacteriocidal concentration in the part, and it is local with ephedrine or naphazoline etc., collunariums such as some hormones of compatibility or antibiotic, life-time service is unfavorable for the recovery of nasal mucosa function, also can cause medicine source property rhinitis.And operative treatment often brings traumatic pain and the mental maladjustment that is difficult to accept to patient, often recurs easily because of repeated infection after the puncture flushing.Therefore, the method for domestic in recent years most employing combination of Chinese and Western medicine is used Chinese patent drugs for treatment rhinitis, sinusitis.Report shows according to investigations, in preceding 10 kinds of rhinitis medication, has 8 to be Chinese patent medicine, and mostly is oral Chinese patent medicine, as BIYANKANG sheet, BIYUANSHU KOUFUYE, middle rhinitis tablet etc. at home.Because oral systemic administration, the drug level that arrives focus is very limited, often needs to take medicine for a long time, and the course of disease is long, and the course of treatment is long, and effect is also not obvious.And the Chinese medicine compound nasal drop prescription compatibility complexity of local external treatment awakening consciousness commonly used, the influence factor is many, can't set forth the mechanism of action and the active ingredient of the medicine of respectively distinguishing the flavor of, and its extraction process is coarse, and quality of the pharmaceutical preparations control is difficult.
Herba Houttuyniae derives from the aerial parts of saururaceae plant houttuynia cordata Houttuynia cordata Thunb., " 2000 editions one one of Chinese pharmacopoeia is recorded it and is had heat-clearing and toxic substances removing, the eliminating carbuncle evacuation of pus, functions such as inducing diuresis for treating stranguria syndrome are for the treatment phlegm-heat obstructing in the lung, send out to lung abscess, cough the key medicine of vomiting bloody pus.Modern pharmacology experimental results show that it has resisiting influenza virus, anti respiratory syncytial virus and antibacterial activity, the energy enhancing body's immunological function, have antipyretic-antalgic, antiinflammatory, antitussive, eliminate the phlegm, multiple pharmacological actions such as antiallergic and diuresis, many clinically in order to department of eye inflammation diseases such as acute respiratory infection such as treatment upper respiratory tract infection, acute/chronic bronchitis, pneumonia and acute and chronic rhinitis, sinusitis, suppurative otitis medias etc.The active ingredient of Herba Houttuyniae is its volatile oil, and decanoylacetaldehyde, methylnonanone etc. is a main active ingredient wherein.Reported in literature about Herba Houttuyniae treatment rhinitis, sinusitis is a lot, is to adopt Herba Houttuyniae injectio to treat mostly, and special-purpose Herba Houttuyniae nasal formulations listing is not arranged.But injection and nasal formulations are two kinds of dosage forms after all, and its characteristics and prescription all have very big difference, and be all inequality as the requirement of its pH value and adjuvant.Injection is very high to the requirement of clarity, reaches requirement for making clarity, the medicinal liquid (every milliliter contains methylnonanone and is not less than 1.0 μ g) of factory's daily life of a family preparation low concentration, thus reduce the local drug effect of using." injection used of 2000 editions regulation injection for intravenous of Chinese pharmacopoeia must not add antibacterial, so Herba Houttuyniae injectio can only once use up after opening, otherwise it is rotten to be easy to microbiological contamination in storage process.And Herba Houttuyniae injectio generally places glass ampoule bottles, opens trouble, stores inconvenience, and needs fill in collunarium or nose sprayer, and the nosal inflammation patient can't conveniently use.Therefore, with the Houttuynia cordata injection dosage form and be unwell to treatment rhinitis, sinusitis, be necessary to develop a kind of novel Herba Houttuyniae nasal formulations.
Summary of the invention
Purpose of the present invention is exactly that a kind of Herba Houttuyniae nasal formulations that can treat various nosal inflammations easily will be provided, and the production technology of this nasal formulations.
For realizing this purpose, the present invention is a raw material with bright Herba Houttuyniae or dry Herba Houttuyniae crude drug, by its effective ingredient of water vapour distillation, and adds suitable adjuvant, is mixed with the isotonic aqueous solution nasal formulations of proper pH value.Specifically:
Herba Houttuyniae nasal formulations of the present invention, formed by 5000 parts of bright Herba Houttuyniae or dry Herba Houttuyniae distillate, 10～50 parts of Tween-80s, 15～20 parts of sodium sulfitees, 1～12 portion of antiseptic, 80～90 parts of sodium chloride, 4700～4900 parts of purified water and an amount of pH value regulator assembly by weight, the pH value of this nasal formulations remains between 5.5～7.0.
Above-mentioned bright Herba Houttuyniae or dry Herba Houttuyniae distillate are every milliliter of distillates that contains main component methylnonanone 0.5～50 μ g.
Foregoing preservatives is a kind of or its combination in thimerosal, nipagin, propyl parabene, the aethyl parabenum.
Above-mentioned pH value regulator is a kind of in sodium hydroxide, the sodium citrate.
The production technology of Herba Houttuyniae nasal formulations of the present invention may further comprise the steps successively:
1) gets bright Herba Houttuyniae or dry Herba Houttuyniae crude drug raw material, add the water of 10～20 times of weight, carry out steam distillation, obtain every milliliter of first distillate that contains main component methylnonanone 0.5～50 μ g;
2) water for injection of adding equivalent in first distillate carries out steam distillation again, obtains every milliliter of Herba Houttuyniae distillate that contains main component methylnonanone 0.5～50 μ g; Also can carry out steam distillation again two to four times, with the purity of further raising Herba Houttuyniae distillate to first distillate;
3) get 5000 parts of bright Herba Houttuyniae distillates, 10～50 parts of Tween-80s, 15～20 parts of sodium sulfitees, 1～12 portion of antiseptic, 80～90 parts of sodium chloride, 4700～4900 parts of purified water by weight, mixing is mixed with solution, and with the pH value regulator pH value of this solution is adjusted to 5.5～7.0 scope;
4) again the filter membrane degerming of this solution by 0.22 μ m～1.0 μ m filtered, and the flowing steam sterilization by 100 ℃ 30 minutes, Herba Houttuyniae nasal formulations medicinal liquid can be obtained.
5) this medicinal liquid is sub-packed in nose and uses drop bottle or spray bottle promptly.
Nose is suitable for intranasal administration with the drop bottle, and spray bottle is suitable for the hydrojet administration.Rhinitis patient advises the hydrojet administration, and is not only easy to use, and can increase the drug absorption surface area, prevents that medicinal liquid from flowing out; Sinusitis patient then advises intranasal administration, so that medicinal liquid is easy to flow into the hole chamber.
The present invention compared with prior art has following tangible advantage:
One, has no side effect at determined curative effect.Nasal formulations of the present invention adopts Herba Houttuyniae to make, and drug effect is remarkable.Pharmacological evaluation proves that this nasal formulations infects encountered pathogenic microorganism streptococcus, staphylococcus, hemophilus influenza, influenza virus, rhinovirus etc. to nose stronger inhibitory action.Adopt the nasal formulations of production technology preparation of the present invention, require to have carried out clinical trial according to clinical trial, show that by clinical observation this product all has curative effect preferably to all kinds of rhinitis 801 routine nosal inflammation cases, total effective rate reaches 98.4%, does not see any toxic and side effects and untoward reaction.Following table has provided the various data of above-mentioned clinical trial:
| The rhinitis type | Case load | Produce effects | Effectively | Invalid | Effective percentage |
| Acute and chronic rhinitis | 361 | 283 | 75 | 3 | 99.2％ |
| Acute and chronic nasal sinusitis | 293 | 192 | 96 | 5 | 98.3％ |
| Rhinitis sicca | 80 | 56 | 20 | 4 | 95.0％ |
| The atrophic rhinitis | 67 | 45 | 21 | 1 | 98.5％ |
| Add up to | 801 | 576 | 212 | 13 | 98.4％ |
Its two, easy to use.This dosage form is according to using curative effect, can improve drug level and make in this preparation of emulsion and added antiseptic, and it is rotten to be difficult for microbiological contamination between the operating period, is easy to preserve.Can be directly with liquid medicine filling in suitable container, the nosal inflammation patient can be as required collunarium or spray nose at any time, very easy to use effectively.
Its three, flavour of a drug are simple, easy to control the quality.Nasal formulations flavour of a drug of the present invention are simple, Herba Houttuyniae Chinese medicine simply only, active ingredient is clear, the mechanism of action is clear and definite, quality is easy to control, quality control standard is easy to meet international standard, has overcome defectives such as existing Chinese medicine compound nasal formulations variable factor is many, compatibility is complicated, the mechanism of action is indeterminate, preparation Quality Control difficulty.
Its four, production cost is low.Bright Herba Houttuyniae or dry Herba Houttuyniae raw material that nasal formulations of the present invention adopts are cheap and easy to get, and production technology is simple, and product price ratio height is accepted by vast common nosal inflammation patient easily.
The specific embodiment
Below in conjunction with specific embodiment Herba Houttuyniae nasal formulations of the present invention and production technology thereof are described in further detail:
Embodiment 1: get bright Herba Houttuyniae 2000g, add water 20000ml, water vapour just distills, and gets distillate 1000ml just; First distillate adds injection water 1000ml again and carries out redistillation, collect double distilled bright Herba Houttuyniae distillate 1000ml, the content that detects the main component methylnonanone in the bright Herba Houttuyniae distillate makes it remain on every milliliter 0.5～50 μ g, add sodium chloride 17g, Tween-80 2g, sodium sulfite 3g, nipagin 0.3g, propyl parabene 0.1g, mixing, add the injection water to 2000ml, and to regulate its pH value with sodium hydroxide be 5.5, then the filter membrane with 0.22 μ m filters, 100 ℃ of flowing steam sterilizations 30 minutes aseptic subpackagedly get final product in nasal drop bottle or spray bottle.
Embodiment 2: get bright Herba Houttuyniae 12000g, add water 240000ml, water vapour just distills, get distillate 1000ml just, first distillate adds injection water 1000ml again and carries out redistillation, collect double distilled bright Herba Houttuyniae distillate 1000ml, the content that detects the main component methylnonanone in the bright Herba Houttuyniae distillate makes it remain on every milliliter 0.5～50 μ g, add sodium chloride 17g, Tween-80 10g, sodium sulfite 3.5g, thimerosal 0.4g, mixing, add the injection water to 2000ml, and to regulate its pH value with sodium hydroxide be 6.5, then filter with the filter membrane of 0.65 μ m, 100 ℃ of flowing steam sterilizations 30 minutes aseptic subpackagedly get final product in nasal drop bottle or spray bottle.
Embodiment 3: get dried Herba Houttuyniae 6000g, add water 90000ml, water vapour just distills, get distillate 1000ml just, first distillate adds injection water 1000ml again and carries out redistillation, collect double distilled dried Herba Houttuyniae distillate 1000ml, the content that detects the main component methylnonanone in the dried Herba Houttuyniae distillate makes it remain on every milliliter 0.5～50 μ g, add sodium chloride 18g, Tween-80 7.5g, sodium sulfite 4.0g, aethyl parabenum 2.0g, mixing, add the injection water to 2000ml, and to regulate its pH value with sodium citrate be 6.0, then filter with the filter membrane degerming of 0.22 μ m, 100 ℃ of flowing steam sterilizations 30 minutes aseptic subpackagedly get final product in nasal drop bottle or spray bottle.
Embodiment 4: get dried Herba Houttuyniae 4000g, add water 40000ml, water vapour just distills, get distillate 1000ml just, first distillate adds injection water 1000ml again and carries out redistillation, collect double distilled dried Herba Houttuyniae distillate 1000ml, the content that detects the main component methylnonanone in the dried Herba Houttuyniae distillate makes it remain on every milliliter 0.5～50 μ g, add sodium chloride 16g, Tween-80 2.5g, sodium sulfite 3.5g, nipagin 1.0g, propyl parabene 0.4g, mixing, add the injection water to 2000ml, and to regulate its pH value with sodium citrate be 7.0, then filter with the filter membrane of 0.8 μ m, 100 ℃ of flowing steam sterilizations 30 minutes aseptic subpackagedly get final product in nasal drop bottle or spray bottle.
Claims (5)
1. Herba Houttuyniae nasal formulations, form by 5000 parts of bright Herba Houttuyniae or dry Herba Houttuyniae distillate, 10～50 parts of Tween-80s, 15～20 parts of sodium sulfitees, 1～12 portion of antiseptic, 80～90 parts of sodium chloride, 4700～4900 parts of purified water and the assembly of pH value regulator by weight, the pH value of this nasal formulations is 5.5～7.0, and wherein: above-mentioned bright Herba Houttuyniae or dry Herba Houttuyniae distillate are every milliliter of distillates that contains main component methylnonanone 0.5～50 μ g.
2. Herba Houttuyniae nasal formulations according to claim 1 is characterized in that: said antiseptic is a kind of or its combination in thimerosal, nipagin, propyl parabene, the aethyl parabenum.
3. Herba Houttuyniae nasal formulations according to claim 1 is characterized in that: said pH value regulator is a kind of in sodium hydroxide, the sodium citrate.
4. the production technology of the described Herba Houttuyniae nasal formulations of claim 1 may further comprise the steps successively:
1) gets bright Herba Houttuyniae or dry Herba Houttuyniae crude drug raw material, add the water of 10～20 times of weight, carry out steam distillation, obtain every milliliter of first distillate that contains main component methylnonanone 0.5～50 μ g;
2) water for injection of adding equivalent in first distillate carries out steam distillation again, obtains every milliliter of Herba Houttuyniae distillate that contains main component methylnonanone 0.5～50 μ g;
3) get 5000 parts of Herba Houttuyniae distillates, 10～50 parts of Tween-80s, 15～20 parts of sodium sulfitees, 1～12 portion of antiseptic, 80～90 parts of sodium chloride, 4700～4900 parts of purified water by weight, mixing is mixed with solution, and with the pH value regulator pH value of this solution is adjusted to 5.5～7.0 scope;
4) again the filter membrane degerming of this solution by 0.22 μ m～1.0 μ m filtered, and the flowing steam sterilization by 100 ℃ 30 minutes, Herba Houttuyniae nasal formulations medicinal liquid can be obtained;
5) this medicinal liquid is sub-packed in nose and uses drop bottle or spray bottle promptly.
5. the production technology of Herba Houttuyniae nasal formulations according to claim 4 is characterized in that: said step 2), first distillate is carried out steam distillation again two to four times, with the purity of further raising Herba Houttuyniae distillate.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200310111552 CN1272044C (en) | 2003-12-11 | 2003-12-11 | Houttuynia cordata nasal preparation and its production process |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200310111552 CN1272044C (en) | 2003-12-11 | 2003-12-11 | Houttuynia cordata nasal preparation and its production process |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1626169A CN1626169A (en) | 2005-06-15 |
| CN1272044C true CN1272044C (en) | 2006-08-30 |
Family
ID=34759422
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200310111552 Expired - Lifetime CN1272044C (en) | 2003-12-11 | 2003-12-11 | Houttuynia cordata nasal preparation and its production process |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1272044C (en) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112957350A (en) * | 2016-03-01 | 2021-06-15 | 神威药业集团有限公司 | A herba Houttuyniae aerosol inhalation solution and its preparation method |
| CN106581256B (en) * | 2016-12-30 | 2020-02-18 | 河南科技大学 | Traditional Chinese medicine composition for treating nasosinusitis, pharmaceutical preparation and preparation method thereof |
| CN111671887A (en) * | 2020-07-27 | 2020-09-18 | 李秀华 | Chinese and western medicine formula for treating chronic rhinitis with comprehensive special effect and treatment method |
-
2003
- 2003-12-11 CN CN 200310111552 patent/CN1272044C/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| CN1626169A (en) | 2005-06-15 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN1272044C (en) | Houttuynia cordata nasal preparation and its production process | |
| CN103877288A (en) | Biomedical film made of chitosan for nasopharyngitis and preparation method thereof | |
| CN112121116A (en) | Natural plant active factor antibacterial atomizing agent and preparation method thereof | |
| CN1589852A (en) | External use nose drop agent for treating common cold and its preparation method | |
| CN115212290A (en) | Atomized inhalation type atomized liquid for preventing and treating virus infection and production method thereof | |
| CN103083404A (en) | Nasal cavity protective agent | |
| CN113288955A (en) | Spray and preparation method and application thereof | |
| CN112472669A (en) | Nasal spray based on red pepper extract and heparin for preventing influenza and preparation method thereof | |
| CN107149611B (en) | Mongolian medicine rhinitis spray and preparation method thereof | |
| CN111529633A (en) | A Chinese medicinal composition for treating chronic tracheitis and asthma | |
| CN114404527B (en) | Traditional Chinese medicine composition for treating respiratory tract infection | |
| CN1150931C (en) | Shuangjinlian oral liquid for curing cold and influenza, and its preparing method | |
| CN1221253C (en) | Application of tea polyphenol in medicine to treat diseases in respiratory system | |
| CN1589856A (en) | External use nose drops agent for treating common cold and its preparation method | |
| CN1274325C (en) | Nose drop agent for treating common cold and its preparation method | |
| CN1274327C (en) | Nose drops agent for treating common cold and its preparation method | |
| CN1162179C (en) | Medicament for curing rhinitis | |
| CN115998715A (en) | Method for treating volatile oil in Chinese medicinal materials by gasifying and inhaling | |
| CN112891452A (en) | Composition for treating pharyngitis and application thereof | |
| CN111214549A (en) | Nasal cavity nursing spray and preparation method thereof | |
| CN1562180A (en) | Preparation of Chinese traditional medicine for curing cough and preparation method | |
| CN1358534A (en) | Compound medicine for treating bronchial asthma and preparation process | |
| CN108403773A (en) | Antipyretic-detoxicant preparation and preparation method thereof through nasil | |
| CN108339037A (en) | Pill of Eight Treasures treats the purposes of rhinitis and its pharmaceutical composition of pill of Eight Treasures | |
| CN1096689A (en) | Anti-cold and detoxicating nose drops |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| EE01 | Entry into force of recordation of patent licensing contract |
Assignee: Wuhan Changlian Laifu Biochemical Pharmaceutical Co.,Ltd. Assignor: Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology Contract fulfillment period: 2008.1.8 to 2013.1.7 Contract record no.: 2009420010073 Denomination of invention: Cordate houttuynia preparation taken through nose Granted publication date: 20060830 License type: Exclusive license Record date: 20091228 |
|
| LIC | Patent licence contract for exploitation submitted for record |
Free format text: EXCLUSIVE LICENSE; TIME LIMIT OF IMPLEMENTING CONTACT: 2008.1.8 TO 2013.1.7; CHANGE OF CONTRACT Name of requester: WUHAN CHANGLIAN LAIFU BIOCHEMICAL PHARMACEUTICAL C Effective date: 20091228 |
|
| EC01 | Cancellation of recordation of patent licensing contract |
Assignee: Wuhan Changlian Laifu Biochemical Pharmaceutical Co.,Ltd. Assignor: Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology Contract record no.: 2009420010073 Date of cancellation: 20140711 |
|
| LICC | Enforcement, change and cancellation of record of contracts on the licence for exploitation of a patent or utility model | ||
| ASS | Succession or assignment of patent right |
Owner name: WUHAN TONGJI MODERN PHARMACEUTICAL TECHNOLOGY CO., Free format text: FORMER OWNER: TONGJI HOSPITAL ATTACHED TO TONGJI MEDICAL COLLEGE, HUAZHONG SCIENCE + TECHNOLOG Effective date: 20140910 |
|
| C41 | Transfer of patent application or patent right or utility model | ||
| COR | Change of bibliographic data |
Free format text: CORRECT: ADDRESS; FROM: 430030 WUHAN, HUBEI PROVINCE TO: 430056 WUHAN, HUBEI PROVINCE |
|
| TR01 | Transfer of patent right |
Effective date of registration: 20140910 Address after: 430056 No. 22 hi tech Industrial Park, Wuhan economic and Technological Development Zone, Hubei Patentee after: WUHAN TONGJI MODERN PHARMACEUTICAL TECHNOLOGY Co.,Ltd. Address before: 430030 No. 1095 Liberation Road, Hankou, Hubei (Tongji Hospital, Wuhan Research Institute) Patentee before: Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology |
|
| PE01 | Entry into force of the registration of the contract for pledge of patent right | ||
| PE01 | Entry into force of the registration of the contract for pledge of patent right |
Denomination of invention: Cordate houttuynia nasal preparation and its production process Effective date of registration: 20201117 Granted publication date: 20060830 Pledgee: Hubei Guo Chuang financing Company limited by guarantee Pledgor: WUHAN TONGJI MODERN PHARMACEUTICAL TECHNOLOGY Co.,Ltd. Registration number: Y2020980008077 |
|
| PC01 | Cancellation of the registration of the contract for pledge of patent right | ||
| PC01 | Cancellation of the registration of the contract for pledge of patent right |
Date of cancellation: 20220328 Granted publication date: 20060830 Pledgee: Hubei Guo Chuang financing Company limited by guarantee Pledgor: WUHAN TONGJI MODERN PHARMACEUTICAL TECHNOLOGY Co.,Ltd. Registration number: Y2020980008077 |
|
| CX01 | Expiry of patent term |
Granted publication date: 20060830 |
|
| CX01 | Expiry of patent term |