CN102205037B - 一种治疗因细菌感染引起的小儿支气管炎的口服药物组合物及其制备方法 - Google Patents
一种治疗因细菌感染引起的小儿支气管炎的口服药物组合物及其制备方法 Download PDFInfo
- Publication number
- CN102205037B CN102205037B CN2011101301727A CN201110130172A CN102205037B CN 102205037 B CN102205037 B CN 102205037B CN 2011101301727 A CN2011101301727 A CN 2011101301727A CN 201110130172 A CN201110130172 A CN 201110130172A CN 102205037 B CN102205037 B CN 102205037B
- Authority
- CN
- China
- Prior art keywords
- grams
- medicinal composition
- root
- bacterial infection
- preparation
- 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 - Fee Related
Links
- 206010006451 bronchitis Diseases 0.000 title claims abstract description 17
- 238000002360 preparation method Methods 0.000 title abstract description 8
- 239000000203 mixture Substances 0.000 title abstract description 6
- 208000035143 Bacterial infection Diseases 0.000 title abstract 3
- 208000022362 bacterial infectious disease Diseases 0.000 title abstract 3
- 238000003539 bacterial infection method Methods 0.000 title 1
- 229920002472 Starch Polymers 0.000 claims abstract description 5
- 239000000314 lubricant Substances 0.000 claims abstract description 5
- 239000002002 slurry Substances 0.000 claims abstract description 5
- 239000008107 starch Substances 0.000 claims abstract description 5
- 235000019698 starch Nutrition 0.000 claims abstract description 5
- 241000130781 Arnebia Species 0.000 claims abstract description 4
- 239000008194 pharmaceutical composition Substances 0.000 claims description 11
- 230000000844 anti-bacterial effect Effects 0.000 claims description 8
- 239000003795 chemical substances by application Substances 0.000 claims description 6
- 239000002671 adjuvant Substances 0.000 claims description 4
- 229940126701 oral medication Drugs 0.000 claims description 4
- 241000628997 Flos Species 0.000 claims description 3
- 239000010231 banlangen Substances 0.000 claims description 3
- UAJTZZNRJCKXJN-UHFFFAOYSA-M sodium;2-dodecoxy-2-oxoethanesulfonate Chemical compound [Na+].CCCCCCCCCCCCOC(=O)CS([O-])(=O)=O UAJTZZNRJCKXJN-UHFFFAOYSA-M 0.000 claims description 3
- 239000003814 drug Substances 0.000 abstract description 28
- 230000000694 effects Effects 0.000 abstract description 9
- 229940079593 drug Drugs 0.000 abstract description 7
- 239000004615 ingredient Substances 0.000 abstract description 3
- 241000605445 Anemarrhena asphodeloides Species 0.000 abstract 1
- 241000471262 Ardisia japonica Species 0.000 abstract 1
- 241000758794 Asarum Species 0.000 abstract 1
- 241000202726 Bupleurum Species 0.000 abstract 1
- 235000007516 Chrysanthemum Nutrition 0.000 abstract 1
- 244000189548 Chrysanthemum x morifolium Species 0.000 abstract 1
- 241000931705 Cicada Species 0.000 abstract 1
- 241000576429 Forsythia suspensa Species 0.000 abstract 1
- 235000013717 Houttuynia Nutrition 0.000 abstract 1
- 240000000691 Houttuynia cordata Species 0.000 abstract 1
- 235000006679 Mentha X verticillata Nutrition 0.000 abstract 1
- 235000002899 Mentha suaveolens Nutrition 0.000 abstract 1
- 235000001636 Mentha x rotundifolia Nutrition 0.000 abstract 1
- 244000235756 Microcos paniculata Species 0.000 abstract 1
- 240000005001 Paeonia suffruticosa Species 0.000 abstract 1
- 235000003889 Paeonia suffruticosa Nutrition 0.000 abstract 1
- 241001530126 Scrophularia Species 0.000 abstract 1
- 241000411851 herbal medicine Species 0.000 abstract 1
- 229940126673 western medicines Drugs 0.000 abstract 1
- 241000699670 Mus sp. Species 0.000 description 9
- 210000004369 blood Anatomy 0.000 description 9
- 239000008280 blood Substances 0.000 description 9
- 210000004072 lung Anatomy 0.000 description 9
- RXZBMPWDPOLZGW-XMRMVWPWSA-N (E)-roxithromycin Chemical compound O([C@@H]1[C@@H](C)C(=O)O[C@@H]([C@@]([C@H](O)[C@@H](C)C(=N/OCOCCOC)/[C@H](C)C[C@@](C)(O)[C@H](O[C@H]2[C@@H]([C@H](C[C@@H](C)O2)N(C)C)O)[C@H]1C)(C)O)CC)[C@H]1C[C@@](C)(OC)[C@@H](O)[C@H](C)O1 RXZBMPWDPOLZGW-XMRMVWPWSA-N 0.000 description 8
- 230000003203 everyday effect Effects 0.000 description 8
- 229960005224 roxithromycin Drugs 0.000 description 8
- 201000010099 disease Diseases 0.000 description 7
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 7
- 206010006448 Bronchiolitis Diseases 0.000 description 6
- 230000006870 function Effects 0.000 description 6
- 210000004185 liver Anatomy 0.000 description 6
- 231100000614 poison Toxicity 0.000 description 6
- 206010011224 Cough Diseases 0.000 description 5
- 235000009508 confectionery Nutrition 0.000 description 5
- 210000002966 serum Anatomy 0.000 description 5
- 239000003440 toxic substance Substances 0.000 description 5
- 206010061218 Inflammation Diseases 0.000 description 4
- 241001465754 Metazoa Species 0.000 description 4
- 238000002474 experimental method Methods 0.000 description 4
- 230000004054 inflammatory process Effects 0.000 description 4
- 210000003734 kidney Anatomy 0.000 description 4
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 4
- 238000000034 method Methods 0.000 description 4
- 210000002784 stomach Anatomy 0.000 description 4
- 230000004083 survival effect Effects 0.000 description 4
- 238000012360 testing method Methods 0.000 description 4
- 241000699666 Mus <mouse, genus> Species 0.000 description 3
- 208000002193 Pain Diseases 0.000 description 3
- 206010037660 Pyrexia Diseases 0.000 description 3
- 208000006673 asthma Diseases 0.000 description 3
- 238000009826 distribution Methods 0.000 description 3
- 239000000284 extract Substances 0.000 description 3
- 239000000796 flavoring agent Substances 0.000 description 3
- 235000019634 flavors Nutrition 0.000 description 3
- 208000015181 infectious disease Diseases 0.000 description 3
- 206010022000 influenza Diseases 0.000 description 3
- 239000000463 material Substances 0.000 description 3
- 230000008961 swelling Effects 0.000 description 3
- 208000024891 symptom Diseases 0.000 description 3
- NHBKXEKEPDILRR-UHFFFAOYSA-N 2,3-bis(butanoylsulfanyl)propyl butanoate Chemical compound CCCC(=O)OCC(SC(=O)CCC)CSC(=O)CCC NHBKXEKEPDILRR-UHFFFAOYSA-N 0.000 description 2
- 206010002198 Anaphylactic reaction Diseases 0.000 description 2
- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 description 2
- 206010051625 Conjunctival hyperaemia Diseases 0.000 description 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
- 206010062717 Increased upper airway secretion Diseases 0.000 description 2
- 208000035756 Infantile asthma Diseases 0.000 description 2
- 206010023126 Jaundice Diseases 0.000 description 2
- LRHPLDYGYMQRHN-UHFFFAOYSA-N N-Butanol Chemical compound CCCCO LRHPLDYGYMQRHN-UHFFFAOYSA-N 0.000 description 2
- 206010035664 Pneumonia Diseases 0.000 description 2
- 208000004880 Polyuria Diseases 0.000 description 2
- 208000007123 Pulmonary Atelectasis Diseases 0.000 description 2
- 206010061481 Renal injury Diseases 0.000 description 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
- 208000005392 Spasm Diseases 0.000 description 2
- 241000700605 Viruses Species 0.000 description 2
- 230000036783 anaphylactic response Effects 0.000 description 2
- 208000003455 anaphylaxis Diseases 0.000 description 2
- 238000010171 animal model Methods 0.000 description 2
- 239000002775 capsule Substances 0.000 description 2
- 238000001514 detection method Methods 0.000 description 2
- 230000035619 diuresis Effects 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 238000000605 extraction Methods 0.000 description 2
- 210000003026 hypopharynx Anatomy 0.000 description 2
- 230000001965 increasing effect Effects 0.000 description 2
- 235000019359 magnesium stearate Nutrition 0.000 description 2
- 238000000386 microscopy Methods 0.000 description 2
- 230000001717 pathogenic effect Effects 0.000 description 2
- 208000026435 phlegm Diseases 0.000 description 2
- 206010037844 rash Diseases 0.000 description 2
- 238000010992 reflux Methods 0.000 description 2
- 230000028327 secretion Effects 0.000 description 2
- 210000000952 spleen Anatomy 0.000 description 2
- 230000003612 virological effect Effects 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- 208000004998 Abdominal Pain Diseases 0.000 description 1
- 206010067484 Adverse reaction Diseases 0.000 description 1
- 208000036065 Airway Remodeling Diseases 0.000 description 1
- 206010007247 Carbuncle Diseases 0.000 description 1
- 206010007559 Cardiac failure congestive Diseases 0.000 description 1
- 206010010904 Convulsion Diseases 0.000 description 1
- 206010011703 Cyanosis Diseases 0.000 description 1
- 206010012735 Diarrhoea Diseases 0.000 description 1
- 208000019872 Drug Eruptions Diseases 0.000 description 1
- 206010013786 Dry skin Diseases 0.000 description 1
- 206010013952 Dysphonia Diseases 0.000 description 1
- 208000000059 Dyspnea Diseases 0.000 description 1
- 206010013975 Dyspnoeas Diseases 0.000 description 1
- 206010014561 Emphysema Diseases 0.000 description 1
- 241000709661 Enterovirus Species 0.000 description 1
- 241000201295 Euphrasia Species 0.000 description 1
- 208000010201 Exanthema Diseases 0.000 description 1
- 206010019233 Headaches Diseases 0.000 description 1
- 206010019280 Heart failures Diseases 0.000 description 1
- 206010019754 Hepatitis cholestatic Diseases 0.000 description 1
- 208000010473 Hoarseness Diseases 0.000 description 1
- 206010020880 Hypertrophy Diseases 0.000 description 1
- 206010021143 Hypoxia Diseases 0.000 description 1
- 206010070511 Hypoxic-ischaemic encephalopathy Diseases 0.000 description 1
- 206010067125 Liver injury Diseases 0.000 description 1
- 201000005505 Measles Diseases 0.000 description 1
- 208000007101 Muscle Cramp Diseases 0.000 description 1
- 241000202934 Mycoplasma pneumoniae Species 0.000 description 1
- 241000475481 Nebula Species 0.000 description 1
- 208000037212 Neonatal hypoxic and ischemic brain injury Diseases 0.000 description 1
- 206010030113 Oedema Diseases 0.000 description 1
- 206010068319 Oropharyngeal pain Diseases 0.000 description 1
- 208000002606 Paramyxoviridae Infections Diseases 0.000 description 1
- 201000007100 Pharyngitis Diseases 0.000 description 1
- 206010036790 Productive cough Diseases 0.000 description 1
- 208000003251 Pruritus Diseases 0.000 description 1
- 208000004756 Respiratory Insufficiency Diseases 0.000 description 1
- 208000037656 Respiratory Sounds Diseases 0.000 description 1
- 241000725643 Respiratory syncytial virus Species 0.000 description 1
- 235000021355 Stearic acid Nutrition 0.000 description 1
- 208000007271 Substance Withdrawal Syndrome Diseases 0.000 description 1
- 206010042674 Swelling Diseases 0.000 description 1
- 206010043376 Tetanus Diseases 0.000 description 1
- 206010043458 Thirst Diseases 0.000 description 1
- 208000009205 Tinnitus Diseases 0.000 description 1
- 206010044302 Tracheitis Diseases 0.000 description 1
- 102000003929 Transaminases Human genes 0.000 description 1
- 108090000340 Transaminases Proteins 0.000 description 1
- 208000024780 Urticaria Diseases 0.000 description 1
- 108091008605 VEGF receptors Proteins 0.000 description 1
- 102000009484 Vascular Endothelial Growth Factor Receptors Human genes 0.000 description 1
- 206010047700 Vomiting Diseases 0.000 description 1
- 206010000059 abdominal discomfort Diseases 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 231100000215 acute (single dose) toxicity testing Toxicity 0.000 description 1
- 238000011047 acute toxicity test Methods 0.000 description 1
- 230000006838 adverse reaction Effects 0.000 description 1
- 208000037883 airway inflammation Diseases 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 230000001387 anti-histamine Effects 0.000 description 1
- 230000001754 anti-pyretic effect Effects 0.000 description 1
- 229940088710 antibiotic agent Drugs 0.000 description 1
- 239000000739 antihistaminic agent Substances 0.000 description 1
- 239000002221 antipyretic Substances 0.000 description 1
- 208000002399 aphthous stomatitis Diseases 0.000 description 1
- 230000036528 appetite Effects 0.000 description 1
- 235000019789 appetite Nutrition 0.000 description 1
- 230000001580 bacterial effect Effects 0.000 description 1
- 239000011324 bead Substances 0.000 description 1
- 230000003115 biocidal effect Effects 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 210000001124 body fluid Anatomy 0.000 description 1
- 239000010839 body fluid Substances 0.000 description 1
- 230000036760 body temperature Effects 0.000 description 1
- 230000037396 body weight Effects 0.000 description 1
- 208000009973 brain hypoxia - ischemia Diseases 0.000 description 1
- 210000000621 bronchi Anatomy 0.000 description 1
- CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 description 1
- 239000008116 calcium stearate Substances 0.000 description 1
- 235000013539 calcium stearate Nutrition 0.000 description 1
- 229910002092 carbon dioxide Inorganic materials 0.000 description 1
- 239000001569 carbon dioxide Substances 0.000 description 1
- 231100000838 cholestatic hepatitis Toxicity 0.000 description 1
- 239000000812 cholinergic antagonist Substances 0.000 description 1
- 208000013116 chronic cough Diseases 0.000 description 1
- 210000000860 cochlear nerve Anatomy 0.000 description 1
- 239000002131 composite material Substances 0.000 description 1
- 238000011443 conventional therapy Methods 0.000 description 1
- 230000036461 convulsion Effects 0.000 description 1
- 238000001816 cooling Methods 0.000 description 1
- 230000006735 deficit Effects 0.000 description 1
- 230000007850 degeneration Effects 0.000 description 1
- 238000003745 diagnosis Methods 0.000 description 1
- 210000002249 digestive system Anatomy 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 201000006549 dyspepsia Diseases 0.000 description 1
- 210000002919 epithelial cell Anatomy 0.000 description 1
- 201000005884 exanthem Diseases 0.000 description 1
- 239000000706 filtrate Substances 0.000 description 1
- 238000001914 filtration Methods 0.000 description 1
- 210000000232 gallbladder Anatomy 0.000 description 1
- 238000004868 gas analysis Methods 0.000 description 1
- 239000008187 granular material Substances 0.000 description 1
- 231100000869 headache Toxicity 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 230000023597 hemostasis Effects 0.000 description 1
- 231100000304 hepatotoxicity Toxicity 0.000 description 1
- 208000018875 hypoxemia Diseases 0.000 description 1
- 230000001709 ictal effect Effects 0.000 description 1
- 230000001939 inductive effect Effects 0.000 description 1
- 239000003112 inhibitor Substances 0.000 description 1
- 208000037806 kidney injury Diseases 0.000 description 1
- 210000000265 leukocyte Anatomy 0.000 description 1
- 230000003908 liver function Effects 0.000 description 1
- 230000007056 liver toxicity Effects 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 210000003584 mesangial cell Anatomy 0.000 description 1
- 238000012544 monitoring process Methods 0.000 description 1
- 238000010172 mouse model Methods 0.000 description 1
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 1
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 description 1
- 229940127249 oral antibiotic Drugs 0.000 description 1
- 239000008203 oral pharmaceutical composition Substances 0.000 description 1
- 231100000915 pathological change Toxicity 0.000 description 1
- 230000036285 pathological change Effects 0.000 description 1
- 210000003516 pericardium Anatomy 0.000 description 1
- 208000033300 perinatal asphyxia Diseases 0.000 description 1
- 230000003285 pharmacodynamic effect Effects 0.000 description 1
- 239000002574 poison Substances 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 230000000241 respiratory effect Effects 0.000 description 1
- 201000004193 respiratory failure Diseases 0.000 description 1
- 230000029058 respiratory gaseous exchange Effects 0.000 description 1
- 230000002441 reversible effect Effects 0.000 description 1
- 201000005404 rubella Diseases 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 239000007779 soft material Substances 0.000 description 1
- 230000002048 spasmolytic effect Effects 0.000 description 1
- 241000894007 species Species 0.000 description 1
- 208000024794 sputum Diseases 0.000 description 1
- 210000003802 sputum Anatomy 0.000 description 1
- 239000008117 stearic acid Substances 0.000 description 1
- 239000000758 substrate Substances 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 230000035900 sweating Effects 0.000 description 1
- 208000011580 syndromic disease Diseases 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 230000008719 thickening Effects 0.000 description 1
- 231100000886 tinnitus Toxicity 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
- 210000003437 trachea Anatomy 0.000 description 1
- 229940126680 traditional chinese medicines Drugs 0.000 description 1
- 201000008827 tuberculosis Diseases 0.000 description 1
- 210000004926 tubular epithelial cell Anatomy 0.000 description 1
- 210000005239 tubule Anatomy 0.000 description 1
- 241000701161 unidentified adenovirus Species 0.000 description 1
- 241000712461 unidentified influenza virus Species 0.000 description 1
- 229940124676 vascular endothelial growth factor receptor Drugs 0.000 description 1
- 230000008673 vomiting Effects 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
本发明公开了一种治疗因细菌感染引起的小儿支气管炎的口服药物组合物及其制备方法。该药物组合物由主药和辅料组成，其中主药由鱼腥草9克、甘草12克、知母2克、元参3克、板蓝根10克、紫草皮11克、大青叶7克、连翘5克、牡丹皮5克、柴胡9克、蝉蜕1克、薄荷5克、布渣叶3克、菊花1克、平地木4克组成，辅料为淀粉浆和润滑剂。本发明药物组合物发明属中草药配制而成，对于治疗因细菌感染引起的小儿支气管炎治疗效果较明显，并且比常规的西药治疗手段更加有效，可作为一种良好的中成药物。
Description
技术领域
本发明属于生物医药领域，涉及一种治疗因细菌感染引起的小儿支气管炎的口服药物组合物及其制备方法。
背景技术
小儿支气管炎，病名为“毛细支气管炎”。毛细支气管炎的病原主要为呼吸道合胞病毒，可占80％或更多；其它依次为腺病毒，副流感病毒，鼻病毒，流感病毒等；少数病例可由肺炎支原体引起，感染病毒后，细小的毛细支气管充血，水肿，粘液分泌增多，加上坏死的粘膜上皮细胞脱落而堵塞管腔，导致明显的肺气肿和肺不张。支气管炎平常可累及肺泡，肺泡壁和肺间质，故可以认为它是肺炎的一种特殊类型。毛细支气管炎，不同于一般的气管炎或支气管炎，临床症状像肺炎，但以喘憋为主，此病多发生在2.5岁以下的小儿，80％在1岁以内，多数是6个月以下的小儿。毛细支气管炎的愈后多数是良好的，病程一般为5天～9天。但应注意的是，患过毛细气管炎的小儿日后容易患哮喘，通过全国小儿哮喘的流行病学调查和对婴幼儿毛细支气管炎患儿的追踪随访，发现其中有20％～40％的患儿以后发展居为小儿哮喘，因此，要积极防治毛细支气管炎，以减少哮喘的发生。
小儿支气管炎起病较急，有感冒前期症状，如咳嗽、喷嚏，1～2天后咳嗽加重，出现发作性呼吸困难、喘憋、面色苍白、口唇发绀、三凹征，肺部体征早期喘鸣音为主，继之出现湿音。症状严重时可伴充血性心力衰竭、呼吸衰竭、缺氧性脑病以及水和电解质紊乱。一般体温不超过38.5℃，病程1～2周，血白细胞多正常或轻度增加。血气分析可见低氧血症以及动脉血二氧化碳分压降低或升高。胸部x线片以肺纹理增粗、双肺透亮度增强或有小片阴影和肺不张，有条件可做呼吸道分泌物病毒快速诊断以明确病毒种类。
在现有技术中：临床上常用的口服抗菌药物主要由口服罗红霉素等抗菌药物。但是上述西药存在多种不良反应，消化系统不良反应，常见临床表现为腹部不适、恶心、呕吐等；正常剂量下其肝毒性很小，大剂量给药时可能引起血清转氨酶的一过性升高，或者引起可逆转的胆汁淤积性肝炎。因此，当给患者用药时一要做到小剂量；二要短期使用，连续用药不超过3周；三要注意监测肝功能。过敏反应。少数患者可能在用药后出现药物热、药疹、荨麻疹等过敏反应表现，遇此要立即停药，必要时使用抗组胺药。听神经损害。见于个别患者，主要是引起耳鸣及听力障碍。
发明内容
本发明的目的在于提供一种治疗因细菌感染引起的小儿支气管炎的口服药物组合物及其制备方法。该药物治疗效果好，副作用可降至最低。
本发明的药物是由以下重量配比的原料药配伍获得的：下述各组分的药物可以制成临床应用的多种药剂。本发明各药物的药理是：鱼腥草性微寒，味苦；功能：清热解毒；排脓消痈；利尿通淋。布渣叶：淡、微酸，平。清热消滞，利湿退黄，化痰。用于感冒，湿热食滞之脘腹痛，食少泄泻，湿热黄疸。紫草皮，具有凉血、活血、清热、解毒之功效；为凉血之要药，性寒，小儿脾气实者犹可用。大青叶：性寒，具有清热解毒、凉血止血之功效；用于外感热病热盛烦渴、咽喉肿痛、口疮等症。连翘：性微寒。具有清热解毒，散结消肿之功效，用于风热感冒，发热，心烦，咽喉肿痛。知母：性味归经：寒；苦、甘；归肺、胃、肾经。功能主治：清热泻火，生津润燥。元参：性味归经：微寒；甘、苦、咸；归肺、胃、肾经。功能主治：凉血滋阴，泻火解毒。甘草：性味归经：平；甘；归心、肺、脾、胃经。功能主治：补脾益气，清热解毒，祛痰止咳，缓急止痛，调和诸药。板蓝根：苦、咸、大寒，入心、胃经，清热解毒凉血。牡丹皮：性寒，味苦；凉；微寒。归心；肝；肾；肺经，降火，解斑毒，利咽喉，通小便血滞。柴胡：苦、辛、微寒，入肝、胆、心包、三焦经，和解暑热。蝉蜕：甘、寒。归肺、肝经。功能散风除热，利咽，透疹，退翳，解痉。用于风热感冒，咽痛，音哑，麻疹不透，风疹瘙痒，目赤翳障，惊风抽搐，破伤风。薄荷是辛凉性发汗解热药，治流行性感冒、头疼、目赤、身热、咽喉、牙床肿痛等症。菊花：味辛，甘，苦；性微寒。归肺、肝经。功能主治，散风清热，平肝明目。平地木：性平，味辛、微苦；归肺、肝经。主治新久咳嗽；痰中带血，湿热攻心。
按照重量组份计算：该药物组合物由主药和辅料组成，其中主药由鱼腥草9克、甘草12克、知母2克、元参3克、板蓝根10克、紫草皮11克、大青叶7克、连翘5克、牡丹皮5克、柴胡9克、蝉蜕1克、薄荷5克、布渣叶3克、菊花1克、平地木4克组成，辅料为淀粉浆和润滑剂。
本发明所述制剂的制备工艺为：
将上述主药混合，用乙醇回流提取2次，每次大约2-3小时，每次用1000ml左右的乙醇回流，滤液浓缩成浸膏，加250ml水，使浸膏成混悬液，再用正丁醇萃取2次，每次250ml，萃取液过滤后合并，然后浓缩至干获得提取物。往上述提取物中加入适量淀粉浆制软材，20目筛制粒，55℃干燥，18目筛整粒。最后加入适量润滑剂混合均匀压片，每片为200mg。
所述淀粉浆可为8-15％的浓度，优选10％；添加量可为100-200ml，优选150ml；润滑剂可为硬脂酸、硬脂酸镁、硬脂酸钙，优选硬脂酸镁，添加量为药物组合物的重量分数0.1％-0.5％。
本发明属中草药配制而成，是一种内服中药，对于治疗因细菌感染引起的小儿支气管炎治疗效果较明显。为了更好地理解和实施本发明，下面结合实施例进一步说明本发明。
实施方式
实施例1、动物急性毒性试验：
1、实验材料：实验动物为健康雄性BABC/L小鼠，体重20±1g，每组20只小鼠。实验药物用本发明的药物组合物(规格200mg/片)、罗红霉素胶囊(规格150mg/粒，生产厂家江苏福邦药业有限公司)。实验材料是ATL测定试剂盒，生产厂家为天津康尔克生物科技有限公司。
2、方法和结果：
口服给药，确定实验组口服本发明的药物最佳剂量为20mg/kg，每天早晚各一次，共7天，对照组服用罗红霉素药物10mg/kg，每天早晚各一次，共7天。空白组每天服用相同量的生理盐水。7天后，小鼠眼眶取血，分离血清.测定血清ALT活性.由表1可知，罗红霉素对照组小鼠血清ALT活性明显高于试验组P＜0.01。
表1小鼠血清ALT含量的影响
注：与对照组比较，*表示P＜0.01。
讨论：根据以上实验结果可知，与常规药物罗红霉素相比，本申请中的药物组合物可以大大降低对肝脏的损伤程度。
同时，本实验还进行了肾脏损伤检测：光镜检查：对照组肾组织光镜检查可见肾小球明显增大，肾小球毛细血管基底膜弥漫性增厚，基质增多，系膜细胞轻度增生，近端肾小管上皮细胞呈现大量空泡变性。实验组和空白组小鼠肾小球及小管间质未见明显的病理改变。
讨论：根据以上实验结果可知，与常规药物罗红霉素相比，本申请中的药物组合物可以大大降低对肾脏的损伤程度。
实施例2、动物药效学试验
一、实验材料
1、药物采用本发明药物组合物以及罗红霉素，剂量同上。
2、实验动物选用正常BALB/C小鼠，购买自第二军医大学动物中心；支气管炎BALB/C小鼠模型，制备方法参照“中华结核和呼吸杂志，血管内皮生长因子受体抑制剂对小鼠支气管炎哮喘模型气道炎症和气道重塑的影响”。
二、方法与结果
1、口服给药，实验组口服本发明的药物20mg/kg，每天早晚各一次，共7天，对照组服用罗红霉素药物10mg/kg。空白组每天服用相同量的生理盐水。每日服药后一小时取血，连续7天。三个组各20只小鼠。实验数据采用t检验处理。
结果：本发明药物组合物明显降低小鼠的炎症。与对照组比较，P＜0.001，见表2。
表2本发明药物组合物对小鼠炎症的影响X±SD
此外，还检测了小鼠在服药后三周以内的存活率，参见表3：
| 组别 | 7天存活率％ | 14天存活率％ | 21天存活率％ |
| 空白组 | -- | -- | -- |
| 治疗组 | 80 | 75 | 75 |
| 对照组 | 50 | 35 | 30 |
讨论：本发明的药物组合物可以有效的治疗支气管炎症，并且优于一般的常规治疗方式。
实施例3：临床检测试验
诊断标准：经过临床和实验室检测，患者均为细菌感染引起的支气管炎。
病例分组：随机分为三组，其中治疗组46例，其中男24例，女22例；年龄2-5岁，平均3.3岁；对照组：44例，其中男28例，女16例；年龄2-5岁，平均3.5岁。所有病例在治疗前均未使用过其它抗生素药物。
本发明药物组合物治疗支气管炎的临床疗效和安全性。方法确诊的因细菌感染引起的支气管炎症患者90例，其中治疗组46例，口服本发明药物组合物，200mg/片，每天早晚各一片；对照组44例，服用罗红霉素胶囊，规格150mg/粒，每天早晚各一粒；上述两个组疗程均为7天。服用一个疗程后疗效分析，治疗组和对照组治疗小儿支气管炎症的有效率分别为84.8％(39/46)和68.2％(30/44)。两组比较有显著统计学差异(P＜0.05)。两组不良反应发生率均较低且无统计学差异。
结论：本发明药物组合物能安全有效地治疗细菌引起的支气管炎症，并且比常规的西药治疗手段更加有效，副作用小，可作为一种良好的治疗药物。
Claims (1)
1.一种治疗因细菌感染引起的小儿支气管炎的口服药物组合物，其特征在于该药物组合物由主药和辅料组成，其中主药由以下组分组成：鱼腥草9g、甘草12g、知母2g、元参3g、板蓝根10g、紫草皮11g、大青叶7g、连翘5g、牡丹皮5g、柴胡9g、蝉蜕1g、薄荷5g、布渣叶3g、菊花1g、平地木4g；辅料为适量淀粉浆和润滑剂。
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2011101301727A CN102205037B (zh) | 2011-05-19 | 2011-05-19 | 一种治疗因细菌感染引起的小儿支气管炎的口服药物组合物及其制备方法 |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2011101301727A CN102205037B (zh) | 2011-05-19 | 2011-05-19 | 一种治疗因细菌感染引起的小儿支气管炎的口服药物组合物及其制备方法 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN102205037A CN102205037A (zh) | 2011-10-05 |
| CN102205037B true CN102205037B (zh) | 2013-03-20 |
Family
ID=44694280
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2011101301727A Expired - Fee Related CN102205037B (zh) | 2011-05-19 | 2011-05-19 | 一种治疗因细菌感染引起的小儿支气管炎的口服药物组合物及其制备方法 |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN102205037B (zh) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103520460B (zh) * | 2013-10-25 | 2015-02-25 | 刘雁 | 一种治疗慢性支气管炎的中药 |
| CN106491853A (zh) * | 2016-12-17 | 2017-03-15 | 郑州仁宏医药科技有限公司 | 一种治疗支气管扩张症的中西药组合及其制备方法 |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1348795A (zh) * | 2001-10-30 | 2002-05-15 | 刘汉超 | 一组治疗小儿上呼吸道感染及肺炎的中药合剂 |
| CN102000270A (zh) * | 2010-10-29 | 2011-04-06 | 荣成市新技术应用研究所 | 一种治疗支气管炎的中药 |
-
2011
- 2011-05-19 CN CN2011101301727A patent/CN102205037B/zh not_active Expired - Fee Related
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1348795A (zh) * | 2001-10-30 | 2002-05-15 | 刘汉超 | 一组治疗小儿上呼吸道感染及肺炎的中药合剂 |
| CN102000270A (zh) * | 2010-10-29 | 2011-04-06 | 荣成市新技术应用研究所 | 一种治疗支气管炎的中药 |
Non-Patent Citations (1)
| Title |
|---|
| 郭来.急性气管－支气管炎中医药治疗进展.《中国中医急症》.2010,第19卷(第7期),1192-1193. * |
Also Published As
| Publication number | Publication date |
|---|---|
| CN102205037A (zh) | 2011-10-05 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN102940832B (zh) | 一种治疗慢性支气管炎的药物及其制备方法 | |
| CN101549101B (zh) | 一种用于治疗尘肺病和耐药性肺结核病的中药及制备方法 | |
| CN103977314A (zh) | 一种治疗呼吸道疾病的药物组合物及制备方法和用途 | |
| CN104324125B (zh) | 一种治疗慢性咽炎的中药组合物及其制备方法 | |
| CN102988851B (zh) | 一种治疗咳血的中药组合物及制备方法 | |
| CN102205037B (zh) | 一种治疗因细菌感染引起的小儿支气管炎的口服药物组合物及其制备方法 | |
| CN116139237B (zh) | 一种防治新型冠状病毒等所致呼吸道感染的中药组合物及其应用 | |
| CN104984292A (zh) | 一种治疗肺炎支原体肺炎的药物组合物及其制备方法 | |
| CN102380075B (zh) | 一种治疗小儿呼吸系统感染发炎的中药 | |
| CN102240352A (zh) | 拔牙麻醉散及其制备方法 | |
| CN102641425B (zh) | 一种治疗小儿急性肺炎的中药制剂 | |
| CN105233252A (zh) | 一种治疗急性化脓性胆管炎的中西药复方制剂 | |
| CN104338040A (zh) | 一种用于治疗慢性肺炎的中药 | |
| CN104288681A (zh) | 一种治疗小儿病毒性肺炎的中药组合物 | |
| CN103690757B (zh) | 一种治疗肺脾虚型小儿支气管炎的中药组合物 | |
| CN105362548A (zh) | 一种治疗过敏性哮喘的中药 | |
| CN104189870A (zh) | 一种治疗过敏性哮喘的中药 | |
| CN105749103A (zh) | 一种治疗发作性睡病的药物制剂及其制备方法 | |
| CN105902943A (zh) | 一种治疗小儿风热咳嗽的药物组合物 | |
| CN105194429A (zh) | 一种治疗支气管哮喘病的中药制剂 | |
| CN104998045A (zh) | 一种治疗胸膜炎的中药制剂 | |
| CN105168860A (zh) | 一种治疗小儿哮喘的中药组合物及其制备方法 | |
| Xu | TCM and Western Medicine: Diagnosis and Treatment of Novel Coronavirus Pneumonia, A Case Study | |
| CN104771673A (zh) | 一种治疗慢性支气管炎的中药 | |
| CN105031444A (zh) | 一种治疗原发性肺结核的中药组合物 |
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 | ||
| ASS | Succession or assignment of patent right |
Owner name: NANTONG KANGWEIER BIOCHEMICAL ENGINEERING CO., LTD Free format text: FORMER OWNER: WU WENBO Effective date: 20141231 Free format text: FORMER OWNER: LIU XUEJIAN Effective date: 20141231 |
|
| C41 | Transfer of patent application or patent right or utility model | ||
| COR | Change of bibliographic data |
Free format text: CORRECT: ADDRESS; FROM: 276001 LINYI, SHANDONG PROVINCE TO: 226500 NANTONG, JIANGSU PROVINCE |
|
| TR01 | Transfer of patent right |
Effective date of registration: 20141231 Address after: 226500, Jiangsu City, Rugao Province, such as Town Star Road 8-6 Patentee after: NANTONG KWESW BIOCHEMICAL CO.,LTD. Address before: 276001 Linyi Tumour Hospital, Linyi cemetery, Shandong, No. 6 Patentee before: Wu Wenbo Patentee before: Liu Xuejian |
|
| CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20130320 |