CN109045193A - 一种咽喉炎喷雾剂及其制备方法 - Google Patents
一种咽喉炎喷雾剂及其制备方法 Download PDFInfo
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- CN109045193A CN109045193A CN201811097913.4A CN201811097913A CN109045193A CN 109045193 A CN109045193 A CN 109045193A CN 201811097913 A CN201811097913 A CN 201811097913A CN 109045193 A CN109045193 A CN 109045193A
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Abstract
本发明属于含有来自藻类、苔藓、真菌或植物或其派生物技术领域，公开了一种咽喉炎喷雾剂及其制备方法，所述咽喉炎喷雾剂由牛蒡子220g、鱼腥草400g、白前220g、浙贝母220g、木蝴蝶100g、蝉蜕100g、薄荷脑0.5g、冰片0.3g、甜菊苷4g和羟苯乙酯0.5g组成。本发明将牛蒡子、鱼腥草、白前、浙贝母、木蝴蝶和蝉蜕六种药材称量备份，加入薄荷脑、冰片、甜菊苷、羟苯乙酯以及纯化水进行配液制得咽咽喉炎喷雾剂，然后经过灭菌过程后灌装，经过包装检验后入库。本发明的咽喉炎喷雾剂的清凉解毒，利咽消肿，止咳化痰。用于急慢性咽喉炎，咽喉肿痛，干咳少痰等。
Description
技术领域
本发明属于含有来自藻类、苔藓、真菌或植物或其派生物技术领域，尤其涉及一种咽喉炎喷雾剂及其制备方法。
背景技术
目前，业内常用的现有技术是这样的：咽喉炎主要为咽部粘膜、粘膜下及淋巴组织和喉室粘膜与声带的弥漫性炎症,为上呼吸道炎症的一部分。中医认为急性咽喉炎为邪热上犯咽喉,热毒灼津所致；慢性咽喉炎系阴虚火旺,虚火上扰,以致咽喉失养,热灼津液。咽喉炎临床治疗非常棘手，西药治疗大多是暂时控制病情，单纯西医治疗没有特效药，而中医在治疗咽喉炎方面是采用清热解毒、清咽利喉的药物，且副作用小，但目前治疗咽喉炎的药物见效慢，易引起中耳炎、鼻窦炎、喉炎、气管支气管炎及肺炎等多种并发症。
综上所述，现有技术存在的问题是：
(1)慢性咽炎为咽部黏膜、黏膜下及淋巴组织的慢性炎症。以咽喉干燥，痒痛不适，咽部异物感或干咳少痰为特征。慢性咽炎属于中医“喉痹”范畴，包括“虚火喉痹”、“阳虚喉痹”、“帘珠喉痹”等。病因病机为脏腑虚损，耗伤阴分，虚火上炎于咽喉，或因风热喉痹反复发作，余邪滞留，或粉尘、浊气刺激，嗜好烟酒辛辣，劳伤过度等引起。常分为肺阴亏虚，肾阴亏虚，痰火郁结，脾肾阳虚等证型
(2)中药处方多组分同时针对人体多部位、多靶点、多环节的整体治疗，对耳鼻喉科一些疑难病症的治疗效果明显，优于西药单组分、单靶点的对抗性治疗；且易导致耐药性、毒副作用，有效周期越来越短)
(3)慢性咽炎是上呼吸道最常见的疾病，约占耳鼻喉科疾病的5～10％，咽喉部直接用药目前品种繁多，但多为粉剂和口含片。因粉剂药物干燥，用药量亦不易控制，而口含片因在口腔内与唾液长时间混合刺激味觉亦有缺点，因此我们想到用喷雾剂型将治疗咽喉炎，是纯中药制剂，它克服了西药的单体作用，咽喉炎喷雾剂是中药的复方制剂，可以多靶点作用于炎症部位，药物直接喷于咽喉部，通过咽喉炎喷雾剂对40例患者的临床观察治疗，总疗效达85％。咽炎喷雾剂具有剂型新，携带方便，喷雾后患者感觉舒适等优点，是耳鼻喉科临床用药剂型上的一种新尝试。
发明内容
针对现有技术存在的问题，本发明提供了一种咽喉炎喷雾剂及其制备方法。
本发明是这样实现的，一种咽喉炎喷雾剂，所述咽喉炎喷雾剂由牛蒡子220g、鱼腥草400g、白前220g、浙贝母220g、木蝴蝶100g、蝉蜕100g、薄荷脑0.5g、冰片0.3g、甜菊苷4g和羟苯乙酯0.5g组成。
本发明的另一目的在于提供一种所述咽喉炎喷雾剂的制备方法，所述咽喉炎喷雾剂的制备方法包括以下步骤：
步骤一，称量牛蒡子220g、鱼腥草400g、白前220g、浙贝母220g、木蝴蝶100g、蝉蜕100g、薄荷脑0.5g、冰片0.3g、甜菊苷4g和羟苯乙酯0.5g；
步骤二，以上六味,取鱼腥草加水蒸馏，收取蒸馏液400ml，蒸馏液再蒸馏一次，收取重蒸馏液200ml，备用；
步骤三，其余各药加水浸渍30分钟，加入鱼腥草药渣，煎煮2次，第一次1.5小时，第二次1小时，合并煎液，滤过，滤液浓缩至800ml，冷却；
步骤四，将浓缩约至800ml的滤液加乙醇使含醇量为60％，静置24小时，滤过，滤液回收乙醇，并浓缩至500ml；
步骤五，将浓缩至500ml的滤液加乙醇使含醇量为75％，静置24小时，滤过，滤液回收乙醇，并挥尽乙醇；
步骤六，将挥尽乙醇的滤液加入鱼腥草重蒸馏液及蒸馏水至950ml，再加入甜菊苷和用少量乙醇溶解的薄荷脑、冰片、对羟基甲苯甲酸乙酯溶液，搅匀，滤过，加水调整总量至1000ml，滤过，加热、煮沸灭菌、分装，即得咽咽喉炎喷雾剂。
进一步，所述在咽喉炎喷雾剂经过灭菌后分瓶装，每瓶装20ml。
综上所述，本发明的优点及积极效果为：3组受试者于治疗后2d及疗程结束时次症指标的评分均较治疗前有明显的下降，差异有统计学意义(P＜0.05)。治疗后3组间各访视点的变化差值的差异有统计学意义(P＜0.05)，其中治疗后2d及疗程结束时咽喉炎喷雾剂组的咽干灼热的积分下降均优于金喉健组(P＜0.05)，而在疗程结束时咽喉炎喷雾剂组优于金嗓子组；治疗后2d及治疗结束时各组头痛症状和咳嗽症状以及下颌角淋巴结肿痛症状的积分下降的差异无统计学意义(P＞0.05)；治疗结束时各组咽后壁淋巴滤泡的充血肿胀症状的积分下降咽喉炎喷雾剂组优于金嗓子组(P＜0.05)，
表1次症不同时点变化情况分析
3组受试者于治疗后2d及治疗结束时各组咽干灼热症状的消失率差异均有统计学意义(P＜0.05)，其中咽喉炎喷雾剂组优于金喉健组(P＜0.05)。治疗后2d及治疗结束时各组头痛和咳嗽症状的消失率差异无统计学意义(P＞0.05)。治疗结束时各组咽后壁淋巴滤泡的充血肿胀症状消失率差异有统计学意义(P＜0.05)，其中咽喉炎喷雾剂组优于金嗓子组(P＜0.05)。治疗后2d及治疗结束时各组下颌角淋巴结肿痛的症状消失率差异无统计学意义(P＞0.05)。见表2。
安全性分析试验期间咽喉炎喷雾剂无不良事件(AE)；金嗓子喉片组的AE共4例(均为轻度)，发生率为3.33％；金喉健喷雾剂组的AE共10例(其中轻度9例、中度1例)，发生率为8.30％；3组AE发生率及严重程度差异无统计学意义(P＞0.05)；咽喉炎喷雾剂组无AE发生，金嗓子组无重要AE发生；金喉健组的重要AE共1例，发生率为0.83％；3组的重要AE发生率差异无统计学意义(P＞0.05)；3组均无严重不良事件发生。咽喉炎喷雾剂无AE的发生率为0％；金嗓子组的药物不良反应共有3例，发生率为2.50％；金喉健组的药物不良反应共2例，发生率为1.67％；3组的药物不良反应发生率差异无统计学意义(P＞0.05)。
表2次症体征消失率情况
牛蒡子：具有疏散风热，宣肺透疹，利咽散结，解毒消肿之功效，鱼腥草：能清热解毒、消肿疗疮、利尿除湿、清热止痢、健胃消食，现代药理实验表明，本品具有抗菌、抗病毒、提高机体免疫力、利尿等作用，白前：味辛、苦，微温，归肺经，降气化痰，止咳；浙贝母：主治清热化痰，散结解毒，木蝴蝶：清肺利咽止咳、蝉蜕：宣散风热、透疹利咽、退翳明目、祛风止痉，冰片：清香宣散，具有开窍醒神，清热散毒，明目退翳；甜菊苷：味感与蔗糖相似，甜味纯正，无异味，用于高血压患者和糖尿病患者的治疗；羟苯乙酯：用作食物、药物和化妆品的防腐剂。本发明的咽喉炎喷雾剂的清凉解毒，利咽消肿，止咳化痰。用于急慢性咽喉炎，咽喉肿痛，干咳少痰等。是耳鼻喉科临床用药剂型上的一种新尝试。
附图说明
图1是本发明实施例提供的咽喉炎喷雾剂的制备方法流程图。
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白，以下结合实施例，对本发明进行进一步详细说明。应当理解，此处所描述的具体实施例仅仅用以解释本发明，并不用于限定本发明。
下面结合附图对本发明的应用原理作详细的描述。
本发明实施例提供的咽喉炎喷雾剂由牛蒡子220g、鱼腥草400g、白前220g、浙贝母220g、木蝴蝶100g、蝉蜕100g、薄荷脑0.5g、冰片0.3g、甜菊苷4g和羟苯乙酯0.5g组成。
如图1所示，本发明实施例提供的咽喉炎喷雾剂的制备方法包括以下步骤：
S101：称量牛蒡子220g、鱼腥草400g、白前220g、浙贝母220g、木蝴蝶100g、蝉蜕100g、薄荷脑0.5g、冰片0.3g、甜菊苷4g和羟苯乙酯0.5g；
S102：以上六味,取鱼腥草加水蒸馏，收取蒸馏液400ml，蒸馏液再蒸馏一次，收取重蒸馏液200ml，备用；
S103：其余各药加水浸渍30分钟，加入鱼腥草药渣，煎煮2次，第一次1.5小时，第二次1小时，合并煎液，滤过，滤液浓缩至约800ml，冷却；
S104：将浓缩约至800ml的滤液加乙醇使含醇量为60％，静置24小时，滤过，滤液回收乙醇，并浓缩至500ml；
S105：将浓缩至500ml的滤液加乙醇使含醇量为75％，静置24小时，滤过，滤液回收乙醇，并挥尽乙醇；
S106：将挥尽乙醇的滤液加入鱼腥草重蒸馏液及蒸馏水至950ml，再加入甜菊苷和用少量乙醇溶解的薄荷脑、冰片、对羟基甲苯甲酸乙酯溶液，搅匀，滤过，加水调整总量至1000ml，滤过，分装，即得咽咽喉炎喷雾剂。
在本发明的优选实施例中，步骤S106所制得的咽咽喉炎喷雾剂经过灭菌后分瓶装，每瓶装20ml。
本发明将牛蒡子、鱼腥草、白前、浙贝母、木蝴蝶和蝉蜕六种药材称量，提取，制备，加入薄荷脑、冰片、甜菊苷、羟苯乙酯以及纯化水进行配液制得咽喉炎喷雾剂，然后经过灭菌过程后灌装，经过包装检验后入库。
下面结合具体实施例对本发明的应用效果做详细的描述。
实施例1：
取本品20ml，用正丁醇振摇提取2次，每次15ml，合并正丁醇提取液，蒸干，残渣加乙醇2ml使溶解,作为供试品溶液。另取牛蒡子苷对照品，加乙醇制成每1ml含5mg的溶液，作为对照品溶液。照薄层色谱法(中国药典2010年版一部附录ⅥB)试验,吸取上述2种溶液各5μl，分别点于同一以羧甲基纤维素钠为黏合剂的硅胶G薄层板上，以甲苯--甲醇--水(40：8：1)为展开剂，展开，取出，晾干，喷以10％硫酸乙醇溶液，在105℃加热至斑点显色清晰。供试品色谱中，在与对照品色谱相应的位置上，显相同的紫色斑点。本发明的咽喉炎喷雾剂的清凉解毒，利咽消肿，止咳化痰。用于急慢性咽喉炎，咽喉肿痛，干咳少痰等。
牛蒡子：味辛，苦，性寒，归肺，胃经，，具有疏散风热，宣肺透疹，利咽散结，解毒消肿之功效，属于解表药中发散风热药，还可用于防治糖尿病肾病，该品能滑肠，气虚便溏者忌用；
鱼腥草：味辛，性寒凉，归肺经。能清热解毒、消肿疗疮、利尿除湿、清热止痢、健胃消食，用治实热、热毒、湿邪、疾热为患的肺痈、疮疡肿毒、痔疮便血、脾胃积热等。现代药理实验表明，本品具有抗菌、抗病毒、提高机体免疫力、利尿等作用，虚寒症及阴性外疡忌服；
白前：味辛、苦，微温，归肺经，降气化痰，止咳；
浙贝母：主治清热化痰，散结解毒，治风热咳嗽，肺痈喉痹，瘰疬，疮疡肿毒，寒痰、湿痰及脾胃虚寒者慎服浙贝母，浙贝母反乌头：
木蝴蝶：味苦、甘、性凉，入肺肝、胃经,有清肺利咽止咳、舒肝牙口胃之功效，主治肺热咳嗽、喉痹、音哑、肝胃气痛、疮口不敛；
蝉蜕：味甘、咸，性凉，归肺、肝经，宣散风热、透疹利咽、退翳明目、祛风止痉，用于风热感冒，温病初起，咽痛音哑，麻疹不透，风疹瘙痒，目赤翳障，急慢惊风，破伤风证，小儿夜啼不安，与薄荷、牛蒡子、金银花、连翘等同用，可用于风热火毒上攻之咽喉红肿疼痛，声音嘶哑等症，孕妇慎用；
薄荷脑：在医药上用作刺激药，作用于皮肤或粘膜，有清凉止痒作用，内服可作为驱风药，用于头痛及鼻，咽，喉炎症等；
冰片：味辛、苦，微寒，归心、肝、肺经，清香宣散，具有开窍醒神，清热散毒，明目退翳的功效，主治热病高热神昏，中风痰厥惊痫，暑湿蒙蔽清窍，喉痹耳聋，口疮齿肿，疮痈疳痔，目赤肿痛，翳膜遮睛；
甜菊苷：味感与蔗糖相似，甜味纯正，无异味，用于高血压患者和糖尿病患者的治疗；
羟苯乙酯：用作食物、药物和化妆品的防腐剂。
本发明的咽咽喉炎喷雾剂pH值应为4.0--6.0(中国药典2010年版一部附录ⅦG)，每揿喷射量应不少于0.084g(中国药典2010年版一部附录ⅠZ)，其他应符合气雾剂项下有关的各项规定(中国药典2010年版一部附录ⅠZ)，用于喷咽喉，每小时1次，每次2—3揿，密闭贮藏，置阴凉干燥处。
急性咽炎属于中医“急喉痹”的范畴，无年龄、地区差异，尤其好发于长期吸烟、嗜酒及用嗓过度者，且可继发其他疾病及全身症状，从而影响正常生活。因为咽喉乃肺之门户，当气候突变，又遇禀赋不足或起居不慎，肺卫不固，风热外邪侵袭，则咽喉首当其冲，风热循经犯肺而蕴热，继而上侵咽喉，邪热蕴结于咽，而致气滞血壅，咽喉部出现黏膜红肿而发病。本质是本虚标实，其标为邪盛，其本为正虚。治疗上宜滋肾润肺、泻火解毒。慢性咽炎急性发作属中医学“梅核气”范畴。该病患者常有咽炎或扁桃体炎反复发作，或有鼻窦和鼻腔感染，或张口呼吸，烟酒过度，或空气干燥和粉尘刺激史。临床症状有咽部不适、异物感、发痒、灼热、干燥和堵塞等，有刺激性咳嗽，咽反射敏感，易作呕等。祖国医学认为，风盛则痒，热盛伤津，燥盛则干，该病究其原委，乃为风、热、燥、痰邪侵犯肺卫，结于咽喉，相搏不去所致。其治疗宜因势利导，以疏风润燥、清热散结为法。但是目前临床上治疗咽炎在辨证论治方面存在“标本分治”现状，即急则治其标，缓则治其本，而非真正意义上的标本兼治。咽喉炎喷雾剂组成牛蒡子：具有疏散风热，宣肺透疹，利咽散结，解毒消肿之功效，鱼腥草：能清热解毒、消肿疗疮、利尿除湿、清热止痢、健胃消食，现代药理实验表明，本品具有抗菌、抗病毒、提高机体免疫力、利尿等作用，白前：味辛、苦，微温，归肺经，降气化痰，止咳；浙贝母：主治清热化痰，散结解毒，木蝴蝶：清肺利咽止咳、蝉蜕：宣散风热、透疹利咽、退翳明目、祛风止痉，冰片：清香宣散，具有开窍醒神，清热散毒，明目退翳；甜菊苷：味感与蔗糖相似，甜味纯正，无异味，用于高血压患者和糖尿病患者的治疗；羟苯乙酯：用作食物、药物和化妆品的防腐剂。本发明的咽喉炎喷雾剂综观全方，清凉解毒，利咽消肿，止咳化痰。为标本兼顾，内外合治之良方，用于急慢性咽喉炎，咽喉肿痛，干咳少痰等。前期的药理研究表明咽喉炎喷雾剂能显著抑制甲醛所致小鼠皮肤炎症的作用，在1h即表现出非常显著的抑制作用(P＜0.01)，并在4h时仍·5·临床耳鼻咽喉头颈外科杂志第32卷能保持这一作用(P＜0.01)；阳性对照药开喉剑喷雾剂在1h时亦出现显著的抑制作用(P＜0.05)，但不能持续到4h(P＞0.05)；除对照组外，各组在2h时均对致炎皮肤有非常显著的抑制作用(P＜0.01)〔16〕。前期展开的240例的临床Ⅱ期试验结果表明，咽喉炎喷雾剂和对照药开喉剑喷雾剂的疗效、痊愈率、总有效率的差别无统计学意义，但冰连组对改善咽黏膜和悬雍垂红肿症状的疗效要优于对照组(P＜0.05)。且无临床不良反应。进一步验证性的440例临床Ⅲ期结果表明冰连组与开喉剑组疗效差别无统计学意义，但冰连组在改善咽痛症状方面疗效优于对照组(P＜0.05)。因此，该药与对照药相比在综合疗效方面没有差异，但在改善某些临床症状方面(如消除咽痛、缓解咽黏膜和悬雍垂红肿症)试验组仍能体现出其优越性。另外，在安全性方面，咽喉炎喷雾剂组在Ⅱ期和Ⅲ期临床中来看，药物还是安全可靠的。为进一步评价咽喉炎喷雾剂对急性咽炎及慢性咽炎急性发作患者的临床疗效及其作用特点，分别以金嗓子喉片和金喉健喷雾剂为平行对照的随机、盲法、多中心临床试验结果表明咽咽喉炎喷雾剂能明显改善急性咽炎或慢性咽炎急性发作患者的咽痛、咽黏膜及悬雍垂红肿、咽干灼热、头痛、咳嗽症状，以及咽后壁淋巴滤泡充血肿胀及下颌角淋巴结肿痛等情况，临床疗效确切；在改善咽痛情况方面上，咽喉炎喷雾剂咽喷雾剂对急性咽炎及慢性咽炎急性发作患者的咽痛症状有明显的改善作用，且优于金嗓子喉片和金喉健喷雾剂；同时治疗后的咽痛症状消失情况优于金嗓子喉片；在改善咽黏膜及悬雍垂红肿情况方面上，咽喉炎喷雾剂对急性咽炎及慢性咽炎急性发作患者的咽黏膜及悬雍垂红肿症状有明显的改善作用，且优于金嗓子喉片和金喉健喷雾剂；同时治疗后的咽黏膜及悬雍垂红肿症状消失情况优于金嗓子喉片；在改善咽干灼热情况方面上，咽喉炎喷雾剂对急性咽炎及慢性咽炎急性发作患者的咽干灼热症状有明显的改善作用；且治疗后的咽干灼热症状消失情况优于金喉健喷雾剂；在改善头痛情况方面上，咽喉炎喷雾剂对急性咽炎及慢性咽炎急性发作患者的头痛症状有明显的改善作用，但其作用与金嗓子喉片和金喉健喷雾剂相当；在改善咳嗽情况方面上咽喉炎喷雾剂对急性咽炎及慢性咽炎急性发作患者的咳嗽症状有明显的改善作用，但其作用与金嗓子喉片和金喉健喷雾剂相当；在改善咽后壁淋巴滤泡充血肿胀情况方面上，咽喉炎喷雾剂对急性咽炎及慢性咽炎急性发作患者的咽后壁淋巴滤泡充血情况有明显的改善作用，且优于金嗓子喉片和金喉健喷雾剂；同时治疗后的咽后壁淋巴滤泡充血消失情况优于金嗓子喉片；在改善下颌角淋巴结肿痛情况方面上，咽喉炎喷雾剂对急性咽炎及慢性咽炎急性发作患者的下颌角淋巴结肿痛情况有明显的改善作用，但其作用与金嗓子喉片和金喉健喷雾剂相当。结果表明，咽喉炎喷雾剂尤其是在改善患者咽痛、咽黏膜及悬雍垂红肿症状及咽后壁淋巴滤泡充血等方面明显优于金嗓子喉片和金喉健喷雾剂，在改善咽干灼热方面明显优于金喉健喷雾剂，同时于治疗后对患者咽痛、咽黏膜及悬雍垂红肿及咽后壁淋巴滤泡充血的症状消失率优于金嗓子喉片，咽干灼热症状消失情况优于金喉健喷雾剂。同时受试者对咽咽喉炎喷雾剂口感满意度为82.1％。推荐急性咽炎及慢性咽炎急性发作患者优先使用咽喉炎喷雾剂治疗。综合疗效良好，且不良反应小，患者依从性高，值得临床推广使用。
以上所述仅为本发明的较佳实施例而已，并不用以限制本发明，凡在本发明的精神和原则之内所作的任何修改、等同替换和改进等，均应包含在本发明的保护范围之内。
Claims (3)
1.一种咽喉炎喷雾剂，其特征在于，所述咽喉炎喷雾剂由牛蒡子220g、鱼腥草400g、白前220g、浙贝母220g、木蝴蝶100g、蝉蜕100g、薄荷脑0.5g、冰片0.3g、甜菊苷4g和羟苯乙酯0.5g组成。
2.一种如权利要求1所述咽喉炎喷雾剂的制备方法，其特征在于，所述咽喉炎喷雾剂的制备方法包括以下步骤：
步骤一，称量牛蒡子220g、鱼腥草400g、白前220g、浙贝母220g、木蝴蝶100g、蝉蜕100g、薄荷脑0.5g、冰片0.3g、甜菊苷4g和羟苯乙酯0.5g；
步骤二，以上六味,取鱼腥草加水蒸馏，收取蒸馏液400ml，蒸馏液再蒸馏一次，收取重蒸馏液200ml，备用；
步骤三，其余各药加水浸渍30分钟，加入鱼腥草药渣，煎煮2次，第一次1.5小时，第二次1小时，合并煎液，滤过，滤液浓缩至800ml，冷却；
步骤四，将浓缩至800ml的滤液加乙醇使含醇量为60％，静置24小时，滤过，滤液回收乙醇，并浓缩至500ml；
步骤五，将浓缩至500ml的滤液加乙醇使含醇量为75％，静置24小时，滤过，滤液回收乙醇，并挥尽乙醇；
步骤六，将挥尽乙醇的滤液加入鱼腥草重蒸馏液及蒸馏水至950ml，再加入甜菊苷和用少量乙醇溶解的薄荷脑、冰片、对羟基甲苯甲酸乙酯溶液，搅匀，滤过，加水调整总量至1000ml，滤过，加热煮沸灭菌，分装，即得咽喉炎喷雾剂。
3.如权利要求2所述的咽喉炎喷雾剂的制备方法，其特征在于，所述在咽喉炎喷雾剂经过灭菌后分瓶装，每瓶装20ml。
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