CN105797092B - Yiyuan anti-cold mixture - Google Patents
Yiyuan anti-cold mixture Download PDFInfo
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- CN105797092B CN105797092B CN201610111351.9A CN201610111351A CN105797092B CN 105797092 B CN105797092 B CN 105797092B CN 201610111351 A CN201610111351 A CN 201610111351A CN 105797092 B CN105797092 B CN 105797092B
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Abstract
益元抗感合剂涉及一种治疗普通感冒的药物组合物。具体地说是以植物中草药为原料而制备的,主要用于治疗普通感冒的中成药及该药的制备方法。本发明所要解决的技术问题是:1.促进身体虚弱的感冒患者缩短治疗期和病后恢复期;2.降低慢性病患者因感冒而引起原发病恶化或出现并发症的概率;3.降低感冒患者再次感冒的概率。解决上述问题的技术方案的要点是:1.运用“汗法”解肌发表,调和营卫,祛邪外出;2.运用“补法”调理和提高脏腑的生理功能;3.运用“和法”将机体失衡的气血、脏腑和寒热转化为平衡状态;达到快速提高免疫力和祛寒能力,使新久之风寒得药渐次消散,传变无途,诸症自愈的治疗效果。主要用途:治疗普通感冒。Yiyuan Kanggan Mixture relates to a medicinal composition for treating common cold. Specifically, it is prepared by using plant Chinese herbal medicines as raw materials, and is mainly used for the Chinese patent medicine for treating common cold and the preparation method of the medicine. The technical problems to be solved by the present invention are: 1. to shorten the treatment period and the recovery period after the illness in the weak cold patients; 2. to reduce the probability of the deterioration of the primary disease or the occurrence of complications in the chronically ill patients due to the cold; 3. to reduce the probability of colds The probability that the patient will catch another cold. The main points of the technical solution to solve the above problems are: 1. Use the "Sweat Method" to release muscles, reconcile Ying and Wei, and expel pathogens and go out; 2. Use the "Tonic Method" to regulate and improve the physiological functions of the viscera; 3. Use the "Harmony Method" "Transform the imbalanced qi and blood, viscera, and cold and heat of the body into a balanced state; achieve the therapeutic effect of rapidly improving immunity and dispelling cold, so that the new long-term wind-cold medicine gradually dissipates, and there is no way to pass on, and all diseases heal themselves. Main use: Treat the common cold.
Description
所属技术领域Technical field
该药涉及一种治疗普通感冒的药物组合物。具体地说是以植物中草药为原料而制备的,主要用于治疗普通感冒的中成药及该药的制备方法。The medicine relates to a medicinal composition for treating common cold. Specifically, it is prepared by using plant Chinese herbal medicines as raw materials, and is mainly used for the Chinese patent medicine for treating common cold and the preparation method of the medicine.
背景技术Background technique
普通感冒概述Overview of the common cold
普通感冒称为上呼吸道感染,简称上感,是包括鼻腔、咽或喉部急性炎症的总称。全年皆可发病,冬、春季发病率较高,体弱及患有慢性疾病的人患感冒的病程较长,并且可能因为感冒而引起原发病恶化或出现并发症,反复感冒的概率也较高。The common cold is called upper respiratory tract infection, or Shanggan for short, which is a general term that includes acute inflammation of the nasal cavity, pharynx or larynx. The disease can occur throughout the year, and the incidence is higher in winter and spring. People who are frail and suffering from chronic diseases have a longer course of colds, and may cause the deterioration of the primary disease or complications due to colds, and the probability of repeated colds is also high. higher.
现有医疗技术治疗普通感冒的常用方法与缺陷Common methods and defects of existing medical technology for treating common cold
现代医学主要采用解热镇痛和抗组胺药等药物进行对症治疗,再加上使用抗病毒药物或抗菌素进行病因治疗,以达到改善症状,缩短病程的目的。如果连续使用抗菌素或抗病毒药物的时间较长,则会导致人体免疫功能减退,体弱及患有慢性疾病的患者,常常因此而延长治疗期,或者引起原发病恶化以及可能出现并发症等副作用。除此之外,这两类药物还有耐药性问题与可能导致药源性疾病的问题以及药物不良反应等等问题。Modern medicine mainly uses antipyretic, analgesic, antihistamine and other drugs for symptomatic treatment, plus the use of antiviral drugs or antibiotics for etiological treatment to achieve the purpose of improving symptoms and shortening the course of the disease. If the continuous use of antibiotics or antiviral drugs for a long time, it will lead to weakened immune function of the human body, and patients with frail and chronic diseases often prolong the treatment period, or cause the deterioration of the primary disease and possible complications, etc. side effect. In addition, these two types of drugs also have problems of drug resistance, problems that may lead to drug-induced diseases, and adverse drug reactions.
中医将普通感冒归入表证的范畴,又将表证分为表寒证、表热证和虚人感受外邪而致的表证。治疗普通感冒的中成药多以辛散解表的中药组成,通过发散风寒或疏散风热而达到改善症状,缩短病程的目的。对于身体虚弱的感冒患者,则采用扶正解表的药物进行治疗。例如:参苏丸,是以党参、紫苏叶、葛根等11味中药组合而成,具有益气解表,疏风散寒,祛痰止咳的功效。临床上常用于身体虚弱、感受风寒所致感冒的治疗。再如:人参败毒胶囊,是以人参、独活、羌活、川芎等12味中药组合而成,具有益气解表,散寒祛湿的功效。临床上常用于气虚兼外感风寒湿邪所致感冒的治疗。体虚抗感合剂是以黄芪、玄参、麦冬、金银花、板蓝根等十一味中药组合而成,具有益气养阴,解表散邪的功效,适用于体虚乏力,外感风寒所致感冒的治疗。诸如此类的扶正解表的中药,均重在改善正虚与感冒的症状,而主要不在提高人体的免疫力。在素体虚弱的普通感冒患者的病理中,由于存在着免疫功能低下的病理因素,所以,感冒病程较长,并且可能因为感冒而引起原发病恶化或出现并发症,反复感冒的概率也较高。就连健康人在患感冒之后,免疫功能也会出现不同程度的减退。而现有治疗普通感冒的中成药,虽然没有像西药那样的毒副作用,但是,在补充患者所亏损的元气、恢复人体的免疫力、注重治本等方面,尚缺乏相应的成分和力度。Traditional Chinese medicine classifies the common cold into the category of external symptoms, and further divides the external symptoms into external cold symptoms, external heat symptoms, and external symptoms caused by deficient people feeling external pathogens. The traditional Chinese medicines used to treat common colds are mostly composed of Chinese medicines that are pungent and dispelling. For the weak cold patients, the medicines that strengthen the body and relieve the table are used for treatment. For example: Shensu Pill is a combination of 11 traditional Chinese medicines such as Codonopsis pilosula, basil leaves, and Pueraria lobata. Clinically, it is commonly used in the treatment of colds caused by frail body and feeling of wind and cold. Another example: Ginseng Baidu Capsule is a combination of 12 traditional Chinese medicines such as ginseng, Duhuo, Qianghuo, and Chuanxiong. It is commonly used clinically for the treatment of colds caused by qi deficiency and exogenous wind-cold-dampness pathogens. Body Deficiency Kanggan Mixture is a combination of eleven traditional Chinese medicines such as Astragalus, Scrophularia, Ophiopogon japonicus, honeysuckle, and Banlangen. Treatment of colds. Such traditional Chinese medicines for strengthening the body and detoxifying the body focus on improving the symptoms of deficiency and colds, but not mainly on improving the body's immunity. In the pathology of common cold patients with weak body, due to the existence of pathological factors of low immune function, the course of colds is longer, and the primary disease may worsen or complications may occur due to colds, and the probability of repeated colds is also higher. high. Even healthy people have varying degrees of immune function decline after suffering from a cold. Although the existing Chinese patent medicines for common cold do not have the same toxic and side effects as Western medicines, they still lack the corresponding ingredients and strengths in terms of replenishing the lost vitality of patients, restoring the body's immunity, and focusing on curing the root cause.
普通感冒已经对人类健康造成了严重的危害The common cold has caused serious harm to human health
由于普通感冒是一种自限性疾病,需要依靠人体的免疫力去消除,而医药市场上缺乏具有重在恢复人体免疫力、从源头上治疗普通感冒的药物,普通感冒如今已经对个人和社会造成了严重的危害。据权威机构统计报道,成人每年患普通感冒平均2-3次,儿童平均5-7次, 10%-15%的儿童每年感冒达12次″[1]。有基础疾病的人可明显增加普通感冒的患病率,例如,有糖尿病者感冒患病率是健康人的3倍、有呼吸系统疾病者是健康人的13倍,有循环系统基础疾病者是健康人的3.5倍[2]。普通感冒可以造成很大的经济负担,据美国的资料显示,30%的误学、40%的误工是由普通感冒引起,普通感冒每年导致23亿天的误学、25亿天的误工,每年因普通感冒就诊的人次为27亿人次,每年用于缓解咳嗽等感冒症状的非处方药物费用近 20亿美元,而抗菌药物的费用22.7亿美元。另外,并发症治疗及引起原发病恶化等使得医疗费用明显增加,加重了疾病负担[3].。普通感冒并不普通,据国内外资料显示,普通感冒不仅可造成严重的社会和经济负担,并且可产生严重的并发症,甚至威胁患者生命而致死[4]。Because the common cold is a self-limiting disease, it needs to rely on the body's immunity to eliminate it, and the pharmaceutical market lacks drugs that focus on restoring the body's immunity and treating the common cold from the source. caused serious harm. According to statistics from authoritative organizations, adults suffer from common colds 2-3 times a year on average, children average 5-7 times a year, and 10%-15% of children have 12 colds a year" [1] . People with underlying diseases can significantly increase the number of common colds. The prevalence of colds, for example, the prevalence of colds in diabetics is 3 times that of healthy people, those with respiratory diseases are 13 times that of healthy people, and those with underlying diseases of the circulatory system are 3.5 times that of healthy people [2] . The common cold can cause a huge economic burden. According to the data from the United States, 30% of missed school and 40% of missed work are caused by common cold. Common cold causes 2.3 billion days of missed school and 2.5 billion days of missed work every year. There are 2.7 billion doctor visits for the common cold, and the annual cost of over-the-counter drugs used to relieve cough and other cold symptoms is nearly 2 billion US dollars, while the cost of antibacterial drugs is 2.27 billion US dollars. In addition, the treatment of complications and the deterioration of the primary disease make the Medical expenses have increased significantly, increasing the burden of disease [3]. The common cold is not common. According to domestic and foreign data, the common cold can not only cause serious social and economic burdens, but also cause serious complications and even threaten the lives of patients. and fatal [4] .
发明的目的与探索之旅Purpose of Invention and Journey of Discovery
因为普通感冒主要依靠人体的免疫力来消除,所以,发明人有意研制出能够以快速提高免疫力为主来治疗普通感冒的中药制剂。在1992年以前,发明人曾经运用扶正解表之法,以桂枝汤等为基本方,加入补充气血阴阳的药物,然后根据正虚的证型分别加重益气、养血、滋阴或助阳的药物的剂量或增加药物进行组方,治疗外感风寒表虚证,分别制成6种制剂,供给对应的6种证型(气虚、血虚、阴虚、阳虚、气阴两虚和阳阳两亏)的感冒患者服用。这种组方方式虽然对证准确,符合中医的组方原则,有一定的治疗效果,因为气血阴阳既是脏腑生理功能的产物,又是调节与增强脏腑生理功能的元素。但还存在着两个缺点:第一、提高免疫功能的力度还嫌不够。第二、需要用6种制剂分别应对6种证型的治疗。如果实行工业化生产,以用于大消费市场,那么在制药、包装、储存以及流通等领域的场地占用、设备投资、生产人员、管理人员等等方面的投入就会比较多。为了寻找既能够提高治疗感冒的疗效,又能够减少制剂的种类的方法,发明人又经历了5年的探索。Because the common cold is mainly eliminated by the immunity of the human body, the inventor intends to develop a traditional Chinese medicine preparation that can treat the common cold mainly by rapidly improving the immunity. Before 1992, the inventor used the method of strengthening the righteousness and detoxifying the table, using Guizhi Decoction as the basic formula, adding medicines to supplement the yin and yang of qi, blood, and then according to the syndrome of zhengxu, respectively aggravating and nourishing qi, nourishing blood, nourishing yin, or nourishing yin. The dosage of the drugs that help yang or increase the drug to formulate prescriptions to treat the syndrome of exogenous wind-cold and external deficiency, respectively make 6 kinds of preparations, and supply the corresponding 6 kinds of syndrome types (qi deficiency, blood deficiency, yin deficiency, yang deficiency, qi and yin deficiency) It is used for cold patients who suffer from yang and yang losses. Although this method of formulating is accurate, it conforms to the principles of traditional Chinese medicine, and has a certain therapeutic effect, because qi, blood, yin and yang are not only the products of the physiological functions of the zang-fu organs, but also the elements that regulate and enhance the physiological functions of the zang-fu organs. But there are still two shortcomings: First, the intensity of improving immune function is not enough. Second, it is necessary to use 6 kinds of preparations to deal with the treatment of 6 kinds of syndromes. If industrialized production is implemented for the large consumer market, then there will be more investment in the fields of pharmacy, packaging, storage and circulation, such as site occupation, equipment investment, production personnel, management personnel, etc. In order to find a method that can not only improve the curative effect of treating colds, but also reduce the types of preparations, the inventor has gone through another 5 years of exploration.
发明人在确立关键技术方案时参考过的主要医学资料The main medical data referenced by the inventor when establishing the key technical solution
1997年6月,发明人在《中国中西医结合脾胃杂志》上,看到了“段英廉的临床经验介绍——肝硬化病理机制及治疗”[5]一文,文中介绍了段老运用自拟的清肝达郁汤以达肝郁、清肝热、养肝阴、温通脉络为法,辅以助脾健运和益肾之药,促进肝脾肾功能的恢复以治疗肝硬化的经验。其基本方为“五味子10g,干姜10g,知母20g,桂枝10g,公英10g,远志 10g,黄芩10g,甘草8g,生地35g,公丁香10g,大枣18个,党参10g,半夏10g”。In June 1997, the inventor saw the article "Introduction of Duan Yinglian's Clinical Experience - Pathological Mechanism and Treatment of Liver Cirrhosis" in the "Chinese Journal of Integrated Traditional Chinese and Western Medicine" [5] . Gan Da Yu Decoction is based on the methods of treating liver stagnation, clearing liver heat, nourishing liver yin, and warming meridians. The basic recipe is "Schisandra 10g, dried ginger 10g, Anemarrhena 20g, cassia twig 10g, Gongying 10g, Polygala 10g, Scutellaria 10g, licorice 8g, Shengdi 35g, Gonglixiang 10g, jujube 18, Codonopsis 10g, Pinellia 10g ".
发明人化裁运用桂枝汤,参考段英廉的清肝达郁汤中促进肝脾肾功能恢复的方法,治疗难治性感冒的经过The inventor Hua Cai used Guizhi Decoction, referring to Duan Yinglian's Qinggan Dayu Decoction to promote the recovery of liver, spleen and kidney functions, and the process of treating refractory colds.
发明人从分析段老的清肝达郁汤的综合药理中发现,该方能够补充气血阴阳,又具有调节、改善与提高脏腑生理功能和补充人体元气的功效,正好可以用于治疗体虚感冒的药物的处方中,作为恢复脏腑的生理功能——特别是提高免疫力的部分,再加上解表药物而实现“疏风解郁,益元解表”的功效。遂将此方合桂枝汤化裁组方,应用于外感风寒表虚证的临床治疗。原方使用桂枝10克,主要功用是温通经脉,化气行水,以治疗肝硬化腹水。本方将桂枝改用为20克,以加强发汗解肌,疏散外感风寒之力,为君药;增加白芍10克,与桂枝合用,调和营卫,使发汗而不伤阴,止汗而不恋邪,为臣药;增加生姜10克,以协桂枝发汗解表,又能暖胃止呕;增加黄芪12克,以补在表之卫气,共为佐药;本方重点在清除外感风寒,故生地黄用34克,以减少寒凉之力;原方用大枣18个(按一般大小折合重量计算,大约合60-80 克),为了充分利用大枣补脾益气,扶正祛邪的功效和配料称重时的方便,改剂量为100克;原方所用甘草为生甘草8克,其主要作用是清热解毒以护肝,而本方需要其协桂枝解肌,助白芍和营,伍大枣益气并调和诸药,故改用炙甘草15克。全方组成为:桂枝20克、白芍10克、生姜10克、黄芪12克、干姜10克、生地黄34克、知母20克、公丁香10克、党参10 克、大枣100克、五味子10克、远志10克、炙甘草15克、制半夏10克、黄芩10克、蒲公英10克。将其制成合剂,用于难治性外感风寒表虚证的治疗。这是经过组方——临床试用——再组方——临床再试用……多次修改处方,反复进行临床疗效检验之后,筛选出的最优方案,结果收到了意想不到的效果:该药可以迅速提高免疫功能,缩短体弱及慢性病患者感冒的治疗期和病后恢复期,特别是能够防止某些原发病因为感冒而恶化或出现并发症的现象发生,屡试屡验。通过日后随访,还发现能够大幅度地降低患者再次感冒的概率(详情见“发明的效果”中“实验性实施例”)。The inventor found from the comprehensive pharmacology of Duan Lao's Qinggan Dayu Decoction that this recipe can supplement qi, blood, yin and yang, and also has the effects of regulating, improving and enhancing the physiological functions of the viscera and replenishing the vitality of the human body, which can just be used for the treatment of physical insufficiency. In the prescription of cold medicine, as a part of restoring the physiological function of the viscera, especially the part of improving immunity, together with the medicine to relieve the body, it can achieve the effect of "dispelling wind and stagnation, benefiting Yuan and releasing the body". Therefore, this formula was combined with Guizhi Decoction, and it was applied to the clinical treatment of exogenous wind-cold and external deficiency syndrome. The original recipe uses 10 grams of cinnamon stick, the main function is to warm the meridians, transform qi and move water, so as to treat liver cirrhosis and ascites. In this recipe, Guizhi is changed to 20 grams to strengthen sweating and muscle relieving, evacuate the power of exogenous wind-cold, and is the king medicine; add 10 grams of white peony root and use it in combination with Guizhi to reconcile Yingwei, make sweating without hurting Yin, stop Sweat but do not love evil, it is a minister's medicine; add 10 grams of ginger to help cinnamon stick to sweat and relieve the surface, and can warm the stomach and stop vomiting; add 12 grams of astragalus to replenish the defense qi on the surface, and it is a total adjuvant. The key is to clear the exogenous cold, so 34 grams of Rehmannia glutinosa is used to reduce the power of cold and cold; the original recipe uses 18 jujubes (calculated according to the general size and weight, about 60-80 grams), in order to make full use of jujube to nourish the spleen The effect of nourishing qi, strengthening the body and eliminating pathogenic factors and the convenience of weighing the ingredients, the dosage is changed to 100 grams; the licorice used in the original recipe is 8 grams of raw licorice. Relieves muscle, helps white peony root and battalion, Wu Dazao nourishes qi and reconciles various medicines, so 15 grams of licorice is used instead. The whole recipe consists of: 20 grams of cassia twig, 10 grams of white peony root, 10 grams of ginger, 12 grams of astragalus, 10 grams of dried ginger, 34 grams of rehmannia glutinosa, 20 grams of Anemarrhena, 10 grams of cloves, 10 grams of Codonopsis pilosula, 100 grams of jujube gram, 10 grams of Schisandra, 10 grams of Polygalaceae, 15 grams of Zhigancao, 10 grams of Pinellia, 10 grams of Scutellaria, and 10 grams of Dandelion. It is made into a mixture for the treatment of refractory exogenous wind-cold appearance deficiency syndrome. This is the optimal solution selected after formulating prescriptions—clinical trials—re-formulations—clinical re-trials… After several revisions to the prescription and repeated clinical efficacy tests, the results received unexpected results: the drug It can rapidly improve immune function, shorten the treatment period and recovery period of colds in frail and chronically ill patients, and especially prevent some primary diseases from worsening or complications due to colds. Through follow-up in the future, it is also found that the probability of the patient getting a cold again can be greatly reduced (see "Experimental Example" in "Effect of the Invention" for details).
益元抗感合剂与清肝达郁汤的异同点Similarities and Differences Between Yiyuan Kanggan Mixture and Qinggan Dayu Decoction
从方剂的构成上看,益元抗感合剂的处方与清肝达郁汤共有12味药物相同,并且益元抗感合剂的组方几乎包含了清肝达郁汤中所有的药物,只是清肝达郁汤中用的是甘草8克,而益元抗感合剂中用的是炙甘草15克。但是,益元抗感合剂与清肝达郁汤的功效却全然不同。这是因为:第一、从药物的剂量上看,益元抗感合剂中桂枝的用量比清肝达郁汤中多了1倍,使桂枝充分发挥出入心化液,通经络而出汗,散解风寒的作用;第二、益元抗感合剂增加了具有解表功能的药物组合物:生姜、白芍和黄芪3味中草药。生姜辛温,祛风散寒;黄芪益脾补肺、扶正祛邪;白芍与桂枝合用,调和营卫,有利于发汗解表。第三、益元抗感合剂用炙甘草替换了清肝达郁汤中的生甘草。生甘草偏凉,长于清热解毒以护肝;而炙甘草偏温,有补气调中缓急与调和药性之能。还增加了养营化卫的大枣的剂量,而性寒的生地黄的用量则比清肝达郁汤中的用量减少了1克,以上药物和剂量上的变化确立了益元抗感合剂祛风散寒的功效,其余的药物就成为提高人体免疫力以助祛邪的佐助药与佐使药了。这样变动的结果,就将清肝达郁汤由一个以达肝郁、清肝热、养肝阴、通脉络为法,辅以助脾健运和益肾之药,促进肝脾肾功能恢复以治疗肝硬化的基本方,转变成为一个以祛肺寒,助肺卫,补元气,扶正气,促进肺脾肾功能恢复以疏风解郁,益元解表的解表剂了。In terms of the composition of the prescription, the prescription of Yiyuan Kanggan Mixture is the same as that of Qinggan Dayu Decoction, and the formula of Yiyuan Kanggan Mixture contains almost all the drugs in Qinggan Dayu Decoction. Gan Dayu Decoction uses 8 grams of licorice, while Yiyuan Kanggan Mixture uses 15 grams of Zhigancao. However, the effects of Yiyuan Kanggan Mixture and Qinggan Dayu Decoction are completely different. This is because: First, in terms of the dosage of the drug, the dosage of Guizhi in Yiyuan Kanggan Mixture is twice as much as that in Qinggan Dayu Decoction, so that Guizhi can fully enter and exit the heart-transforming fluid, and the meridians and collaterals can flow out. The effect of sweating, dispersing wind-cold; secondly, Yiyuan Kanggan Mixture has added a medicinal composition with the function of relieving the body: ginger, white peony root and astragalus 3 Chinese herbal medicines. Ginger is pungent and warm, dispelling wind and dispelling cold; astragalus nourishes the spleen and tonifies the lung, strengthens the body and dispels pathogens; the combination of white peony root and cinnamon twig can reconcile the yin and wei, and is conducive to sweating and relieving the exterior. Third, Yiyuan Kanggan Mixture replaces raw licorice in Qinggan Dayu decoction with Zhigancao. Raw licorice is relatively cool, better than clearing away heat and detoxifying to protect the liver; while roasted licorice is relatively warm, and has the ability to invigorate the qi and adjust the urgency and harmonize the medicinal properties. The dosage of jujube for nourishing Huawei was also increased, while the dosage of raw rehmannia glutinosa with cold nature was reduced by 1 gram compared with that in Qinggan Dayu Decoction. The above changes in medicine and dosage established Yiyuan Kanggan Mixture. With the effect of dispelling wind and dispelling cold, the rest of the medicines become adjuvant medicines and adjuvant medicines to improve the body's immunity to help dispel pathogens. As a result of such changes, the Qinggan Dayu Decoction has been transformed from a method that treats liver stagnation, clears liver heat, nourishes liver yin, and clears meridians, supplemented by medicines that help the spleen to invigorate and nourish the kidney to promote the recovery of liver, spleen and kidney functions. The basic formula for the treatment of liver cirrhosis has been transformed into a detoxifying agent that dispels the cold of the lungs, helps the lungs to defend, replenishes the vitality, strengthens the vital energy, promotes the recovery of the functions of the lungs, spleen and kidneys, soothes the wind and relieves the depression, and benefits the yuan and relieves the surface.
发明的内容content of invention
治疗普通感冒的中成药——益元抗感合剂,由以下重量份配比的原料药制成:桂枝60克、白芍30克、生姜30克、黄芪36克、干姜30克、生地黄102克、知母60克、公丁香30克、党参30克、大枣300克、五味子30克、远志30克、炙甘草克45、制半夏30克、黄芩30 克、蒲公英30克。A Chinese patent medicine for treating common cold, Yiyuan Kanggan Mixture, is made from the following raw materials by weight: 60 grams of cinnamon twig, 30 grams of white peony root, 30 grams of ginger, 36 grams of astragalus, 30 grams of dried ginger, and raw ground 102 grams of yellow, 60 grams of Zhimu, 30 grams of cloves, 30 grams of Codonopsis, 300 grams of jujube, 30 grams of Schisandra, 30 grams of Polygala, 45 grams of Zhigancao, 30 grams of Pinellia, 30 grams of Scutellaria baicalensis, 30 grams of dandelion.
益元抗感合剂的功能主治Functions and Indications of Yiyuan Kanggan Mixture
功能:疏风解郁,益元解表。Function: Dispel wind and relieve depression, benefit Yuan and relieve external appearance.
主治:外感风寒表虚证。适用于普通感冒见下述症状者:恶寒发热,汗出恶风,头痛,或项强,鼻塞流涕,咳嗽,咯痰稀白,虚烦不眠,肢体酸痛,干呕或呕吐,舌苔薄白,脉浮缓或浮弱。Indications: Exogenous wind-cold manifests deficiency syndrome. It is suitable for people with the following symptoms of common cold: aversion to cold and fever, sweating and aversion to wind, headache, or strong neck, nasal congestion and runny nose, cough, expectoration of white phlegm, restlessness and insomnia, body aches, retching or vomiting, thin tongue coating White, slow or weak pulse.
本发明所要解决的医疗技术问题及解决该问题的技术方案要点The medical technical problem to be solved by the present invention and the main points of the technical solution to solve the problem
本发明所要解决的医疗技术问题是:促进身体虚弱的感冒患者缩短治疗期和病后恢复期;降低慢性病患者因感冒而引起原发病恶化或出现并发症的概率;降低感冒患者再次感冒的概率。The medical technical problems to be solved by the present invention are as follows: promoting the frail cold patients to shorten the treatment period and the recovery period after illness; reducing the probability of the deterioration of the primary disease or the occurrence of complications caused by the cold in the chronic disease patients; reducing the probability of the cold patients getting cold again .
解决该问题的技术方案的要点是:运用“汗法”解肌发表,调和营卫,驱邪外出;运用“补法”调理和提高脏腑的生理功能;运用“和法”将机体失衡的气血、失衡的脏腑和失衡的寒热转化为平衡状态;通过以上3项方案的综合运用,增强人体元气,提升正气(免疫力和祛寒能力),防病传变,使新久之风寒得药渐次消散,诸症自愈。The main points of the technical solution to this problem are: using the "Sweat Method" to release muscles, reconcile the yin and guards, and exorcise evil spirits; use the "Replenishing Method" to regulate and improve the physiological functions of the viscera; , Unbalanced viscera and unbalanced cold and heat are transformed into a balanced state; through the comprehensive application of the above 3 programs, the vitality of the human body is enhanced, the righteousness (immunity and cold-dispelling ability) is enhanced, disease is prevented from spreading, and the new long-term wind-cold medicine is gradually dissipated , the symptoms healed themselves.
外感风寒表虚证的病理和益元抗感合剂配方所运用的治疗方法以及各药物及其组合物的功效与特点Pathology of exogenous wind-cold and external deficiency syndrome, the treatment method of Yiyuan Kanggan mixture formula, and the efficacy and characteristics of each drug and its composition
本配方原为治疗素体虚弱之外感风寒表虚证(感冒的一种证候)而设,但也可以用于常人所患之外感风寒表虚证。素体虚弱者最易患外感风寒表虚证。由于这类人群的脏腑功能减退、气血阴阳亏损,元气衰弱,正气不足,一旦感受风寒,因卫阳虚弱而不能固外,则肌表腠理疏松,恶风恶寒、脉浮缓或浮弱;寒邪留滞经脉,而出现头痛或项强不舒,肢体酸痛,四肢乏力等身楚不适之症;肺经鼻、口与外界相通,又合皮毛,最易遭受风寒侵袭而受伤,出现鼻鸣、鼻塞流涕;或胃气不和而干呕或呕吐;或胸脘满闷,不思饮食。卫气与邪气相抗争则发热,热致肌肤腠理开泄,而营阴虚弱不能内守,故汗自出。反复发热汗出不愈,新寒久冷交织为患,导致营卫更虚,元气更弱,正气更亏,气机郁滞,故新久病邪流连不解。治宜疏风解郁,益元解表。This formula was originally designed for the treatment of exogenous wind-cold-appearing deficiency syndrome (a syndrome of colds) due to physical weakness, but it can also be used for exogenous wind-cold-appearing-deficiency syndrome suffered by ordinary people. People with weak body are most likely to suffer from exogenous wind-cold symptoms. Due to the decline of viscera function, loss of qi, blood, yin and yang, weak vitality, and lack of righteous qi in these people, once they feel wind-cold and cannot consolidate the external due to the weakness of Wei yang, the muscle surface will be loose, aversion to wind and cold, and a slow or floating pulse. Weak; cold pathogens stay in the meridians, causing headaches or discomfort in the neck, soreness of the limbs, and weakness in the limbs and other physical discomforts; the lung meridian, nose and mouth communicate with the outside world, and they are combined with the skin and fur, and are most likely to be injured by wind and cold. Nasal snoring, nasal congestion and runny nose; or retching or vomiting due to disharmony in the stomach; When the Wei qi and the evil qi fight against each other, there is a fever, and the heat causes the skin to open up. Repeated fever and sweating are unhealed, new cold and long-term cold are intertwined, resulting in more deficient Ying and Wei, weaker vitality, more loss of righteousness, and stagnant Qi, so the evil of new chronic disease lingers in confusion. Governance is suitable to dispel wind and relieve depression, and benefit Yuan to relieve the exterior.
方中桂枝辛、甘,温,能祛风散寒,通心阳,温胸腹,暖脾胃,发汗解肌以助卫,温通经脉,助阳化气以养营,故为君药。白芍养血敛阴,能加强营阴内守之功,以治汗出之症,与桂枝为伍,一散一收,调和营卫,使发汗而不伤阴,止汗而不恋邪,故为臣药。生姜辛温,祛风散寒,可协桂枝发汗解表,助桂、芍解肌和营,又能暖胃止呕。黄芪甘、微温,养肺气、固卫气,无汗能发,有汗能止,可增强卫外之力;生姜、黄芪共为佐药。如果元气充盛之人,外邪当乘药势以出。由于素体虚弱者元气不足,营虚卫弱,今药虽欲驱邪于外,而元气内馁,轻者邪气半出不出,重者邪气反随元气缩入,所以,恶寒发热缠绵不已。为此,必须多靶点祛寒,并提高脏腑的生理功能,以培补不足之元气而提升正气,还要将具有温经通脉、行气解郁、调畅气机的药物加入到表药中以助药力,使邪气得药渐次消散。故用温中散寒之干姜,以其辛热之性逐脘腹冷痛,祛脏腑虚寒,止吐泻,以复脾胃之阳;还能温肺化饮而止咳、化痰、通鼻窍、除鼻涕,可助桂枝祛风散寒。生地黄性寒,味甘、苦,养阴、生津;与干姜为伍,不但无寒凉之弊,而且能够生血、化津;还可滋肺、脾、肾之阴,助肺、脾、肾之阳。公丁香性温,味辛,可温中、降逆,和胃,止虚寒呕吐,除心腹冷痛,温肾助阳;知母寒、苦、甘,滋阴润燥,可泻无根之肾火,疗有汗之骨蒸;止虚劳之热,滋化源之阴,以防温燥之桂枝、干姜及公丁香生出壮火而食气、耗血、伤阴、损阳;配伍公丁香可加强干姜、生地黄滋补肺、脾、肾之力。肺卫是人体卫气的藩篱,肺卫得助,则机体祛邪增力。脾为后天之本,脾阴脾阳得扶,则气血营卫生化有源,卫气得助,则肺卫不惧邪扰。肾气为肺卫的根基,人体阴阳的根本,肾阴肾阳得济,则营卫生化有序,肺卫充盛可期。上4味药中二阴二阳,阴赖阳之使而化营,阳赖阴之用而化卫,补而不滞,宣而不散。更加甘、温之党参、大枣,健脾益气,有利于鼓邪外出。大枣并可滋阴补血,养营化卫,为白芍和营之助;与二姜为伍,有“辛甘发散为阳”之义。五味子敛肺补肾,敛汗生津,与桂枝、干姜为伍,散中有收,补而不滞。白芍、生地黄、知母与五味子均有收敛诸散药之能,且可缓桂枝、干姜的刚猛之性,使风寒痰湿皆除而气血不伤。远志味辛、苦,性微温,祛痰止咳,宁心安神。再伍参、枣、草有交接水火之效。炙甘草协桂枝解肌,助白芍和营,伍大枣益气,有安内攘外之功。二姜、大枣与甘草合用,可补中气,调营卫,兼助发汗之功;上9味药合用,可提高脏腑的生理功能,补益元气,温通经脉,行气解郁,调畅气机,使诸虚不足得益;并且可以预保脏腑,防邪陷里,拒生变证,有扶正以助祛邪之效,为托里之法,并非全在补虚之用。其与桂、芍之间的功能关系为厚积薄发之用,共为佐药。制半夏燥湿化痰;黄芩清热燥湿;蒲公英化热毒、散滞气,上3味药合用,共除配方中多余之湿热,为使药。炙甘草调和诸药,兼为使药。该方综合运用了“汗”、“补”、“和”三法。“汗法”与“补法”已如上述,“和法”则融于“汗法”与“补法”之中,即在运用“汗法”与“补法”的过程中,采用了寒热并用,补泻合剂,补中寓攻,泻中寄养;调和营卫,调和肝脾,调和肠胃;平衡气血,平衡脏腑,平衡寒热之法,可将失衡的阴阳转化为平衡状态,使体内气机复其升降之常,脏腑各司其职,从多方面促进元气恢复,正气提升,并针对多靶点排解邪气。全方合用,以解表为目标,综合运用了发汗、补脏腑、益元气、扶正气、解郁气和平衡阴阳之法,促进肺脾肾功能的恢复,使机体的免疫力快速提高,新久之风寒得药渐次消散,传变无途,诸症速愈,共收疏风解郁,益元解表之效,为标本兼治、重在治本之法。In the prescription, Guizhi is pungent, sweet, warm, can dispel wind and dispel cold, clear the heart and yang, warm the chest and abdomen, warm the spleen and stomach, sweat and relieve the muscles to help the defense, warm the meridians, and help the yang to transform the qi for nourishment, so it is the king medicine. White peony root nourishes blood and astringes yin, and can strengthen the function of yin-yin inner guard, so as to treat the symptoms of sweating. It works with cinnamon twigs, disperses and gathers, reconciles yin and yin, makes sweating without hurting yin, and stops sweating and does not love evil. Therefore, it is a medicine for ministers. Ginger is pungent and warm, expelling wind and dispelling cold, can assist Guizhi to sweat and relieve external appearance, help Gui and Paeonia to relieve muscle and camp, and warm the stomach and stop vomiting. Astragalus is sweet and slightly warm, nourishes lung qi, solidifies Wei qi, can produce without sweat, and stop sweating, which can enhance the power of Wei outside. Ginger and astragalus are adjuvant. If a person is full of vitality, exogenous evil should take advantage of the power of the medicine to come out. Because the body is weak, the vitality is insufficient, the camp is weak, and the defense is weak. Although this medicine wants to exorcise the evil outside, the vitality is discouraged. The mild evil does not escape halfway, and the severe evil shrinks in with the vitality. Therefore, the aversion to cold and fever is lingering. . To this end, it is necessary to eliminate cold with multiple targets, improve the physiological functions of the zang-fu organs, and improve the righteousness by cultivating the insufficient vitality. It is also necessary to add medicines that warm the meridians, clear the stagnation, and regulate the Qi mechanism. With the help of medicinal power, the evil spirits can be gradually dissipated. Therefore, dry ginger, which warms the middle and disperses cold, is used to dispel cold pain in the abdomen and abdomen with its pungent and hot nature, dispel visceral deficiency and cold, stop vomiting and diarrhea, and restore the yang of the spleen and stomach; it can also warm the lungs and change the drink to relieve cough, resolve phlegm, and clear the nose. Orifices, in addition to nasal discharge, can help Guizhi to dispel wind and cold. Rehmannia glutinosa is cold in nature, sweet and bitter in taste, nourishes yin and produces body fluid; when combined with dried ginger, it not only has no disadvantages of cold and cool, but also can generate blood and transform body fluid; it can also nourish the yin of lung, spleen and kidney, and help lung, spleen and kidney. Positive. Male cloves are warm in nature, pungent in taste, can warm the middle, reduce the inverse, and stomach, stop vomiting due to deficiency and cold, eliminate cold pain in the confidant, warm the kidneys and help yang; Zhimu is cold, bitter, sweet, nourishing yin and moisturizing dryness, and can diarrhoea rootless The kidney fire can cure the bone steaming caused by sweating; stop the heat of consumptive fatigue, nourish the yin of the source, prevent the warm and dry cinnamon sticks, dried ginger and cloves from producing strong fire and eat qi, consume blood, injure yin and damage yang; Compatibility with cloves can strengthen the power of dried ginger and rehmannia to nourish the lungs, spleen and kidneys. Lung health is the barrier of the body's defense of qi. With the help of lung health, the body will expel pathogens and increase its strength. The spleen is the foundation of the day after tomorrow. If the spleen yin and spleen yang are supported, the qi and blood will be hygienically transformed, and if the guard qi is aided, the lung guard will not be afraid of evil disturbances. Kidney qi is the foundation of lung health, the foundation of yin and yang of the human body, and if kidney yin and kidney yang are enriched, health care will be in an orderly manner, and lung health will be prosperous. In the above four herbs, there are two yin and two yang. Yin depends on the use of yang to transform into camp, and yang depends on the use of yin to transform into Wei. More sweet, warm Codonopsis, jujube, invigorating the spleen and qi, which is conducive to encouraging evil spirits to go out. Jujube can nourish yin and blood, nourish and transform health, and help white peony and ying; when combined with Erjiang, it has the meaning of "Xin Gan diverges into Yang". Schisandra astringes the lungs and invigorates the kidneys, astringes sweat and promotes fluid production. It is in the company of cinnamon twigs and dried ginger. Baishao, Shengdihuang, Zhimu and Schisandra all have the ability to astringe various powders, and can slow down the toughness of cinnamon sticks and dried ginger, so that wind, cold, phlegm and dampness are eliminated without injury to qi and blood. Yuanzhi is pungent and bitter in taste, slightly warm in nature, expectorating phlegm and relieving cough, calming the mind and soothing the nerves. Then Wu ginseng, jujube and grass have the effect of handing over water and fire. Zhigancao assists Guizhi to relieve muscle, helps white peony root and camp, and Wudazao nourishes qi, which has the power of calming the inside and preventing the outside. The combination of two ginger, jujube and licorice can replenish the middle qi, regulate the health of the body, and help sweating. Unblocking the qi machine can benefit all the deficiency and deficiency; it can also protect the viscera, prevent the evil from trapping, and prevent the growth and change of the syndrome. The functional relationship between it and Gui and Shao is for the purpose of accumulation and thin hair, and they are adjuvant. To make Pinellia to remove dampness and phlegm; Scutellaria baicalensis to clear heat and dry dampness; Dandelion removes heat toxin and disperses stagnant qi. The above three herbs are used in combination to remove excess dampness and heat in the formula. Zhigancao reconciles various medicines, and is also used as a medicine. The party comprehensively used the three methods of "Khan", "Replenishing" and "Harmony". "Khan method" and "replenishing method" have been described above, while "harmonious method" is integrated into "Khan method" and "replenishing method", that is, in the process of applying "Khan method" and "replenishing method", the Combined use of cold and heat, tonifying and purging mixture, tonifying the middle and attacking, purging for nourishment; reconciling yin and wei, reconciling liver and spleen, reconciling stomach; The qi in the body resumes its normal rise and fall, and the viscera perform their respective functions, promoting the recovery of vitality from various aspects, the improvement of righteousness, and the elimination of evil qi at multiple targets. All prescriptions are used together, aiming to relieve the body, and comprehensively use the methods of sweating, nourishing the viscera, nourishing the vitality, strengthening the righteousness, relieving the stagnation and balancing the yin and yang, promoting the recovery of the functions of the lungs, spleen and kidneys, and rapidly improving the body's immunity. After a long period of wind and cold, the medicine gradually dissipates, and there is no way for the transmission to change.
益元抗感合剂的制备方法Preparation method of Yiyuan Kanggan mixture
首先称取大枣300克,另器存放,加水0.5kg,浸泡2h;再按照重量份称取其余15味中药材,合并大枣及浸泡大枣之水,置多能式中药提取罐,向罐内加水5.5Kg,浸泡药物60min;向罐内通入蒸汽对药物进行加热,当药物温度达到100℃时,改向夹层进蒸汽,对药物进行间接加热,维持罐内温度在100℃左右,时间3h;滤取煎出液,另器存放;再次向罐内药物加水3Kg,煎煮方法同上,时间3h,滤取煎出液,压榨残渣,合并2次煎液,静置沉淀24h,滤过,吸取上部清液浓缩至相对密度1.15,所述相对密度是90-95℃时的相对密度,加苯甲酸钠0.6g,搅拌,混匀,得剂量600ml;在微沸状态下,即灌装于已洗净、灭菌、干燥的热瓶内,灌装时的热瓶温度80℃左右,立即密封瓶口,放冷后贴签。First, weigh 300 grams of jujube, store in another container, add 0.5 kg of water, and soak for 2 hours; then weigh the remaining 15 Chinese medicinal materials according to weight, combine the jujube and the water for soaking the jujube, put a multi-energy Chinese medicine extraction tank, and put it in the Add 5.5Kg of water to the tank, soak the medicine for 60min; inject steam into the tank to heat the medicine, when the temperature of the medicine reaches 100°C, turn the steam into the interlayer to heat the medicine indirectly, and maintain the temperature in the tank at about 100°C. Time 3h; filter out the decoction, store it in another container; add 3Kg of water to the medicine in the tank again, the decoction method is the same as above, time 3h, filter the decoction, squeeze the residue, combine the 2 decoctions, stand for precipitation for 24h, filter Then, absorb the supernatant and concentrate it to a relative density of 1.15, which is the relative density at 90-95 °C, add 0.6 g of sodium benzoate, stir, and mix to obtain a dose of 600 ml; In the cleaned, sterilized and dried thermos bottle, the temperature of the thermos bottle during filling is about 80 ℃, immediately seal the bottle mouth, and label it after cooling.
工艺流程图Flow chart
浸提→纯化→浓缩→灭菌→分装Extraction→purification→concentration→sterilization→packing
关于工艺及工艺流程的3点说明3 points about the process and process flow
关于浸提工艺由于该药的功效重在增强人体的免疫力,而不是主要通过发汗而解表,故不采用油水分离法另外提取桂枝和干姜的挥发油的生产工艺。Regarding the extraction process, because the efficacy of the drug focuses on enhancing the immunity of the human body, rather than releasing the surface mainly through sweating, the production process of additionally extracting the volatile oils of cinnamon sticks and dried ginger by the oil-water separation method is not used.
关于煎煮的时间与次数根据发明人的制剂经验和贾传春等人对中药合剂生产工艺的研究资料,确定煎煮的时间与次数为:每次煎煮3h,共煎煮2次。贾传春等人关于中药合剂生产工艺的研究报告指出:每次煎煮3h比煎煮2h的得膏率高3.37%,而比煎煮4h的得膏率低 0.33%。故以每次煎煮3小时为最佳煎煮时间。煎煮2次可将煎煮3次所得总膏汁的93.4%提起出来。综合考虑人工费用、能源消耗及设备折旧等因素,故以煎煮2次为宜。[6] About the time and frequency of decoction According to the inventor's preparation experience and the research data of Jia Chuanchun and others on the production process of traditional Chinese medicine mixture, the time and frequency of decoction are determined as follows: 3 hours of decoction each time, a total of 2 times of decoction. The research report of Jia Chuanchun et al. on the production process of traditional Chinese medicine mixture pointed out that the rate of obtaining paste is 3.37% higher than that of decocting for 2h each time, and 0.33% lower than that of decocting for 4h. Therefore, the best cooking time is 3 hours each time. 93.4% of the total paste juice obtained by decocting 3 times can be lifted out by decocting twice. Considering factors such as labor costs, energy consumption and equipment depreciation, it is advisable to cook twice. [6]
关于灭菌与分装的顺序合剂的一般生产工艺的后期工序,多为先分装,后灭菌。本工艺采用在最后浓缩阶段通过煮沸灭菌,加苯甲酸钠,灌装于已灭菌的热瓶内,立即密封瓶口。属于先灭菌,后分装。无菌车间和严格的工艺操作规程可以确保灭菌效果。Regarding the later stages of the general production process of the sequential mixture of sterilization and sub-packaging, most of them are sub-packaging first, followed by sterilization. This process adopts boiling sterilization in the final concentration stage, adding sodium benzoate, filling it into a sterilized thermos bottle, and sealing the bottle mouth immediately. It belongs to sterilization first, and then repacking. Sterile workshop and strict process operation procedures can ensure the sterilization effect.
制备益元抗感合剂的原料The raw material for preparing Yiyuan anti-infection mixture
中药材Chinese herbal medicine
桂枝 为樟科常绿乔木植物肉桂(Cinnamomum cassia Presl)的干燥嫩枝RamulusCinnamomi。春、夏二季采收,除去叶,用水稍浸泡,捞起,闷润至透,切片,晾干,筛去屑。桂枝性温,味辛、甘;归膀胱、心、肺经。我国福建、中国 台湾、海南、广东、广西、云南等热带及亚热带地区均有栽培,其中尤以广西栽培为多,大多为人工纯林。选用广西品种。Cinnamomum cassia is the dry shoot Ramulus Cinnamomi of the evergreen tree plant Cinnamomum cassia Presl in the Lauraceae family. Harvest in spring and summer, remove leaves, soak in water for a while, pick up, smother and moisten until thoroughly, slice, dry, and sieve to remove crumbs. Cinnamon twig is warm in nature, pungent and sweet in taste; it belongs to the bladder, heart and lung meridians. my country's Fujian, China Taiwan, Hainan, Guangdong, Guangxi, Yunnan and other tropical and subtropical regions are cultivated, especially in Guangxi, most of which are artificial pure forests. Choose Guangxi varieties.
白芍 为多年生草本双子叶植物药毛茛科植物芍药(Paeonia lactiflora Pall)(栽培种)的根。采挖已栽植3~4年的芍药根,除去根茎及须根,洗净,刮去粗皮,入沸水中略煮,使其发软,润透,捞出晾干,去杂质,切片,晒干。白芍性微寒,味微苦而酸;归肝、脾经。全国各地均有栽培。产于浙江者,商品称为杭白芍,品质最佳;产于安徽者称为毫白芍,产量最大;产于四川者名川白芍,又名中江芍,产量亦大。选用安徽品种。Paeonia lactiflora is the root of Paeonia lactiflora Pall (cultivar). Dig the peony root that has been planted for 3 to 4 years, remove the rhizome and fibrous root, wash it, scrape off the rough skin, cook it in boiling water for a while to make it soft, moisten thoroughly, remove and dry, remove impurities, slice and dry in the sun. Paeonia lactiflora is slightly cold in nature, slightly bitter and sour in taste; it belongs to the liver and spleen meridians. It is cultivated all over the country. Produced in Zhejiang, the commodity is called Hangbaishao, with the best quality; produced in Anhui is called Haobaishao, with the largest yield; produced in Sichuan, it is called Chuanbaishao, also known as Zhongjiang peony, and the yield is also large. Select Anhui varieties.
生姜 为姜科植物姜Zingiber officinale Rosc.的新鲜根茎。秋、冬二季采挖,除去须根及泥沙,切片,生用。性温,味辛。归肺、脾、胃经。各地均产。选用安徽品种。Ginger is the fresh rhizome of Zingiber officinale Rosc. Excavate in autumn and winter, remove fibrous roots and sediment, slice, and use raw. Warm in nature, spicy in taste. Returns the lung, spleen and stomach meridians. Produced everywhere. Select Anhui varieties.
黄芪 为豆科草本植物蒙古黄芪Astragalus membranaceus(Fisch.)Bunge、膜荚黄芪Astragalus membranaceus(Fisch.)的根。在秋季植株枯萎时或翌年春季尚未萌发前采收,一般9月中下旬采收为佳。用工具小心挖取植种了2-3年的全根,生长年限过久可产生黑心,影响品质。避免碰伤外皮和断根,去净泥土,趁鲜切去芦头,修去须根,晒至半干,堆放1-2d,使其回潮,再摊开反复晾晒,直至全干,将根理直,扎成小捆,切薄片,质量以条粗、皱纹少、断面色黄白、粉性足,味甘者为佳。黄芪性微温、味甘;归肺、脾、肝、肾经。全国各地多有栽培,市场上大部分为内蒙古黄芪的根(箭黄芪),质佳。小部分为膜荚黄芪的根。选用内蒙古品种。Astragalus is the root of the leguminous herb Astragalus membranaceus (Fisch.) Bunge and Astragalus membranaceus (Fisch.). Harvest in autumn when the plants wither or before germination in spring of the following year, generally in the middle and late September. Use tools to carefully dig out the whole roots that have been planted for 2-3 years. If the growth period is too long, black hearts may occur and the quality will be affected. Avoid bruising the outer skin and broken roots, remove the soil, cut off the reed heads while fresh, trim off the fibrous roots, dry them in the sun, stack them for 1-2 days to regain moisture, and then spread them out and dry them repeatedly until they are completely dry, and straighten the roots. , tied into small bundles, cut into thin slices, the quality is thicker, less wrinkled, yellow-white in color, powdery enough, and sweet in taste. Astragalus is slightly warm in nature and sweet in taste; it belongs to the lung, spleen, liver and kidney meridians. It is cultivated all over the country, and most of the roots in the market are the roots of Astragalus in Inner Mongolia (Astragalus arrows), which are of good quality. A small part is the root of Astragalus membranaceus. Select Inner Mongolia varieties.
干姜 为姜科多年生草本植物姜(Zingiber oj-jicinale Rosc)的干燥根茎。采挖后除去茎叶及须根,洗净、晒干或低温干燥,切片。干姜味辛,性热。归脾、胃、心、肺经。我国大部分地区均有栽培,主产四川、贵州。选用四川品种。Dried ginger is the dried rhizome of Zingiber oj-jicinale Rosc, a perennial herb of the ginger family. After excavation, the stems, leaves and fibrous roots are removed, washed, sun-dried or dried at low temperature, and sliced. Dried ginger is spicy and hot in nature. Return to the spleen, stomach, heart and lung meridians. It is cultivated in most parts of my country, mainly in Sichuan and Guizhou. Select Sichuan varieties.
生地黄 为双子叶植物玄参科植物药地黄(Rehmannia glutinosa)的块根。秋季采挖根茎,除去芦头、茎叶、须根,洗净泥土,为鲜地黄,切片、晒干或烘干而成。生地黄性寒,味甘、苦,入心、肝、肾经。主产于河南、辽宁、河北、山东、浙江,以河南所产者最为著名,选用河南品种。Rehmannia glutinosa is the tuberous root of the dicotyledonous plant Scrophulariaceae (Rehmannia glutinosa). In autumn, the rhizomes are excavated, the reed heads, stems and leaves, and fibrous roots are removed, and the soil is washed. Rehmannia glutinosa is cold in nature, sweet and bitter in taste, and enters the heart, liver and kidney meridians. Mainly produced in Henan, Liaoning, Hebei, Shandong and Zhejiang, the most famous ones are those produced in Henan, and Henan varieties are selected.
公丁香 为桃金娘科常绿乔木植物(Eugenia caryophyllata Thunb)的花蕾。采下后除去花梗,晒干。公丁香性温,味辛。入肺、脾、胃、肾经。公丁香是我国传统进口“南药”之一,原产于印尼的摩鹿加岛及坦桑尼亚的桑哈巴尔岛。现在印尼的槟榔屿、苏门塔腊、爪哇以及马来半岛、越南和大洋洲等国家和地区均产。我国50年代引种成功,海南省及雷州半岛、广东、广西等地有栽培。选用广西品种。Male lilac is the flower bud of Eugenia caryophyllata Thunb, an evergreen tree plant of the family Myrtaceae. After harvesting, remove the pedicels and dry them in the sun. Public cloves are warm in nature and pungent in taste. Enter the lung, spleen, stomach and kidney meridians. Lilac is one of the traditional imported "Southern medicines" in my country, originating in Moluccas Island in Indonesia and Sanhabar Island in Tanzania. Now Indonesia's Penang, Sumatra, Java and the Malay Peninsula, Vietnam and Oceania and other countries and regions are produced. It was successfully introduced in my country in the 1950s and cultivated in Hainan Province, Leizhou Peninsula, Guangdong, Guangxi and other places. Choose Guangxi varieties.
知母 为多年生草本单子叶植物百合科Liliaceae知母(Anemarrhenaasphodeloides Bunge)的干燥根茎。春秋两季可采挖栽种2-3年的知母根,以秋季采收较佳,除掉茎苗、须根及泥沙,晒干,习称“毛知母”。或除去外皮,置通风处干燥,切片备用。知母性寒、味苦、甘;归肺、胃、肾经。主产河北、山西、内蒙、陕西及东北等地。选用河北品种。Anemarrhena is the dry rhizome of Anemarrhenaasphodeloides Bunge, a perennial herb monocotyledonous plant Liliaceae. In spring and autumn, 2-3 years old Anemarrhena root can be harvested and planted. It is better to harvest in autumn, remove stems, fibrous roots and sediment, and dry it in the sun. Or remove the outer skin, dry in a ventilated place, and slice for later use. Anemarrhena is cold in nature, bitter in taste and sweet; it belongs to the lung, stomach and kidney meridians. Mainly produced in Hebei, Shanxi, Inner Mongolia, Shaanxi and Northeast China. Use Hebei varieties.
党参 为桔梗科多年生草本植物党参、素花党参、川党参及其同属多种植物的根素花党参(西党参)Codonopsis pilosula Nannf.var.modesta(Nannf.)L.T.Shen或川党参Codonopsis tangshen Oliv的干燥根。以原产于山西上党盆地而得名,以五台县出产为多,故称为“台党参”。台党参以野生者品质特优,为党参中之珍品。秋季采挖,洗净,晒干。党参性平,味甘、微酸。归脾、肺经。主产山西,多为栽培品。东北、华北及陕西、宁夏、甘肃、青海、河南、四川、云南、西藏等地亦产。选用河南品种。Codonopsis is the perennial herb Codonopsis, Codonopsis, Sichuan Codonopsis and the root of Codonopsis (West Codonopsis) Codonopsis pilosula Nannf.var.modesta (Nannf.) L.T.Shen or Codonopsis Codonopsis tangshen Oliv dry roots. It is named after its origin in Shangdang Basin, Shanxi, and is mostly produced in Wutai County, so it is called "Taiwan Codonopsis". Taiwan Codonopsis is a treasure of Codonopsis due to its excellent quality. Excavated in autumn, washed and sun-dried. Codonopsis is flat, sweet and slightly sour. Return to the spleen and lung meridians. Mainly produced in Shanxi, mostly cultivated products. Northeast, North China and Shaanxi, Ningxia, Gansu, Qinghai, Henan, Sichuan, Yunnan, Tibet and other places are also produced. Choose Henan varieties.
大枣 为鼠李科枣属植物枣Ziziphus jujuba Mill.var.inermis(Bunge)Rehd 的干燥成熟果实。又名红枣,8~9月果熟,采摘后除去杂质,晒干。大枣性平,味甘。归脾、胃经。全国大部分地区均产,山东、河北、山西、陕西及安徽省所生产的枣占年总产量的80%以上。我国著名的大枣品种有山西黄河滩枣,五佛大枣,山东大枣,泗洪大枣,阜平大枣,赞皇大枣,哈密大枣,新郑大枣等。选用山东品种。Jujube is the dry ripe fruit of the jujube Ziziphus jujuba Mill.var.inermis (Bunge) Rehd. Also known as red jujube, the fruit is ripe from August to September. After picking, impurities are removed and dried in the sun. Jujube is flat in nature and sweet in taste. Return to the spleen and stomach meridians. It is produced in most parts of the country, and the jujubes produced in Shandong, Hebei, Shanxi, Shaanxi and Anhui provinces account for more than 80% of the total annual output. The famous jujube varieties in my country include Shanxi Yellow River Tan jujube, Wufo jujube, Shandong jujube, Sihong jujube, Fuping jujube, Zanhuang jujube, Hami jujube, Xinzheng jujube, etc. Select Shandong varieties.
五味子 为多年生落叶藤本木兰科植物五味子Schisandra chinensis(Turcz.)Baill的干燥成熟果实,习称北五味子。秋后果实呈紫红色时采摘,晒干或阴干。五味子性温,味酸、甘。归肺、心、肾经。主产于黑龙江、辽宁、吉林、河北等地,为传统正品,品质优良。选用辽宁品种。Schisandra chinensis is the dry ripe fruit of the perennial deciduous vine Magnoliaceae Schisandra chinensis (Turcz.) Baill, commonly known as Schisandra chinensis. After autumn, the fruit is picked when it is purple-red and dried in the sun or shade. Schisandra is warm, sour and sweet. Returns the lung, heart and kidney meridians. Mainly produced in Heilongjiang, Liaoning, Jilin, Hebei and other places, it is a traditional authentic product with good quality. Use Liaoning varieties.
远志 为远志科植物远志(Polygala tenuifolia Willd)或卵叶远志(Polygalasibirica L)的干燥根。农历四月采根,除去杂质,略洗,润透,切段,干燥。远志性温,味苦、辛。归心、肺、肾经。其主流产品:小叶者即今用的远志,秦岭南北坡均产;大叶者即今用的西伯利亚远志。选用陕西品种。Polygala is the dried root of Polygala tenuifolia Willd or Polygalasibirica L. Roots were harvested in April of the lunar calendar, impurities were removed, washed slightly, moistened thoroughly, cut into sections, and dried. Yuanzhi is warm in nature, bitter and acrid in taste. Return to the heart, lung and kidney meridians. Its mainstream products: the small-leafed ones are the Polygala for today's use, and they are produced on both the southern and northern slopes of the Qinling Mountains; Shaanxi varieties are selected.
蒲公英 (araxacum mongolicum Hand.-Mazz)菊科,属多年生草本植物。晚秋时节采挖带根的全草,去泥、晒干以备药用。蒲公英性寒,味苦、甘。归肝、肾经。中国大部分地区均有栽培,选用安徽品种。Dandelion (araxacum mongolicum Hand.-Mazz) is a perennial herb. In late autumn, the whole grass with roots is excavated, removed from the mud, and dried in the sun for medicinal use. Dandelion is cold, bitter and sweet. Return to the liver and kidney meridians. It is cultivated in most parts of China, and Anhui varieties are selected.
制半夏 为天南星科植物半夏Pinellia ternata(Thunb)Breit的块茎。夏、秋二季茎叶茂盛时采挖,除去外皮及须根.晒干。中国大部分地区均有栽培,主产于四川、湖北、江苏、安徽等地。选用湖北品种。The system of Pinellia is the tuber of Pinellia ternata (Thunb) Breit of the Araceae. In summer and autumn, when the stems and leaves are lush, excavate, remove the outer skin and fibrous roots, and dry in the sun. It is cultivated in most parts of China, mainly in Sichuan, Hubei, Jiangsu, Anhui and other places. Select Hubei varieties.
炮制方法:取净半夏,大小分开,用水浸泡至内无干心,取出;另取甘草适量(每100kg净半夏,用甘草15kg),加水煎煮二次,合并煎液,倒入用适量水制成的石灰液(每100kg净半夏用生石灰10kg)中,搅匀,加入上述已浸透的半夏,浸泡,每日搅拌1~ 2次,并保持浸液pH值12以上,至剖面黄色均匀,口尝微有麻舌感时,取出,洗净,阴干或烘干即得。制半夏性温,味辛。归脾、胃、肺经。Processing method: Take net Pinellia, separate the size, soak in water until there is no dry heart, take it out; take an appropriate amount of licorice (15kg of licorice per 100kg of net pinellia), add water and decocted twice, combine the decoction, and pour in an appropriate amount of licorice. In the lime liquid made of water (10kg of quicklime per 100kg of net Pinellia sinensis), stir well, add the soaked Pinellia sinensis, soak, stir 1-2 times a day, and keep the pH value of the soaking liquid above 12, to the profile When the yellow color is uniform, and the taste is slightly numb, take it out, wash it, dry it in the shade or dry it. The system of Pinellia is warm in nature and spicy in taste. Returns to the spleen, stomach and lung meridians.
黄芩 为唇形科植物黄芩(Scutellaria baicalensis Georgi)的干燥根。春、秋二季采挖,除去须根及泥沙、杂质,置沸水中煮10分钟,取出,闷透,切薄片,干燥(避免曝晒)。撞去粗皮,晒干。黄芩性寒,味苦。归肺、胆、脾、大肠、小肠经。产于河北、内蒙古、陕西、辽宁、黑龙江等省、自治区。选用内蒙古品种,不可贮存过久。Scutellaria baicalensis is the dried root of Scutellaria baicalensis Georgi. Excavate in spring and autumn, remove fibrous roots, sediment and impurities, cook in boiling water for 10 minutes, take out, smother, cut into thin slices, and dry (avoid exposure to sunlight). Rip off the rough skin and dry in the sun. Scutellaria baicalensis is cold in nature and bitter in taste. Returns the lung, gallbladder, spleen, large intestine and small intestine meridians. Produced in Hebei, Inner Mongolia, Shaanxi, Liaoning, Heilongjiang and other provinces and autonomous regions. Use Inner Mongolia varieties, do not store for too long.
炙甘草 系双子叶植物豆科(Leguminosae)甘草(Glycyrrhiza uralensisFisch)、胀果甘草(G.inflataBat)或光果甘草(G.glabraL)的根及根茎。春、秋二季采挖,除去须根,晒干。切厚片,蜜炙。在亚洲、欧洲、澳洲、美洲等地都有分布;中国主要分布于新疆、内蒙古、宁夏、甘肃、山西朔州野生为主。人工种植甘草主产于新疆、内蒙古、甘肃的河西走廊,宁夏部分地区。选用内蒙古品种。Glycyrrhiza is the root and rhizome of dicotyledonous plants Leguminosae Glycyrrhiza uralensis Fisch, G. inflataBat or G. glabraL. Excavated in spring and autumn, removed fibrous roots, and sun-dried. Cut into thick slices and grilled with honey. It is distributed in Asia, Europe, Australia, America and other places; China is mainly distributed in Xinjiang, Inner Mongolia, Ningxia, Gansu, and Shanxi Shuozhou. Artificially planted licorice is mainly produced in the Hexi Corridor of Xinjiang, Inner Mongolia, Gansu, and parts of Ningxia. Select Inner Mongolia varieties.
炮制方法 蜂蜜置锅中炼成中蜜,取炼蜜,加适量开水稀释后,淋入净甘草片中,拌匀,闷润3h,中途翻动2次。用文火拌炒润透的甘草片3-5min,使其混合均匀,出锅;置恒温干燥箱干燥,温度60℃,恒温干燥1h,至不粘手时取出,放凉。甘草片每100kg,用炼蜜25kg。Processing method: Put the honey in a pot and make it into medium honey, take the refined honey, dilute it with an appropriate amount of boiling water, pour it into the net licorice slices, mix well, simmer for 3 hours, and turn it twice in the middle. Stir-fry the thoroughly moistened licorice slices for 3-5min with simmering heat to make them evenly mixed, and take out of the pot; dry in a constant temperature drying oven at a temperature of 60 ℃, dry at a constant temperature for 1 hour, take it out when it is not sticky, and let it cool. For every 100kg of licorice tablets, use 25kg of refined honey.
原料药物的贮存、真伪鉴别、质量要求、净化方法与药物来源Storage, authenticity identification, quality requirements, purification methods and drug sources of APIs
桂枝、干姜、公丁香等药材,由于其中所含有的化学成分容易自然分解、挥发而不能久贮,需要采用密封法、冷藏法保存。黄芩,如果贮存过久,其中的黄芩苷酶在一定条件下会使黄芩苷及汉黄芩苷酶解,生成黄芩素和汉黄芩素,其抗病毒作用显著下降。生地黄、党参、大枣等药材中含有较多糖分,其分解后产生糠醛及其类似化合物,与一些含氮化合物缩合成棕色色素;或因药材中含有的蛋白质中的氨基酸与还原糖作用,生成大分子的棕色物质,使药材变色、变质。所以,除制半夏可用陈货之外,其余药材一律不用陈货。Cinnamon sticks, dried ginger, cloves and other medicinal materials cannot be stored for a long time because the chemical components contained in them are easily decomposed and volatilized, and need to be preserved by sealing and refrigeration. If baicalin is stored for a long time, the baicalinase in it will hydrolyze baicalin and wogonin under certain conditions to generate baicalein and wogonin, and its antiviral effect will be significantly reduced. Rehmannia glutinosa, Codonopsis, jujube and other medicinal materials contain a lot of sugar, and after their decomposition, furfural and its similar compounds are produced, which are condensed with some nitrogen-containing compounds to form brown pigments; The brown substance of macromolecules is formed, which makes the medicinal materials discolor and deteriorate. Therefore, except for the production of Pinellia, the other medicinal materials should not be used.
以上16味中药饮片均通过性状鉴定辨别其真伪。The above 16 Chinese herbal decoction pieces were all identified by character identification to identify their authenticity.
以上16味中药饮片均各筛去泥沙和碎末,拣除杂物,剔出已经变质的药材,干燥,备用。The above 16 Chinese herbal decoction pieces were all sieved to remove the sediment and debris, and the sundries were removed, and the spoiled medicinal materials were removed, dried and set aside.
以上16味中药饮片均为《中国药典》所记载。The above 16 herbal decoction pieces are all recorded in the Chinese Pharmacopoeia.
辅料Excipients
水 符合卫生部《生活饮用水卫生标准》(GB5749-2006)。The water is in line with the Hygienic Standards for Drinking Water (GB5749-2006) of the Ministry of Health.
苯甲酸钠 符合国家标准GB 1902-2005。Sodium benzoate complies with the national standard GB 1902-2005.
发明的效果——临床应用情况The effect of the invention - clinical application
从以下临床应用情况和实验数据及实验实施例可以看出益元抗感合剂的发明效果The invention effect of Yiyuan Kanggan Mixture can be seen from the following clinical application, experimental data and experimental examples
临床用于治疗感冒的项目 包括解除恶风、恶寒、发热,鼻塞流涕,干呕或呕吐,头痛、身痛、肢体酸痛,提高自愈能力与免疫功能等主要项目和止咳、祛痰、平喘,发汗,镇静、抗过敏等辅助项目。Items clinically used in the treatment of colds include relieving aversion to wind, chills, fever, nasal congestion and runny nose, retching or vomiting, headache, body pain, and limb aches, improving self-healing ability and immune function and other major items, as well as relieving cough, expectorant, Asthma, sweating, sedation, anti-allergic and other auxiliary items.
诊断标准 参照《中药新药临床研究指导原则(试行)》中关于感冒的中医证候诊断标准和王永炎、鲁兆麟主编的《中医内科学》关于风寒表虚证诊断标准[7].拟定出如下标准:The diagnostic criteria refer to the TCM syndrome diagnostic criteria for colds in "Guiding Principles of Clinical Research on New Chinese Medicines (Trial)" and the "Traditional Chinese Medicine Internal Medicine" edited by Wang Yongyan and Lu Zhaolin on the diagnostic criteria for wind-cold surface deficiency syndrome [7]. The formulas are as follows standard:
恶风寒重,发热轻,无汗或汗出恶风,头痛,或身痛,肢体酸痛,或有项强,鼻塞声重,时流清涕,干呕或呕吐,或咽痒,咳嗽,吐痰稀薄色白,舌苔薄白而润,脉浮缓或浮弱。Severe aversion to wind and cold, mild fever, no sweating or sweating, aversion to wind, headache, body pain, soreness in limbs, or strong neck, heavy nasal congestion, frequent runny nose, retching or vomiting, or itchy throat, cough, vomiting Thin and white phlegm, thin white and moist tongue coating, and slow or weak pulse.
实验病例的排除与纳入标准Exclusion and inclusion criteria of experimental cases
排除标准Exclusion criteria
发病后超过48h者;More than 48 hours after onset;
精神病患者;Mentally ill;
糖尿病重症患者;Severely diabetic patients;
孕妇;pregnant woman;
面色潮红、舌红干无苔、脉细数者(外感风热证)。Flush complexion, red and dry tongue without coating, and thin pulse (exogenous wind-heat syndrome).
纳入标准:Inclusion criteria:
符合中医关于外感风寒表虚证的诊断标准;Conform to the diagnostic criteria of TCM on exogenous wind-cold manifesting deficiency syndrome;
年龄在3周岁以上;Aged over 3 years old;
患者兼有气虚、血虚、阳虚、阴虚(不严重)或交叉型虚证(不必俱全);The patient has qi deficiency, blood deficiency, yang deficiency, yin deficiency (not serious) or cross-type deficiency syndrome (not all of them);
经常感冒,持续时间在1年以上者。Frequent colds that last for more than 1 year.
病例选择 研制人从2000年-2008年接诊的感冒患者中,挑选出过去经常感冒,在他处久治难愈(有的月月感冒长达10年之久)的患者。在治疗组29例病人中,男 13例,女16例,年龄3-81岁,平均32岁。Case selection The researchers selected from the cold patients admitted from 2000 to 2008, the patients who often had colds in the past and were refractory to other treatments for a long time (some colds lasted as long as 10 years). Among the 29 patients in the treatment group, there were 13 males and 16 females, ranging in age from 3 to 81 years old, with an average age of 32 years.
研究方法Research methods
用益元抗感合剂给感冒患者口服,观察临床疗效。Oral administration of Yiyuan Kanggan mixture to cold patients to observe the clinical curative effect.
益元抗感合剂,每瓶装240ml。Yiyuan anti-infection mixture, 240ml per bottle.
成人一次口服40ml,服用时摇匀,温开水兑服,一日3次。兼阴虚证的患者半量服用,一日4-5次;儿童一次口服10ml。Adults take 40ml orally at a time, shake well when taking, mix with warm water, 3 times a day. Patients with yin deficiency syndrome take half dose, 4-5 times a day; children take 10ml orally at a time.
医嘱:避风,注意保暖,休息静养;忌烟、酒及辛辣、生冷、油腻食物。Doctor's advice: take shelter from the wind, keep warm, rest and recuperate; avoid smoking, alcohol and spicy, cold and greasy food.
疗效判定标准[8] Efficacy criteria [8]
临床痊愈:治疗3t以内体温恢复正常,感冒症状全部消失。Clinical recovery: The body temperature returned to normal within 3t of treatment, and all cold symptoms disappeared.
显效:治疗3t以内体温恢复正常,感冒的大部分症状消失。Significantly effective: The body temperature returned to normal within 3t of treatment, and most of the symptoms of colds disappeared.
有效:治疗3t以内体温较以前降低,感冒的主要症状部分消失。Effective: within 3t of treatment, the body temperature is lower than before, and the main symptoms of colds partially disappear.
无效:治疗3t以内体温未降或升高,感冒的主要症状无改善。Ineffective: the body temperature did not drop or rise within 3t of treatment, and the main symptoms of colds did not improve.
主要研究项目的治疗效果Therapeutic effects of the main research project
恶风恶寒症状:轻症患者在服药1次以后缓解;重症患者在服药2次以后缓解。Symptoms of aversion to wind and cold: mild patients relieved after taking the medicine once; severe patients relieved after taking the medicine twice.
鼻塞、声重、流涕,喷嚏等症状:轻症患者在服药后平均1h左右缓解,重症患者在服药后平均2h左右缓解。Nasal congestion, heavy voice, runny nose, sneezing and other symptoms: mild patients relieved on average about 1 hour after taking the drug, and severe patients relieved on average about 2 hours after taking the drug.
发热症状:体温37.1-37.9℃(腋窝温度)的患者,在服药后平均30min左右开始退热;体温38-38.5℃的患者,在服药后平均60min左右开始退热。Fever symptoms: Patients with a body temperature of 37.1-37.9°C (armpit temperature) start to cool down on average about 30 minutes after taking the medicine; patients with a body temperature of 38-38.5°C start to cool down on average about 60 minutes after taking the medicine.
风寒性干呕或呕吐症状:患者在服药后平均15min左右症状开始改善。Wind-cold retching or vomiting symptoms: The patient's symptoms began to improve on average about 15 minutes after taking the drug.
纳差症状:患者在服药2h后开始改善。Anorexia symptoms: The patient began to improve 2 hours after taking the drug.
头痛、项强、身痛和肢体酸痛症状:轻症患者在服药后平均30min左右开始缓解;无慢性疾病的重症患者,在服药60min左右开始缓解。Symptoms of headache, neck strength, body pain and limb soreness: mild patients start to relieve on average about 30 minutes after taking the medicine; severe patients without chronic diseases start to relieve about 60 minutes after taking the medicine.
自愈能力与免疫功能低下的改善状况:患者曾经月月感冒、久治难愈,经服用益元抗感合剂后,一般能够在3t内痊愈,大多数患者痊愈后,在6个月内不易再度感冒,表明患者自愈能力与免疫功能得到提高。Improvement of self-healing ability and low immune function: The patient has had a cold every month, and it is difficult to recover after long-term treatment. After taking Yiyuan Anti-Infection Mixture, he can generally recover within 3T, and most patients are not easy to recover within 6 months after recovery. Cold, indicating that the patient's self-healing ability and immune function have been improved.
辅助研究项目的治疗效果Therapeutic effects of ancillary research projects
咳嗽、咯稀白痰症状:轻症患者在服药后平均30min左右开始缓解;重症在服药后平均60min左右开始缓解。Symptoms of cough and thin white phlegm: mild patients start to relieve on average about 30 minutes after taking the medicine; severe patients start to relieve on average about 60 minutes after taking the medicine.
出汗症状:患者在服药期间多见微汗,不见大汗和妄汗。汗出后全身轻松、舒适。Symptoms of sweating: During the medication, patients often see micro sweats, but no profuse sweating and paradoxical sweating. The whole body is relaxed and comfortable after sweating.
睡眠状况:患者在服药平均2次以后,原先虚烦不眠的症状逐渐得到改善。Sleep status: After taking the medicine for an average of 2 times, the original symptoms of restlessness and insomnia were gradually improved.
情绪、应激与抗过敏状况:患者服用本品2次以后,情绪逐渐趋向稳定;服药24h后,身体对多种应激原的刺激,原先表现为精神紧张的现象得到缓解,个别患者偶尔出现反应亦较前平和,逐渐出现较稳定的良性情绪;原先患有过敏性荨麻疹、过敏性鼻炎的患者在服用本品后,荨麻疹症状与慢性鼻炎症状得到改善,表明本品具有一定的抗过敏功能。Emotion, stress and anti-allergic conditions: After taking this product for two times, the patient's mood gradually becomes stable; after 24 hours of taking the drug, the body's stimulation of various stressors, which originally manifested as mental stress, is relieved, and individual patients occasionally appear The reaction was also calmer than before, and a more stable benign mood gradually appeared; after taking this product, the symptoms of urticaria and chronic rhinitis were improved in patients who had previously suffered from allergic urticaria and allergic rhinitis, indicating that this product has a certain anti-inflammatory effect. Allergy function.
实验数据Experimental data
给药3t的治疗效果统计Statistics on the therapeutic effect of administration of 3t
总有效率:(痊愈数+显效数+有效数)/总例数×100%=96.55%;Total effective rate: (number of cured + number of marked effect + number of effective) / total number of cases × 100% = 96.55%;
总显效率:(痊愈数+显效数)/总例数×100%=93.10%。Total effective rate: (number of cured + number of marked effect)/total number of cases×100%=93.10%.
益元抗感合剂与其它药物疗法在治疗感冒的疗效方面的比较Comparison of Yiyuan Kanggan Mixture and Other Drug Therapy in Treating Colds
临床疗效比较治疗组中无慢性疾病的一般感冒患者在服用益元抗感合剂2t内,体温正常,感冒症状消失,原有体能强度不但没有下降,反而有所提高,痊愈后即可从事工作与学习。曾经屡患感冒的患者服用1t后,诸症改善,一般能够在3t内痊愈,恢复期1t左右。一般人在3-6个月内不易再度感冒。而原屡患感冒的患者在接受其它疗法时,治疗期一般在3-5t 或以上,恢复期2t以上。感冒痊愈后,在15-20t左右,常常还会再次感冒。Comparison of clinical curative effect The general cold patients without chronic diseases in the treatment group had normal body temperature within 2t of taking Yiyuan Kanggan Mixture, the cold symptoms disappeared, and the original physical strength not only did not decrease, but improved, and they could work and work after recovery. study. After taking 1t of colds for patients who have suffered from frequent colds, their symptoms are improved, and they can generally be cured within 3t, and the recovery period is about 1t. Most people are less likely to catch a cold within 3-6 months. When the patients who have suffered from frequent colds receive other treatments, the treatment period is generally 3-5t or more, and the recovery period is more than 2t. After the cold is cured, at about 15-20t, it is often common to catch a cold again.
费用、实际药物消耗量与成本比较由于治疗组感冒患者痊愈快,痊愈后在3-6个月内不易再度感冒,而他们曾经在接受其它疗法时痊愈相对较慢;有的还会因感冒而引起原发病恶化或出现并发症而住院治疗,所以在治疗感冒的费用、实际药物消耗量等方面,益元抗感合剂都具有明显的优势。Comparison of cost, actual drug consumption and cost Because the cold patients in the treatment group recovered quickly, they were not easy to catch a cold again within 3-6 months after recovery, and they had a relatively slow recovery when they received other treatments; Caused by the deterioration of the primary disease or the occurrence of complications and hospitalization, Yiyuan Kanggan Mixture has obvious advantages in terms of the cost of treating colds and the actual consumption of drugs.
实验性实施例Experimental Example
病例1:曾某某,男,58岁,退休干部,2006年11月12日就诊,曾某近3年来月月感冒,同时患有心律不齐、心动过缓3年。今又感冒,前来就诊。症见:体胖,面色晄白,唇色紫黯,汗出微恶风寒,头晕头痛,咳嗽、醒后难眠,短气,心胸憋闷,舌淡白,边尖光嫩,苔薄白,脉浮缓、迟,心率53次/分,体温37.9℃。诊为气虚血亏之外感风寒表虚证。治宜疏风解郁,益元解表,药用益元抗感合剂,每次口服40ml,一日4次。服用3日,感冒告愈,睡眠、心律不齐有所改善。随访2年,没有再次感冒。Case 1: Zeng Moumou, male, 58 years old, retired cadre, went to the doctor on November 12, 2006. Zeng Mou had a cold every month for the past 3 years, and also suffered from arrhythmia and bradycardia for 3 years. I have a cold again today, so I came to see a doctor. Symptoms: body fat, pale complexion, dark purple lips, sweating slightly aversion to wind and cold, dizziness, headache, cough, insomnia after waking up, shortness of breath, chest tightness, pale tongue, glossy edge, thin white coating, pulse Floating slowly, late, heart rate 53 beats/min, body temperature 37.9 ℃. Diagnosed as deficiency syndrome of qi deficiency and blood deficiency outside the feeling of wind and cold. For the treatment of expelling wind and stagnation, Yiyuan detoxification, medicinal Yiyuan Kanggan Mixture, 40ml orally each time, 4 times a day. After taking it for 3 days, the cold was cured, and the sleep and arrhythmia improved. Follow-up for 2 years, no cold again.
病例2:吴某某,女,51岁,退休职工,2008年7月18日就诊。患慢性肾功能不全4 年,近2年来月月感冒,今又感冒,前来就诊。症见:神疲,面色萎黄,浮肿,唇色紫黯,汗出恶风恶寒,胸背冷痛,头痛,咳嗽,不欲饮食,夜尿3-4次,多梦少寐,舌色淡暗,苔薄白,脉浮细无力;体温37.6℃。诊为气血阴阳皆虚之外感风寒表虚证,阳虚偏盛型证候。治宜疏风解郁,益元解表,药用益元抗感合剂,首日每次口服20ml,以后一次40ml,一日4次。服用3日,感冒告愈,可见浮肿减轻,原先表现为精神紧张的现象得到缓解,每晚夜尿2次,睡眠改善。随访3个月,未见再次感冒。Case 2: Wu Moumou, female, 51 years old, retired worker, went to the doctor on July 18, 2008. Suffering from chronic renal insufficiency for 4 years, I have had a cold every month for the past 2 years, and now I have a cold again, so I came to see a doctor. Symptoms: fatigue, pale complexion, edema, dark purple lips, sweating, aversion to wind and cold, cold chest and back pain, headache, cough, inability to eat, 3-4 times of nocturnal urination, more dreams and less sleepiness, tongue color Dull, thin white fur, thin and weak pulse; body temperature 37.6 ℃. Diagnosed as deficiency of both qi, blood and yin and yang, the syndrome of deficiency of wind and cold, and the excess of yang deficiency. For the treatment of expelling wind and depressing stagnation, Yiyuan relieves the table, and medicinal Yiyuan Kanggan Mixture, take 20ml each time on the first day, and then 40ml each time, 4 times a day. After taking it for 3 days, the cold was cured, the swelling was relieved, and the phenomenon of mental tension was relieved, and the sleep was improved twice a night. During the 3-month follow-up, no cold was found again.
病例3:何某某,男,18岁,汉川市学生,2007年5月9日就诊,何某近1年多以来月月感冒,并发咽喉炎,今又感冒,前来就诊。症见:身体瘦弱,面色萎白,汗出恶风,头痛,咳嗽,厌食,舌紫红少苔,脉浮细;体温38.9℃。诊为阴虚之外感风寒表虚证。治宜疏风解郁,益元解表,药用益元抗感合剂,一次口服20ml,一日4次,服用2日,感冒告愈,没有并发咽喉炎。随访2年,未见再次感冒。Case 3: He Moumou, male, 18 years old, student in Hanchuan City, went to see a doctor on May 9, 2007. He Mou had a cold every month for more than a year and was complicated by pharyngitis. He has a cold again today and came to see a doctor. Symptoms: thin body, pale complexion, sweating, aversion to wind, headache, cough, anorexia, purplish red tongue with little coating, floating and thin pulse; body temperature 38.9°C. Diagnosed as syndrome of yin deficiency and wind-cold exterior deficiency. The treatment is suitable for dispelling wind and stagnation, and Yiyuan relieves the table. The medicinal Yiyuan Kanggan Mixture is taken orally 20ml at a time, 4 times a day, for 2 days, the cold is cured, and there is no concomitant pharyngitis. During the 2-year follow-up, no recurrence was found.
病例4:周某某:男,10岁又3个月,汉川市仙女山街儿童。2003年2月18日就诊,其奶奶代述:该童出生时体重2.25kg,自满月洗澡后,月月感冒、咳嗽。今又感冒,前来就诊。症见:体型消瘦,面色晄白,时常发出“吭吭”声,舌质瘦小、红嫩、无苔,脉浮细弱。诊为气阴两虚之外感风寒表虚证。治宜疏风解郁,益元解表,药用益元抗感合剂,一次口服 20ml,一日4次,服用3日,感冒告愈,慢性咽炎症状亦有所改善。随访1年,没有再次感冒。Case 4: Zhou Moumou: Male, 10 years old and 3 months old, child in Fairy Mountain Street, Hanchuan City. On February 18, 2003, he went to the doctor and his grandmother stated that the child weighed 2.25kg at birth. After taking a bath at the full moon, he had a cold and cough. I have a cold again today, so I came to see a doctor. Symptoms and symptoms: body weight loss, pale complexion, often making a "squeaky" sound, thin, red and tender tongue, no coating, floating and weak pulse. Diagnosed as deficiency of both qi and yin outside the sense of wind and cold. It is suitable for dispelling wind and stagnation, and benefiting Yuan to relieve external appearance. The medicinal Yiyuan Kanggan Mixture is taken orally at a time, 20ml, 4 times a day, for 3 days, the cold is cured, and the symptoms of chronic pharyngitis are also improved. Follow-up for 1 year, no cold again.
病例5:王某某,女,37岁,教师,自述自幼身体虚弱,从1993年起经常感冒、头晕、心悸,曾病休2年半。近2个月以来,感冒一直不愈,时轻时重,进食、喝水、洗衣、走路即出汗,汗后即恶风寒,咳嗽。2002年6月13日病情加重,前来就诊。症见:面色萎黄,神疲乏力,声低气弱,恶风恶寒较重,咳嗽无力,吐白沫稀痰。舌瘦小、色暗红,苔略腻,脉浮弱。诊为气血阴阳皆虚之外感风寒表虚证。治宜疏风解郁,益元解表,药用益元抗感合剂,首日一次口服20ml,以后一次40ml,一日4次,服用3日,感冒告愈。患者此次感冒正处于月经期间,在没有服用其它药物的情况下,而月经的颜色、经量与经期均比过去正常。随访1年,没有再度感冒。Case 5: Wang Moumou, female, 37 years old, teacher, said that she had been weak since she was a child. Since 1993, she has often caught colds, dizziness, and palpitations. She had been on sick leave for two and a half years. In the past 2 months, the cold has been unhealed, sometimes mild and sometimes severe. After eating, drinking, washing, and walking, I sweat. After sweating, I have aversion to cold and cough. On June 13, 2002, her condition worsened and she came to see a doctor. Symptoms and symptoms: pale complexion, mental fatigue, fatigue, low voice, weak breath, severe aversion to wind and cold, weak cough, spit white foam and thin phlegm. The tongue is thin and small, dark red in color, slightly greasy fur, and weak pulse. Diagnosed as deficiency of both qi, blood and yin and yang, the external sensation is wind-cold and the syndrome is manifested as deficiency. It is suitable for dispelling wind and stagnation, and benefiting Yuan to relieve external appearance. Medicinal Yiyuan Kanggan Mixture is taken orally with 20ml once on the first day, and 40ml once on the next day, 4 times a day. After taking it for 3 days, the cold will be cured. The patient's cold is during menstruation, and without taking other medicines, the color, volume and menstrual period of menstruation are normal than before. During the 1-year follow-up, there was no recurrence of colds.
发明效果小结 从以上临床疗效可以看出,该发明具有实用性、创造性和新颖性。Summary of the effect of the invention It can be seen from the above clinical effects that the invention has practicality, creativity and novelty.
实用性 生产该药的原料来源广阔,生产工艺合理,质量可控;治疗感冒疗效显著,适口性好;没有明显的毒副作用,安全性高,因此具有实用性。Practicality The raw materials for the production of the medicine are widely sourced, the production process is reasonable, and the quality is controllable; the curative effect of treating colds is remarkable, and the palatability is good; there is no obvious toxic and side effects, and the safety is high, so it is practical.
创造性 感冒是一种自限性疾病,主要依靠患者自身的免疫力来消除。医药市场上现有治疗感冒的中成药,重在改善感冒症状,有些中成药中虽然含有扶正的成分,但也只能改善某些正虚的症状,而不能够解决由于脏腑生理功能减退和元气亏损而免疫功能低下这个病根。益元抗感合剂则具有快速恢复人体元气以提高机体的免疫功能的特殊功效,从上述临床应用情况和实验数据及实验性实施例可以看出,该药可以缩短体弱及慢性病感冒患者因的治疗期和病后恢复期,总显效率达93.10%;特别是能够减少某些原发病因为感冒而引起恶化或出现并发症的概率,还能够大幅度地降低日后再次感冒的概率和可以用于多种虚证兼感冒的治疗,只是实热证感冒患者不宜服用。该药对于降低人类感冒的发生率,减轻感冒患者的疾病痛苦和经济负担,减少因为患感冒而误工、误学的时间,增加社会劳动能力将具有积极的促进作用。益元抗感合剂之所以能够具有以上的特殊功效,是因为该药的配方注入了用“标本兼治,注重治本”的方法去治疗感冒的缘故。治标就需要用强力去攻邪,而身体虚弱的感冒患者自稳能力较弱,不耐强攻。治本就需要用补法补其不足,提高五脏六腑的生理功能,并恰当地处理扶正与祛邪的关系,如果在药物的选配与比例方面不能丝丝入扣,则会很容易出现闭门留寇,外邪流连不解的弊端。为了避开这一对矛盾,一般主张先去外邪,后治本虚。该药的配方则恰到好处地处理了这一对矛盾,从多方面扶正而不恋邪,用大力度攻邪而不伤正,这是该药的创造性。Creative Cold is a self-limiting disease, mainly rely on the patient's own immunity to eliminate. The existing Chinese patent medicines for the treatment of colds in the pharmaceutical market focus on improving the symptoms of colds. Although some Chinese patent medicines contain ingredients that strengthen the body, they can only improve some symptoms of deficiency, but cannot solve the problems caused by the decline of the physiological functions of the viscera and vitality. The root cause of the disease is loss and low immune function. Yiyuan Kanggan Mixture has the special effect of quickly restoring the vitality of the human body to improve the immune function of the body. It can be seen from the above-mentioned clinical application, experimental data and experimental examples that the drug can shorten the risk of illness caused by frail and chronic cold patients. During the treatment period and the recovery period after the illness, the total effective rate is 93.10%; in particular, it can reduce the probability of deterioration or complications of some primary diseases caused by colds, and can also greatly reduce the probability of future colds and can be used. For the treatment of various deficiency syndromes and colds, it is not suitable for patients with colds with excess heat syndrome. The drug will play a positive role in reducing the incidence of human colds, alleviating the pain and economic burden of cold patients, reducing the time of missed work and school due to colds, and increasing social labor capacity. The reason why Yiyuan Kanggan Mixture can have the above special effects is because the formula of this medicine is injected with the method of "treat both the symptoms and the root causes" to treat the common cold. To treat the symptoms, it is necessary to use force to attack the evil, and the weak cold patients have weak self-stabilization ability and are not resistant to strong attacks. To cure the root cause, it is necessary to make up for its deficiencies, improve the physiological functions of the internal organs, and properly deal with the relationship between strengthening the righteousness and eliminating pathogenic factors. The evils of the lingering evil. In order to avoid this pair of contradictions, it is generally advocated to eliminate external evils first, and then treat the root deficiency. The formula of the medicine properly handles this pair of contradictions. It supports the righteous in many ways without loving the evil, and uses great strength to attack the evil without harming the righteous. This is the creativity of the medicine.
新颖性 益元抗感合剂的配方是一种全新的配方,在现有的治疗感冒的中成药中,没有记载与之相近或类似的配方;其治疗感冒的特殊功效,至今没有先例,这是该药的新颖性。The formula of Novel Yiyuan Anti-Infection Mixture is a brand-new formula. There is no similar or similar formula recorded in the existing Chinese patent medicines for the treatment of colds. There is no precedent for its special efficacy in the treatment of colds. Novelty of the drug.
【注释】【Notes】
[1]、[2]、[3]、[4]、中华内科杂志2012年4月第51卷第4期 殷凯生:《普通感冒的流行病学与疾病负担》[1], [2], [3], [4], Chinese Journal of Internal Medicine, Volume 51, Issue 4, April 2012, Yin Kaisheng: "Epidemiology and Disease Burden of the Common Cold"
[5]段英廉的临床经验介绍——肝硬化病理机制及治疗 作者:孙雍达 钱宝珠 作者单位:长春市中医院 载于《中国中西医结合脾胃杂志》1997年第5卷第2期 103-104页 共2页 编辑出版者:中国中西医结合脾胃杂志编辑部[5] Duan Yinglian's clinical experience introduction - pathological mechanism and treatment of liver cirrhosis A total of 2 pages edited and published by: Editorial Department of Chinese Journal of Integrated Traditional Chinese and Western Medicine Spleen and Stomach
[6]参阅豆丁网 中药合剂制备工艺探讨 贾传春 上传时间:2013年11月23日[6] See Douding.com, Discussion on the Preparation Technology of Traditional Chinese Medicine Mixtures by Jia Chuanchun Uploaded on: November 23, 2013
[7]中药新药临床研究指导原则(试行)郑筱萸主编 中国医药科技出版社2002年5月第1版 58页 王永炎、鲁兆麟主编 中医内科学 风寒表虚 证候(人民卫生出版社 1999年10月第1版 129页[7] Guidelines for Clinical Research of New Drugs of Traditional Chinese Medicine (Trial), edited by Zheng Xiaoyu, China Medical Science and Technology Press, May 2002, 1st edition, page 58 1st edition of the month page 129
[8]中药新药临床研究指导原则(试行)郑筱萸主编 中国医药科技出版社 2002年5月第1版 60页[8] Guiding principles for clinical research of new Chinese medicines (trial), editor-in-chief of Zheng Xiaoyu, China Medical Science and Technology Press, May 2002, 1st edition, p. 60
[9]关于总显效率的说明 实际实验人数29人,实际痊愈人数也是29人,所以,总显效率应该是100%。为什么统计数据中痊愈人数为26人,显效1人,总显效率为 93.10%呢?这是因为发明人考虑到以下情况:从长远看,总会有快走完生命历程的人和病情复杂的感冒患者就医,如果遇到这样的情况,该药也许会是无效的;或者虽然有效,但是患者可能不会在3日内痊愈,只是发明人暂时还没有遇到这样的情况而已。所以,有必要将“痊愈”人数减少3人,移入“显效”栏1人,移入“有效”栏1人,移入“无效”栏1人,所以,统计数据中的痊愈人数就成为26人,总显效率为93.10%。这样有意地降低统计数据中总显效率的做法,是为了弥补因为受试人员所患感冒证型的局限性,而影响统计数据所反映的客观实际的准确性的缺陷。[9] Explanation on the total apparent efficiency The actual number of people in the experiment is 29, and the actual number of people cured is also 29, so the total apparent efficiency should be 100%. Why are there 26 recovered persons in the statistics, 1 markedly effective, and the total marked efficiency is 93.10%? This is because the inventors have taken into account the following situations: In the long run, there will always be people who are about to complete their life course and cold patients with complicated conditions to seek medical treatment. If such a situation is encountered, the drug may be ineffective; However, the patient may not recover within 3 days, but the inventor has not encountered such a situation for the time being. Therefore, it is necessary to reduce the number of "recovered" people by 3, move 1 person into the "marked" column, move 1 person into the "effective" column, and move 1 person into the "invalid" column, so the number of people who have recovered in the statistics becomes 26. The total apparent efficiency is 93.10%. The purpose of deliberately reducing the total apparent efficiency in the statistical data is to make up for the deficiency of the objective reality reflected in the statistical data because of the limitations of the cold syndrome type of the subjects.
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