CN113347966A - 肠溶用酸性矿物组合物 - Google Patents
肠溶用酸性矿物组合物 Download PDFInfo
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- CN113347966A CN113347966A CN201980088572.0A CN201980088572A CN113347966A CN 113347966 A CN113347966 A CN 113347966A CN 201980088572 A CN201980088572 A CN 201980088572A CN 113347966 A CN113347966 A CN 113347966A
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- acid
- solution
- sodium
- chloride
- water
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Abstract
本发明涉及医学领域,尤其涉及胃肠病学和毒理学,并且可用于全肠道灌洗和/或用于肠内稳态校正。为了制备酸性矿物质组合物和肠内溶液,使用以下物质:钠盐、钾盐、钙盐和镁盐的混合物,其量提供每升溶液10.7g‑14.0g的肠溶液矿化;聚氨基聚羧酸或其钠盐,其量可防止在溶液中形成不溶性钙和镁盐;以及短链羧酸脂肪酸(乳酸、丁酸和丙酸)和柠檬酸,其总量足以维持溶液中的pH值为4.61‑5.8。作为制备肠内溶液的溶剂,纯净饮用水的用量应能在溶液中提供280‑310mOsm/l的渗透浓度和4.61‑5的pH值。所提出的组合物溶液提供了具有长保质期(超过1年),且在加热时保持其特性,允许减少胃肠粘膜再生所花费的时间。
Description
发明领域
本发明涉及医学领域,涉及胃肠病学,阴道内科,外科手术,治疗学,变应原学,毒理学,麻醉学,复苏科学,皮肤病学,肾病学,肠胃病学,修复医学等,并可以用于洗肠和肠内平衡体内稳态的疾病,缩短胃肠道(GIT)受损或发炎时的粘膜再生时间,降低与肠屏障通透性有关的肠外并发症发生率,防止在各种疾病下洗肠后出现水肿。
现有技术的描述
用于胃肠道灌洗的各种酸矿物组合物是本领域已知的。特别地,已知聚乙二醇-电解质溶液(以Fortrans和Lavacole的商标名出售)。这些溶液用于进行洗肠(IL),以在急性中毒的情况下使生物体解毒[Tenenbein M.立场声明:整体灌肠/临床毒理学,1997年。–第35(7)号]。准备大肠以进行诊断和手术干预[KostenkoN.V.洗肠是准备大肠进行检查和手术的方法。作者的医学博士学位论文摘要,M.,1998年。-20页。Delmotte J.S.等,Ann。肠胃病学。Hepatol。,1988,24,n4211–216。]。其作用机理是基于引起高渗性腹泻的能力。溶液中包含的Macrogol(例如Macrogol 4000)是一种渗透活性物质,其分子能够吸引水,包括将水从血液循环通道吸引到胃肠道腔中,从而在肠中产生过多的容积,因此,肌纤维收缩引起腹泻。
该溶液的缺点是其相对于血浆的高渗透压,这导致水从血液循环通道不受控制地输送到胃肠道腔中,并且由于该血液凝结,可能导致中枢血流动力学和微循环障碍。该溶液的另一个缺点是它包含一组不完整的微量元素。因此,由于腹泻,生物体会丢失溶液中缺少的大量元素,这可能会对患者的健康状况产生负面影响。而且,该溶液的缺点在于其pH值在7.9至8.5的范围内,导致通常为弱酸的肠内部培养基向着碱侧移动,从而为正常的肠道菌群的存在创造了不利的条件,即弱酸介质有利的双歧杆菌和乳杆菌。基本培养基抑制正常菌群的上升,表现为数量减少,并促进有条件的病原性和病原性微生物的上升,即基本溶液引起肠道菌群失调[Shenderov B.A.医学微生物生态学和功能营养:3卷/ShenderovB.A..-M.:GRANT,1998.-V.I:人类和动物的微生物区系及其功能。-288页.]。
专利RU 2473330公开了一种用于洗肠的药物,该药物是一种电解质溶液,包含60-63g的山梨醇作为主要活性物质。山梨醇涉及六醇,并表现出渗透活性,因此它对肠蠕动。
该溶液的缺点是,与聚乙二醇类似,它引起了高渗性腹泻,具有上述所有后果。与Macrogol不同,山梨糖醇的使用会进一步导致虚弱,恶心,呕吐,头晕,流星症,高血糖症(糖尿病失代偿患者),肠易激综合症以及果糖吸收不良,酸中毒,尿留,口干口渴,脱水,肺部充血,低血压,心动过速,类似于狭窄性心绞痛的疼痛,视力模糊,抽搐,鼻炎,发冷,背部疼痛,过敏反应,包括荨麻疹。神经和眼睛细胞中所含的山梨糖醇可能成为神经病变和糖尿病性视网膜病的病因。大量的山梨糖醇可能会改变心肺功能和肾脏功能。使用山梨糖醇的禁忌症有:超敏反应,果糖耐受不良,糖尿病代偿失调,腹水,结肠炎,胆石症,易激惹的大肠综合征,肥胖症。不建议长时间用作泻药[山梨糖醇。物质描述//访问:http://www.neboleem.net/sorbit.php;http://gipocrat.ru/farmacied_d1_22.phtml]。
因此,包含山梨糖醇的溶液,如果用于进行肠灌洗,则能够引起临床上显着的反应,并且由于禁忌症和副反应的风险,仅可能作为短时间使用的泻药。
从文献上知道,所有溶液的理化性质都与食糜的理化性质不同,因此在灌洗胃肠道时会对血液成分和肠道微生物群落的状况产生负面影响[Galperin Yu.M.消化和体内平衡/Galperin Yu.M.,Lazarev P.I.-M.:Nauka,1986.-304页.]。当Fortrans型灌洗溶液的体积较小(例如,最大1.5–2L)时,由于有机体的补偿能力,这些疾病可能仍未被注意到。问题在于,为了有效清洁胃肠道和生物体排毒,需要的冲洗溶液体积要大于胃肠道体积。对于体重为60-70公斤的成年患者,平均重量为3升。冲洗液的体积越大,肠的清洁效率就越高。因此,例如,在临床毒理学实践中存在对胃和大肠进行灌洗的规则“直到灌洗水是干净的”。为此,需要数十升的水。在急性中毒时,使用数十升溶液进行洗肠[Matkevich V.A.急性口服中毒时的肠道灌洗/Matkevich V.A.,Luzhnikov Ye.A.//紧急临床毒理学:《医师手册》/Ye.A.Luzhnikov-M.编撰:Medpractica-M,2007.-第6卷-第269-276页。]。
众所周知,小肠内部培养基(食糜)的组成相当严格地稳定[Baklykova N.M.用于腹膜炎的肠内引入的培养基的组成和制备。–有条理的建议。M.,1986.-19页。GalperinYu.M.,Popova T.S.在书中:纠正紧急手术和计划手术中的代谢紊乱的方法。-M.,1976年]。肠微生物区系和肠介质与血浆之间的大量物质交换可确保食糜的体内平衡。在选择灌肠液时应考虑这些条件。如果溶液和食糜的物理和化学特性不匹配,那么,当溶液的体积很大时,肠内介质的组成就会改变,肠腔和肠腔中化学物质浓度的生理梯度也会改变。血液被改变,引起它们的重新分布,结果导致出现血浆的水电解紊乱。这种疾病的性质和程度直接取决于用于灌洗溶液的体积,性质和不平衡程度。因此,例如,如果灌洗溶液中缺少钾离子或钾离子不足,则钾离子会从较高浓度的介质(即从血浆)移至较低浓度的介质(即进入胃肠道腔),并与溶液一起从生物体中除去。此后,血浆中的钾浓度降低。钾的流失可能对患者的健康和生命造成危险。如果灌洗溶液中的钾浓度过高,则在灌洗溶液中会出现相反的情况。通过肠壁的其他大量元素的大量交换遵循相同的模式。
血浆电解质(特别是钠)的浓度值的变化需要在生物体水平衡中改变血浆渗透压浓度和pH值。
因此,使用与食糜不相关的非生理性溶液来灌洗小肠,使其体积大于3L,例如Fortrans,Lavacole或包含其他渗透活性物质(山梨糖醇,甘露醇,乳果糖)的溶液等,不可避免地导致上述疾病并对患者的病情产生负面影响[Baklykova N.M.使用肠道透析来纠正腹腔器官急性外科疾病的代谢紊乱的可能性//以N.V.Sklifosovsky命名的急诊医学科学研究所的作品。第二十三卷。莫斯科。1976年。第152页。Glozman O.S.,Kasatkina A.P.急性毒素主动治疗的现代方法。-M.Medgiz。1959年。276页]。
肠盐溶液(ESS)是本领域已知的,其是根据食糜中所含阴离子和阳离子的定性组成而制备的[Baklykova N.M.组合物和在腹膜炎时用于肠内引入的介质的制备。有条理的建议。M.,1986.19页]。该肠溶液根据具有六个变体的制剂通过用蒸馏水溶解盐制备。根据作者的说法,无论配方如何变化,最终溶液的离子组成在每种情况下都是相同的。根据六个制剂变型,该溶液的组成包含盐,例如氯化钠和氯化钾和磷酸盐,乙酸钠,氯化钙和硫酸镁,柠檬酸以及蒸馏水作为盐溶解剂。溶液渗透压是大约235mOsm/L,它的рН值在5.5到5.8之间。
ESS被用作腹膜炎的肠内营养,以及在功能性肠梗阻和急性口腔中毒时进行洗肠。
ESS的缺点是,由于在制备后的几个小时内会变浑浊,然后在其中形成沉淀物,因此可能无法长时间保存。为了防止在洗肠手术期间患者的身体流失热量,应在使用溶液之前将溶液加热至37-40℃。此外,应在一定条件和规则下(在水浴中或在专用设备中)加热溶液。快速加热或过度加热,甚至略高于40℃,也会导致浑浊。溶液的浊度和沉淀取决于以下事实:溶液组合物中存在的钙(Са2+)和镁(Mg2+)阳离子与阴离子SO42–和РО43–发生化学反应,形成不溶性盐СаSO4,Са3(РО4)2和MgHPO4。不允许使用浑浊的溶液或含有沉淀物的溶液,因为在这种情况下,其离子组成与初始组成不符,并可能导致洗肠手术中血液电解质平衡失调。溶液组合物的不稳定性降低了其作为商品的消费质量。
该溶液的另一个缺点是在洗肠手术后相当频繁地发生生物体水合作用(水肿)[Matkevich V.A.急性口腔中毒时洗肠。–医学科学博士学位论文的作者摘要,M.,1988年]。此缺点与以下事实有关:溶液的渗透压值(235mOsm/L)显着低于人血浆的渗透压(正常值280-310mOsm/kg的范围内变化,并且在平294.1±1.3mOsm/kg)[Fabian MJ,Proctor KG.创伤性脑损伤复苏后急性乙醇的血流动力学作用。J.创伤2002年;53:864-75]。已知液体吸收到胃肠道中的体积和速率直接取决于该液体和血浆的渗透压梯度。由于ESS渗透压低于血浆的胶体渗透压,因此溶液很容易从胃肠道吸收到血液中。它到达过多会导致水肿的形成,使患者的病情恶化,需要采取特殊的医学措施。
该溶液的另一个缺点是作者建议使用蒸馏水将其制备为盐溶解剂,没有提出其他变体,这限制了该溶液的技术可能性。
同样,已知根据专利RU 2178696的ESS,其具有在前述类似物的描述中揭示的缺点。
作为原型,采用渗透压值与特定患者的血浆渗透压值相对应的ESS,这能够防止进行肠灌洗时机体水平衡的紊乱[发明专利RU 2190412]。通过改变其中的盐浓度来实现溶液摩尔渗透压浓度的增加或减少。可以通过将不同数量的盐溶解在给定量的水中来制备具有不同浓度的溶液,这在批量生产的条件下是不方便的,或者可以将给定量的盐溶解在不同体积的水中,这似乎更符合人体工程学。
上述发明人提议根据提供的公式计算溶解给定量的盐所需的水量,以制备具有与血浆渗透压相对应的所需渗透压值的溶液。此外,有必要知道血浆的胶体渗透压的初始值。制备溶液所需的水量的值与血浆的胶体渗透压的值成反比。
该技术方案的缺点在于,为了制备具有与特定患者的血浆渗透压相对应的给定渗透压的溶液,在每种情况下都需要对患者的血液进行实验室分析以确定该参数,这仅在配备实验室的医疗机构的情况下才可行。在动态,野外和家庭条件下这是不可行的。而且,这种方法排除了大规模生产准备使用的溶液的可能性。该解决方案的另一个缺点是它不稳定并且很快变浑浊并出现沉淀物。此外,如果增加盐浓度以增加溶液的渗透压,则其储存寿命会进一步降低。此外,没有数据表明,如果胃肠道粘膜受损或发炎,原型解决方案可促进胃肠道粘膜再生。在动态,野外和家庭条件下这是不可行的。而且,这种溶液排除了大规模生产准备使用的溶液的可能性。该溶液的另一个缺点是它不稳定并且很快变浑浊并出现沉淀物。此外,如果增加盐浓度以增加溶液的渗透压,则其储存寿命会进一步降低。此外,没有数据表明,如果胃肠道粘膜受损或发炎,原型溶液可促进胃肠道粘膜再生。
发明内容
通过要求保护的发明实现的技术目的是开发一种肠溶液的组合物,其可用于灌洗胃肠道和纠正稳态障碍,其消除了上述类似物的典型缺点。
所要求保护的发明的技术效果是保持酸矿物组合物(AMC)以干粉和即用溶液形式的定性特征,以长期保存(至少一年)。并且在加热溶液期间,同时确保其作为药物的可用性,以促进胃肠道粘膜的再生。建议的肠溶液也可用于预防水肿。AMC和肠溶组合物对于患者的胃肠道灌洗和/或矫正体内稳态疾病是通用的。
由于为了制备所提出的酸矿物组合物(AMC)和肠溶液,使用了单取代或两次取代或三取代的磷酸钠或单取代或两次取代的磷酸钾来实现该技术结果。分别使用氯化钠,乙酸钠(或无氯化钠),氯化钾,氯化钙,硫酸镁,柠檬酸(或无柠檬酸);纯化的饮用水用于从AMC制备肠溶溶液,其体积范围应使溶解的盐和酸可以使溶液的摩尔渗透压浓度为280至310mOsm/L;此外,AMC和溶液还包含防止溶液中形成不溶性盐的氨基聚羧酸和提供溶液pH值在4.61至5.8范围内的量的短链羧酸(脂肪酸)。
六种等效变体中的一种用于制备AMC和拟议的肠溶溶液(表1和2):
表1酸性矿物组合物(AMC)的配方变体
表2所提出的肠内溶液的制剂变体
·根据第一变体,AMC和肠溶溶液包含三取代的磷酸钠,氯化钠,氯化钾,柠檬酸,乳酸,丙酸和丁酸,络合物,例如Na2EDTA或Nа3DTPA以及氯化钙和硫酸镁;
·根据第二种变体,AMC和肠溶溶液包含二次取代的磷酸钠,氯化钠,乙酸钠,氯化钾,柠檬酸,乳酸,丙酸和丁酸,络合物,例如Na2EDTA或Nа3DTPA以及氯化钙和硫酸镁;
·根据第三种变型,AMC和肠溶溶液包含单取代的磷酸钠,氯化钠,乙酸钠,氯化钾,乳酸,丙酸和丁酸,络合物,例如Na2EDTA或Nа3DTPA以及氯化钙和硫酸镁;
·根据第四种变型,AMC和肠溶溶液包含单取代的磷酸钾,氯化钠,乙酸钠,氯化钾,乳酸,丙酸和丁酸,络合物,例如Na2EDTA或Nа3DTPA以及氯化钙和硫酸镁;
·根据第五种变型,AMC和肠溶溶液包含单取代的磷酸钠,氯化钠,乙酸钠,磷酸钾两次取代的3-水,柠檬酸,乳酸,丙酸和丁酸,络合物,例如Na2EDTA或Nа3DTPA以及氯化钙和硫酸镁;
·根据第六种变体,AMC和肠溶溶液包含二次取代的磷酸钠,氯化钠,乙酸钠,氯化钾,柠檬酸,乳酸,丙酸和丁酸,络合物,例如Na2EDTA或Nа3DTPA以及氯化钙和硫酸镁。
在所有AMC变体中,氯化钙和硫酸镁都是相互隔离的,并且是与其余成分的混合物隔离的。表1列出了所有六个变体在AMC中的成分比;表2中列出了所有六种变体在肠溶液中的成分比,以wt%计。
本发明使用无水酸:丙酸,丁酸(液体)和柠檬酸(粉末)以及80%的乳酸。
所提出的技术解决方案为肠溶溶液提供了额外的特性,由于其用于洗肠的用途有助于缩短胃肠道粘膜在受损和发炎时的再生时间,并且由于胃肠道粘膜的加速再生,降低由肠屏障通透性过高引起的肠外感染并发症的发生率。
该声称组合物所提出的溶液的特点是延长了肠溶溶液的储存时间(与商品的消费属性相对应的时期内),并且有可能在保持其特性的情况下加热到37–40℃,当加速胃肠道上皮细胞的再生时,这会阻止其浑浊和在其中形成沉淀物。通过更改组分的定性和定量组成,包括在溶液中添加短链脂肪酸(SCFA)和氨基多元羧酸引起的变化,这些变化可阻止阳离子和阴离子在水中形成不溶性盐的相互作用,从而提供这些特性。
该声称组合物不会引起肠道灌洗后患者的水肿(并且尤其可用于预防水肿),原因是使用了血浆中的渗透剂,渗透压值涵盖了生理指标的范围(280-310mOsm/kg)的血浆渗透压,在洗肠之前可以选择预先确定患者的血浆渗透压,但是如果使用原型,则必须这样做。
肠溶液与食糜是等离子的,并且与血浆是半渗透的,包含单或两次或三次取代的磷酸钠,或单或两次取代的磷酸钾,氯化钠,乙酸钠,氯化钾,氯化钙,硫酸镁,柠檬酸(或无柠檬酸),纯净饮用水,另外,络合物的数量足以阻断溶液中的阳离子Ca2+和Mg2+,特别是氨基多元羧酸(APCA)或它们的盐,例如,乙二胺四乙酸的二钠盐(Nа2EDTA,或“Trilon B”),或二亚乙基三胺五乙酸的三钠盐(Nа3DTPA),或亚氨基二乙酸,或次氮基三乙酸。
APCA(例如Nа2EDTA和Nа3DTPA)能够与二价,三价和四价阳离子形成稳定且难解离的络合物,在考虑的情况下–与阳离子Са2+分别形成CaNa2EDTA(破伤风)和СаNа3DTPA(戊糖)和阳离子Mg2+,可防止它们与盐溶液中的阴离子SO42-和РО43-相互作用,从而防止形成水不溶性盐:СаSO4,Са3(РО4)2和MgHPO4。此外,它们不会改变溶液的pH值,也不会降低血液中钙和镁的浓度,它们会与尿素迅速从生物体中清除,并在肾脏中代谢直至形成二氧化碳。他们从生物体中吸收重金属和自由基。
可以将包含牛毛霉素或戊糖的溶液加热并长时间保存。溶液的储存时间取决于这些络合物的浓度。为了结合阳离子,例如溶液中的钙需要等量的Na2EDTA或Nа3DTPA。所提出的复合物打算用于肠胃外引入,因为它们很难从胃肠道中吸收,即仅口服的总量的2%至5%进入血液。[Semenov D.I.,Tregubenko I.P.生物学和医学领域的复合体/Sverdlovsk:UNTs of USSR AS,1984.-281页。//访问:https://www.ipae.uran.ru/sites/default/files/Complexons.pdf]。静脉内引入的单次治疗剂量为2g,日剂量为4g[MashkovskyM.D.Medicinal Agents。第2卷。V.2.第11版。ster.–M.:医学杂志,1988年。186页。]。提议的溶液包含Na2EDTA或Nа3DTPA,旨在用于口服。计算表明,静脉注射2g的单剂量相当于口服Na2EDTA或Nа3DTPA的40g。
为了找出溶液的储存时间如何取决于其中所含Na2EDTA的浓度,我们进行了研究,结果表明Na2EDTA的浓度在0.07至0.09%的范围内,对应于所提出溶液配方1-6中0.029-0.118wt%的比含量,可稳定1-4年。在观察期内,溶液保持澄清,没有沉淀。在溶液中的Na2EDTA浓度较低时(表3),溶液变得浑浊并有沉淀物。保持溶液无菌的1-4年的储存时间符合其批量生产和大量消费的条件。
表3列出了肠溶液储存寿命对其中所含Na2EDTA浓度的依赖性。
表3.所提溶液的储存寿命取决于Na2EDTA浓度
注意:*–指示的溶液存储时间是在室温和光照下确定的。观察期为4年。
与原型溶液相反,将含有0.07–0.09%的Na2EDTA的溶液加热到40℃不会使其变得浑浊。小于0.07%的Na2EDTA浓度不能确保溶液在加热时浑浊。
根据适应,可以用4至30L的ESS体积进行洗肠手术[Matkevich V.A.肠灌洗//医学毒理学:国家手册/Ye.A.Luzhnikov.M.编撰:GEOTAR-Medicine,2012.-第4章-第162–186页。
计算表明,为了制备30L的溶液,需要27.0g的Na2EDTA才能制备0.09%的浓度,该量的5%部分,1.35g,将被包括在吸收过程中。小于静脉注射时的单次治疗剂量。该溶液的量足以对患有严重体细胞状态的患者进行洗肠治疗。如果患者的状况令人满意,则需要较小体积的溶液,例如4.5L,其中包含0.09%的浓度4.05g的Na2EDTA,并且该量的5%为0.2g。实际上,在肠道灌洗过程中,以自然方式去除了大约90%引入GIT的溶液体积。因此,残留在患者体内的溶液部分的Na2EDTA含量为总量的1/10。这种剂量的所提复合物对患者是安全的。СаNа2EDTA和СаNа3DTPA很好地溶于水,因此,它们进入血液的部分很容易通过肾脏从生物体中清除。[Semenov D.I.,Tregubenko I.P.生物学和医学领域的复合体/Sverdlovsk:UNTs of USSR AS,1984-281页。//访问:https://www.ipae.uran.ru/sites/default/files/Complexons.pdf;Zorina L.A.在临床上铅中毒时使用CaNa2EDTA的问题的现代状况。-Labot Hygiene–1963–No.8-9-14页。
此外,肠溶溶液还包含一定量的SCFA复合物,该SCFA复合物在混合物中以其比重比接近生理性的溶液提供4.61至5.8的pH值。
从实验上可以确定,将所建议的溶液中的酸(例如乳酸,丙酸和丁酸)的添加量分别为0.026-0.092、0.026-0.063和0.013-0.031wt%,可以将其酸化至pH值到范围4.61-5.8。这些酸的添加量超过指示值,会使溶液pH值降低至4.61以下,这对肠道而言是非生理性的,并且考虑到进行洗肠手术所需的体积较大,因此可能会对患者的病情产生负面影响。
选择酸浓度及其在混合物中的比例时要适当考虑到在食品工业中使用这些酸的允许规范及其在肠道中的生理含量。根据T.D.Bokova,N.I.Ursova和M.D.Ardatskaya(2008),每1克粪便中丙酸和丁酸的参考值分别为1.79±0.95和1.75±0.85mg[T.D.Bokova,N.I.Ursova,M.D.Ardatskaya.肥胖儿童中短链脂肪酸谱的失调,以及使用诺莫弗林菌素-D的校正//访问:http://normoflorin.ru/disorders-spectrum-short- chain]。在这样的浓度值下,一次生理性肠排空的结果是除去了大约0.25-0.8g的丙酸和0.27-0.78g的丁酸,这仅占它们肠内总池的5%。[Shenderov B.A.短链脂肪酸的目标和作用//Sovremennaya Meditsinskaya Nauka 2013,第1-2号。访问:https:// www.researchgate.net/publication/286456237_Effekty_i_miseni_letucih_ztrnyh_ kislot]。
乳酸(α-oxypropionic)是天然产物,可以被认为是生物安全的产物,由于它是人类有机体,动植物的天然代谢产物,具有很强的抗菌作用,因此具有抑制肠道中腐败菌群生长,减少有机物中有机物分解的有毒产物形成,改善微生物的能力。代谢过程,调节pH值。食品级乳酸没有禁忌症,肾脏,胆囊和胰腺各种疾病的饮食中都允许使用乳酸。
SCFA是糖酵解菌群加工寡糖和多糖的过程中在肠中形成的天然代谢产物。在酸化肠道介质的同时,它们表现出对蛋白水解微生物群(包括条件病原菌群)的拮抗作用,从而抑制了其生长[Shenderov B.A.,药物微生物生态学和功能营养:3卷/Shenderov B.A.-M.:GRANT,1998年。-V.I:人类和动物的微生物区系及其功能。-288页]。当条件病原菌库减少时,其毒力和侵袭性就会降低。因此,富含SCFA的溶液表现出有利于预防和消除肠内炎症过程的益生元特性。
另一个关键点是,不同于仅通过循环系统吸收营养的真核细胞的主要部分,肠道粘膜的上皮细胞主要以SCFA的形式从肠道腔中获取营养,其中SCFAs用于这些细胞是唯一的食物(能量)底物。以食物底物缺陷为特征的州会引起肠道粘膜萎缩。肠内上皮细胞可将所提肠溶溶液中所含的SCFA用作额外的能量来源。在其最初缺乏的情况下提供足够的额外食物资源有助于上皮细胞的生长,并因此促进粘膜的再生和其缺陷的愈合。
反过来,在肠粘膜完整性受损和发炎的情况下,再生过程对于预防和纠正微生物毒素和病原体自身的肠屏障通透性过高综合征极为重要,其他可能进入机体内部介质的生物活性病理物质,包括全身血液流动。肠通透性的正常化有助于降低炎症性肠外并发症(包括肺炎)的发生风险。
在所提溶液中,根据六个变体的配方,水的质量等于溶液总重量的97.78-98.68wt%,可以预先确定盐浓度和酸的浓度,溶液的摩尔渗透压浓度应在280到310mOsm/L范围中。溶液的渗透压取决于盐和酸的浓度,并且它们在相同重量值下的浓度与它们溶解所需的水量成反比。由于溶液的渗透压(准渗透)接近血浆的胶体渗透压的生理值,所以防止了水从肠道过量进入血流,因此降低了水肿的风险。如果患者遭受水肿,合理的方法是使用最大渗透压值即310mOsm/L的溶液进行洗肠手术。当溶液的渗透压值大于310mOsm/L时,由于水从血液中流到肠道腔内,然后以腹泻的形式从外部流向[Matkevich V.A.肠灌洗//医学毒理学:国家手册/Ye.A.Luzhnikov.M.编撰:GEOTAR-Medicine,2012.-第4章.-第162–186页。]
附图的简要说明
通过说明性材料解释了本发明,所述说明性材料由于使用了所提出的溶液而呈现出特定患者的肠道粘膜的加速再生的模式(根据临床观察的结果)。
图1/5显示了在开始治疗之前,对患者食道部位的粘膜造成的损害(化学灼伤)的情况。
图2/5和3/5显示了在5天内食管各个部位的粘膜状况。
图4/5和5/5分别显示了同一时期后胃和十二指肠的粘膜状况。
实施发明的最佳模式
制备AMC和肠溶溶液(ES)
拟议的溶液既可以以即用形式制备,也可以以半成品形式制备,即AMC套装(包含所有成分的浓缩物,硫酸镁(呈粉末或溶液形式)和钙从其他成分中分离出氯化物溶液)。在后一种情况下,用户可以按照随附的说明自己准备溶液。对于一定体积的溶液,例如4.5或30L等,AMC可以按系列制备。在这种情况下,将显示成分的总重量和计算出的水量。
肠溶溶液可以通过以下方式从AMC制备。将AMC(除镁盐和钙盐之外)溶解在规定体积的纯净饮用水的三分之二中,然后添加硫酸镁(呈粉末或溶液形式)和氯化钙(呈溶液形式)。此后,添加纯净的饮用水,直到达到预设的体积。
所提溶液如下使用。
I.洗肠
有效冲洗成年患者的肠道所需的最小溶液量为每次手术3.0-4.5L。应当在空腹的情况下洗肠(禁食期至少应为5-6小时)。该手术,尤其是第一次,应优选在早晨进行。使用前将溶液加热(最高37-40℃)。
患者应每5分钟按150–200mL的比例分批饮用溶液。通常,在患者饮用1.5–2.5L的溶液后,肠本身也开始逐渐排空。该手术应继续进行,直到排泄物变清(可能呈淡黄色),然后患者停止饮用该溶液,但排便可能在接下来的30–40分钟内继续;然后肠道排出停止。1-1.5小时后,患者应接受富含可食用纤维的食物(由未打磨的全谷物谷物制成的粥,加水不加糖,杏干)。之后,患者恢复照常饮食,2-3天之内不能吃辛辣和高脂肪食物,烟熏产品和酒精。
该手术的平均持续时间为3个小时。洗肠手术后,患者可以从事日常业务,而不必担心腹泻的复发。
如果患者由于病情严重而无法独自服用溶液,专家会通过导管将其引入。
洗肠的适应症:
1.外毒素和内毒素中毒;
2.肠道营养不良;
3.急性和慢性肝炎;
4.急性和慢性胰腺炎;
5.胃炎,小肠结肠炎;
6.胆道运动障碍;
7,具有功能性的I*III度便秘;
8.传染性肠道疾病;
9.慢性肾盂肾炎;
10.伴随皮肤损害的疾病(特应性皮炎,神经性皮炎,牛皮癣,湿疹,痤疮等);
11.急性和慢性过敏性疾病;
12.支气管哮喘,炎性非特异性支气管肺疾病;
13.与荷尔蒙失调和代谢紊乱有关的疾病,包括钙化病(皮肌炎,硬皮病,骨化性肌炎),病理性骨化,关节炎伴有盐沉积,肾脏钙沉积;
14.戒酒综合症,纵欲,禁欲综合症(包括酒精性幻觉,谵妄);
15.骨盆小器官的慢性炎性疾病;
16.手术后和外伤性小肠结石;
17.烧伤疾病;
18.放射病;
19.肿瘤疾病;
20.计划进行的手术和内窥镜检查的准备;
21.气坏疽。
为了预防疾病,建议对患者进行洗肠手术:
压力过大后,由于配给错误,其配给包括纤维量不足,饮食不规律,惯于久坐的生活习惯,肥胖,患上频繁的卡他性疾病,从事对健康有害的因子的生产,不良习惯。
绝对禁忌症是:机械病因肠梗阻(肠肿瘤,肠瘢痕狭窄,从外部挤压机械肠等),胃肠道和其他内部出血,肠道中空器官的威胁和穿孔,急性阑尾炎,妊娠后半段,高血压危机,急性心血管病理和肺代偿失调。
相对的禁忌症是:胆石症和尿石症,I型糖尿病,痔疮的急性病,怀孕的前半段,血友病。
II.营养校正
患者分次(例如200mL)服用溶液1天,总体积最大为1.5L。如果溶液的体积大于1.5L,则在成年患者中可能会出现腹泻,即可能会出现洗肠的效果。
适应症:
1.生物体中的电解质缺乏(例如,由于出汗过多,在肠道感染引起的腹泻等过程中电解质的流失);
2.胃肠道功能障碍;
3.酸中毒,包括运动员在剧烈身体负荷期间的酸中毒;戒酒综合症;
4.休克,包括出血后休克;
5.放射病;
6.手术后期间。
所提溶液要求保护的特性已通过进行的研究结果得到证实。
观察到19位年龄在37至85岁之间的男性患者,他们因烧灼液体而严重中毒。在11例中,口服摄入会引起中毒,其中8例是浓乙酸。内窥镜检查-食管胃十二指肠镜检查(EGDS)的结果确定了口腔,咽,食道和胃粘膜的化学灼伤。在所有患者中,有13人的胃灼热为2-3度,有6人的胃灼热为3-4度。对于11例患者,包括3例胃烧伤为3-4度的患者,采用所提溶液进行洗肠被包括在一系列的医疗措施中(观察组)。对照组由8例接受标准疗法的患者组成,他们使用ESS(原型)进行洗肠手术。
在麻醉药,解痉剂和胃管灌洗后的化学损伤最初几个小时内,每5分钟给予观察组的患200mL所提溶液。考虑到中毒的特殊性(出血的危险),在这些情况下,不加热溶液,温度为18-22℃。患者出现腹泻的时间为1.5-2小时。冲洗肠道,直到直肠出现轻度半透明的水为止。溶液的总体积在3至4.5L范围内。患者满意地接受了洗肠手术,未发现任何反应和并发症。在接下来的几天,以200mL的剂量口服给患者相同的溶液,每日总体积为1.5-3L,以进行营养校正。
对治疗结果的比较评估表明,在第5天记录了清洁食道和胃粘膜受损部位的过程的积极动态,即坏死肿块消失,纤维蛋白层厚度减少,出现了肉芽区域。到那时,还没有记录到食道和胃粘膜上局部缺损的再生迹象。观察组和比较组的肺炎发生率分别为18.2和37.5%。比较组中有2例患者死亡,观察组的患者还活着,后者的平均住院时间比前者减少了25%。
因此,在烧灼液体中毒的复杂疗法中使用所提溶液有助于加速粘膜受损区域的愈合,作为中毒并发症的肺炎发生率降低48.5%并缩短平均住院时间。
由于使用了所提溶液,以下临床观察可作为肠道粘膜加速再生的一个实例。
D.患者,年龄44岁。诊断:日期为2017年1月17日的醋酸中毒。
第一次EGDS检查于2017年1月18日进行,当时患者被送往医院。
EGDS图像的描述:食道粘膜明显水肿,汇聚了各种密度的轻纤维蛋白的圆形叠层。可见多次侵蚀。胃粘膜充血,水肿,多发急性糜烂,直径达0.2cm,底部干净。十二指肠粘膜上层融合了轻度纤维蛋白。球后粘膜也充血,水肿。发现多个底部干净的线状溃疡缺损,深度达0.2cm,并检测到底部干净的线状侵蚀。
结论:弥漫性糜烂性溃疡性食管炎,弥漫性糜烂性胃炎,弥漫性溃疡性十二指肠炎。
图1示出了在开始治疗之前患者的食道部分的粘膜受损(化学灼伤)的图像。
除了标准疗法的复杂性之外,第一天,按照上述方法,对患者进行洗肠手术,使用的是4.5L的所提溶液,该溶液是根据制剂的第二种变体制备的(成分的比重(以wt%计):磷酸钠,两次取代,12水溶液-0.61;氯化钠-0.375;三水醋酸钠-0.074;氯化钾-0.168;酸:柠檬酸-0.055,乳酸-0.026,丙酸-0.026和丁酸-0.013;Na2EDTA-0.029,氯化钙-0.164;硫酸镁-0.137和纯净饮用水-98.35。
在接下来的5天中,以200mL的剂量对患者口服相同的溶液,营养总量为每天2-3L。没有并发症和副作用的记录,患者对溶液的摄入量耐受良好。改善了患者的状况,记录了水电解平衡的正常化。在医疗措施的第5天,患者接受了第二次EGDS。
EGDS图像日期为2017年1月23日的描述:
烧伤表面状况明显呈积极变化:食道-粘膜中度水肿;纤维蛋白在上三分之一处断裂;食管中部三分之一处保留了各种密度的轻质纤维蛋白汇合的圆形叠层;从35至40厘米的部分清除粘膜上的纤维蛋白。食道粘膜充血,中度水肿;侵蚀结皮。十二指肠粘膜充血,水肿,溃疡缺损。
图2和图3示出了在5天内食管的各个部分的粘膜状况的图像。图4和图5分别示出了同一时期后胃和十二指肠的粘膜状况。
病程平稳,无并发症,并得以恢复。
所提溶液是新的,因此从现有技术来看还不是很明显。它与原型产品有显着区别,即,由于可以防止溶液中形成不溶性盐类,因此可以确保溶液的长期保存(超过1年),并在加热时保持其特性。由于溶液渗透压的范围覆盖了血浆渗透压的生理值,因此可确保在肠道灌洗后预防水肿,而无需对血浆渗透压进行强制性实验室研究,从而避免了过多的水进入血液在洗肠手术期间从肠道腔中排出,有助于缩短肠胃黏膜在受损和发炎时的再生时间,并降低了由于溶液的益生元特性而引起的肠屏障通透性过高的肠外并发症发生率。
所提溶液提高了消费者的质量,使其能够批量生产,长期存储和运输,不仅可以在专门的医疗设施中使用,而且还可以在其他设施以及门诊和野外条件下使用,从而扩大了医疗器械的领域。与原型相比,它的适用性更实际可行,更符合人体工程学。
Claims (16)
1.一种酸矿物组合物,其用于产生用于洗肠和/或纠正稳态障碍的肠溶溶液,其包含:钠,钾,钙和镁的盐的混合物,所述盐的量被提供以提供所述矿物质的矿化。肠溶溶液的范围为每1升溶液10.7克至14.0克;氨基多羧酸或其钠盐,其数量可防止在溶液中形成钙和镁的不溶盐;以及短链羧酸脂肪酸(SCFA),例如乳酸,丁酸和丙酸以及柠檬酸,其总量足以保持溶液的pH在4.61至5.8范围内。
2.权利要求1的酸矿物组合物,其特征在于单或两次取代的磷酸钠和/或单或两次取代的磷酸钾,氯化钠,乙酸钠,氯化钾,氯化钙,硫酸镁用作所述盐。
3.权利要求2所述的酸矿物组合物,其特征在于,氯化钙和硫酸镁彼此分离,并且与其他组分分离。
4.权利要求2所述的酸矿物组合物,其特征在于,所述酸矿物组合物包含以下重量百分比的组分:
磷酸钠,三取代,12水-35.7-40.48;
氯化钠-17.68-20.03;
氯化钾-9.52-10.79;
氯化钙-9.27-10.5;
硫酸镁-7.73-8.75;
Na2EDTA或Nа3DTPA-1.5-5.8;
柠檬酸,无水-3.1-7.0;
乳酸-1.48-4.9;
丙酸-1.48-3.36;
丁酸-0.74-1.68。
5.权利要求2所述的酸矿物组合物,其特征在于,所述酸矿物组合物包含以下重量百分比的组分:
磷酸钠,两次取代,12水-33.0-36.48;
氯化钠-20.24-22.34;
醋酸钠,3水-4.0-4.43;
氯化钾-9.08-10.03;
氯化钙-8.85-9.77;
硫酸镁-7.37-8.14;
Na2EDTA或Nа3DTPA-1.47-5.4;
柠檬酸,无水-2.95-4.56;
乳酸1.4-4.56;
丙酸-1.4-3.13;
丁酸-0.71-1.56;
6.权利要求2的酸矿物组合物,其特征在于它包含以下组分的重量百分比:
磷酸钠,单取代,无水-16.29-17.92;
氯化钠-22.34-24.59;
醋酸钠,3水-18.76-20.64;
氯化钾-10.03-11.04;
氯化钙-9.77-10.75;
硫酸镁-8.14-8.96;
Na2EDTA或Nа3DTPA-1.63-5.95;
乳酸-1.56-5.0;
丙酸-1.56-3.44;
丁酸-0.78-1.72。
7.权利要求2的酸矿物组合物,其特征在于它包含以下组分的重量百分比:
氯化钠-29.63-32.73;
醋酸钠,3水-19.32-21.35;
氯化钾-2.24-2.47;
磷酸钾,单取代-14.91-16.48;
氯化钙-10.17-11.24;
硫酸镁-8.47-9.36;
Na2EDTA或Nа3DTPA-1.69-6.22;
乳酸-1.63-5.24;
丙酸-1.63-3.59;
丁酸-0.81-1.8。
8.权利要求2的酸矿物组合物,其特征在于它包含以下组分的重量百分比:
磷酸钠,单取代,无水-5.99-6.71;
氯化钠-30.82-34.5;
醋酸钠,3水-9.72-10.88;
磷酸钾,两次取代,3水-15.51-17.36;
氯化钙-9.99-11.18;
硫酸镁-8.32-9.31;
Na2EDTA或Nа3DTPA-1.66-6.18;
柠檬酸,无水-3.33-5.22;
乳酸-1.6-5.22;
丙酸-1.6-3.58;
丁酸-0.8-1.79。
9.权利要求1的酸矿物组合物,其特征在于它包含以下组分的重量百分比:
磷酸钠,两次取代,无水-16.85-19.09;
氯化钠-25.13-28.46;
醋酸钠,3水-4.98-5.64;
氯化钾-11.28-12.78;
氯化钙-10.99-12.45;
硫酸镁-9.16-10.37;
Na2EDTA或Nа3DTPA-1.83-6.89;
柠檬酸,无水-3.66-5.81;
乳酸-1.76--5.81;
丙酸-1.76-3.98;
丁酸-0.88-1.99。
10.一种用于洗肠胃肠道和/或纠正体内稳态疾病的肠溶溶液,其包含权利要求1的酸矿物质组合物和纯净饮用水,所述纯净水的含量使溶液的摩尔渗透压浓度为280至310mOsm/L,pH从4.61至5.8。
11.权利要求10的肠溶溶液,其特征在于它包含以下组分的重量百分比:
磷酸钠,三取代,12水-0.63-0.754;
氯化钠-0.31-0.37;
氯化钾-0.168-0.2;
氯化钙-0.164-0.196;
硫酸镁-0.137-0.163;
Na2EDTA或Nа3DTPA-0.029-0.117;
柠檬酸,无水-0.055-0.13;
乳酸-0.026-0.091;
丙酸-0.026-0.063;
丁酸-0.013-0.031;
纯净饮用水-97.9-98.4。
12.权利要求10的肠溶溶液,其特征在于它包含以下组分的重量百分比:
磷酸氢钠,两次取代,12水-0.61-0.73;
氯化钠-0.375-0.45;
三水醋酸钠-0.074-0.089;
氯化钾-0.168-0.2;
氯化钙-0.164-0.196;
硫酸镁-0.137-0.163;
Na2EDTA或Nа3DTPA-0.029-0.117;
柠檬酸,无水-0.055-0.091;
乳酸-0.026-0.091;
丙酸-0.026-0.063;
丁酸-0.013-0.031;
纯净饮用水-97.78-98.35。
13.权利要求10的肠溶溶液,其特征在于它包含以下组分的重量百分比:
磷酸钠,单取代,无水-0.273-0.327;
氯化钠-0.375-0.448;
醋酸钠,3水-0.315-0.376;
氯化钾-0.168-0.2;
氯化钙-0.164-0.196;
硫酸镁-0.137-0.163;
Na2EDTA或Nа3DTPA-0.029--0.118;
乳酸-0.026-0.091;
丙酸-0.026-0.063;
丁酸-0.013-0.031;
纯净饮用水-97.98-98.47。
14.权利要求10的肠溶溶液,其特征在于它包含以下组分的重量百分比:
氯化钠-0.478-0.571;
醋酸钠,3水-0.312-0.373;
氯化钾-0.036-0.043;
磷酸钾,单取代-0.241-0.288;
氯化钙-0.164-0.196;
硫酸镁-0.137-0.163;
Na2EDTA或Nа3DTPA-0.03-0.118;
乳酸-0.026-0.091;
丙酸-0.026-0.063;
丁酸-0.013-0.031;
纯净饮用水-98.06-98.54。
15.权利要求10的肠溶溶液,其特征在于其包含以下组分的重量百分比:
磷酸钠,单取代,无水-0.098-0.118;
氯化钠-0.507-0.605;
醋酸钠,3水-0.16-0.191;
磷酸钾,两次取代,3水-0.255-0.304;
氯化钙-0.164-0.196;
硫酸镁-0.137-0.163;
Na2EDTA或Nа3DTPA-0.03--0.118;
柠檬酸,无水-0.055-0.091;
乳酸-0.026-0.091;
丙酸-0.026-0.063;
丁酸-0.013-0.031;
纯净饮用水-98.03-98.53。
16.权利要求10的肠溶溶液,其特征在于它包含以下组分的重量百分比:
磷酸钠,两次取代,无水-0.252-0.301;
氯化钠-0.376-0.449;
醋酸钠,3水-0.075-0.089;
氯化钾-0.169-0.202;
氯化钙-0.164-0.196;
硫酸镁-0.137-0.164;
Na2EDTA或Nа3DTPA-0.03-0.118;
柠檬酸,无水-0.055-0.092;
乳酸-0.026--0.092;
丙酸-0.026-0.063;
丁酸-0.013-0.031;
纯净饮用水-98.2-98.68。
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RU2019103048 | 2019-02-04 | ||
PCT/RU2019/001036 WO2020162788A1 (ru) | 2019-02-04 | 2019-12-27 | Кислотно-минеральная композиция для энтерального раствора |
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RU2178696C2 (ru) * | 2000-03-22 | 2002-01-27 | Маткевич Виктор Анатольевич | Энтеральная смесь для кишечного лаважа, коррекции метаболических расстройств организма, профилактики и лечения дисбактериоза кишечника |
CN101804068A (zh) * | 2006-03-06 | 2010-08-18 | 桑苏君 | 聚乙二醇-电解质口服溶液 |
RU2473330C1 (ru) * | 2011-12-09 | 2013-01-27 | Александр Павлович Погромов | Средство для кишечного лаважа |
WO2016015055A1 (en) * | 2014-07-25 | 2016-01-28 | Ironwood Pharmaceuticals, Inc. | Colon cleansing compositions |
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US6447763B1 (en) * | 1998-06-12 | 2002-09-10 | Ian L. Gordon | Method and system for production and collection of lavage induced stool (LIS) for chemical and biologic tests of cells |
RU2190412C2 (ru) | 2000-02-03 | 2002-10-10 | Московский городской научно-исследовательский институт скорой помощи им. Н.В.Склифосовского | Способ детоксикации организма |
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RU2178696C2 (ru) * | 2000-03-22 | 2002-01-27 | Маткевич Виктор Анатольевич | Энтеральная смесь для кишечного лаважа, коррекции метаболических расстройств организма, профилактики и лечения дисбактериоза кишечника |
CN101804068A (zh) * | 2006-03-06 | 2010-08-18 | 桑苏君 | 聚乙二醇-电解质口服溶液 |
RU2473330C1 (ru) * | 2011-12-09 | 2013-01-27 | Александр Павлович Погромов | Средство для кишечного лаважа |
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