CN116059288A - 一种治疗糖尿病足创面修复的抗菌外敷药物的制备方法 - Google Patents
一种治疗糖尿病足创面修复的抗菌外敷药物的制备方法 Download PDFInfo
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- CN116059288A CN116059288A CN202211592031.1A CN202211592031A CN116059288A CN 116059288 A CN116059288 A CN 116059288A CN 202211592031 A CN202211592031 A CN 202211592031A CN 116059288 A CN116059288 A CN 116059288A
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Abstract
本发明属于医药技术领域,公开了一种治疗糖尿病足创面修复的抗菌外敷药物的制备方法。本发明通过威灵仙提取物制备方法有效提取出威灵仙中有效成分,其制备工艺稳定,使得工艺标准化;通过威灵仙提取物进行对质量标准化测定方法的研究,使得获得的威灵仙提取物的质量能稳定控制;同时,通过糖尿病足风险评估方法获取患者的体征数据和医学影像之后,将上述数据输入预先训练得到的评估模型中,可以得到评估模型输出的评估值,接着便可以根据数值的大小帮助医护人员进行决策。由于通过评估模型为医护人员提供了一个糖尿病足风险的量化评估依据,降低了人为经验影响,因此,提高了糖尿病足风险风险评估的准确性。
Description
技术领域
本发明属于医药技术领域,尤其涉及一种治疗糖尿病足创面修复的抗菌外敷药物的制备方法。
背景技术
糖尿病患者因下肢远端神经异常和不同程度的血管病变导致的足部感染、溃疡和(或)深层组织破坏;糖尿病患者的很多足部并发症起自感觉性神经病变及轻度的自主与运动神经病变。其中感觉神经病变合并过高的机械应力,是引起足部溃疡和感染的主要始动因素。炎症与组织损害是一定程度的反复应力作用于一个特定的失去感觉的区域的结果。来自地面、鞋子或其他邻近足趾的压力或剪切力导致溃疡形成,由于缺乏正常的神经保护机制,溃疡常因骨突的存在而加重。自主神经系统的病变造成皮肤正常排汗调节功能、皮肤温度调节功能和血运调节能力丧失,导致局部组织柔韧性降低,形成厚的胼胝以及更易破碎和开裂;然而,现有治疗糖尿病足创面修复的抗菌外敷药物的制备方法采用的提取物原料质量差,影响药物效果;同时,不能准确对糖尿病足风险进行准确评估。
通过上述分析,现有技术存在的问题及缺陷为:
(1)现有治疗糖尿病足创面修复的抗菌外敷药物的制备方法采用的提取物原料质量差,影响药物效果。
(2)不能准确对糖尿病足风险进行准确评估。
发明内容
针对现有技术存在的问题,本发明提供了一种治疗糖尿病足创面修复的抗菌外敷药物的制备方法。
本发明是这样实现的,一种治疗糖尿病足创面修复的抗菌外敷药物的制备方法包括:
步骤一,按重量份数称取威灵仙提取物10份、透骨草5份、鸡屎藤12份、栝楼子8份、杠板归9份、海金沙6份、刘寄奴5份、紫草13份、矮脚杨梅皮16份、茶籽油12份、乳化剂3份;
步骤二,将透骨草、鸡屎藤、栝楼子、杠板归、海金沙、刘寄、紫草、矮脚杨梅皮清洗干净,并干燥;
步骤三,将干燥后的药材进行粉碎混合加水,常压下煎制130min,过滤取液体,然后加入威灵仙提取物、茶籽油、乳化剂;获得抗菌外敷药物;
步骤四,对糖尿病足风险评估。
进一步,所述乳化剂为聚丙烯酰胺、异链烷基脂肪醇、脂肪醇聚氧乙烯醚中的一种或多种。
进一步,所述威灵仙提取物制备方法如下:
(1)对威灵仙进行清洗,干燥,粉碎,将粉碎的威灵仙加水煎煮1~3次,合并滤液,滤液水浴冷却后浓缩;滤液减压浓缩至适量,置于进行冷冻干燥,即得威灵仙提取物;
(2)对威灵仙提取物质量检测;
取威灵仙提取物样品0.15g~0.2g,精密称定,置具塞锥形瓶中,精密加入水溶液25mL,密塞,称定重量,超声处理20~30min,放冷,再称定重量,用水补足减失的重量,摇匀,滤过,取过滤液即为威灵仙提取物样品液;
制备齐墩果酸对照品溶液:采用超高效液相色谱仪进行色谱分析,记录色谱图,与齐墩果酸对照品相应的峰为1峰;
所述特征峰图谱的测定的色谱柱为WatersACQUITYHSST3色谱柱,其柱长为150mm,内径2.1mm,粒径为1.8μm;以乙腈为流动相A,以0.1%磷酸为流动相B;进行梯度洗脱,柱温为30℃;流速为每分钟0.25mL;检测波长为205nm;
所述梯度洗脱为:0~4min,0%流动相A;4~25min,0%→22%流动相A;25~27min,22%→28%流动相A;27~29min,28%→29%流动相A;29~32min,29%→33%流动相A;32~36min,33%→38%流动相A;36~37min,38%~40%流动相A;37~42min,40%→90%流动相A;42~48min,90%→90%流动相A;48~48.1min,90%→0%流动相A;48.1~52min,0%流动相A,其中,每个时间段中除流动相A外,剩余为流动相B,流动相A与流动相B之和为100%;
所述减压浓缩的温度为60~70℃,浓缩真空度-0.085~-0.09Mpa,至相对密度为1.035~1.054g/mL;
所述冷冻干燥包括:第一阶段-40℃,持续时间2h,第二阶段-60℃,持续时间2h;升华干燥温度为-40℃-25℃,时间为24h。
进一步,所述威灵仙加入10倍水浸泡33min,每次加10倍量水煎煮33min,趁热过滤,合并每次滤液。
进一步,所述对糖尿病足风险评估方法如下:
1)通过医疗设备获取患者的体征数据及足部病灶的医学影像;对医学影像进行增强处理;将所述体征数据和所述医学影像输入预先训练得到的评估模型中,得到用于表征糖尿病足风险大小的评估值;
2)根据所述评估值的大小,输出对所述患者执行目标操作的决策信息。
进一步,所述将所述体征数据和所述医学影像输入预先训练得到的评估模型中,得到用于表征糖尿病足风险大小的评估值,包括:
将所述体征数据输入预先训练得到的第一评估模型中以得到第一输出值以及将所述医学影像输入预先训练得到的第二评估模型中以得到第二输出值;
对所述第一输出值和所述第二输出值赋予预设的权重,利用加权求和方法得到用于表征糖尿病足风险大小的评估值。
进一步,所述第一评估模型的训练方法,包括:
从检测设备中获取患者的体征数据,对所述体征数据进行预处理后得到训练集和测试集;
利用所述训练集对预设神经网络进行训练,得到各个候选学习器;
利用所述测试集对各个所述候选学习器进行测试,将准确率最高的候选学习器作为第一评估模型。
进一步,所述体征数据包括:血红蛋白含量、血氧饱和度、双下肢及足部位置的温度、足背动脉搏动、踝部血压、足部神经反射强度和/或经皮氧分压。
进一步,所述第二评估模型的训练方法,包括:
获取患者足部病灶的医学影像作为原始样本集;
对所述原始样本集中的样本医疗影像标注,得到各个样本医疗影像以及与目标操作对应的执行结果标签;
将各个样本医疗影像及对应的已标注的执行结果标签作为训练集,利用所述训练集对预设深度学习模型进行训练;
根据训练所得的执行结果与样本校验数据的匹配结果,优化所述深度学习模型,直到训练所得的执行结果与样本校验数据的匹配率达到预设阈值,以得到所述第二评估模型。
进一步,所述足部病灶的医学影像包括:血管B超、血管造影影像、足底红外影像、X线和/或MRI影像。
结合上述的技术方案和解决的技术问题,请从以下几方面分析本发明所要保护的技术方案所具备的优点及积极效果为:
第一、针对上述现有技术存在的技术问题以及解决该问题的难度,紧密结合本发明的所要保护的技术方案以及研发过程中结果和数据等,详细、深刻地分析本发明技术方案如何解决的技术问题,解决问题之后带来的一些具备创造性的技术效果。具体描述如下:
本发明通过威灵仙提取物制备方法有效提取出威灵仙中有效成分,其制备工艺稳定,使得工艺标准化;通过威灵仙提取物进行对质量标准化测定方法的研究,使得获得的威灵仙提取物的质量能稳定控制;同时,通过糖尿病足风险评估方法获取患者的体征数据和医学影像之后,将上述数据输入预先训练得到的评估模型中,可以得到评估模型输出的评估值,接着便可以根据数值的大小帮助医护人员进行决策。由于通过评估模型为医护人员提供了一个糖尿病足风险的量化评估依据,降低了人为经验影响,因此,提高了糖尿病足风险风险评估的准确性。
第二,把技术方案看做一个整体或者从产品的角度,本发明所要保护的技术方案具备的技术效果和优点,具体描述如下:
本发明通过威灵仙提取物制备方法有效提取出威灵仙中有效成分,其制备工艺稳定,使得工艺标准化;通过威灵仙提取物进行对质量标准化测定方法的研究,使得获得的威灵仙提取物的质量能稳定控制;同时,通过糖尿病足风险评估方法获取患者的体征数据和医学影像之后,将上述数据输入预先训练得到的评估模型中,可以得到评估模型输出的评估值,接着便可以根据数值的大小帮助医护人员进行决策。由于通过评估模型为医护人员提供了一个糖尿病足风险的量化评估依据,降低了人为经验影响,因此,提高了糖尿病足风险风险评估的准确性。
附图说明
图1是本发明实施例提供的治疗糖尿病足创面修复的抗菌外敷药物的制备方法流程图。
图2是本发明实施例提供的威灵仙提取物制备方法流程图。
图3是本发明实施例提供的对糖尿病足风险评估方法流程图。
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白,以下结合实施例,对本发明进行进一步详细说明。应当理解,此处所描述的具体实施例仅仅用以解释本发明,并不用于限定本发明。
一、解释说明实施例。为了使本领域技术人员充分了解本发明如何具体实现,该部分是对权利要求技术方案进行展开说明的解释说明实施例。
如图1所示,本发明提供一种治疗糖尿病足创面修复的抗菌外敷药物的制备方法包括以下步骤:
S101,按重量份数称取威灵仙提取物10份、透骨草5份、鸡屎藤12份、栝楼子8份、杠板归9份、海金沙6份、刘寄奴5份、紫草13份、矮脚杨梅皮16份、茶籽油12份、乳化剂3份;
S102,将透骨草、鸡屎藤、栝楼子、杠板归、海金沙、刘寄、紫草、矮脚杨梅皮清洗干净,并干燥;
S103,将干燥后的药材进行粉碎混合加水,常压下煎制130min,过滤取液体,然后加入威灵仙提取物、茶籽油、乳化剂;获得抗菌外敷药物;
S104,对糖尿病足风险评估。
本发明提供的乳化剂为聚丙烯酰胺、异链烷基脂肪醇、脂肪醇聚氧乙烯醚中的一种或多种。
如图2所示,本发明提供的威灵仙提取物制备方法如下:
S201,对威灵仙进行清洗,干燥,粉碎,将粉碎的威灵仙加水煎煮1~3次,合并滤液,滤液水浴冷却后浓缩;滤液减压浓缩至适量,置于进行冷冻干燥,即得威灵仙提取物;
S202,对威灵仙提取物质量检测;
取威灵仙提取物样品0.15g~0.2g,精密称定,置具塞锥形瓶中,精密加入水溶液25mL,密塞,称定重量,超声处理20~30min,放冷,再称定重量,用水补足减失的重量,摇匀,滤过,取过滤液即为威灵仙提取物样品液;
制备齐墩果酸对照品溶液:采用超高效液相色谱仪进行色谱分析,记录色谱图,与齐墩果酸对照品相应的峰为1峰;
所述特征峰图谱的测定的色谱柱为WatersACQUITYHSST3色谱柱,其柱长为150mm,内径2.1mm,粒径为1.8μm;以乙腈为流动相A,以0.1%磷酸为流动相B;进行梯度洗脱,柱温为30℃;流速为每分钟0.25mL;检测波长为205nm;
所述梯度洗脱为:0~4min,0%流动相A;4~25min,0%→22%流动相A;25~27min,22%→28%流动相A;27~29min,28%→29%流动相A;29~32min,29%→33%流动相A;32~36min,33%→38%流动相A;36~37min,38%~40%流动相A;37~42min,40%→90%流动相A;42~48min,90%→90%流动相A;48~48.1min,90%→0%流动相A;48.1~52min,0%流动相A,其中,每个时间段中除流动相A外,剩余为流动相B,流动相A与流动相B之和为100%;
所述减压浓缩的温度为60~70℃,浓缩真空度-0.085~-0.09Mpa,至相对密度为1.035~1.054g/mL;
所述冷冻干燥包括:第一阶段-40℃,持续时间2h,第二阶段-60℃,持续时间2h;升华干燥温度为-40℃-25℃,时间为24h。
本发明提供的威灵仙加入10倍水浸泡33min,每次加10倍量水煎煮33min,趁热过滤,合并每次滤液。
如图3所示,本发明提供的对糖尿病足风险评估方法如下:
S301,通过医疗设备获取患者的体征数据及足部病灶的医学影像;对医学影像进行增强处理;将所述体征数据和所述医学影像输入预先训练得到的评估模型中,得到用于表征糖尿病足风险大小的评估值;
S302,根据所述评估值的大小,输出对所述患者执行目标操作的决策信息。
本发明提供的将所述体征数据和所述医学影像输入预先训练得到的评估模型中,得到用于表征糖尿病足风险大小的评估值,包括:
将所述体征数据输入预先训练得到的第一评估模型中以得到第一输出值以及将所述医学影像输入预先训练得到的第二评估模型中以得到第二输出值;
对所述第一输出值和所述第二输出值赋予预设的权重,利用加权求和方法得到用于表征糖尿病足风险大小的评估值。
本发明提供的第一评估模型的训练方法,包括:
从检测设备中获取患者的体征数据,对所述体征数据进行预处理后得到训练集和测试集;
利用所述训练集对预设神经网络进行训练,得到各个候选学习器;
利用所述测试集对各个所述候选学习器进行测试,将准确率最高的候选学习器作为第一评估模型。
本发明提供的体征数据包括:血红蛋白含量、血氧饱和度、双下肢及足部位置的温度、足背动脉搏动、踝部血压、足部神经反射强度和/或经皮氧分压。
本发明提供的第二评估模型的训练方法,包括:
获取患者足部病灶的医学影像作为原始样本集;
对所述原始样本集中的样本医疗影像标注,得到各个样本医疗影像以及与目标操作对应的执行结果标签;
将各个样本医疗影像及对应的已标注的执行结果标签作为训练集,利用所述训练集对预设深度学习模型进行训练;
根据训练所得的执行结果与样本校验数据的匹配结果,优化所述深度学习模型,直到训练所得的执行结果与样本校验数据的匹配率达到预设阈值,以得到所述第二评估模型。
本发明提供的足部病灶的医学影像包括:血管B超、血管造影影像、足底红外影像、X线和/或MRI影像。
二、应用实施例。为了证明本发明的技术方案的创造性和技术价值,该部分是对权利要求技术方案进行具体产品上或相关技术上的应用实施例。
本发明通过威灵仙提取物制备方法有效提取出威灵仙中有效成分,其制备工艺稳定,使得工艺标准化;通过威灵仙提取物进行对质量标准化测定方法的研究,使得获得的威灵仙提取物的质量能稳定控制;同时,通过糖尿病足风险评估方法获取患者的体征数据和医学影像之后,将上述数据输入预先训练得到的评估模型中,可以得到评估模型输出的评估值,接着便可以根据数值的大小帮助医护人员进行决策。由于通过评估模型为医护人员提供了一个糖尿病足风险的量化评估依据,降低了人为经验影响,因此,提高了糖尿病足风险风险评估的准确性。
应当注意,本发明的实施方式可以通过硬件、软件或者软件和硬件的结合来实现。硬件部分可以利用专用逻辑来实现;软件部分可以存储在存储器中,由适当的指令执行系统,例如微处理器或者专用设计硬件来执行。本领域的普通技术人员可以理解上述的设备和方法可以使用计算机可执行指令和/或包含在处理器控制代码中来实现,例如在诸如磁盘、CD或DVD-ROM的载体介质、诸如只读存储器(固件)的可编程的存储器或者诸如光学或电子信号载体的数据载体上提供了这样的代码。本发明的设备及其模块可以由诸如超大规模集成电路或门阵列、诸如逻辑芯片、晶体管等的半导体、或者诸如现场可编程门阵列、可编程逻辑设备等的可编程硬件设备的硬件电路实现,也可以用由各种类型的处理器执行的软件实现,也可以由上述硬件电路和软件的结合例如固件来实现。
三、实施例相关效果的证据。本发明实施例在研发或者使用过程中取得了一些积极效果,和现有技术相比的确具备很大的优势,下面内容结合试验过程的数据、图表等进行描述。
本发明通过威灵仙提取物制备方法有效提取出威灵仙中有效成分,其制备工艺稳定,使得工艺标准化;通过威灵仙提取物进行对质量标准化测定方法的研究,使得获得的威灵仙提取物的质量能稳定控制;同时,通过糖尿病足风险评估方法获取患者的体征数据和医学影像之后,将上述数据输入预先训练得到的评估模型中,可以得到评估模型输出的评估值,接着便可以根据数值的大小帮助医护人员进行决策。由于通过评估模型为医护人员提供了一个糖尿病足风险的量化评估依据,降低了人为经验影响,因此,提高了糖尿病足风险风险评估的准确性。
以上所述,仅为本发明的具体实施方式,但本发明的保护范围并不局限于此,任何熟悉本技术领域的技术人员在本发明揭露的技术范围内,凡在本发明的精神和原则之内所作的任何修改、等同替换和改进等,都应涵盖在本发明的保护范围之内。
Claims (10)
1.一种治疗糖尿病足创面修复的抗菌外敷药物的制备方法,其特征在于,所述治疗糖尿病足创面修复的抗菌外敷药物的制备方法包括以下步骤:
步骤一,按重量份数称取威灵仙提取物10份、透骨草5份、鸡屎藤12份、栝楼子8份、杠板归9份、海金沙6份、刘寄奴5份、紫草13份、矮脚杨梅皮16份、茶籽油12份、乳化剂3份;
步骤二,将透骨草、鸡屎藤、栝楼子、杠板归、海金沙、刘寄、紫草、矮脚杨梅皮清洗干净,并干燥;
步骤三,将干燥后的药材进行粉碎混合加水,常压下煎制130min,过滤取液体,然后加入威灵仙提取物、茶籽油、乳化剂;获得抗菌外敷药物;
步骤四,对糖尿病足风险评估。
2.如权利要求1所述治疗糖尿病足创面修复的抗菌外敷药物的制备方法,其特征在于,所述乳化剂为聚丙烯酰胺、异链烷基脂肪醇、脂肪醇聚氧乙烯醚中的一种或多种。
3.如权利要求1所述治疗糖尿病足创面修复的抗菌外敷药物的制备方法,其特征在于,所述威灵仙提取物制备方法如下:
(1)对威灵仙进行清洗,干燥,粉碎,将粉碎的威灵仙加水煎煮1~3次,合并滤液,滤液水浴冷却后浓缩;滤液减压浓缩至适量,置于进行冷冻干燥,即得威灵仙提取物;
(2)对威灵仙提取物质量检测;
取威灵仙提取物样品0.15g~0.2g,精密称定,置具塞锥形瓶中,精密加入水溶液25mL,密塞,称定重量,超声处理20~30min,放冷,再称定重量,用水补足减失的重量,摇匀,滤过,取过滤液即为威灵仙提取物样品液;
制备齐墩果酸对照品溶液:采用超高效液相色谱仪进行色谱分析,记录色谱图,与齐墩果酸对照品相应的峰为1峰;
所述特征峰图谱的测定的色谱柱为WatersACQUITYHSST3色谱柱,其柱长为150mm,内径2.1mm,粒径为1.8μm;以乙腈为流动相A,以0.1%磷酸为流动相B;进行梯度洗脱,柱温为30℃;流速为每分钟0.25mL;检测波长为205nm;
所述梯度洗脱为:0~4min,0%流动相A;4~25min,0%→22%流动相A;25~27min,22%→28%流动相A;27~29min,28%→29%流动相A;29~32min,29%→33%流动相A;32~36min,33%→38%流动相A;36~37min,38%~40%流动相A;37~42min,40%→90%流动相A;42~48min,90%→90%流动相A;48~48.1min,90%→0%流动相A;48.1~52min,0%流动相A,其中,每个时间段中除流动相A外,剩余为流动相B,流动相A与流动相B之和为100%;
所述减压浓缩的温度为60~70℃,浓缩真空度-0.085~-0.09Mpa,至相对密度为1.035~1.054g/mL;
所述冷冻干燥包括:第一阶段-40℃,持续时间2h,第二阶段-60℃,持续时间2h;升华干燥温度为-40℃-25℃,时间为24h。
4.如权利要求1所述治疗糖尿病足创面修复的抗菌外敷药物的制备方法,其特征在于,所述威灵仙加入10倍水浸泡33min,每次加10倍量水煎煮33min,趁热过滤,合并每次滤液。
5.如权利要求1所述治疗糖尿病足创面修复的抗菌外敷药物的制备方法,其特征在于,所述对糖尿病足风险评估方法如下:
1)通过医疗设备获取患者的体征数据及足部病灶的医学影像;对医学影像进行增强处理;将所述体征数据和所述医学影像输入预先训练得到的评估模型中,得到用于表征糖尿病足风险大小的评估值;
2)根据所述评估值的大小,输出对所述患者执行目标操作的决策信息。
6.如权利要求5所述治疗糖尿病足创面修复的抗菌外敷药物的制备方法,其特征在于,所述将所述体征数据和所述医学影像输入预先训练得到的评估模型中,得到用于表征糖尿病足风险大小的评估值,包括:
将所述体征数据输入预先训练得到的第一评估模型中以得到第一输出值以及将所述医学影像输入预先训练得到的第二评估模型中以得到第二输出值;
对所述第一输出值和所述第二输出值赋予预设的权重,利用加权求和方法得到用于表征糖尿病足风险大小的评估值。
7.如权利要求5所述治疗糖尿病足创面修复的抗菌外敷药物的制备方法,其特征在于,所述第一评估模型的训练方法,包括:
从检测设备中获取患者的体征数据,对所述体征数据进行预处理后得到训练集和测试集;
利用所述训练集对预设神经网络进行训练,得到各个候选学习器;
利用所述测试集对各个所述候选学习器进行测试,将准确率最高的候选学习器作为第一评估模型。
8.如权利要求5所述治疗糖尿病足创面修复的抗菌外敷药物的制备方法,其特征在于,所述体征数据包括:血红蛋白含量、血氧饱和度、双下肢及足部位置的温度、足背动脉搏动、踝部血压、足部神经反射强度和/或经皮氧分压。
9.如权利要求5所述治疗糖尿病足创面修复的抗菌外敷药物的制备方法,其特征在于,所述第二评估模型的训练方法,包括:
获取患者足部病灶的医学影像作为原始样本集;
对所述原始样本集中的样本医疗影像标注,得到各个样本医疗影像以及与目标操作对应的执行结果标签;
将各个样本医疗影像及对应的已标注的执行结果标签作为训练集,利用所述训练集对预设深度学习模型进行训练;
根据训练所得的执行结果与样本校验数据的匹配结果,优化所述深度学习模型,直到训练所得的执行结果与样本校验数据的匹配率达到预设阈值,以得到所述第二评估模型。
10.如权利要求5所述治疗糖尿病足创面修复的抗菌外敷药物的制备方法,其特征在于,所述足部病灶的医学影像包括:血管B超、血管造影影像、足底红外影像、X线和/或MRI影像。
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