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CN107029219B - 一种促进皮肤组织再生的药膏 - Google Patents

一种促进皮肤组织再生的药膏 Download PDF

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CN107029219B
CN107029219B CN201710410768.XA CN201710410768A CN107029219B CN 107029219 B CN107029219 B CN 107029219B CN 201710410768 A CN201710410768 A CN 201710410768A CN 107029219 B CN107029219 B CN 107029219B
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周欢
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Chongqing Man Biotechnology Research Institute Co ltd
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Chongqing Man Medical Beauty Hospital Co ltd
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Abstract

本发明提供一种促进皮肤组织再生的药膏，它由富血小板血浆2ml(其血小板浓度为0.9‑1.4×1015个/L)凝血酶0.01‑0.15mg、蜂王浆2‑5g、谷胱甘肽0.03‑0.12mg、维生素0.001‑3mg、胶原蛋白肽5‑25mg、核苷酸0.01‑7.5mg、氯化钙0.03‑0.5mg、壳聚糖0.1‑0.3mg、明胶2‑5mg、甘油3‑10mg、辅酶0.1‑2mg、氯化钾0.01‑0.4mg，硫酸镁0.04‑0.6mg、氧化锌0.03‑0.5mg和蒸馏水10‑50ml混合而成。本发明促进皮肤组织再生的药膏，它能促进人体凹陷性疤痕皮肤组织再生，适用于辅助治疗凹陷性疤痕，尤其对深度(5‑15mm)凹陷性疤痕创口具有显著的疗效，同时能够缩短治疗周期，对于深度为5mm以内的凹陷性疤痕，治疗周期缩短至25天。

Description

一种促进皮肤组织再生的药膏
技术领域
本发明涉及一种促进皮肤组织再生的药膏，具体是于人体凹陷性疤痕术后，用于促进其创口处的皮肤组织再生。
背景技术
凹陷性疤痕，又称之为凹陷性瘢痕，是指皮肤组织缺损而造成的凹陷性伤疤，通常因痤疮、手术、外伤感染，水痘、天花等疾病而造成皮肤胶原蛋白、弹力蛋白缺失，并留下永久性的凹陷性疤痕。
目前，促进凹陷性疤痕皮肤组织再生的药物有果酸，其主要成分是葡萄酸、苹果酸、柑橘酸和乳酸，采用高浓度的果酸虽然能够通过促进真皮层内弹性纤维增生来改善疤痕。此外，通过提取自体脂肪细胞和生长因子，将其立体式注入到凹陷部位，可以补充缺失脂肪，激活萎缩组织，重塑健康肌肤。但是前述方法仅对浅层疤痕(疤痕凹陷深度0-3mm)具有较好的疗效。
CN105963239A公开了一种可促进皮肤再生的乳液，包括保湿剂0.02-0.2份；渗透剂2-8份；防腐剂0.06-0.1份；乳化剂1-3份、干细胞复合因子0.01-10份、细胞脂质体0.005-0.1份、尿囊素0.01-0.03份。该乳液采用人脐带间充质干细胞分泌的细胞脂质体裹干细胞因子，协助皮肤自我修复，促进皮肤损伤愈合，但该文献中未证明是否可将其用于凹陷性疤痕处并修复凹陷性疤痕皮肤组织。
CN102600363A公开了一种用于深度烧创伤修复，促使组织和皮肤再生的中药复方制剂，包括白芨0.1-100份，樟脑0.1-10份，冰片0.1-5份。该药物主要是用于各类深度烧、烫伤能迅速止痛，使坏死组织逐步脱落，存活组织迅速生长，同时可用于整形、外伤、妇科手术缝合创面预防和抑制疤痕增生(参见其有益效果部分)。
CN1902307B公开了一种组织再生的方法，采用红细胞生成素(EPO)制备成药物，用于促进肝脏组织或皮肤组织结构性再生。在皮肤范围内的烧伤、创伤、烫伤、机械性损伤或炎症之后的修复方面，通过给予EPO或TPO，可以在有或没有结构性替代结构的情况下获得再生。特别是在慢性疾病、血流障碍、糖尿病性溃疡、还有免疫性质的现象的情况下，EPO在此可以调控性地参与。在组织学上看到，恢复了正常的表皮、真皮和皮下组织，其完成了相应的具有微结构的血管形成。在手掌和足底上，形成了基底层、粒层、透明层、角质层。在真皮和外侧上形成了真皮乳头(Dermispapillen)。在表皮(内表面)上，重新形成了相应的表皮凹陷。另外，共同促进了附属器官及其从祖先细胞的形成。在迄今的组织工程中的一个问题是，在皮肤范围内结构性修复与皮肤附属器官的形成之间的结合。通过给予EPO能够在人的黑素细胞的范围内达到相互作用过程。考虑了眼、脑膜和色素沉着的形成之间的生理学反馈过程，因为在此不涉及分离的细胞化合物，而是涉及器官类型的再生产物。真皮部分的再生过程包括肌肉结构(立毛肌(musculusarectorpili))、触觉结构、毛发的毛根鞘外层和内层以及毛球结构。这或许突入脂肪组织中。在毛发和毛囊中，出现了结缔组织状的毛根鞘，其包含在再生中重要的功能结构。由此形成玻璃样膜、毛根鞘外层、毛根鞘内层和最终的毛发。在甲再生的范围内可以支持和引起类似的构成。在组织结构的内部，一起形成了汗腺。在皮肤结构中，重新形成了毛囊周围的网结构、网络、毛细血管下的动脉网、末端的(termale)静脉网(参见其应用领域第4部分)。发明人采用CN1902307B公开的技术治疗凹陷性疤痕，发现其治疗周期较长。
除此之外，文献(点阵CO2激光治疗凹陷性瘢痕疗效观察及治疗体会，江苏省盐城市疾病预防控制中心，江苏盐城，224001)公开了一种治疗凹陷性瘢痕的方法，治疗方法：清洁皮肤后在瘢痕治疗区涂敷复方利多卡因凝胶，用保鲜膜包封1小时。做前用湿生理盐水棉球轻搽去利多卡因凝胶，后按瘢痕的大小、深浅调节图形、能量参数﹑点间距﹑扫描次数，可先在报纸上试做一下看看图形大小、深浅，然后再到面部操作，通常凹陷性瘢痕治疗的量第1次次能量设定为15-20mj，激光扫描次数1次，对小面积的瘢痕间距设定为1.1，对大面积的点间距设计为1.2，第一次治疗若无明显副反应，第2次治疗能量可加大，设定为20-40mj，扫描次数1次，具体的能量以激光照射到皮肤表面后呈点状发白样较安全。同时，根据瘢痕的面积大小选择图形，面积越大，可选大图形﹑高密度，图形面积与瘢痕面积不相符时再选择小图形或其它图形，使激光覆盖于整个瘢痕区域。所有病例均进行2次治疗，第2次治疗在第1次治疗后2个月进行，治疗结束2月后评价疗效。术后处理：术后立即冰敷1-2小时以减少红斑水肿，减轻痛感，冰敷后涂金万红乳膏保护创面，无红肿、疼痛后，一天3次涂抹成纤维细胞因子促进修复，皮损结痂处禁水，禁止强行剥离痂皮，待其自然脱落，同时口服维生素C、E，痂皮脱落后严格防晒，戒烟、酒及刺激性食物。采用该方法需要经过多次用药，多次治疗才能达到较好的疗效。
发明内容
针对现有技术中存在的问题，本发明的目的在于提供一种促进皮肤组织再生的药膏。
为了实现上述目的，本发明采用如下技术方案：
一种促进皮肤组织再生的药膏，其特征在于：它包括富血小板血浆(PRP)、凝血酶、蜂王浆、谷胱甘肽、维生素、胶原蛋白肽、核苷酸、辅助添加剂和矿物质添加剂；
所述维生素为维生素A、维生素B1、维生素B2、维生素B5、维生素B9、维生素B12、维生素C、维生素E中的一种或几种组合；
所述胶原蛋白肽为羟脯胺酸、脯氨酸、甘氨酸中的一种或几种组合；
所述核苷酸为腺苷酸、鸟嘌呤核苷酸、尿嘧啶核苷酸、胸腺嘧啶核苷酸、胞苷酸中的一种或几种组合；
所述辅助添加剂为壳聚糖、明胶和甘油的组合物；
所述矿物质添加剂为氯化钾、硫酸镁、氧化锌组成的混合物；
本发明所述富血小板血浆是取自患者的静脉血，并经两次离心后得到的富血小板血浆(其血小板浓度为0.9-1.4×1015个/L)。
采用前述技术方案中促进皮肤组织再生的药膏，能促进人体凹陷性疤痕皮肤组织再生，适用于辅助治疗凹陷性疤痕，尤其对深度(5-15mm)凹陷性疤痕创口具有显著的疗效，同时还能够缩短治疗周期。
作为进一步限定，上述促进皮肤组织再生的药膏具体是由富血小板血浆、凝血酶、蜂王浆、谷胱甘肽、维生素、胶原蛋白肽、核苷酸、氯化钙、辅助添加剂、辅酶、氯化钾、硫酸镁、氧化锌和蒸馏水组成；
其中，各组分含量分别为：富血小板血浆2ml(抽取患者的静脉血18-28ml，经两次离心后得到血小板浓度为0.9-1.4×1015个/L富血小板血浆)、凝血酶0.01-0.15mg、蜂王浆2-5g、谷胱甘肽0.03-0.12mg、维生素0.001-3mg、胶原蛋白肽5-25mg、核苷酸0.01-7.5mg、氯化钙0.03-0.5mg、辅助添加剂(壳聚糖0.1-0.3mg、明胶2-5mg、甘油3-10mg)、辅酶0.1-2mg、矿物质添加剂(氯化钾0.01-0.4mg，硫酸镁0.04-0.6mg、氧化锌0.03-0.5mg)、蒸馏水10-50ml。
优选地，上述各组分地含量为：富血小板血浆2ml(其中血小板浓度为1-1.2×1015个/L)、凝血酶0.08-0.1mg、蜂王浆3-5g、谷胱甘肽0.05-0.1mg、维生素0.5-2mg、胶原蛋白肽10-15mg、核苷酸2-5mg、氯化钙0.05-0.2mg、壳聚糖0.15-0.2mg、明胶3-4mg、甘油4-6mg、辅酶0.5-1mg、氯化钾0.1-0.3mg，硫酸镁0.1-0.4mg、氧化锌0.1-0.3mg、蒸馏水20-35ml。
上述辅酶可以选用烟酰胺替代，但其含量控制为0.1-1.2mg。
本发明具有如下有益效果：
本发明促进皮肤组织再生的药膏，由前述各物质按照特定配比配制而成，并通过各物质的协同配合促进人体凹陷性疤痕皮肤组织再生，适用于辅助治疗凹陷性疤痕，尤其对深度(5-15mm)凹陷性疤痕创口具有显著的疗效。
采用本发明促进皮肤组织再生的药膏外敷于凹陷性疤痕术后的创口处，可缩短创口恢复期。相比于现有药物，对于深度为5mm以内的凹陷性疤痕，治疗周期缩短至24-45天。
采用本发明促进皮肤组织再生的药膏辅助治疗凹陷性疤痕，对凹陷性疤痕区域的皮肤质地、颜色及轮廓等方面都有非常明显的改善，患者康复后其凹陷性疤痕区域皮肤紧致，平整度好，颜色与正常肤色一致，肉眼观察不到创口痕迹。
采用本发明配方配制成的试剂，还为促进血液再生提供了依据。
具体实施方式
实施例1
一种促进皮肤组织再生的药膏，它由富血小板血浆2ml(抽取患者的静脉血20ml，经两次离心后得到富血小板血浆，其血小板浓度为1×1015个/L),凝血酶0.1mg、蜂王浆4g、谷胱甘肽0.08mg、维生素1.3mg(维生素A为0.025mg、维生素B1为0.025mg、维生素C为1mg、维生素E为0.25mg)、胶原蛋白肽12mg(羟脯胺酸5mg、脯氨酸5mg、甘氨酸2mg)、腺苷酸0.8mg、鸟嘌呤核苷酸0.8mg、尿嘧啶核苷酸0.8mg、胸腺嘧啶核苷酸0.8mg、胞苷酸0.8mg、氯化钙0.08mg、壳聚糖0.15mg、明胶3mg、甘油4mg、辅酶0.8mg、氯化钾0.2mg，硫酸镁0.3mg、氧化锌0.2mg、和蒸馏水25ml混合而成。
为得出本发明促进皮肤组织再生的药膏疗效，发明人对其进行了以下探究：
患者：于我院2016年3月-2017年3月期间就诊病例，共计86人，其中男60例，女26例，年龄10-45岁。将胸部、背部或腿部的凹陷性疤痕患者作为第一大组，疤痕凹陷深度为4-15mm，将疤痕凹陷深度为4-6mm的患者作为第1组，共计16人；将疤痕凹陷深度为6-8mm的患者作为第2组，共计10人；将疤痕凹陷深度为8-10mm的患者作为第3组，共计8人；将疤痕凹陷深度为10-12mm的患者作为第4组，共计10人；将疤痕凹陷深度为12-15mm的患者作为第5组，共计6人。其余36人作为第二大组，为面部凹陷性疤痕患者，疤痕深度为1-5mm。所有患者均无白癜风、银屑病、暴晒、口服维甲酸等病史，所有患者均非疤痕体质。治疗前申请人及发明人与患者及其家属充分沟通，告知治疗过程、风险情况、预期治疗效果，然后签署意见书。
患者在行常规激光治疗术(超超脉冲CO2激光手术、Er:YAG激光手术、点阵激光手术或脉冲染料激光手术)、皮肤磨削术(微晶磨削术或砂轮磨削术)或者外科手术(单纯切除直接缝合法、瘢痕核内切除缝合法)后，于患处创口面均匀涂敷本例中药物，用纱布包好创口，每隔3天更换一次药膏和纱布。用药过程中严格防晒，戒烟、酒及刺激性食物。
其中疗效评定标准：显效，疤痕平整度好，视觉上无凹凸不平感，颜色接近周边正常皮肤的95％以上，患者满意；有效，疤痕略有凹凸不平，平整度60％以上，色泽不均，患者较满意；无效：疤痕凹凸感、色泽不均无明显改变﹑有明显色素沉着或色素减退，患者不满意。
对于第一大组的凹陷性疤痕患者，分别于用药后第6天、第18天、第24天、第27天、第33天、第45天、第60天观察创口情况，评价其疗效，结果见表1；
表1凹陷性疤痕患者用药后的疗效
Figure BDA0001312324150000051
由表1可知，采用本例中促进皮肤组织再生的药膏对50位患者进行辅助治疗后，用药4天后患者无疼痛感，用药6天后开始有效，且总有效率为100％，显效率为70.99％，仅2为患者第一次用药后出现无效的情况，但是经二次治疗后有效。对于凹陷深度为4-8mm的疤痕患者，用药后达到有效疗效的时间为6-27天，达到显效的时间为27-33天；对于凹陷深度为8-12mm的疤痕患者，用药后达到有效疗效的时间为6-45天，达到显效的时间为24-45天；对于凹陷深度为12-15mm的疤痕患者，用药后达到有效疗效的时间为6-45天，达到显效的时间为33-60天。
对于第二大组(面部凹陷性疤痕患者)，分别于用药后第18天、24天、27天、33天、45天、54天观察创口情况，评价其疗效，结果见表2；
表2 36例面部凹陷性疤痕患者治疗效果
Figure BDA0001312324150000061
以文献(点阵CO2激光治疗凹陷性瘢痕疗效观察及治疗体会，江苏省盐城市疾病预防控制中心，江苏盐城，224001)公开的一种治疗凹陷性疤痕的方法为对照。术后立即冰敷1-2小时以减少红斑水肿，减轻痛感，冰敷后涂金万红乳膏保护创面，无红、肿、痛后，一天3次涂抹成纤维细胞因子促进修复，皮损结痂处禁水，禁止强行剥离痂皮，待其自然脱落，同时口服维生素C、E，痂皮脱落后严格防晒，戒烟、酒及刺激性食物。所有病例均进行2次治疗，第2次治疗在第1次治疗后2个月进行，治疗结束2月后评价疗效，结果见表3。所有病例治疗后均出现灼热，疼痛、红斑、轻度水肿情况，用冰块冷敷后均减轻，有6例红斑期超过1天，最长3天，有4例出现色素沉着，出现色素沉着率为11％，期中1例色素沉着明显，外用氢醌霜后1月后色素消退(参见其结果部分)；
表3 36例面部凹陷性瘢痕点阵激光治疗效果
Figure BDA0001312324150000071
由表3可知，采用本例中促进皮肤组织再生的药膏对36位面部凹陷性疤痕患者进行辅助治疗后，总有效率为100％，显效率为83.3％，相比于对照组(表3),其显效期缩短至24-45天，显效率提高了15.3％，且该36位患者用药过程中均无红肿、瘙痒的情况。
实施例2
一种促进皮肤组织再生的药膏，它由富血小板血浆2ml(抽取患者的静脉血24ml，经两次离心后得到富血小板血浆，其血小板浓度为1.2×1015个/L)、凝血酶0.1mg、蜂王浆3g、谷胱甘肽0.08mg、维生素1.3mg(维生素A为0.025mg、维生素B1为0.025mg、维生素C为1mg、维生素E为0.25mg)、胶原蛋白肽12mg(羟脯胺酸5mg、脯氨酸5mg、甘氨酸2mg)、尿嘧啶核苷酸4mg、壳聚糖0.15mg、明胶3mg、甘油4mg、氯化钾0.25mg，硫酸镁0.2mg、氧化锌0.15mg和蒸馏水25ml混合而成。
实施例3
一种促进皮肤组织再生的药膏，它由富血小板血浆2ml(抽取患者的静脉血18ml，经两次离心后得到富血小板血浆，其血小板浓度为1×1015个/L)、凝血酶0.08mg、蜂王浆5g、谷胱甘肽0.05mg、维生素A为0.05mg、胶原蛋白肽10mg(羟脯胺酸5mg、脯氨酸5mg)、尿嘧啶核苷酸2mg、氯化钙0.08mg、壳聚糖0.15mg、明胶3mg、甘油4mg、辅酶0.5mg、氯化钾0.1mg，硫酸镁0.1mg、氧化锌0.1mg和蒸馏水25ml混合而成。
实施例4
一种促进皮肤组织再生的药膏，它由富血小板血浆2ml(抽取患者的静脉血21ml，经两次离心后得到富血小板血浆，其血小板浓度为1.05×1015个/L)、凝血酶0.1mg、蜂王浆3.5g、谷胱甘肽0.1mg、维生素2mg(维生素A为0.15mg、维生素B1为0.12mg、维生素B2为0.1mg、维生素B5为0.03mg、维生素B9为0.05mg、维生素B12为0.05mg、维生素C为0.7mg、维生素E为0.8mg)、胶原蛋白肽15mg(羟脯胺酸6mg、脯氨酸6mg、甘氨酸3mg)、腺苷酸15mg、氯化钙0.2mg、壳聚糖0.2mg、明胶4mg、甘油6mg、辅酶2mg、氯化钾0.3mg，硫酸镁0.4mg、氧化锌0.3mg和蒸馏水35ml混合而成。
实施例5：一种促进皮肤组织再生的药膏，它由富血小板血浆2ml(抽取患者的静脉血20ml，经两次离心后得到富血小板血浆，其血小板浓度为0.9×1015个/L)、凝血酶0.01mg、蜂王浆2g、谷胱甘肽0.03mg、维生素C为0.001mg、胶原蛋白肽5mg(羟脯胺酸5mg)、鸟嘌呤核苷酸0.01mg、氯化钙0.03mg、壳聚糖0.1mg、明胶2mg、甘油3mg、辅酶0.1mg、氯化钾0.01mg，硫酸镁0.04mg、氧化锌0.03mg和蒸馏水10ml混合而成。
实施例6：一种促进皮肤组织再生的药膏，它由富血小板血浆2ml(抽取患者的静脉血28ml，经两次离心后得到富血小板血浆，其血小板浓度为1.4×1015个/L)、凝血酶0.15mg、蜂王浆5g、谷胱甘肽0.12mg、维生素3mg(维生素A为0.1mg、维生素B1为0.1mg、维生素C为2mg、维生素E为0.8mg)、胶原蛋白肽25mg(羟脯胺酸10mg、脯氨酸10mg、甘氨酸5mg)、腺苷酸1.5mg、鸟嘌呤核苷酸1.5mg、尿嘧啶核苷酸1.5mg、胸腺嘧啶核苷酸1.5mg、胞苷酸1.5mg、氯化钙0.5mg、壳聚糖0.3mg、明胶5mg、甘油10mg、辅酶2mg、氯化钾0.4mg，硫酸镁0.6mg、氧化锌0.5mg和蒸馏水50ml混合而成。
实施例7：一种促进皮肤组织再生的药膏，它由富血小板血浆2ml(抽取患者的静脉血25ml，经两次离心后得到富血小板血浆，其血小板浓度为1.25×1015个/L)、凝血酶0.09mg、蜂王浆3g、谷胱甘肽0.09mg、维生素A为0.3mg、维生素C为0.7mg、胶原蛋白肽12mg(甘氨酸12mg)、胞苷酸3mg、氯化钙0.153mg、壳聚糖0.18mg、明胶2.5mg、甘油3.5mg、烟酰胺0.8mg、氯化钾0.25mg，硫酸镁0.25mg、氧化锌0.15mg和蒸馏水30ml混合而成。
为得出实施例2-7中促进皮肤组织再生的药膏疗效，发明人也对其进行了探究，用药对象为2017年3-4月于我院就诊的疤痕6位患者，每个实施例中的药用于其中一位患者，截止目前，其疗效情况见表4；
表4疤痕患者用药后的疗效
Figure BDA0001312324150000081
由表4可知，采用本发明实施例2-7中促进皮肤组织再生的药膏对6位患者进行辅助治疗后，用药2-3天后患者无疼痛感，用药后达到有效疗效的时间为6-27天，且总有效率为100％，另外有2位患者还处于观察期。
相比于现有治疗凹陷性疤痕的药物，本发明所述促进皮肤组织再生的药膏不仅对深度(5-15mm)凹陷性疤痕有显著的疗效，在用药过程中不会出现红肿、瘙痒的情况，还能够快速促进皮肤组织再生，缩短治疗周期。
此外，发明人经研究发现，取医用小白鼠体内的富血小板血浆，按照本发明配比配制成注射试剂，将其注射至医用小白鼠体内后，能够释放多种生长因子(如血小板源性生长因子、转化生长因子)，并能促进小白鼠的血液合成。
上述实施例仅是对本发明作出的进一步说明，不能理解为对本发明保护范围的限制，本领域技术人员可以根据本发明的内容作出一些非本质的改进和调整(例如按照本发明方式同步扩大或缩小原料用量)。本发明中所述凝血酶从Sigma公司购得，所述蜂王浆为市售正品黑蜂王浆，所述谷胱甘肽从Solarbio公司购得，所述维生素从Solarbio公司购得，所述胶原蛋白肽从Sigma公司购得，所述核苷酸从Sigma公司购得，所述氯化钙从国药集团公司购得，所述壳聚糖从国药集团公司购得，所述明胶从国药集团公司购得，所述甘油从国药集团公司购得，所述辅酶从Sigma公司购得。

Claims (2)

1.一种促进皮肤组织再生的药膏，其特征在于：它由富血小板血浆2ml、凝血酶0.1mg、蜂王浆3g、谷胱甘肽0.08mg、0.025mg维生素A、0.025mg维生素B1、1mg维生素C、0.25mg维生素E、羟脯胺酸5mg、脯氨酸5mg、甘氨酸2mg、尿嘧啶核苷酸4mg、壳聚糖0.15mg、明胶3mg、甘油4mg、氯化钾0.25mg，硫酸镁0.2mg、氧化锌0.15mg和蒸馏水25ml混合而成；其中，富血小板血浆是抽取患者的静脉血24ml，经两次离心后制得。
2.一种促进皮肤组织再生的药膏，其特征在于：它由富血小板血浆2ml、凝血酶0.09mg、蜂王浆3g、谷胱甘肽0.09mg、0.3mg维生素A、0.7mg维生素C、甘氨酸12mg、胞苷酸3mg、氯化钙0.153mg、壳聚糖0.18mg、明胶2.5mg、甘油3.5mg、烟酰胺0.8mg、氯化钾0.25mg，硫酸镁0.25mg、氧化锌0.15mg和蒸馏水30ml混合而成；其中，富血小板血浆是抽取患者的静脉血25ml，经两次离心后制得。
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