OBJECTIVEShenkang injection (SKI) has been widely used in China for many years for the treatment of kidney disease. The objective of this systematic review was to assess the efficacy of Shenkang injection for the treatment of acute kidney injury (AKI).METHODSA search was conducted across seven databases, encompassing data from the inception of each database through October 8^th, 2023. Randomized controlled trials comparing SKI-treated AKI patients with control subjects were extracted. The main outcome measure was serum creatinine (SCr) levels. Secondary outcomes included blood urea nitrogen (BUN), serum cystatin C (CysC), 24-h urine protein (24 h-Upro) levels, APACHE II score and adverse reactions.RESULTSThis meta-analysis included eleven studies, and the analysis indicated that, compared with the control group, SKI significantly decreased SCr [WMD = -23.31, 95% CI (-28.06, -18.57); p < 0.001]; BUN [WMD = -2.07, 95% CI (-2.56, -1.57); p < 0.001]; CysC [WMD = -0.55, 95% CI (-0.78, -0.32), p < 0.001]; 24-h urine protein [WMD = -0.43, 95% CI (-0.53, -0.34), p < 0.001]; and the APACHE II score [WMD = -3.07, 95% CI (-3.67, -2.48), p < 0.001]. There was no difference in adverse reactions between the SKI group and the control group [RR = 1.32, 95% CI (0.66, 2.63), p = 0.431].CONCLUSIONThe use of SKI in AKI patients may reduce SCr, BUN, CysC, 24-h Upro levels, and APACHE II scores in AKI patients. The incidence of adverse reactions did not differ from that in the control group. Additional rigorous clinical trials will be necessary in the future to thoroughly evaluate and establish the effectiveness of SKI in the treatment of AKI.

2024-02-22·Biological and Pharmaceutical Bulletin

Renal Metabolomics Study and Critical Pathway Validation of Shenkang Injection in the Treatment of Chronic Renal Failure

Article

作者: Xia, Jinlan ; Xie, Yan ; Zhou, Lin ; Cui, Rui ; Sun, Zhi ; Wang, Xiaohui ; Zhang, Yi

To reveal the mechanism of Shenkang injection (SKI) in the treatment of chronic renal failure, and verify the key pathway. In this work, an untargeted metabolomics approach was performed by LC-MS coupled with multivariate statistical analysis to provide new insights into therapeutic mechanism of SKI. Hematoxylin-eosin (H&E) Staining and Immunohistochemistry were used to evaluate the effects of drug treatment, Western blot was used to verify the critical pathway. Then, a total of 44 potential biomarkers of chronic renal failure (CRF) were identified and reversed regulation, including 2,8-dihydroxypurine, 5-methoxytryptophan, uric acid, acetylcarnitine, taurine, etc. Mainly concerned with arginine and proline metabolism, purine metabolism, histidine metabolism, etc. Pathological examination showed that the renal interstitium of SKI group was significantly improved, with fewer inflammatory cells and thinner vascular walls compared with the model group. Immunohistochemical results showed that the expression of α-smooth muscle actin (α-SMA) was decreased, and the expression of E-cadherin was increased in CRF model group, and the two indicators were reversed regulation in SKI injection, indicating that the degree of fibrosis was relieved. Critical signaling pathway phosphatidylinositol 3-kinase (PI3K)/protein kinase B (Akt) and nuclear factor-kappaB (NF-κB) protein expressions were significantly inhibited. This study was the first to employ metabolomics to elucidate the underlying mechanisms of SKI in chronic renal failure. The results would provide some support for clinical application of traditional Chinese medicines in clinic.

2023-12-01·Biopharmaceutics & Drug Disposition

Pharmacokinetic–pharmacodynamic modeling of the active components of Shenkang injection in rats with chronic renal failure and its protective effect on damaged renal cells

Article

作者: Fu, Zhihui ; Zhou, Lin ; Xue, Lianping ; Xia, Jinlan ; Jia, Qingquan ; Wang, Xiaohui ; Sun, Zhi ; Zhang, Liyuan

AbstractThe study aimed to explore the pharmacokinetic and pharmacodynamic alterations of the active components of Shenkang injection (i.e. hydroxy saffron yellow pigment A [HSYA], tanshinol, rheum emodin, and astragaloside IV) in rats with chronic renal failure (CRF), and establish a pharmacokinetic–pharmacodynamic model (PK‐PD model) in order to provide a scientific and theoretical basis for the rational clinical use of Shenkang injection. Sprague–Dawley (SD) rats were randomly divided into a normal group, model group, and Shenkang injection group. A rat model of CRF was induced by adenine gavage and then followed by drug administration via tail vein injection. Orbital blood was collected at different timepoints and the blood concentrations of the four active components were measured by UHPLC‐Q‐Orbitrap HRMS. Serum levels of creatinine (Scr), urea nitrogen (BUN), and uric acid (UA) were determined using an automatic biochemical analyzer. A PK‐PD model was established, and DAS 3.2.6 software was used for model fitting as well as statistical analysis. TGF‐β1 was utilized to induce normal rat kidney cells to construct a renal fibrosis model to investigate the protective effect of the pharmacological components on renal fibrosis. The pharmacokinetic analysis of hydroxy saffron yellow pigment A, tanshinol, rheum emodin, and astragaloside IV based on UHPLC‐Q‐Orbitrap HRMS was stable. The linear regression equations for the four active components were as follows: Y = 0.031X + 0.0091 (R2 = 0.9986) for hydroxy saffron yellow pigment A, Y = 0.0389X + 0.164 (R2 = 0.9979) for tanshinol, Y = 0.0257X + 0.0146 (R2 = 0.9973) for rheum emodin, and Y = 0.0763X + 0.0139 (R2 = 0.9993) for astragaloside IV, which indicated good linear relationships. The methodological investigation was stable, with the interday and intraday precision RSD <10%. Meanwhile, the recoveries ranged between 90% and 120%, in accordance with the requirements for in vivo analysis of drugs. Compared with the model group, the levels of Scr, BUN, and UA were significantly decreased after 20 min in the Shenkang injection group (p < 0.01). The PK‐PD model showed that the four active components in the Shenkang injection group could fit well with the three effect measures (i.e. Scr, BUN, and UA), with the measured values similar to the predicted values. The cell model of renal fibrosis showed that the connective tissue growth factor and FN1 protein expression levels were significantly lower in the Shenkang injection group than those in the model group, and the cell fibrosis was improved. The established method for in vivo analysis of Shenkang injection was highly specific, with good separation of the components and simple operation. The total statistical moment could well integrate the pharmacokinetic parameters of the four active components. After treatment with Shenkang injection, all indexes in the administered group improved and showed significant inhibition of renal cell fibrosis in vitro. This study could provide scientific reference ideas for the clinical rational use of traditional Chinese medicine.

项与肾康相关的新闻（医药）

2024-11-09

·药筛

江苏5批省采，中药绝大部分独家，价格数据已就位！

昨天江苏公布五批省采文件，我已经整理好中药目录相关数据，关注药数包服务号，可同步查看。中药品种，有多个重磅品种，摩熵医药数据显示，肾康注射液销售规模最大，2023年江苏样本医院市场销售规模近8000万，鸦胆子油乳注射液5400万，尿毒清颗粒5000万、滋肾育胎丸4000多万，生血宝合剂也有3000多万。除鸦胆子油外，全是独家品种，外省的集采价和江苏挂网价，相差不大，这次省采的作用，就是一次价格调平。以下数数据截图：化药数据，同步整理中，关注药数包服务号，可随时查看。最后，提醒一下：江苏联盟集采微信分享群已建，欢迎企业和代理商入群，对接资源。加客服小狐微信，拉你入群！

带量采购

2024-11-08

·药筛

江苏5批省采，这次搞大了：人血白蛋白、中药大单品……

刚刚，江苏公布5批集采目录，75个西药，9个中药，很多重磅爆品，如：人血白蛋白、乙酰半胱氨酸、肾康注射液、四磨汤等。这次江苏动真格的了。我会持续更进，尽快跟新相关数据到药数包微信服务号。十批国采分享微信群已建，欢迎企业和代理商入群，对接资源，先到先得了。加客服小狐微信，拉你入群！

带量采购

2024-06-07

·药智网

中药注射剂，又行了

中药注射剂一直在争议中前行，尤其在2015年辅助用药概念兴起、2017年医保对中药注射剂增加限制、说明书修订以及实行集采后，中药注射剂增长压力倍增。 2020年3月，国家卫生健康委、国家中医药管理局发布《新型冠状病毒肺炎诊疗方案（试行第七版）》将8个中药注射剂纳入其中，叠加2022年医保对中药注射剂逐渐解限，2023年，中药注射剂一改颓势，实现明显增长。 2020年3月，国家卫生健康委等发布《新型冠状病毒肺炎诊疗方案（试行第七版）》将8个中药注射剂纳入其中，叠加2022版医保对中药注射剂逐渐解限，2023年，中药注射剂一改颓势，实现大幅增长。 01 品类：心脑血管类最大 2023年，中药注射剂终端销售超过500亿元。其中，心脑血管类最大（332亿元），占比超过6成（62%）。呼吸（100亿元）和抗肿瘤类（70亿元）次之，分别占19%、13%。上述三类占了中药注射剂总销售额的94%。泌尿（15亿元）、消化（14亿元）、妇科（3.1亿元）和骨骼肌肉类（1.5亿元）分别占2.8%、2.7%、0.6%和0.3%。 2023年，所有大类中药注射剂都实现了正向增长。其中，增长最快的是呼吸类（+42%）。心脑血管（+12%）和消化类（+7%）次之。其后依次是抗肿瘤（+5%）、骨骼肌肉（+4.5%）、泌尿（+3.5%）和妇科（+3%）。（详见图一） 02 品种（销售额）一、销售额：注射用血塞通（冻干）最大 2023年，终端销售额＞10亿元的中药注射剂有20个。其中，＞40亿元的有1个，即注射用血塞通（冻干），珍宝岛和昆药各占6成和4成。 30～40亿元的有1个，即喜炎平注射液； 20～30亿元的有3个，即银杏叶提取物注射液、丹红注射液、注射用血栓通(冻干)； 15～20亿元的有5个，即舒血宁注射液、香丹注射液、丹参注射液、痰热清注射液、康莱特注射液； 11～15亿元的有7个，即肾康注射液、舒肝宁注射液、醒脑静注射液、注射用炎琥宁、热毒宁注射液、参麦注射液、血必净注射液。（详见图二）二、增速：丹参注射液最快如图二所示，2023年，在终端销售额Top20中药注射剂中，除醒脑静注射液（-17%）、参麦注射液（-6%）、银杏叶提取物注射液（-2%）等3个销售额下降外，其余17个中药注射剂都实现了正向增长。其中，增长最快的是丹参注射液。增速＞1倍的有1个，即丹参注射液，增长了1.5倍；增速50%～1倍的有3个，即香丹注射液（+58%）、丹参酮IIA磺酸钠注射液（+57%）、喜炎平注射液（+56%）；增速30%～50%的有4个，即康莱特注射液（+46%）、注射用血塞通(冻干，+37%）、注射用炎琥宁（+36%）、痰热清注射液（+35%）；增速20%～30%的有3个，即丹红注射液（+29%）、冠心宁注射液（+26.3%）、热毒宁注射液（+25.8%）；增速10%～20%的有3个，即银杏二萜内酯葡胺注射液（+17%）、血必净注射液（+13%）、舒血宁注射液（+12%）。 03 品种（销售量）：热毒宁增长最快再看下销售数量（按各公司年报数据）。 2023年，销售量最大的中药注射剂是珍宝岛药业的注射用炎琥宁（1.8亿支），其次是振东制药的以复方苦参注射液为主的几个中药注射剂（1.5亿支）。在销售数量Top20中，除天麻素注射液（-5%）和艾迪注射液（-1%）下降外，其余18个中药注射剂的销售数量都实现了正向增长。其中，销售数量增长最快的是康缘的热毒宁（+91%）。其次是珍宝岛药业的注射用炎琥宁(+72%)和注射用血塞通（冻干，+60%）以及上海第一生化的丹参酮IIA磺酸钠注射液(+52%)，增长也都在50%以上。（详见图三） 04 企业一、销售额：康缘最大再看下中药注射剂主要企业情况。 2023年，10家主要中药注射剂企业的中药注射剂销售额都超过4亿元。其中，中药注射剂销售额最大的是康缘药业。＞20亿元的有1家，即康缘（22亿元）； 15～20亿元的有3家，即神威药业（18亿元）、振东制药（17亿元）和珍宝岛药业（16亿元）； 10～15亿元的有3家，即上海凯宝（14亿元）、中恒集团（12.2亿元）、昆药集团（11.6亿元）。（详见图四）二、增速：珍宝岛最快 2023年，10家主要中药注射剂企业的中药注射剂销售额都实现了正向增长，且增速都在10%以上。其中，增速最快的是珍宝岛药业。增速＞50%的有2家，即珍宝岛药业（+84%）、上海凯宝（+51%）；增速30～50%的有3家，即康缘药业（+49.7%）、丽珠集团（+35%）、中恒集团（+34%）；增速15～30%的有2家，即神威药业（+25%）、金陵药业（+20%）。 2023版国家医保目录对更多的中药注射剂解除了使用限制。 2023年12月18日，国家药监局宣布推动持有人加快开展中药注射剂上市后研究和评价工作。中药注射剂将驶入高质量发展轨道。注：以上图片来源赛柏蓝来源 | 赛柏蓝（药智网获取授权转载）撰稿 | 张自然博士责任编辑 | 八角声明：本文系药智网转载内容，图片、文字版权归原作者所有，转载目的在于传递更多信息，并不代表本平台观点。如涉及作品内容、版权和其它问题，请在本平台留言，我们将在第一时间删除。商务合作 | 王存星 19922864877（同微信）阅读原文，是受欢迎的文章哦

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