Serious Concerns about Chinese Medicine Injection

 Introduction

    Past

        Traditional Chinese Medicine (TCM) injections (TCMIs) are preparations of herbal extracts formulated for injection. Compared with traditional forms such as pills, powders, and decoctions, TCMIs emerged relatively late. During the 1930s, TCMIs were developed in order to address the shortage of medical resources and the limited efficacy of traditional preparations. TCMIs are characterized by high bioavailability, definite therapeutic effects, and rapid onset of action, making them widely used in the clinical treatment of acute and severe diseases. 

    Now

        Currently, in China, TCMIs are regulated as traditional chinese medicine products because their approval numbers begin with "国药准字Z" (indicating a TCM drug), while those for chemical drugs begin with "国药准字H." Till July 6, 2022, data from the National Medical Products Administration shows that 872 approval numbers have been granted for 128 types of TCM injections produced by 196 manufacturing enterprises. Among the approved TCMIs, eight have been included in the Insurance system.

    controversy

        TCMIs have sparked numerous public controversies due to safety concerns and irrational use. Compared to their peak in 2016, their market size across all hospital terminals nationwide has experienced a steep decline.

        In 2006, the National Center for Adverse Drug Reaction Monitoring received a total of 5,488 reports of adverse reactions related to Yu Xing Cao （Houttuynia cordata, also known as fish mint）Injection, including 258 cases of serious adverse drug reactions and 44 deaths. 

        “They attempt to mimic modern medicine, but they refuse to test these medications under scientific strategy.” 

    Why people develop TCMIs at that time? （My personal opinion!!!!）

        At the time when TCMIs were first developed, there was a widespread misconception: people believed that the slow efficacy of TCM was mainly due to its "backward" route of administration—absorption through the digestive tract.

        Clearly, the concept of pharmacokinetics didn’t exist at that time 

        Moreover, injecting plant-based medicines into the vessel is not without precedent. As early as the 1950s, researchers successfully extracted the active compound ergometrine from the ergot plant.

         All these efforts aimed to expand the administration routes of TCM and enhance the bioavailability of its active components.

        However, the core issue lies in a critical missing step in the process of turning TCM into injectable formulations — the identification and standardization of the active ingredients.

        Studying the active components of TCM has become a popular research field in China in recent years. With advancements in technology, such as high-performance liquid chromatography (HPLC) and mass spectrometry, researchers are increasingly able to isolate, identify, and standardize the bioactive compounds in TCM. This not only helps in validating the efficacy of these medicines but also contributes to ensuring their safety and consistency in clinical use.

(The flowchart of hypaconitine’s metabolites in rat liver microsomes by UPLC-MS/MS)