Palmatine

In the clinical diagnosis and treatment of nervous system, cardiovascular system and other systemic diseases, naturally derived alkaloids have gradually become a research hotspot due to their multi-target regulatory advantages, and palmatine is a representative isoquinoline alkaloid among them. As an effective active ingredient of commonly used traditional Chinese medicinal materials such as Coptis chinensis and Phellodendron chinense, its mechanism of action focuses on inhibiting acetylcholinesterase activity, regulating the release of inflammatory factors, and improving myocardial ischemia-reperfusion injury. Meanwhile, it has a significant inhibitory effect on a variety of pathogenic bacteria such as Staphylococcus aureus and Shigella dysenteriae. At the clinical level, palmatine is mainly used for the treatment of bacillary dysentery, enteritis, bronchitis and respiratory tract infections. Some studies have also confirmed its potential application value in neuroprotection and anti-arrhythmia. The applicable population covers patients with bacterial infectious diseases of all age groups, and the overall medication safety is good.

At present, the domestic API market of anti-infective natural drugs maintains a stable expansion trend. As a basic antibacterial alkaloid API, palmatine had a domestic market size of approximately 120 million yuan in 2023, with a compound annual growth rate of around 7.8% in the past three years. Due to the mature extraction process and sufficient supply of core production raw materials, the domestic market is dominated by generic drug enterprises, the industry concentration is relatively scattered, and the total market share of the top 3 enterprises is approximately 42%. After the implementation of the centralized procurement policy, the winning bid price of compound preparations containing palmatine decreased by approximately 36%, which further drives the demand for upstream APIs to concentrate on compliant production enterprises, and the market competitiveness of production capacity with traditional Chinese medicine traceability systems and qualified impurity control continues to improve.

There is no globally unified original research enterprise for palmatine. The first enterprise in China to realize industrialized production is Yunnan Plant Pharmaceutical Co., Ltd., whose marketed product is named "Palmatine Hydrochloride", and the core extraction process patent expired in 2012. At present, the main dosage form marketed in China is tablet, with the main specification of 100mg. Palmatine Hydrochloride Tablets have been included in the National Essential Medicines List, and are also included in the Reference Listed Drug Catalogue published by the NMPA. In terms of API registration, as of now, the CDE API registration platform has included 6 valid registration numbers for palmatine hydrochloride, among which 3 are in status A (approved for use in marketed preparations), and 12 domestic enterprises have obtained the production approvals for preparations containing palmatine. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full range of palmatine impurity reference standards, covering process impurities, degradation impurities and custom reference standard services. Most products are available from stock, and in-stock orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the various needs of API R&D, quality research and routine quality control.