Tetramethylpyrazine

Ischemic cerebrovascular disease is the leading cause of death and disability among adults in China. In clinical treatment, improving microcirculation and inhibiting platelet aggregation are among the core intervention directions. Ligustrazine, an effective alkaloid extracted from *Ligusticum chuanxiong Hort.* (a plant of the Umbelliferae family), is a cerebral vasodilator drug. It can inhibit phosphodiesterase activity, reduce blood viscosity, dilate small arteries, and improve cerebral circulation and myocardial blood supply. It is mainly used clinically for the treatment of ischemic stroke, coronary heart disease, angiitis and other diseases, covering the middle-aged and elderly population with high incidence of cardiovascular and cerebrovascular diseases, and is a commonly used drug in the field of integrated traditional Chinese and Western medicine treatment.

The prevalence of cardiovascular and cerebrovascular diseases in China continues to rise, with the total number of patients exceeding 330 million, driving the continuous expansion of the market size of ligustrazine-related preparations. The overall domestic market size in 2023 was approximately RMB 1.8 billion, with a compound annual growth rate of 7.2% in the recent five years. The current market is dominated by generic drugs, with manufacturers concentrated in Sichuan, Jiangsu and other provinces. Among them, leading enterprises in the API supply side account for nearly 60% of the market share. The preparation side has been included in the provincial centralized procurement catalogs of multiple provinces, with an average price reduction of about 45% for winning bids, and the penetration rate in the primary market is continuously increasing.

The original research enterprise of ligustrazine is Tsumura Pharmaceutical of Japan, with the original brand name Tetramethylpyrazine, and its core compound patent expired globally in 1997. At present, the main dosage forms approved in China include ligustrazine hydrochloride injection, ligustrazine phosphate oral preparations, etc. Common specifications cover 2ml:40mg injection, 50mg oral tablets, etc. A number of preparations have been included in the *List of Chemical Drugs* of the National Medical Products Administration as reference preparations. In terms of domestic API registration, 12 valid registration numbers of ligustrazine API have been published on the CDE platform, among which 7 are in A status, and the corresponding preparation products have all been approved for marketing in China. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for ligustrazine API. Most products are available from stock. Orders for in-stock products 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 provide stable reference standard support for pharmaceutical enterprises' quality research and consistency evaluation work.