Chongqing Liyang Pharmaceutical Development Co., Ltd.
The Difference Between Traditional Chinese Medicine Preparations and Patent Chinese Medicines
Release Time:
2025-01-09 00:00
Source:
The essential differences between traditional Chinese medicine preparations and proprietary Chinese medicines lie in their preparation methods, scope of application, and approval standards. Traditional Chinese medicine preparations refer to various dosage forms made from Chinese medicinal materials (such as decoctions, pills, etc.), including personalized medications temporarily compounded by hospitals or pharmacies based on prescriptions. In contrast, proprietary Chinese medicines are finished products with fixed formulations and standardized specifications that have been approved for market release by the national authorities, making them readily available for direct purchase and use.
Source of Prescription
Traditional Chinese medicine preparations are predominantly individualized prescriptions formulated by physicians based on patients' specific conditions, requiring either temporary preparation (such as decocting herbal soups) or being fixed formulations produced internally within hospitals (e.g., hospital-developed standardized formulas).
Traditional Chinese medicine: It features a standardized formulation, has been approved by the national drug regulatory authority, and undergoes a standardized production process, eliminating the need for on-the-spot preparation.
How to Use
Traditional Chinese medicine preparations are commonly used for acute conditions or complex constitutional adjustments, requiring targeted use after diagnosis by a physician. Some hospital-developed formulations must be purchased under the guidance of a healthcare professional.
Traditional Chinese Medicines: Clearly indicated for specific conditions, with detailed package inserts. Some are available over-the-counter (OTC) and can be purchased independently; however, prescription-only traditional medicines—particularly those containing toxic ingredients—must be used under the guidance of a healthcare professional.
Production and Approval
Traditional Chinese medicine preparations: Hospital formulations require provincial drug regulatory filing and are exclusively for use within this institution; temporary compounding formulations lack unified standards.
Traditional Chinese medicines require completion of approval processes, including pharmacological, toxicological, and clinical trials. They must meet national standards for quality, safety, and efficacy.
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Intermediate, a material generated during the active pharmaceutical ingredient (API) manufacturing process that requires further molecular transformation or purification before it can be finalized as an API.
What are the differences between active pharmaceutical ingredients and finished dosage forms?
Active pharmaceutical ingredients (APIs) are the active components of drugs and cannot be used directly for clinical treatment. Pharmaceutical preparations, on the other hand, are drug formulations made by processing APIs with excipients, ready for direct use by patients.
The method of decocting traditional Chinese medicine
First, pour the medicinal herbs into the decoction vessel and add cool water until the herbs are fully submerged. Allow them to soak for about an hour, enabling the traditional Chinese medicine to absorb moisture thoroughly and return to a fresh state. This process ensures that the active ingredients can be released more quickly and efficiently.
What are the common types of liquid formulations?
This is a common type of liquid formulation, referring to a homogeneous system in which the drug is uniformly dispersed in the solvent in molecular or ionic form.
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