“Recently, the "Yiguanjian Granules" developed by Shanghai Kaibao Pharmaceutical Co., Ltd. were approved by the National Medical Products Administration for marketing, becoming the first 3.1-type new Chinese medicine in Shanghai derived from an ancient classical prescription. In 2018, the National Administration of Traditional Chinese Medicine, in conjunction with the National Medical Products Administration, announced the "Directory of Ancient Classical Prescriptions (First Batch)", which included a total of 100 prescriptions, with "Yiguanjian" being listed among them. After more than 6 years of research and development, this classic prescription has regained new vitality and been transformed into a modern preparation with stable quality, good safety, and convenient administration.

In recent years, the National Administration of Traditional Chinese Medicine has organized and promoted the research work on the key information verification of ancient classical prescriptions, and jointly with the National Medical Products Administration, announced three batches of the "Directory of Ancient Classical Prescriptions", accelerating the listing of traditional Chinese medicine compound preparations derived from ancient classical prescriptions to better exert the characteristic advantages of traditional Chinese medicine and meet the medication needs of the people.

Although these prescriptions have long been documented in literature, there were problems with non-standard usage in the past. In 2020, the National Medical Products Review Center released the "Principles for the Verification of Key Information of Ancient Classical Prescriptions" and the "Key Information Table of Ancient Classical Prescriptions (7 Prescriptions)", clarifying the modern corresponding key information such as the conversion dosage of medicinal materials in ancient and modern times, usage and dosage, and indications for the treatment of 7 prescriptions including "Yiguanjian", providing a basis for the research on the pharmaceutic properties of these compound preparations.

Under the guidance of national policies and authoritative information, Shanghai Kaibao is currently researching more than ten ancient classical prescription projects, among which the first to be initiated is "Yiguanjian". "The advantage disease types treated by traditional Chinese medicine are chronic diseases, frequently-occurring diseases, geriatric diseases, as well as gynecological and pediatric diseases. According to this screening criterion, combined with the company's pipeline advantages and resource assessment results, we decided to develop Yiguanjian first," said Xue Dongsheng, the technical director of Shanghai Kaibao.

This prescription originated from the book "Medical Prescriptions and Measures" written by the famous doctor Qian Minjie in the late Qing Dynasty. It is recorded in the book that "Yiguanjian (Liuzhou) is mainly used for treating insufficient liver blood, epigastric pain, and hypochondriac pain". Its prescription is composed of rehmannia, angelica, wolfberry, and other ingredients, with the efficacy of nourishing yin and soothing the liver, and is used for the syndrome of insufficient liver yin and blood dryness and qi depression. Through the synergistic effect of various Chinese medicinal materials, it can effectively regulate liver and stomach functions, nourish yin and moisten dryness, and has therapeutic effects on a series of symptoms caused by hyperactivity of fire due to yin deficiency and disharmony between the liver and stomach. It can be used to treat patients with chronic hepatitis, chronic gastritis, gastric and duodenal ulcers, intercostal neuralgia, neurosis, and other conditions of yin deficiency and liver depression.

Fingerprint chromatogram and other technologies ensure the stability of drug quality

How to transform this ancient classical prescription into a modern new drug? Since the project was initiated in 2017, the R & D team has carried out a series of studies such as literature research, medicinal material research, processing of prepared slices of Chinese crude drugs, standard decoction, and modern preparations, and established a quality standard system. "We use fingerprint chromatogram technology for the whole process quality control, and this technology is applied in the detection from medicinal materials to prepared slices and then to preparations," Xue Dongsheng introduced. Fingerprint chromatogram is suitable for the detection of complex substances such as traditional Chinese medicine, and through modern scientific and technological means, chromatograms or spectrograms marking the chemical characteristics of complex substances can be obtained. They are like human fingerprints, showing a one-to-one correspondence relationship with the substances to be detected.

Based on the collected data of multiple batches of samples, the R & D team has drawn its own standard fingerprint chromatograms for each type of medicinal material, semi-finished product, and finished product through computer modeling. These chromatograms are the quality standards and can be used for the detection and comparison of samples. Only when the similarity between the fingerprint chromatogram of the sample and the standard fingerprint chromatogram exceeds 90% can it pass the detection.

In terms of the source of medicinal materials, Shanghai Kaibao uses detection technologies such as fingerprint chromatogram to compare the medicinal materials from different origins and select high-quality genuine regional medicinal materials. In terms of safety, the R & D team has completed toxicological experiments on mice and rats as required by the National Medical Products Administration to ensure that "Yiguanjian" is safe for the human body. In terms of production, the company has adopted extraction, concentration, drying, preparation equipment, and a digital production automatic control system to establish a whole process quality control system from medicinal materials to prepared slices and then to preparations.

After six years of refinement, the "Yiguanjian Granules" have gone through the process from project initiation and research to approval for marketing, opening up the path for Shanghai enterprises to participate in the inheritance and innovation of ancient classical prescriptions. "We will use science and technology to promote the modernization process of traditional Chinese medicine, contribute to the development of the Shanghai biomedicine industry, and also provide higher-quality traditional Chinese medicine compound preparations for the majority of patients," Xue Dongsheng said.”

Source: https://finance.eastmoney.com/a/202501263308320429.html