As a strategic emerging industry related to national economy, people's livelihood, economic development, and national security, biomedicine is a typical innovation driven industry and an important battlefield for accelerating the formation of new quality productivity. Shanghai Huanghai Pharmaceutical, a subsidiary of Baiyang Pharmaceutical, adheres to the principle of "international quality and health care". With the confidence of daring to think, daring to act, and daring to be the first, it promotes the development of various strategic and innovative traditional Chinese medicines that fill the international clinical gap. In recent years, driven by innovation, the company has comprehensively improved its production equipment, innovated digital and automated production modes, and greatly improved production efficiency. The company has demonstrated significant advantages in modern production technology, advanced production equipment, and quality standards improvement in the field of traditional Chinese medicine.

The company applies modern production technology, adopts advanced extraction and formulation technology, pharmaceutical equipment, production process control, and computer system integration to achieve digital, automated, and green energy-saving production.

（The newly completed digital traditional Chinese medicine extraction workshop of the company has been successfully put into operation）

（Interior of Digital Traditional Chinese Medicine Extraction Workshop）

（Extract workshop control room）

The newly put into operation digital traditional Chinese medicine extraction workshop is a production line that applies industry-leading pharmaceutical equipment and self-control technology to build high standard, high-quality, green and energy-saving pharmaceuticals. It realizes the automation of the entire process of extracting, separating, concentrating, purifying and drying traditional Chinese medicine, which can minimize human pollution and errors.

How to use new quality productivity to break through the traditional economic growth mode, achieve standardization of traditional Chinese medicine production, and ensure uniform product quality between batches is a proposition that must be solved. The company's extraction workshop adopts imported concentration equipment for single/double effect concentration, which has lower concentration temperature, more stable control, improved quality stability, reduced energy consumption, and increased production efficiency. The spray drying equipment comes from the leading Sino Japanese joint venture in the industry. Its scientific design makes the equipment run more stably. The production process adopts DCS automation control system to achieve automatic control of the entire process from extraction, concentration to drying in traditional Chinese medicine extraction production. It fully combines digital, networked, and intelligent technology applications, leading the new development of informationization in the traditional Chinese medicine industry.

（Extraction workshop automatic control system）

The company's formulation workshop has introduced the German Glatt fluidized bed one-step granulation equipment, which fully controls the entire granulation process and further improves the uniformity and stability of the particles. The newly put into use tablet presses and capsule canning machines this year have greatly increased production capacity. In the packaging process, the company adopts automated packaging equipment and introduces automatic weighing and machine vision recognition technology, which has the function of identifying, detecting and removing (weight reduction removal, white bottle removal, empty box removal), reducing errors in the packaging process; The external packaging process also introduces automated equipment such as robotic arm palletizing, which can quickly and neatly arrange the boxes, reduce unnecessary manual operations, improve the continuity and stability of the packaging process, and significantly increase packaging speed; After the finished products are packaged, they are automatically transported to the warehouse by AGV carts, making logistics transportation faster, more accurate, and more automated.

The application of these automated packaging equipment and technologies not only improves packaging efficiency, but also ensures the quality and compliance of drug packaging, meeting the market's demand for efficient and safe drug packaging.

（Preparation workshop packaging line）

（Stacking machine robotic arm）

In recent years, while improving equipment and processes, the company has conducted research on key issues affecting the quality of traditional Chinese medicine, including safety and internal quality control technology methods, whole process standardization systems, databases, and support platforms. In accordance with NMPA and FDA requirements, the company has conducted research on DNA identification of raw materials, screening of active ingredients, biological activity testing, quantitative standards for multiple components, fingerprint/feature maps, etc., and has formed a quality control standard for Fuzheng Huayu based on traditional Chinese medicine fingerprint/feature maps, biological activity detection, and quantification of 10 components. Using ultra-high performance liquid chromatography high-resolution mass spectrometry (UPLC-Q-TOF/MS), more than 80 compounds were identified from Fuzheng Huayu and the source of medicinal materials was determined. Qualitative and quantitative analysis was conducted on the structure and quantity of blood components and metabolites of Fuzheng Huayu Formula. Dozens of components were identified from plasma samples of humans, Beagle dogs, and rats, and representative components were selected for pharmacokinetic studies to explore the main blood components and tissue distribution characteristics of Fuzheng Huayu Formula in different species of animals. The comprehensive improvement research on the quality standards of traditional Chinese medicine for strengthening the body and removing blood stasis has led to an overall improvement and qualitative leap in the quality of strengthening the body and removing blood stasis products after the introduction of new equipment in the extraction and preparation workshops, effectively ensuring the safety and effectiveness of the drugs.

The upgrade of production equipment at Shanghai Huanghai Pharmaceutical is helping to create a new chapter in the development of the enterprise; The research on improving the quality standards of traditional Chinese medicine provides a solid guarantee for promoting high-quality development of the industry. In recent years, the company's sales and profits have been increasing year by year. The company's product advantages, technological advantages, and quality advantages have exploded with strong momentum and are unstoppable. In the future, the company will continue to build a solid quality "levee" and pursue "charming quality". With a standardized and regulated management model, it will continuously improve and implement the strategy of building a strong quality country. It will persist and create a benchmark factory for intelligent manufacturing in the traditional Chinese medicine industry with new quality productivity.

As the transformation base of modern scientific research achievements of Baiyang Pharmaceutical, Huanghai Pharmaceutical has built a modern compound Chinese medicine digital production workshop facing the international market according to FDA quality control standards, based on the concept of modern Chinese medicine R&D and production of "disease can be diagnosed, quality can be controlled, and efficacy can be verified". Its R&D and production of reverse liver fibrosis products, strengthening the body and removing blood stasis, is the only traditional Chinese patent medicines and simple preparations in the field of liver disease that has completed Phase II clinical trials in the United States. In the future, the company will continue to upgrade from "manufacturing" to "intelligent manufacturing", constantly improving the level of product technology and competitive advantage; At the same time, we will continue to focus on market and clinical needs, actively collaborate with national research institutions on technology exchange and cooperation based on independent research and development, jointly explore source innovation, develop and produce more innovative drugs that can truly optimize medical scenarios and have Chinese original independent intellectual property rights, and continue to provide international quality drugs to global consumers to better serve human health!