1 Introduction

Compound Purple Mussel Capsules are a new health product, mainly composed of a marine organism called Perna canaliculus from New Zealand. This type of berry contains many beneficial ingredients, such as omega-3 polyunsaturated fatty acids, mucopolysaccharides, and peptides (Sukumaran et al., 2010). These ingredients are beneficial to the body, such as lowering blood lipids, anti-inflammatory, and antioxidant properties. This capsule may be helpful for diseases such as hyperlipidemia, cardiovascular problems, and chronic inflammation. People are increasingly concerned about natural, safe, and effective treatment methods. Compound Purple Mussel Capsules perfectly meet this demand and are also in line with current health concepts (Saltzman et al., 2017).

To make the capsule effective, its functional components must remain stable. If there are changes in temperature, humidity, or light exposure, or improper storage conditions, these active ingredients may be destroyed and their efficacy may decrease (Eason et al., 2018). Maintaining the stability of ingredients is not only to ensure drug efficacy and safety, but also to extend the shelf life of the product, making consumers more at ease. In the fiercely competitive pharmaceutical and health product market, a product with stable ingredients and guaranteed quality will have more advantages, be easier to win users, enhance brand image, and occupy more market share (Taylor et al., 2023).

This study aims to establish a set of methods to make the active ingredients of compound purple oyster capsules more stable, and also establish a complete quality management system. Research on various factors that affect ingredient stability shows that trying new technologies such as microencapsulation and nanotechnology can help improve product stability. Standard quality control processes will also be developed to ensure that each batch of products is the same, traceable, and compliant with regulations. This study will also provide reference for future large-scale production and industrialization, and be helpful for the long-term development of health food and medicine fields.

2 Functional Components and Pharmacological Effects of Compound Purple Yibei Capsules

2.1 Main functional components and lipid-lowering and anti-inflammatory mechanisms of purple mussel extract

There are three main active ingredients in the extract of purple mussels: omega-3 polyunsaturated fatty acids (PUFAs), mucopolysaccharides (GAGs), and some bioactive small molecule proteins. For example, EPA and DHA, two types of omega-3 fatty acids, can regulate fat metabolism, reduce triglyceride synthesis in the body, and increase good cholesterol (HDL-C) (Shei et al., 2018). These fatty acids can also inhibit the inflammatory pathways of COX and LOX, reducing inflammatory substances such as prostaglandins and leukotrienes.

GAGs are beneficial for joints and can also reduce chronic inflammation in the body. There are also some small molecule active proteins that can clear free radicals in the body, improve vascular function, and have a protective effect on the cardiovascular system (Alghamdi et al., 2021).

2.2 Synergistic effects and mechanisms of action of compound ingredients

If the extract of purple mussels is used together with other ingredients such as antioxidants, vitamins, or plant extracts, they can complement each other. After adding curcumin or quercetin, they can act together on signaling pathways such as NF-κB or MAPK, enhancing anti-inflammatory effects and making omega-3 fatty acids more easily absorbed and utilized. Adding vitamin D or E can help regulate fat metabolism and enhance antioxidant capacity, providing dual protection for the body. These combinations together improve blood lipids, reduce inflammation, enhance overall biological activity and stability (Wakimoto et al., 2011).

2.3 Current Status of Stability of Functional Components in Compound Preparations

Although the effect of compound purple oyster capsules is good, there are also some problems, the most important of which is that the ingredients are not very stable. Substances like omega-3 fatty acids are easily oxidized and can deteriorate over time, affecting therapeutic efficacy and even potentially causing side effects. GAGs and active proteins may also degrade in high temperature or humid environments (Lee et al., 2007).

When various components in a capsule are mixed together, they may react with each other or affect each other's stability and activity. The current research suggests that in order to make these ingredients more stable, the storage temperature and humidity can be controlled, embedding techniques can be used, or suitable excipients can be selected to be used in combination (Emelyanov et al., 2002).

3 factors affecting the stability of functional components

3.1 Effects of Temperature, Humidity, and Light on the Stability of Key Components in Purple Mussel Capsules

The key components in Ziyibei capsules, such as omega-3 polyunsaturated fatty acids (PUFAs), glycosaminoglycans (GAGs), and some active peptides, are highly sensitive to the environment. When the temperature is high, omega-3 fatty acids are more easily oxidized, which not only changes their taste but also loses their activity. When the humidity is too high, GAGs and peptides are easily decomposed by water, their structure deteriorates, and their effectiveness weakens. Light, especially ultraviolet radiation, can also damage these components. If the storage environment is kept at low temperature, low humidity, and protected from light, the stability time of these components can be significantly prolonged (Ericson and Ragg, 2021).

3.2 Regulation of stability by formulation process

The stability of these functional components also depends on the processing method. For example, using supercritical CO₂ technology for extraction can reduce the damage of heat and oxygen to the components, and better protect the effects of omega-3 and active peptides. Freeze drying is more effective in reducing moisture and making ingredients more stable than traditional heat drying (Chandruvelan et al., 2012). If too much air is introduced or heat is generated during the mixing process, the components will also be destroyed. These processes are adjusted to protect the integrity of the ingredients (Figure 1) (English et al., 2023).

Figure 1 Preparation encapsulation technology can be divided into three categories: (1) physical-mechanical methods, (2) chemical methods, and (3) physicochemical methods (Adopted from English et al., 2023)

3.3 The impact of packaging and storage conditions on the degradation of functional components

The packaging method and storage conditions are also important. If the packaging is not oxygen sealed, omega-3 is easily oxidized. If the packaging cannot prevent moisture, GAGs and peptides are also prone to decomposition due to moisture (Gale et al., 2016). Vacuum or nitrogen filled packaging can reduce oxygen contact, while aluminum foil or special coating materials can prevent moisture from entering. Refrigeration or temperature controlled storage methods can also slow down the degradation rate of ingredients. Some packaging also includes desiccants and UV resistant materials to better protect the product, maintain quality and effectiveness (Juliano et al., 2016).

4 Quality Control System of Compound Purple Yibei Capsules

4.1 Selection and establishment of key quality control indicators

The first step in establishing a quality control system for compound purple oyster capsules is to identify key indicators that can represent the ingredients and effects. These indicators mainly include the content of omega-3 polyunsaturated fatty acids (PUFAs), glycosaminoglycans (GAGs), and active peptides (Chen, 2024). PUFA will oxidize, and the peroxide value and anisidine value can be used to determine its freshness. The structural integrity of GAGs and the normality of peptide chains can be checked by spectroscopic or chromatographic methods. These indicators ensure that the quality of each batch of products is consistent, meets regulatory requirements, and ensures effectiveness and safety (Young et al., 2011).

4.2 Application of multi component analysis technology in quality monitoring of functional components

There are currently various analytical methods commonly used to detect the functional components in Ziyibei capsules. High performance liquid chromatography (HPLC) and liquid chromatography-mass spectrometry (LC-MS) can accurately measure the specific contents of PUFA, GAG, and active peptides (Mani and Lawson, 2006). Fourier transform infrared spectroscopy (FTIR) and nuclear magnetic resonance (NMR) can reveal whether the molecular structure has been disrupted and also reflect whether oxidation has occurred. The real-time PCR method can also detect whether there is contamination such as microbial DNA. These techniques can detect problems early, with high detection sensitivity and reliable results (Shavandi et al., 2015).

4.3 The role of standardized quality control system in product consistency and traceability

A standardized quality control system can make the entire process of product procurement from raw materials to packaging more consistent and traceable. Each step is executed according to standard operating procedures (SOPs) to stabilize product quality. With digital tools such as blockchain and QR codes, information such as where raw materials come from, how they are processed, and which batch of products are available can be viewed at any time (Zaborowska et al., 2021). Regular inspections and obtaining certifications can also increase consumers' trust. The system meets regulatory requirements and can also enhance the market competitiveness of the product (Tuckey et al., 2013).

5 Strategies for Enhancing the Stability of Functional Components

5.1 Application of microcapsulation and nanotechnology in functional component protection

In order to make the active ingredients in compound purple oyster capsules more stable, microencapsulation and nanotechnology can be used. Microcapsulation is the process of encapsulating active substances such as omega-3 fatty acids and glycosaminoglycans (GAGs) in a protective film, which can be made of materials such as alginate or chitosan. This can prevent the influence of air, water vapor, and light, and the ingredients are not easily spoiled, while also maintaining their activity (English et al., 2023).

Nanotechnology, such as lipid nanoparticles and nanoemulsions, can also help stabilize these components. Nanostructured materials increase the body's absorption rate of them, making it easier for components to function and less susceptible to external environmental influences (Ye et al., 2018).

5.2 The promoting effect of auxiliary material optimization on stability

The auxiliary materials in the formula are also important for maintaining the stability of the ingredients. For example, adding antioxidants such as vitamin E or ascorbate palmitate can reduce the oxidation problem of omega-3 fatty acids. Glycerol and sorbitol are common moisturizers that can help maintain appropriate humidity.

Some buffering agents and stabilizers, such as citrate and phosphate salts, can maintain a suitable pH value, which is helpful in protecting the structure of glycosaminoglycans. If these excipients are well matched, they can make the capsule more stable, safe, and effective (Cui et al., 2023).

5.3 The role of packaging material selection and storage condition optimization in extending product shelf life

Packaging materials and storage methods are also crucial for products to last longer. Packaging materials such as aluminum foil and multi-layer plastic film can effectively block oxygen, water vapor, and light. Vacuum packaging or the addition of inert gas can further reduce the risk of oxidation (Pateiro et al., 2021).

When stored, it is best to keep the temperature at 15 to 25 C and the relative humidity at no more than 50% to prevent the components from being destroyed. Now some intelligent packaging can also add desiccant or oxygen absorber, which can provide an additional layer of protection, make the product more stable, and also extend the shelf life (Hosseini and Jafari, 2020).

6 Industrialization and Promotion of Compound Purple Mussel Capsules

6.1 Industrialization potential of extraction, analysis and processing of purple mussels

The extraction technology of purple mussels has great development opportunities in the pharmaceutical and health food industries. Chronic diseases such as cardiovascular disease and arthritis are becoming increasingly common, and people's demand for lipid-lowering and anti-inflammatory products is also increasing (Wang, 2024). The extract of purple mussels has special biological activity, and when used to make capsules, it can be used as a natural medicine. By optimizing the extraction and analysis methods, the ingredients can be made purer, the effects more stable, and it is also beneficial for controlling product quality.

If large-scale extraction and precise analysis techniques can be used in combination, it can significantly increase the profit of the product (Figure 2). According to predictions, the global market for such products may grow by over 8% annually. North America, Europe, and Asia Pacific are the most promising markets (Kitundu et al., 2021).

Figure 2 Extraction and analytical processing of Perna canaliculus (Adopted from Ericson et al., 2024)

6.2 Support of quality control system for large scale production

A comprehensive quality control system is crucial for the large-scale production of capsules. By detecting key indicators such as the content and stability of active ingredients, it can be ensured that the quality of each batch of products is consistent. The commonly used high-performance liquid chromatography (HPLC) and multi-component analysis techniques can accurately detect and analyze these components (Ren et al., 2019). Establishing a traceability system during the production process can make the entire process more transparent and easier to meet international standards, enhancing users' trust in the product. If the product is stable and of high quality, it is also easier to pass the review and enter the market smoothly (Ericson et al., 2024).

6.3 Challenges and solutions in promotion

Although compound purple oyster capsules have great market potential, they have also encountered some problems in promotion, such as high production costs, consumers' lack of understanding of the product, and some regulatory restrictions. Advanced technologies such as extraction techniques, microencapsulation processes, and quality control require significant initial investment, which may result in high product prices and affect market competitiveness.

To solve this problem, the government can provide some subsidies or tax incentives to alleviate the economic pressure on enterprises. You can also use science popularization activities to tell everyone that this capsule can not only lower blood lipids, but also has anti-inflammatory effects, so that more people can understand and be willing to try it. The regulatory requirements vary in different countries and regions, and companies need to actively communicate with regulatory agencies to obtain certification according to globally recognized standards. Enterprises can also collaborate with pharmaceutical distributors and use digital marketing methods to expand their influence, allowing more people to know and recognize this product (Cave et al., 2024).

7 The industrial application prospects of compound purple oyster capsules

7.1 Building a quality control system that complies with international standards to enhance market competitiveness

In order to enhance the market competitiveness of compound purple oyster capsules, it is necessary to align the quality control system with international standards, which can refer to the standards provided by the International Organization for Standardization (ISO) and the World Health Organization (WHO). We can use standardized component detection methods and real-time monitoring systems to facilitate traceability of the source. If the product can obtain some international certifications, it can not only reassure consumers, but also help to enter high-end markets such as North America, Europe, and Asia Pacific (Ajeeshkumar et al., 2021).

7.2 The wide application of functional component stability technology in industrial production

If the active ingredients in compound purple oyster capsules are to remain stable in large-scale factory production, some technical support is needed, such as microencapsulation technology, nanotechnology, and controlled release technology. These technologies are well integrated with industrial production processes, allowing key components to remain intact during manufacturing and extending shelf life. Even if temperature or humidity changes are encountered during transportation and storage, it can better cope with them. These methods have been applied in the production of compound purple oyster capsules and can also be extended to other products that require high stability, such as functional foods and drugs (Tadesse and Emire, 2020; Cayzer et al., 2012).

7.3 Market potential of compound purple oyster capsules in functional food and pharmaceutical fields

Compound Purple Mussel Capsules have the characteristics of natural and composite functions, which meet the health needs of current consumers. It can lower blood lipids and has anti-inflammatory effects, making it unique among similar products. In the field of functional foods, it can be promoted as a health supplement for cardiovascular and joint health. In terms of medicine, it can also serve as an auxiliary means to control hyperlipidemia and inflammatory diseases, and sometimes even replace some traditional therapies. Nowadays, everyone is paying attention to personalized medicine, and this capsule can meet the special health needs of some people with relatively few side effects. If combined with reasonable market promotion and excellent quality, it may occupy a place in the expanding health product market (Coulson et al., 2015).

8 Conclusive Comments

This study focuses on analyzing the factors that affect the stability of functional components in compound purple oyster capsules, including environmental conditions, formulation process, and packaging methods. The use of microcapsules and nanotechnology can better protect the activity of active ingredients. Choosing appropriate accessories and designing reasonable storage methods can greatly help maintain product quality. The study also established a quality control system that checks product consistency, traceability, and compliance with regulatory requirements through multi-component analysis, laying the foundation for stable and reliable industrial production in the future.

The research results contribute to ensuring the efficacy and safety of compound purple oyster capsules. The stability of the product is better, it is less likely to deteriorate, and it can also win the trust of consumers. Through this research, companies can produce high-quality products more smoothly, with longer shelf life and more stable effects. This has played a driving role in the application of the product in lipid-lowering and anti-inflammatory functional foods and drugs.

This study also provides reference for the production of other functional foods and drugs. The method used is not only applicable to this product, but can also be promoted to other products. Introducing a quality control system in the production process and aligning it with international standards not only helps to open up international markets, but also improves environmental and economic efficiency. This study supports the development of healthy and high-quality products, and provides new directions for the development and sustainable improvement of functional food and pharmaceutical industries.

Acknowledgments

Thanks to the members of the research group for their assistance and inspiration in the data collection process, their efforts have provided a strong guarantee for the research work.

Conflict of Interest Disclosure

The authors affirm that this research was conducted without any commercial or financial relationships that could be construed as a potential conflict of interest.

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