To ensure a safe, consistent, and high-quality product, TianJiang Pharmaceutical has developed a number of standardization protocols that regulate the process of converting raw herbs into concentrated granule herbs. These protocols prescribe the use of specialized technology to control for each herb’s identity, origin, concentration of effective components, optimal binding material, and the proper dosage in concentrated form. To date, TianJiang has established quality standards for over 600 granule herbs. TianJiang' s standardization protocols for concentrated granule herbs have been internationally recognized and adopted as the pharmaceutical industry’s national standard in the People’s Republic of China.
Control of Seeding
Good seeds are the first step to guarantee quality granule herbs. Due to serious deterioration of existing varieties of Chinese herbal raw materials, the efficacy of Chinese herbal materials at present is less powerful than that in the past. Besides, from the perspective of botany, after one variety goes through 3 cycles of plantation, the efficacy of such variety will be reduced and it can be infected with viruses easily, so as to cause pathological changes and finally lead to decreased quality of Chinese herbal materials. One of the main solutions is to establish GAP cultivation base to ensure their quality. To fundamentally solve these problems, Tianjiang worked cooperatively with Genetics and Breeding Teaching and Research Section of China Pharmaceutical University 中国药科大学 and jointly devoted themselves to the research and application of fine varieties of medicinal materials. From plantation of seeds to plantation of traditional Chinese herbs, TianJiang has begun trying to top the quality of herbal seeding.
GAP Herbal Growing Plantations
TianJiang established multiple GAP (Good Agricultural Practice) herbal plantations to grow authentic herbs. Raw herbs sold on the herbal market are facing issues in prolonged storage, improper storage condition and inappropriate harvesting time. They also face herbal damages from mildew, worms,oil leakage, airing, loss of aroma and flavor. This causes property loss, deterioration and even affects the efficacy of the herbs. Therefore, the company uses fresh seasonal raw materials from the right season or in the same year of harvest. That includes plants, nuts and kernels, and flower raw materials. The goal is to guarantee only the raw herbs with high quality, safety, stability, and controllability are selected to put into the next step of production.
DaoDi Raw Material Selection
Tianjiang considers quality control of raw materials to be a top priority.The quality of materials is closely related to their places of origin, harvesting season, processing method and storage conditions. Besides using raw herbs from TianJiang's own GAP plantations, raw herbs are sourced through established relationships at over 320 farms and production regions spanning 22 provinces in China. Many individual herbs come from GAP certified farms or ethically wild-crafted sources. At present, nearly 430 varieties of raw herbs are directly from classical origins. Only raw materials pass the inspection of quality control in seeding, growing, harvesting, restoring, and production. Tests in authentication to detect Heavy-metal, Pesticide Residues, flavacin and sulfur dioxide are performed. Sulfur is never used on the incoming raw herbs.
Traditional Processing and Verification -PaoZhi
Chinese medicine has thousands of years of history processing -PaoZhi herbs to reduce toxicity and increase effectiveness. Tianjiang follows the specifications of “Chinese Pharmacopoeia" and standardizations in the whole preparation process strictly and adopts the modern science and technology to receive the best of two worlds. The methods conducted in processing raw herbs are: Stir-fried with liquid adjuvants, Steaming, Parching, Germinating, Fermenting and Frosting. Studies are conducted on processing technology to figure out the effects of the parameters of processing raw herbs, and the changes to the effective constituent and the content with different processing methods and the extraction ratio of effective constituent. Tianjiang has carried out a large number of studies on the determination of specific particle size to ensure the best practice of extraction and made a requirement that all the particle size margins is to be less than 5%. The key factor of traditional PaoZhi is seen in the difference from the granule herbs produced in Japan, South Korea and European countries.
Water Based Extraction
Extracted with only purified water to replicate a traditional decoction in order to reach the full spectrum of ingredients and balance the herbs. While conducting the modern technology extraction, consideration is taken on the control of temperature, pressure and water adjustment, length of the decoction, and adopting the traditional pre-decocting, after-decocting, mild fire and strong fire methods, rather than using chemical substances. Water full spectrum extraction maintains the balance of components within the original plant, which allows for the safety and effectiveness of the herbs to be ensured.
Manufacturing Process Monitoring
Tianjiang products are produced in accordance with the Good Manufacture Practice (GMP). The workshop is an ISO Class 6 clean area and the company takes strict control of the entire process from raw materials selection, processing, production to packaging, which can provide a reliable guarantee for stable quality, efficiency and safety. TianJiang established a three-level quality system network, strengthening the control of the production process as well as effectively ensuring the stability, uniformity and effectiveness of the quality of products. Established standard production processes of Five Quality Control step checking system (raw material, decoction, fluid extract, semi-finished products and finished products) which includes detection of more than 100 quality control points: amount of water added, length of decoction, temperature of decoction, spray drying inlet, outlet air temperature, contraction temperature, extract weight, etc. Computerized Digital Control System is implemented during the production procedure to ensure consistency.
Quality Control Tests
In order to guarantee the safety, effectiveness and stability of single Chinese herbal granules, Tianjiang established a laboratory at the national level taking quality monitoring on the whole process, from seed to finished products and made a quality monitoring system from original herbs, extract, self-finished products to finished products. Laboratories use state-of-the-art technology to examine variables such as quality, quantification, dissolubility, bacterial levels, heavy metals, pesticide residue and flavacin. The products manufactured by Tianjiang pharmaceutical meet the double requirements of food and drug in China. The company possesses modern analytical and testing instruments such as CAMAG REPROSTAR, HPLC, GC and ICP-AES. High-performance liquid chromatography, gas chromatography are used to determine the content of active ingredients in the granules. Thin layer scanning Fingerprint Technology is used to identify the fingerprint code of each botanical. Tests are verified by independent laboratories in the US and Germany. Certificates of Analysis provided for every batch include: Authentication, Heavy-metal, Pesticide Residue, and Microbiological Analysis.
Large scale of Clinical Practice
TianJiang concentrated granule herbs have been accepted in more than 30 countries and regions in the world and have been used by several thousand domestic hospitals and several hundred million people over 20 years of clinical application. Up to today, no accident has occurred with the use of the products. Granule extract herbs have gained increasing popularity among the clinical Chinese medicine practitioners and patients.
Globalization of Quality Standards
Adoption of international standards to set up international quality control measures. Tianjiang complies with international standards and has attained EU food and drug standards following over 340 of single granule herbs have passed the inspection of Germany in their security indexes such as heavy metal, pesticide residue, aflatoxin, and microorganism. The products are not only popular in China, but are also sold to over 30 countries and regions bringing benefits to millions of people across the globe.
Retention of Samples and Safety Tracing
Tianjiang retains samples for different batches of raw materials and finished products, to ensure the traceability of herb quality. Tianjiang has established a digital and computerized mode warehouse for raw materials and finished product management. The same batch of herbal raw materials, finished products and sold products can be traced from the recoding and tracing system. If there is any concern with the quality of the products, the original samples in the lab and remaining products in the warehouse, and the records of origins of farming, the production data, the test results could be traced with the Safety Tracing System.
US Sale Safety Tracking System
To comply with FDA regulations, Treasure of the East herb distribution developed a specialized bar coding system that is linked to Tianjiang Safety Tracing system. Herbs distributed through Treasure of the East are controlled with a barcode scanning and tracking system which can be traced back to the original source of raw materials and finished product samples at TianJiang pharmaceutical. This allows practitioners to track every single herb to its original identification from the manufacturer. The tracking system records the information of production date, batch number, test results, and tracks herbs to their original batch samples.