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萃取流程

Manufacturing Processes

Image result for gmp imagesTianjiang Pharmaceutical Co., Ltd is the first TCM Concentrated Granule manufacturer to receive the State GMP certification as national high-tech enterprise in China. Tianjiang also is one of the first “experimental manufacturing enterprise of Concentrated Granule herbs"  approved by State Food and Drug Administration. Experimental unit of reform of TCM decoction approved by State Administration of Traditional Chinese Medicine. TianJiang owns 17 patents for herbal granulation invention, 1 application model patent, and all the independent intellectual property rights of key technologies for granule herb production.Tianjiang’s patented extraction methods utilize a new generation of technology, producing granules that dissolve better and come out like a decoction.

         

 

 

Traditional Raw Herb Processing/ PaoZhi
Once the authentic raw herbs are selected, they are cleaned and prepared according to the traditional Pao zhi to reduce the toxicity and side effects of some raw herbs; to promote therapeutic effects. All the Chinese medicine traditional processing methods and the “Chinese Pharmacopeia” standard requirements are adopted to enhance the quality of the products. The methods conducted in processing raw herbs are: Stir-fried with liquid adjuvants, steaming, parching, germinating, fermenting and frosting.

 

 

Water Based ExtractionOur single herb granules are extracted with purified water and are stewed individually, in adherence with traditional methods of decoction, in order to maximize the medicinal value of each herb. A fully automated system of new generation extraction machines allows the decoction process to be customized for raw herbs in a variety of forms including: rhizomes, flowers, fruits, entire plants, and seeds, which are then classified into the following categories: sugar-containing, natural base, glycoside, fat-soluble, water-soluble, and essential oil. During water-based extraction, the essential oils are collected to be reintroduced at a later stage of production, which helps to maximize the herbs’ flavor and efficacy. To optimize the extraction process, we research the ideal decoction time, temperature, water-to-herb ratio, Pao Zhi method, and maximum concentration ratio of each individual herb.

 

 

 

Filtration & ConcentrationOnce the herbs have been extracted they undergo low temperature vacuum concentration. During this step, the filtered extracts are placed into a concentration pot where the temperature ranges from 40-60° C before the vacuum treatment is applied. Afterwards, the herbs undergo cryoconcentration in an ISO Class 6 clean area that is equipped with more than ten fully-automated production lines. A strict monitoring system put in place for each working procedure ensures the consistency of our products, and only products approved by inspection can enter into the next phase of production.

 

 

Spray Drying

Our advanced spray drying process instantly dries the extract and ensures that the herbs’ active ingredients are not destroyed, which helps to maintain our herbs’ consistent standards of freshness, color, texture, taste, and water content.

 

 

Spray Drying (2)

Our spray drying technique involves misting the herbs while the solvent is under hot air, which allows for rapid evaporation, and converts the herbs into a fine powder. Because the herbs are dried in an instant, the heating time is very short, which allows us to protect the herbs’ active ingredients. Some herbs are ready to be distributed at this stage of production, while others must undergo granulation before they are ready for distribution. 

 

 

Re-introduction of Essential Oils

During water-based extraction, essential oils are collected from the herbs and preserved to be reintroduced at this stage of production. To maximize the amount of essential oils in the final product, the liquid oils are converted into a solid, before undergoing the Beta-Cyclodextrin procedure. Reintroduction of essential oils increases the herbs’ efficacy while infusing the herbs with their natural aroma.

 

 

Dry Granulation

In the history of Chinese herbal medicine, the development of granulation technology was a key innovation that helped to shape the reform of Chinese herbs.  Dry granulation involves mechanically extruding granules. First the dry powder or fine crystalline material is extruded into thin slices, then it is smashed and adjusted into particle size, before being sieved; this process converts the product into ​​uniform particles of a predetermined size. Dry granulation has an advantage over extracts because it can be produced without wetting, mixing, drying, or any other processes. This invention earned a national patent in November, 2000.

 

 

Product Quality Control
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 safety in China. The company possesses modern analytical and testing instruments such as CAMAG REPROSTAR, HPLC, GC and ICP-AES. High-performance liquid chromatography and gas chromatography are used to determine the content of active ingredients in the granules. Thin layer scanning technology is used to identify the fingerprint code of each botanical. Certificates of Analysis provided for every batch include: Authentication, Heavy-metal, Pesticide Residue, and Microbiological Analysis.

 

 

 

Final Checking Up
When the granule herbs passed all the quality control inspections, bottling and labeling will take place. The manufacture uses an automotive bottling and packaging operation system to finish the production. Skilled personnels follow all the pharmaceutical GMP requirements to finish the final check ups before products are transferred to the warehouse.

 

 

 

 

Storing and Distribution
Only packaged products that fulfill the quality control standard are stored and distributed.The finished product is safely stored in a computerized controlling warehouse. The warehouse covers an area of 7000m2 which rigorously monitors inventory and distributions.

 

 

Finished products of Treasure of the East Herbs
To comply with US FDA regulations, Treasure of the East herbs are labeled with a specialized bar coding system that is linked to Tianjiang Safety Tracing system and the US tracking System. All the US distributed herbs have been scanned and recorded in the computer, which allows practitioners in the US to track every single herb to its original identification from the manufacturer and to access the information of production date, batch number, test results, and allows them to track herbs to their original batch samples.