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Granule 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 Extraction
Extracted with only purified water to replicate a traditional decoction. Single Chinese herbal granules follows the decoction methods of traditional decoction and are stewed individually. This method can maximize the preservation of 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 type of rhizome,flower and fruit, entire plant and seed, they are classified into sugar-containing type, natural base, glycoside, fat soluble type, water soluble type and volatile oil etc. To optimize the extraction process, research is used to determine the ideal decoction time, temperature, water-to-herb ratio, pao zhi method, and maximum concentration ratio of each individual herb. Complete capture of volatile oils to maximize flavor and efficacy is taking place during this step.




Filtration & Concentration
Low Temperature Vacuum Concentration. The filtered extracts are placed into a concentration pot, where the temperature ranges from 40-60 degrees Celsius and the vacuum treatment is immediately applied. Then the cryoconcentration is performed. The workshop is an ISO Class 6 clean area and is equipped with more than ten full-automated production lines. To ensure the consistency of the products, a strict monitoring system is established for each working procedure. Only the products qualified by inspection can be entered into the next procedure.



Spray Drying
This advanced spray drying process instantly dries the extract. This kind of drying process ensures that the active ingredients of herbs are not destroyed. This maintains a consistent standard of freshness, color, texture, taste and water content of the herb extracts.



Spray Drying (2)
Spray drying technique involves mist that is dispersed into tiny droplets. Mist droplets are dispersed while the solvent is under hot air drying effects which allows for rapid evaporation, thereby obtaining a powdery or fine granular allowing for finished or semi-finished products . Because the material is dried in an instant,the heating time is very short. This method is specifically used in order to protect the active herbal ingredients.



Re-introduction of Volatile Oils
During the extraction procedure, volatile oils are captured and preserved by the volatile oils retrieval system, then liquid oils are produced into solid volatile oil which is combined with the use of the Beta-Cyclodextrin procedure to maximize the amount of essential oils and other fragile compounds in the final product. Reintroducing volatile oils increases the efficacy and infuses the herbs with their natural aroma. Reintroducing volatile oils takes place during this procedure.



Dry Granulation
Granulation is one of the key technologies used during the reform of Chinese granule herbs. Dry granulation includes mechanically extruding granules, then the dry powder or fine crystalline material is extruded into thin slices and smashed and adjusted into particle size, then sieved and made into a ​​uniform product of particles that are a predetermined size. Dry granulation has the advantage over extracts that can be granulated directly, without wetting, mixing, drying or other processes. This kind of granulation was mastered by advanced technology that granulated herbs using complex and diverse natures without auxiliary materials.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.