Patented Production Process


From raw material to final product, Tianjiang’s state of the art full spectrum extraction methods preserve flavor, increase solubility, and deliver consistently high-quality herbal extracts. Our cutting edge production technology is fully automated and backed by 30 patents across the manufacturing process. Of all the innovations, our dry granulation process is particularly remarkable - read on to learn more.

1. Identification. Following procurement of high-quality raw herbs, the first step of the production process is inspection and identification. Tianjiang uses hundreds of thin-layer chromatography (TLC) botanical identification standards in order to verify authenticity with absolute certainty.  Each batch of incoming materials is tested prior to acceptance into the production process.

2. Pao Zhi (Traditional Processing). Once procured and authenticated, raw herbs are cleaned and prepared according to traditional Pao Zhi practices, the Chinese Pharmacopeia, and internal research on optimal production parameters (described in more detail here). The various Pao Zhi processing methods employed include soaking, steaming, stir-frying, germinating, fermenting, toasting, freezing, and more.

Pao Zhi at Tianjiang Pharmaceutical

3. Water-Based Extraction. In adherence with traditional methods of decoction, our full-spectrum extraction process uses only purified water.  We employ a two-step extraction that captures botanical constituents and essential oils without the use of solvents like alcohol, acetone, or hexane. The extraction process is conducted according to experimentally derived production parameters that are specific to the plant species and the plant part (root, rhizome, flower, fruit, seed, bark, entire plant, etc.). Fully automated production equipment allows the temperature, pressure and other parameters of the extraction process to be precisely controlled. Essential oils are captured for reintroduction prior to the granulation step. Read more about full-spectrum extraction here.Tianjiang Extraction Facilities

4. Filtration and Concentration. Once extracted and filtered, a low-temperature vacuum concentration method is employed to rapidly concentrate the herbs.  Extracts held at a temperature range of 40-60°C while placed under vacuum, which is then followed by a cryo-concentration process. Quality control personnel inspect all materials before they are permitted to move forward.

5. Spray Drying. Tianjiang’s advanced spray drying techniques dry the extracts instantly, preserving the active ingredients, and maintaining our high standards for freshness, color, texture, taste, and water content. Our technique employs high speed centrifugal atomizers to disperse the extract into tiny droplets that dry instantly when in contact with warm air. The temperature of the extract during the drying process remains low, which helps to preserve heat-sensitive extracts. A pneumatic conveying system promptly separates the extract from residual heat and moisture to prevent reabsorption or agglomeration. The product of this process is a pure extract with varying concentration ratios. For some products, this is the final stage of production while others will move on to granulation.

6. Re-introduction of Essential Oils.  Essential oils are captured during the extraction process for reintroduction into the final product. To minimize evaporative losses of essential oils in the final product, liquid oils are solidified before being incorporated into the granules. Reintroduction of essential oils is a key part of ensuring that an extract maintains the raw material’s flavor and aroma as well as valuable biochemical components that may be otherwise lost.

7. Dry Granulation. Tianjiang uses a patented dry granulation process that mechanically forms granules at lower temperatures and with minimal excipients compared to standard wet spray techniques. The dry powder extract is mechanically compressed and formed into thin sheets, which are then broken into granules before being sieved and pressed again to form particles of uniform size. Granulation is entirely performed within an ISO Class 6 cleanroom environment. 

8. Laboratory Testing. Laboratory analysis with state of the art technology examines variables such as concentration ratio, solubility, bacterial contamination, heavy metal presence, pesticide residue, and aflatoxin. Tianjiang's world class laboratory uses modern analytical and testing instruments such as thin-layer chromatography (TLC), high-performance liquid chromatography (HPLC), gas chromatography (GC), inductively coupled plasma atomic emission spectroscopy (ICP-AES), and mass spectrometry. HPLC, GC, and mass spectrometry are used to evaluate the level of active chemical constituents in the herbal extract granules against Tianjiang's internal standards for 150 herbs. Certificates of Analysis are available for every batch. Read more about our laboratory testing here.

9. Packaging, Quality Control, and Distribution. Once the extracts have passed laboratory analysis and inspection, an automated bottling and packaging system completes the production process. Skilled quality control personnel, following all Chinese Pharmaceutical GMP requirements, oversee the process and perform final quality checks before the products are stored and distributed. 

Full-Spectrum vs. Standardized Extracts

Full-Spectrum Extracts.  Full-spectrum extracts contain all the active chemical constituents of whole herbs in concentrated form. Full-spectrum extracts most closely mimic the effects of whole herbs because full-spectrum extracts contain the same balance of chemical constituents and the same complex interactions between chemical constituents as whole herbs.

Standardized Extracts.  In the US, many herbal extracts on the market are known as standardized extracts. Standardized extracts concentrate a single chemical within the herb to a specified concentration, which is expressed as a percentage (0.01% to 99%).  The specified chemical is isolated using chemical solvents like alcohol, acetone, or hexane so that it may be added to botanical materials to reach a specified concentration.

Why Full-Spectrum vs. Standardized?  All traditional evidence-based medicine systems are based on whole herbs. Full-spectrum extracts contain the same balance of chemical constituents and the same complex interactions between chemical constituents as whole herbs.  However, full-spectrum herbs may suffer from inconsistent potency from batch-to-batch.

Standardized extracts are particularly prevalent in the West, where medical research is often focused on the effects of an isolated chemical.  The benefit of standardization is that batch-to-batch concentrations are consistent; however, many other important chemicals may be lost or diluted in the process.  As a result, no matter the concentration of the specified chemical, the medicinal value of standardized extracts cannot be not considered comparable to that of whole herbs or of full-spectrum extracts.  

TLC Bu Gu Zhi

TLC chemical signatures for Bu Gu Zhi full-spectrum extracts from Tianjiang (1-8), Bu Gu Zhi raw herb samples (9-10), isolated Psoralen (11), and isolated Isopsoralen (12).

Treasure of the East Full-Spectrum Extracts. Treasure of the East’s herbal extracts are full-spectrum, water-based extracts produced by Tianjiang Pharmaceutical. Tianjiang's two-step extraction process captures water-soluble active components and essential oils using only purified water. Tianjiang's patented dry granulation process minimizes heat and the use of excipients that might otherwise denature and dilute the active chemical constituents of herbs granulated using common wet spray techniques.  These processes help ensure that Treasure of the East herbal extracts align as closely as possible to the original whole herb.

Tianjiang overcomes issues with batch-to-batch inconsistency that is prevalent with many full-spectrum herbs by developing characteristic single- and multi-constituent chromatography standards for more than 150 varieties of Chinese herbal extracts. In other words, Treasure of the East herbs are full-spectrum herbal extracts that, in many cases, also have the consistency of standardized extracts.

Example Product Specification for Huang Qi (click image above for full PDF)

Research

Since its founding, Tianjiang has been focused on research and development. Today, Tianjiang's research spans topics from the identification of botanical varietals to clinical studies of modern Chinese herbal formulas.  Tianjiang's research team includes Dr. Chen Keji, a Member of the National Academy of Sciences, and its research partners include 22 Chinese medicine research universities and 26 leading Chinese research hospitals.  Published results are available on Chinese research portals as well as on the National Institute of Health's PubMed Central.

Botanical Research

Together with the Department of Genetics and Breeding at China Pharmaceutical University, Tianjiang has led the identification and cultivation of varieties of Chinese herbs selected specifically for disease resistance and for low toxicity. For example, Tianjiang's research on Ju Hua (Chrysanthemum) has identified a virus-resistant varietal that has successfully deployed to production fields.

(1) Ju Hua seedlings at different stages of growth; (2) a virus-resistant varietal (L) vs. a control (R) of Ju Hua grown under the same environmental conditions.

A Ju Hua farm growing a virus-resistant varietal in Yanma, Jiangsu Province

 

Pao Zhi and Processing Research

Tianjiang conducts research into processing parameters to optimize the active chemical constituents and to reduce toxicity.  For example, Tianjiang's research identified the ideal processing time for Bai Shao (Chao) (White Peony Root (Processed)) to maximize the active chemical component Paeoniflorin. The Chinese Pharmacopeia specifies that Bai Shao should be fried until the surface is slightly yellow with visible spots of charring. Tianjiang determined the ideal time by frying samples of Bai Shao for different periods of time and by measuring the content of the active chemical Paeoniflorin in the resulting samples.  This process identified that 8 minutes was the optimal frying time in compliance with the Chinese Pharmacopeia.

G3.pngBai Shao (Chao) fried for different durations at the same temperature

Tianjiang performs quantitative experiments like this on a wide range of production parameters (processing time, temperature, pressure, etc.).  Tianjiang also evaluates and develops new processes aimed at increasing the potency, purity, and efficacy of our herbal extracts.

Clinical Research

Tianjiang collaborates on clinical research with China's top research universities and Chinese medicine research hospitals.  These research partners include the China Academy of Chinese Medical Sciences, China Pharmaceutical University, Nanjing University of Chinese Medicine, Shanghai Jiao Tong University School of Medicine, Beijing University of Chinese Medicine, and 70% of China's AAA-level research hospitals.  Further, Tianjiang leads or participates in the following Chinese medicine research consortiums:

  • Jiangsu Association of Chinese Medicine TCM Decoction Reform Collaborative Innovation Research Center
  • Shanghai Jiao Tong University School of Medicine TCM Research Center
  • Nanjing University of Chinese Medicine Granule herbs Industrial Technology Research Institute
  • China Pharmaceutical University TCM Fine Varieties Breeding and Research Center 
  • Jiangsu Province Chinese Medicine Granule Herbs Engineering Research Center 
  • Jiangsu Province TCM Decoction Innovation Center

These partnerships have led to an extraordinary body of work related to Chinese herbal extracts.  See PubMed Central for more information.

Laboratory Testing

Treasure of the East herbal extracts are tested in a world-class laboratory jointly established by Tianjiang Pharmaceutical and the biotechnology research leader, Waters Corporation.  The laboratory is certified to ISO/IEC17025 Standards for testing and calibration laboratories by ILAC-MRA/CNAS, international accreditation bodies recognized in 28 countries, including the United States, United Kingdom, Germany, France, Japan, and South Korea (current certificate)

The laboratory is advised by Dr. Chen Keji, a member of the Chinese National Academy of Sciences, and is staffed by many PhD's, post-doctoral fellows, and leaders in the field of Chinese herbal extracts. 

The laboratory is a 20,000 sq. ft. space equipped with industry-leading instrumentation. Tianjiang was the first in the industry to employ liquid chromatography-mass spectrometry (LC-MS) capable of simultaneous multiple-constituent chemical characterization. Other modern analytical and testing instruments used in the laboratory include thin-layer chromatography (TLC), high-performance liquid chromatography (HPLC), gas chromatography, UV-visible spectrophotometry, and inductively coupled plasma atomic emission spectroscopy (ICP-AES).

A Liquid Chromatography Mass Spectrometer (LC-MS) in the Tianjiang Waters Laboratory

HPLC used in the characterization of chemical signatures in Treasure of the East herbs.

Tianjiang laboratory personnel at work

Trained laboratory personnel use these instruments to test against Tianjiang's internally developed standards for TLC botanical identity and for HPLC chemical marker content for 150 herbal extracts. Requirements for HPLC chemical marker content is extremely rare amongst producers of full-spectrum herbal extracts. These requirements give our herbs the consistent potency of standardized herbs with the same balance of chemical constituents as whole or full-spectrum herbs. Read more about full-spectrum extracts vs. standardized extracts here.

Treasure of the East Chemical Marker Requirements
Minimum chemical content requirements for sample single herbs

 

Additionally, Tianjiang tests for a suite of marker chemicals for compliance with Tianjiang's internal standards.  These tests can be done with extremely high accuracy using LC/MS or for characterizing batch-to-batch consistency using HPLC.  Sample chemical constituent test results are shown below for for Jin Yin Hua (Honeysuckle) and for multiple batches of Ban Zhi Lian (Scutellaria). The latter demonstrates exceptional batch-to-batch consistency for multiple chemicals. 

LC/MS chemical constituents analysis of Jin Yin Hua (Honeysuckle)

HPLC analysis of multiple batches of Ban Zhi Lian (Scutellaria)

Testing is performed for all raw botanical materials, as well as for intermediate products and finished products. Treasure of the East herbs are comprehensively tested for identity, single- and multiple-constituent compounds, solubility, bacterial contamination, heavy metals, aflatoxin, sulfur compounds, and pesticide residues. Certificates of Analysis are available for every batch of herbs.

To request a COA or to read more about the full traceability of our herbs, please click here.

Full Traceability

We employ a unique end-to-end tracking system that manages all the data involved from seeds to final products, so that the entire process is traceable. 

The tracking system consists of three main components: cultivation, production, and commercial. The cultivation component includes data on the farmer, land, planting conditions, growing conditions, harvest conditions and more (see below).  

Cultivation Tracking

Sample QR Code

The granule production tracking component covers steps from purchasing raw material to finished products release, including purchasing, raw material testing, storage, processing, finished goods testing, storage, packaging, and more.

Production Tracking

Samples of incoming raw herbs are kept and maintained for every batch of Treasure of the East herbs for a minimum of 8 years. Raw herb samples with high sugar content (such as Gou Qi Zi (Goji Berry)) are stored in temperature-controlled conditions.

 

In addition to compliance with many international standards, we meet all requirements of the US FDA and USDA, including the current Good Manufacturing Practices (cGMP) and the Food Safety Modernization Act (FSMA).  Herbs in our US facilities are tracked using a barcode scanning system.  Based on the order number, we can identify the exact varieties and batches associated with each order.  We offer Certificates of Analysis (COAs) with any order of herbs.  To request a COA, please contact us with your barcode number at info@treasureoftheeast.com.

Sample COA