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Leading Manufacturer in Quality Control

 

TianJiang pharmaceutical is the world's largest manufacturer of full-spectrum Chinese herbal extracts, also the leader in scientific research and production globally in the industry. TianJiang sales network reaches all over the world, more than 30 countries and regions. The company owns 30 patents for herbal extraction invention and all the independent intellectual property rights of key technologies for concentrated granule herb production.

 

Fully Standardized Production Process in:

 

  • Botanical seeding

  • Raw material growing and harvests

  • Raw material safety testing

  • Raw material pretreat procedures

  • Full Spectrum water extraction procedures

  • Digital controlled manufacturing process

  • Active constituents monitoring and testing

  • Intelligent distribution system

  • From seeding to finished products traceability platform

 

 Quality control from the source:

 

More than 480 herbs are gathered from controlled sources with high-quality seedlings, guided growing methods and stabilized locations to ensure the quality, stability, and potency.

 

 

Raw material controlled for:

 

  • Origin (Stable)

  • Production location (Stable)

  • Growth Period

  • Harvest Time

  • Processing Methods

  • Growth climate (Soil, Water, Weather)

  • Grade and Specification

 

 

Control Raw Material Quality with Indicators

 

  • Characteristics

  • Identification

  • Inspection (including toxicity, etc.)

  • Content Determination

  • Leachate

  • Characteristic Spectrometry

  • Others

 

Safety Related Quality Control

  • Heavy metals and harmful elements

  • Pesticide residues

  • Sulfur dioxide

  • Aflatoxin

 

 

 

Advanced production technology:

 

Tianjiang adopts the most advanced automatic production line to ensure the stability of the quality

 

 

 

 

 

Optimal Extraction

The key factor for the potency of the product is optimal extraction process. New dynamic extraction technology of basket extraction and forced circulation is used to improve the component transfer rate and extraction rate as well as to stabilize the product quality; Steam distillation technology is used to maximize the retrieval of essential oil.

 

Quality in Extraction Purity

Membrane filtration technology and ultra-high-speed tangential jet vortex rotary technology is used to improve flavoring, solubility, and clarity of the solution.


Quality in Concentration

The high temperature will affect the plant constituents during the concentration process. We believe that the true efficacy of herbal therapies arises from the inherent therapeutic properties of the whole herb. Using low-temperature vacuum concentration, with lower temperature (40 ° C - 60 ° C) to avoid the sensitive constituents to be decomposed by heat. The “Method for Improving the Concentration Efficiency of Chinese Herbal Granules with fatty oil Content” was granted a national authorized patent.

 

Quality in Drying Process

 

A crucial step in making Chinese herbal extracts is to turn the herbal decoction into easily preserved powder extracts.

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The spray drying equipment Tianjiang designed is for high heat and moisture sensitivity. The spray drying equipment is specially customized for heat sensitivity, poor drying property, low softening point, and strong hygroscopicity to maintain the stability of the products.

Quality in Granulation

Dry granulation technology uses the inherent viscosity of Chinese herbal powders, to produce herbal extracts through multiple steps of compression, molding, pulverization, and granulation. The success is hailed as a major breakthrough in the production of Chinese herbal extracts, and it is at the leading edge both domestically and internationally. It is combined with various granulation methods such as dry method, wet method, and fluidized bed to ensure the stability of product quality.

 

The “method for improving the dry granulation formability and particle quality of Chinese herbal extracts” has obtained the national authorized patent.

 

 

Optimize Product Qualities

As the leader in the industry and the innovator of the granule herbal extracts, Tianjiang has developed many menthol and technologies to optimize the quality of the products, and obtained relevant authorized patents:

 

'"Method for Improving Water Dispensability of Chinese Herbs with High Fatty Oil Content”

"Method for Improving the Solubility of High Mucus Content Chinese Herbal Extracts”

"Method for Preparation and Usage of Flavoring Agent in Chinese Herbal Extracts"

 

 

 

 

Effectiveness and stability:

With high-performance liquid chromatography (HPLC), over 200 varieties of herb content standards were established. The contents of the index components of Tianjiang Chinese herbal extracts are both higher and more consistent in comparing with other leading manufacturers. For each batch of herbal extract, the contents of index components are restricted within a certain range, with very limited fluctuations, thus guaranteeing the clinical efficacy.

The chemical component quality transfer in the production process of Scutellaria Extracts

State of the art monitoring technology:

Tianjiang has collected standard characteristic chromatographies of more than 150 varieties of Chinese herbal extracts. This is to ensure high quality and stability.

The chemical component quantity transfer in the production process of Scutellaria extracts

QR code scanning tracking:

Tianjiang uses QR code on every finished product of herbal extract, achieving quality traceability.

Standardized Assessment

Tianjiang undertook numerous research projects, collected a large amount of production and research data, and established a proprietary TLC identification method for Chinese herbal extracts so as to ensure the safety of the users. The safety of herbs has gained more and more attention. Tianjiang Pharmaceutical has conducted a survey of more than 7,000 batches of more than 700 varieties of Chinese medicinal materials and established internal control standards from raw materials to finished products, with more regular and strict tests.

 

 

Thin Layer Chromatography (TLC)

TLC was used to test raw materials, intermediates and finished products of each batch of Chinese herbal extracts. For the varieties with the same composition, a proprietary test was established to distinguish them.

Under the premise of stabilizing raw materials and processes, after repeated experiments, a TLC identification method for more than 500 varieties was developed, and two volumes of TLC color atlas of Chinese herbal granule extracts were published.

Example: TLC identification of Scurf Pea Berry

1-8: Scurf Pea BerryGranules; 9-10: Scurf Pea BerryStandardSample; 11: Psoralen; 12: Isopsoralen

 

Conclusion: 11, 12 are known active ingredients; 9, 10 are reference TLC, with blue-purple unknown spots, and the 1-8 granules are in perfect consistency with the reference medicinal materials. The granule retains all the active ingredients, and has good stability.

High-Performance Liquid Chromatography - Feature Chromatography

 

UPLC-Q-TOF, HPLC-DAD/ELSD establish the feature chromatography and identify the base chemical compositions of 70 herbs and 150 granules and thus enabled a quality control method with multi-index instead of single-index and multi-component instead of single-component.  It represents the future of quality control in Chinese herbal extracts.

The technical high light: identify the extracts, identify the quality of the raw materials, and generate comprehensive chemical components.

 

Example: feature chromatography of Chrysanthemum extracts

a. Reference Sample 1-10, Scrophularia extracts b, harpago glucoside reference substance

Example: feature chromatography Cape Jasmine Fruit extracts

Example: feature chromatography Scrophularia extracts

Example: feature chromatography Cape Jasmine Fruit extracts

Measuring the Extracts Active Constituents Contents:

Quantitatively measuring the chemical constituents of more than 220 varieties of granules was standardized based on the physical and chemical properties of the sample. The upper and lower limits of the characteristic chemical contents were established based on the average values of at least 10 batches. So far, this method has shown to be simple and produces results that are very stable.

LC/MS Technology:

Liquid chromatography-mass spectrometry (LC/MS) is a multi-constituent determination and quantification technology, so far, Tianjiang is the only one in the industry that applies it to its quality control.

 

The liquid mass spectrometry technology was used to follow the effective constituent in the Chinese herbal extracts, and to examine how it changes during the production, to generate a comprehensively quality history of particular extracts, and to bring quality control to a new level. The technique of UPLC-Q-TOF can provide the molecular weight of the corresponding characteristic peak, through which the molecular formula was deduced. Combined with the related literature, it can be inferred which chemical substance is represented by the characteristic peak.

8 active constituents of honeysuckle flower granules are determined by LC/MS

 

Constituents of honeysuckle flower granule extracts

(Chinese Pharmacopoeia 2010 version of honeysuckle flower: Containing chlorogenic acid not less than 1.5%, containing luteolin not less than 0.050%)