Research

Information About Concentrated Herbal Granules

• Granules are extracted from traditional Chinese bulk herbs using modern technology.
• Concentrated granules uphold the same principles and maintain the same characteristics as Chinese traditional decoction, i.e. flavor, property, “path effectiveness,” and healing power.
• Granules are safe, highly efficient, stable, and quality controlled.

The Research and Development of Concentrated Herbal Granules

• Production process developed for over 500 herbs based on scientific studies
• Optimization of manufacturing procedures
• Establishment of quality control standards
• Verification of products’ effectiveness through clinical studies
• Provision of products that conform to the tenets of Traditional Chinese Medicine practitioners as well as to the regulation requirements for quality control, efficiency, and standardization.

Merits of Concentrated Granules

• Convenient portability
• Convenient formulation and modification
• Practical usage for both the practitioner and consumer
• Standardized and quality-controlled product
• Produced by GMP standard manufacturer and compliant to the new FDA safety regulations

Concentrated granules overcome TCM’s typical issues regarding uniformity, safety, and controllability. Concentrated granules meet the quality standards of both food and drugs in China. This is a tremendous improvement over traditional herbal decoction.

Tianjiang Pharmaceutical Co., Ltd.

• In 1993, the State Administration of TCM in China named Tianjiang Co. as a TCM Reform Trial Center - to change decoctions to granules for hospital use.
• In 2001, the Chinese SDA (equivalent to US FDA) named Tianjiang Co. a Trial Center - to determining herbal granules for herbal drug use.

Research and Development of Concentrated Herbal Granules

Research Projects and Publications in China on Concentrated Granules

• 14 central government-sponsored projects
• 3 province-funded projects
• 100+ company-sponsored projects
• 3 books published on the clinical
• application of granules
• 1 TLC Atlas of Concentrated Granules
• for Prescription
• 500+ papers published

?. The Study of Raw Materials

Establishing a series of production methods can only come after research. The quality comparisons of raw herbs grown in various locations and from various sources allowed for the creation of a knowledgeable list to purchase raw materials. This ensures the stability of processes and products with stability of quality raw materials.

1. 1.Selecting the Species for Raw Materials

The data collected when comparing the quality of herbs from different locations determined both the basic species and the parts of the plant to be utilized.

In addition, to support these results, 43 of the most commonly used herbs also underwent clinical studies.


2. Selection of Production Bases for Multi-Regional Herbs

Due to variances in growing regions and methods of cultivation, the effective components of some herbs can vary considerably. The concentration measurements of these components help to determine which regions will be the production bases for each species, thus ensuring the quality of raw materials used.

For example, the selection of Shandong Pingyi as the purchasing base for Huang Qin was ideal because this region’s Huang Qin has the highest concentration of baicalin.

Standardization of Raw Herbs

1. Since 1994, over 20 production bases across 10 provinces have been established for 320 herb species.
2. Chemical compositions of over 150 herbal products were scientifically and statistically analyzed.
3. Over 80 decoctions and products have been found to be best prepared using fresh (rather than dry) herbs.
4. Herbs went through vigorous testing of heavy metal content.

?. Development Manufacture Procedures

Theoretical Bases:

Traditional Theory: According to traditional preparation methods, water is used as principal solvent.

Modern Theory: Different herbs have different chemical compositions, structural properties, and are processed accordingly.

Key Development

1. The use of new technology, new procedures, and new auxiliary material to enhance quality of final product.
2. The execution of appropriate manufacturing procedures in order to preserve the effective constituents of each herb.

Manufacturing Procedure for Qin Pi

The uniform optimization design method was applied to determine the appropriate amount of water, the number of times cooked, and the duration of each cooking. Then, the resulting product for this data was analyzed. An example of the resulting product is the amount of decoction produced and the concentration of chemical constituents. The results are shown on the following page of U6(63)Testing.

• Separation Procedure Development:
The development of unique methods and equipment to remove impurities in each herb (examples: viscous or mucous material, starches, fruit gelatin, etc...
• Concentration Procedure Development:
The design and development of vacuum membrane concentration equipment used to achieve the desired density for herbs under low pressure and low temperature conditions, thereby preserving more effective constituents.
• Mist-Spray Procedure:
This procedure monitors the strict parameters concerning the temperature of incoming and outgoing air, air pressure, and the decoction’s ratio of solid to liquid contents.
• Granulation Procedure:
This procedure examines certain factors for each granule product, including the use of various fillers, quantities of fillers used, front and side pressure, feeding speed, etc. Special attention is paid to avoid the re-introduction of moisture to the granules.

?. Institution of Quality Standards

Quality standards established for such issues as physical properties, verification, examination, composite tests, dosage and administration, itemization, storage, etc. (13 subjects total)

Achievement of Quality Standards

• The institution of quality standards for over 600 herbal granules.
• The use of thin-film verification on over 300 popular single herbs and an even higher level of verification on over 100 herbs.
• Analysis of the compositions of over 150 products using “high-efficiency liquid phase” equipment.
• The monitoring of levels of heavy metals, carcinogens, and bacteria present in all products.

Start-to-Finish Quality Control

• GMP certification
• The management of over 3600 units of documentation falling into six major categories.
• 3-tier Q.C. network, with checkpoints at each step of the manufacturing process.
• 5-step chemical analysis at points throughout the conversion of raw herb to granule.
• Digital archives of collected and analyzed data for every batch of product.
• Buildings, personnel, and equipment that all satisfy GMP standards.

Clinical Studies

Research was conducted on 10 classical formulas that induce measurable physiological effects to discern the differences in efficacy between “pre-” and “post-mix” versions of these formulas.

Results:

1. 20 clinical studies show no significant difference in efficacy between pre-mix and post-mix formulas
2. 29 studies were sponsored by the central government of the PRC
3. 96 hospitals have conducted documented clinical applications involving over 200 patent and special formulas
4. Daily clinical applications: The products have been prescribed for more than two billion patients in over 1,000 hospitals in China and clinically used by practitioners from 21 different countries, the overall results have been marked by its safety and efficacy

?. Pharmacological Studies

In conjunction with the China Academy of TCM’s Institute of Chinese Materia Medica, Nanjing University of TCM, and the Chinese University of Pharmacology, Tianjiang studied the effects of pre- and post-mixed versions of ten classical formulas to determine their pharmacodynamic effects. Some of these formulas are Sheng Mai San, Jia Wei Sheng Hua Tang, Ge Gen Huang Qin Tang, Huo Xiang Zheng Qi San, etc.

Example 1: Sheng Mai Yin

Aconitine was administered to lab mice, causing irregular heart beats. Both premixed and post-mixed Sheng Mai Yin counteracted this effect, returned heart beats to normal. Both versions of the formula were also given to rats experiencing shock due to blood loss; both versions mitigated this shock.



Graphic shows the blood pressure per dosage of both the pre- and post-mix formulas.

Example 1: Sheng Mai Yin

Aconitine was administered to lab mice, causing irregular heart beats. Both premixed and post-mixed Sheng Mai Yin counteracted this effect, returned heart beats to normal. Both versions of the formula were also given to rats experiencing shock due to blood loss; both versions mitigated this shock.



The graph shows the effects of different preparations of formula on bleeding time and clotting time of mice.



The research results show that in most cases, there is no significant difference between the measurable effects of the pre- and post-mix preparations, and with regard to some variables the granules outperformed raw herb decoctions.



?. Future Prospects for Scientific Research

1. Seed research—improve species through selection
2. Cultivation research—seed + irrigation + air + soil = high-quality raw material)
3. Decoction research—uniform standards for decoction
4. Technological research—applying new technology, equipment, fillers
5. Development of quality standards—new methodologies, instruments for enforcing quality standards, new methods of analyzing chemical constituents
6. Clinical application research—dosages, methods of administration, formulation of prescriptions



In Conclusion:

The research and development of herbal granules is part of the vision of modernizing TCM. It involves the in-depth study of each herb from seed to finished product which has important practical value as well as intellectual implications.

Herbal granules carry not only the potential for new enterprise, but also the possibility of bringing TCM to the rest of the world.