Over the past decade, the Botanical Analytic Laboratory has amassed a vast collection of herbs from around the globe, and followed the process below to create a repository bank of botanical ingredients:
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Dividing each herb into 4 to 8 segments.
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Conducting HPLC (High-Performance Liquid Chromatography) analyses on these segments to identify and isolate specific compound.
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Storing each isolated ingredient in a vial and precisely regulating the temperature to ensure preservation.
The botanical reference standards repository bank holds over 10,000 botanical ingredient standards with each precisely dosed at 20mg in vials and boasting a purity of HPLC≥98%. Those standards serve as an essential asset for the research and development in botanical and pharmaceutical fields. They are available upon request, ready to support and enhance research and development initiatives worldwide.
Developed & Validated HPLC Method:
Column name: Agilent SB-Aq, 2.1*100mm, 1.8um
Detection wavelength: 203nm, injection volume: 3ul Column temperature: 25℃
Mobile phase gradient: A-water, B-acetonitrile, 0.3ml/min
0-3-6-8-9.5-10.5-15-18-21-25min
20-20-23-24-30-32-34-40-95%B
each pick represents an ingredient which was separated, isolated, and stored in a vile, serves as a reference standard
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Ginsenoside Rh3
ST80490110
10mg
HPLC≥98%
√
√
Ginsenoside Rh4
ST18960210
10mg
HPLC≥95%
√
√
Ginsenoside Rh10
ST55810105
5mg
HPLC≥98%
√
√
√
Isoginsenoside Rh3
STG8380205
5mg
HPLC≥95%
√
√
√
Ginsenoside Rk1
ST13360120
20mg
HPLC≥98%
√
Ginsenoside Rk2
ST21000105
5mg
HPLC≥98%
√
Ginsenoside Rk3
ST23220305
5mg
HPLC≥90%
√
√
Ginsenoside Rs3
STC9270105
5mg
HPLC≥98%
√
√
Notoginsenoside Fa
ST55770105
5mg
HPLC≥98%
√
√
√
Notoginsenoside Fc
ST55570105
5mg
HPLC≥98%
√
√
√
Notoginsenoside Fe
ST04750120
20mg
HPLC≥98%
√
√
√
Notoginsenoside FP2
ST82760105
5mg
HPLC≥98%
√
√
√
Ingredient Name
Product#
Quantity in Package
Purity
in fruits
in leaves
in stems
in roots
What are Botanical Drugs?
Botanical drugs are therapeutic materials derived from plants, plant extracts, algae, fungi, or other natural sources. These materials may come from a single plant or a combination of multiple plants. As per the regulations of the US FDA, the collective combination of these components is recognized as the active pharmaceutical ingredient (API) for a botanical drug.
A searchable herb formula database containing 46,929 herb formulas with 4 variables:
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Prescription Name (Pinyin)
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Composition (Pinyin)
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Indication in Native Language
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Reference in Native Language
The Quantitative Composition variable is omitted from this online version, but available by request for research and development purpose.
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In the United States, the FDA Investigational New Drug (IND) Application is a critical regulatory hurdle for any product aspiring to become a prescription medication. For herbal medicines to transition into prescription botanical drugs, manufacturers must submit a botanical drug IND application to the FDA.
While sharing similarities with traditional IND processes for small and large molecules, cell therapies, and gene therapies, botanical drug INDs have unique considerations. The FDA's Botanical Drug Development Guidance for Industry outlines a streamlined approach, exempting plant-derived products from the rigorous requirements of detailing molecular structure, mechanism of action, and specific active ingredients. However, botanical products must still undergo robust clinical trials to demonstrate safety and efficacy, aligning with the stringent standards for all prescription medications.
ABDA assists member companies in the development of herbal products into botanical drugs, providing valuable guidance and expertise throughout the complex regulatory landscape.
We believe the FDA's Botanical Drug Development Guidance for Industry is thoughtfully designed, providing clear and actionable direction for conducting botanical INDs. The limited number of botanical drug products on the market is not due to the guidance itself but rather to the following factors:
1. The concept of "botanical drugs" is relatively new, and there has been insufficient investment in this area.
2. The guidance was introduced to the industry only in recent years, and developing a drug product typically takes over a decade. Currently, many botanical drug candidates are in Phase 3 clinical trials.
3. Botanical drug APIs often involve full-spectrum extractions from single or multiple herbs. The FDA emphasizes robust quality control measures before clinical trials can proceed. This presents a challenge for chemists accustomed to working with single-molecule drugs.
In conclusion, the FDA's Botanical Guidance creates valuable opportunities for transforming herbal medicines into prescription botanical drugs.
Developing Herbal Medicines to Prescription Botanical Drugs
The American Botanical Drug Association (ABDA), a 501(c)(3) nonprofit organization, is committed to advancing research in herbal medicine and facilitating the development of FDA-approved prescription botanical drugs.
Modern herbal medicines, often available in convenient pill or capsule form, have demonstrated safety and efficacy through widespread use. By capitalizing on the US regulatory framework for botanical drugs and harnessing the global wealth of traditional botanical knowledge, ABDA collaborates with international partners to identify promising herbal medicines with proven safety and efficacy, transforming them into prescription botanical drugs.
about the
David Allen, PhD
President & CEO
Mukash Kumar, PhD , RAC, DABRM
SVP, Regulatory & Clinical Services
Stevie Council
SVP, Strategic Initiatives
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SVP, Public Relationship
Perdeep Gupta, PhD
SVP, Research & Development
John Tobin
SVP, Global Business Development
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SVP, China
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SVP, France
Alex Semprini, PhD
SVP, New Zealand
André Boulet, PhD
SVP, Canada
Joerg Gruenwald, PhD
SVP, German
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Chief Financial Officer