Pharmaceutical-Grade Herbal Products: Are They Clinically Superior?

An Interview with Dr. Dan Wen, President of Honso® USA, Inc. Part I.

JG: With all your background in herbal and medical science, why did you choose to work for Kampo product manufacturer Honso®?

DW: "I believe Honso® is bringing to the United States a really new concept of producing quality herbal products pharmaceutically. There are other companies like Tsumura and Kanebo in Japan, but only Honso® sells in America."

JG: What do you mean by “pharmaceutically?”

DW: "Honso® has done a good job of solving the major problems of quality control and quality assurance for its herbal granule products through pharmaceutical methods. Their products for professionals are only sold in granule form. The problems of QC/QA are 1) the variation of amounts of raw herbs that enter an herbal formula [different manufacturers use different amounts of ingredients for a similar formula], 2) variation of methods by which the herbal mixtures are processed [water boiling, alcohol extract, or direct compression of ground herbs], and 3) variation of levels of active constituents in a finished product among different manufacturers or among different lots within one manufacturer, that is, whether or not a manufacturer’s QC department assays the finished product in every lot and rejects the lot if it fails testing."

JG: How does Honso® determine the amounts of raw herbs that go into various herbal formulas?

DW: "The Japanese Ministry of Health and Welfare studied all the historical herbal textbooks and compared dosages for each ingredient among the textbooks, then adopted a median range based on laboratory and clinical determination of therapeutic dosages tied to standardization of active herbal components. Manufacturers are required to pick dosages from that median range. It turns out that the range is generally lower than modern TCM dosages, but clinically our effectiveness rate has been most excellent."

JG: How are Honso®’s herbs processed?

DW: "Kampo medicine has been passed down through generations the way Chinese medicine has been. The most common method of herbal processing is water decoction of sliced raw herbs. So modern herbal industries in Japan and China have used a similar process for the mass production of herb formulas. The process usually goes like this: Raw herbs are sliced, weighed, blended, then boiled in water in precisely controlled conditions. Then the solid herbal residue is separated from the liquid, condensed and then spray-dried, granulated and packaged. Granules are the most commonly accepted way herbal formulas are taken in Japan."

JG: What is the concentration ratio? The usual is 5:1.

DW: "The amount of one-day dosage is usually 7.5 grams, which is the total weight of the mixture [herbal extract and binder such as rice starch and crystalline cellulose, etc.]. The concentration ratio is really not the issue as long as the requested daily amount of herbs can be “carried” within the 7.5 grams of granules. In Honso®’s case, we use 5-6:1 concentration ratio in most formulas. We also fully disclose the formulation information."

JG: That leaves the third variation to discuss: levels of active constituents, standardization and assaying. What can you tell me about these?

The importance of assaying herbal formulas is obvious. Let’s take Minor Bupleurum Formula as an example. One of the key herbs is Bupleurum (Saiko) in the formula, with an active constituent called Saikosaponin (A. B. C…). The levels of Saikosaponins can vary between 5 to 10 times if the Bupleurum is harvested in different areas from north China to south China and to Japan. Therefore if a manufacturer is only controlling the weight of bupleurum, the efficacy of the product can be good or none depending upon whether the active constituents are at the right level. From the TCM point of view, although we did not know Saikosaponin thousands of years ago, a good practitioner did pay great attention to where the herbs were harvested, and a good herb seller did grade raw herbs according to their quality. In modern times, the only way to assure the best quality herbal formulas that a practitioner can get is to assay and standardize them.

At Honso®, the quality control of a finished herbal formula is performed under the scrutiny of the Ministry of Health and Welfare at two levels on every lot: first assay each individual herb qualitatively by TLC, and then measure at least two active constituents quantitatively by HPLC. For example, Minor Bupleurum formula is processed as follows:

TLC testing: to identify Bupleurum, Ginger, Scutellaria, Jujube, Ginseng, and Glycyrrhiza. HPLC testing: specification is as such: 24.7-46.0 mg/day of Glycyrrhizin, 110.6-205.6 mg/day of Baicalin, and 6.5-19.7 mg/day of Saikosaponin. Other testing is routinely performed on each lot according to the Japanese Pharmacopoeia, including heavy metals, arsenic, and water content and microbiological tests.

We have recently conducted a comparison test on Honso®’s and three other leading companies’ granule products. The testing samples were randomly purchased in the U.S. and tested against Honso®’s specifications in Honso®’s QC department (the samples are stored at Honso® in case anybody wants to repeat the test on their own). We have tested Minor Blue Dragon Formula (Xiao Qing Long Tang), All-Inclusive Great Tonifying Formula (Shi Quan Da Bu Tang) and Minor Bupleurum Formula (Xiao Chai Hu Tang) on their active constituents (bioactive markers). The results show Honso®’s products come out on top in every parameter we tested. For more details about this test, you may visit our website at: http://honsousa.com/Quality/comparison.htm