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Herbal Medicine
 

Manufacturing

Introduction: Commitment to Quality

During the past 40 years, it has been our family's mission to uphold a commitment to quality.

In the early 1990’s, the general public read news of Traditional Chinese Medicine (TCM) products adulterated with pharmaceutical drugs or heavy metals. We realized the need for more quality guaranteed products that protected the community, our industry, and reassured patients and practitioners alike. We decided to significantly expand our selection of our Plum Flower® brand products, offering products from Good Manufacturing Practices (GMP) certified factories that were guaranteed to be pharmaceutical free and laboratory tested for individual heavy metals.

We began by researching reputable Chinese factories and visiting them to inspect their facilities and production methods. We interviewed their engineers and managers about Good Manufacturing Practices. We chose to work with those we felt really understood the need for quality control, and only those who had the necessary procedures in place to meet the safety and quality measures we required. Those we selected impressed us with their dedication, innovative spirit and proven accomplishments. Our manufacturing partners are ranked among the top 1% of medicine manufacturers in all of China. The people who make up these companies have integrity, honor, and they are earnest about the requisite responsibilities of producing medicine.

The fruits of these labors and partnerships are the various products of the Plum FlowerŪ brand line, and the other fine brands we distribute. We proudly feature products manufactured by GMP certified factories including the Lanzhou Foci Pharmaceutical Co. Ltd., the Guangzhou Qixing Pharmaceutical Co. Ltd., the Guangzhou Pangaoshou Pharmaceutical Co. Ltd., and the Chengde Jingfukang Pharmaceutical Group.

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Raw Material Selection
Our commitment to quality starts from the very beginning. First, we begin with the correct species and the correct herb part. All herbs, whether Plum Flower® unsulfured herbs or constituents in our Plum Flower® products, are the officially validated species as listed in the Chinese Pharmacopoeia or other government accepted Materia Medicas. This dedication to accuracy in our raw material selection helps ensure efficacy, and more importantly, safety, as substituted herbs may cause harmful side effects. Herbs are sourced from their indigenous regions, ensuring authenticity and quality. Most of our herbs are ordered directly from the growers and harvesting co–ops. Upon receipt, each herb is inspected to ensure correct species identification, proper maturity, and quality before it can be used in our products. Inspection is conducted by highly trained staff using macroscopic, microscopic, and sometimes thin layer chromatography (TLC) to confirm species. Herbs are tested also for sulfur dioxide residues and for certain pesticide residues.

Traditional Technology
As prescribed by the Chinese medicine tradition, our herbs are decocted together to create a tea. This allows for the complex interactions between herbs that make our formulas so effective. In Chinese medical theory, the recipes for herbal decoctions require not only that the herbs be cooked together but often involve the reduction and addition of herbs at different times, as not all herbs release their medicinal properties under the same circumstances. The People’s Republic of China has codified and modernized many of these ancient recipes in the PRC Pharmacopoeia, which includes individual monographs for formulas and manufacturing guidelines. The monographs describe fully how formulas are to be manufactured, and specify how quality is to be assessed. This ensures that the resulting medication is both safe and effective. Our manufacturers carefully follow the protocols and standards set forth in the Pharmacopoeia in the creation of our products.

Low Temperature Extraction
One of two types of extraction is used, depending upon the nature of the herb(s) being extracted. A formula or single herb begins extraction with either a water decoction or a water–alcohol decoction at a low temperature (below 100 degrees centigrade). This low temperature extraction preserves all essential ingredients.

Herbs requiring alcohol as a solvent for ideal extraction are extracted in a single multi–capability extractor. This equipment can extract herbs to their fullest potential by utilizing different combinations of solvents, by adjusting to a wider range of extraction temperatures and pressure levels, and by centrifuging and separating ingredients in the extract liquid.

For herbs not suited for alcohol extraction (such as those with higher concentrations of sugars), we utilize a Dynamic Extraction Line. These extractors contain an internal apparatus for blending that ensures the herbs cook evenly and do not burn on the wall of the cooker.

Both types of extractors are stainless steel, vacuum-sealed chambers that allow us to control the temperature precisely. This combination of low temperature extraction and vacuum–sealed containers ensures that no active ingredients or essential oils are lost when released during the decoction process. Essential oils are lifted up by the steam within the extractor and collected in an attached cylinder for later addition. The formulas are cooked between two to five hours and then filtered to remove any dregs.

Condensing
The extracted liquid is then pumped into heated condensers to further concentrate the tea. The condenser slowly reduces the amount of water through evaporation. The precious oils, collected during the initial extraction process, are blended back into the resulting condensed paste. Following this phase, the process will differ depending upon the type of product.

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Teapill Manufacturing
To produce teapills, an herbal “dough” must be formed from this concentrated paste. We avoid adding inert fillers by powdering one or more raw herbs from the original formula and adding them to create a highly concentrated paste. The dough is rolled out and machine cut into small round pieces that are then spun into our superior quality teapills.

In the final stage, a tiny amount of talcum (hua shi) and activated carbon is added for smoothness. The teapills are coated with a fine layer of botanical wax to provide for easier swallowing and to help naturally preserve freshness. These excipients combined make up less than 1% of the pill.

Finished batches of teapills are tested for various quality assurance parameters including active ingredient constituents, moisture content, disintegration time, heavy metals (lead, arsenic, mercury, cadmium) and microbial contamination. These tests are performed on every batch of finished product. Following extensive in–house testing, heavy metal testing is conducted again at third party accredited labs to confirm results and to ensure that our standards of purity and safety are met.

Tablet Manufacturing
Like teapills, tablets are made by creating an herbal “dough” by adding a powdered herb that is an ingredient of the original decoction to the highly concentrated paste. This dough is then pressed into shape with carefully controlled pressure to ensure appropriate dissolution rate and absorption time when ingested. The amount of pressure used is crucial, as a balance must be reached between the dissolution rate and absorption time, and the hardness of the tablet.

Finished batches of tablets are tested for various quality assurance parameters including active ingredient constituents, moisture content, disintegration time, heavy metals (lead, arsenic, mercury, cadmium) and microbial contamination. These tests are performed on every batch of finished product. Following extensive in–house testing, heavy metal testing is conducted again at third party accredited labs to confirm results and to ensure that our standards of purity and safety are met.

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5:1 Extract Powder Manufacturing
The concentrated liquid used to make our 5:1 extract powders is decocted using the same low temperature distillation process as our teapills and tablets. Once decocted, the extracted fluid is piped into a circulating vacuum condenser for further concentration. As many chemical constituents are heat sensitive, heat damage is minimized by evaporation under vacuum to reduce the boiling point to between 70–75 degrees centigrade. Finally, all batches are combined and blended with the essential oils collected during the initial extraction process of making the concentrated liquid.

Spray Drying
Concentrated liquid from either a single herb or a formula is sent to a 20–foot vacuum drying apparatus to form a fine powder. The liquid concentrate is atomized into a mist and introduced into the spray–drying tower, along with a helix of hot air. As the small droplets make contact with the heated air, they release their moisture, become small particles, and spiral to the bottom of the tower. A short drying time – a matter of seconds, makes this method especially useful for material that is sensitive to heat. The methods we employ throughout the entire process, from extraction to drying, ensure that there is no point at which the medicinals may be burned.

Single Herb Extract Powders: Minimal Fillers or Carriers
The concentrated liquid is passed through a fine mesh filter before being spray–dried into extract powder. At this stage, measurements are taken to ascertain if the extract yield has achieved a 5:1 ratio of raw material to finished product. Individual herbs can vary significantly in the amount of physical substance they yield during extraction. Many do not have the needed substance to form a powder as described above, and a carrier such as dextrin is required.

A 20% yield produces a 5:1 ratio, and can continue on to the spray- drying process without the addition of fillers. If the yield is more concentrated (for example, a 10% yield, is technically a 10:1 ratio), this requires “dilution” with inert filler (such as dextrin) to conform to the 5:1 standard.

Extract Powders Excipients
We have chosen to use dextrin as the excipient in our single herb extracts where necessary. Dextrin can function as a carrier, filler, and drying agent. It is added to the liquid paste before the drying process, bringing the final product in line with the 5:1 ratio to achieve a more stable and uniform dosing standard. The dextrin used is 100% corn based (derived from corn starch) pharmaceutical grade material. Each batch of dextrin is extensively tested prior to use and results must conform to the established standards of the Chinese Pharmacopoeia before it may be used. The amount of dextrin used depends upon the nature of the herb and its natural extraction yield.

Formula Extract Powders: No Fillers or Carriers
While Plum Flower® 5:1 formulas are decocted, condensed and spray dried in the same manner as the single herbs, it is important to note that our 5:1 formulas do not contain any excipients. They are spray-dried directly from the condensed herbal decoction, and the resulting powder is the natural yield of the formulation.

Finished Product Quality Control
Every step in the above process has been detailed in a set of Standard Operating Procedures (SOP’s) and is overseen by highly trained personnel. Individual herb extract standards are set by a small committee within the Quality Control Department, which has developed optimal production guidelines for each herb by creating micro-batches in a laboratory environment.

After drying, each batch of finished powder is tested to our quality assurance standards for moisture content, dissolution, heavy metals (lead, arsenic, mercury, cadmium) and microbial contamination. Following extensive in–house testing, heavy metal testing is conducted again at third party labs to confirm results and to ensure that our standards of purity and safety are met.

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Plum Flower® unsulfured herbs
All Plum Flower® unsulfured herbs are the officially validated species as listed in the Chinese Pharmacopoeia or other government accepted Materia Medicas. This dedication to accuracy in our raw material selection helps ensure efficacy, and more importantly, safety, as substituted herbs may cause harmful side effects. Herbs are sourced from their indigenous regions, ensuring authenticity and quality. Most of our herbs are ordered directly from the growers and harvesting co–ops. Upon receipt, each herb is inspected to ensure correct species identification, proper maturity, and quality before it can be used in our products. Inspection is conducted by highly trained staff using macroscopic, microscopic, and sometimes thin layer chromatography (TLC) to confirm species. Herbs are tested also for sulfur dioxide residues and for certain pesticide residues.

Depending upon the type of herb, Plum Flower® herbs are cleaned by soaking, scrubbing, peeling, or rinsing in a rotating drum herb cleaner. Our herbs are processed according to Official PRC Pharmacopoeia and Materia Medica methods to reduce toxicity, modify herb characteristics, and to enhance efficacy. Further processing may include cutting, (by machine or hand), steaming, and drying. Some herbs are sterilized during the drying process using heat or steam heat. We developed proprietary methods to keep Plum Flower® herbs unsulfured, avoiding the typical manner of preserving herbs with sulfur dioxide. The processed and prepared herbs are vacuum packaged and nitrogen injected, either in between the double bags, or into the bag if singly bagged, to naturally preserve their freshness.

Finished batches of Plum Flower® unsulfured herbs are tested for various quality assurance parameters including heavy metals (lead, arsenic, mercury, cadmium) and microbial contamination. Herbs are also tested for DDT and Benzene Hexachloride pesticide residues. These tests are performed on every batch of finished product.

Liquid Extract Manufacturing
Plum Flower® brand liquid extracts are produced in a fully enclosed system. Once the lid of the extractor is sealed, the herbs are extracted, filtered, concentrated, and filtered again without exposure to air. Any additions, such as water and honey, are added and blended within various stainless steel containers and piped along until the product is finally ready for bottling. The product is not exposed to air until bottling to minimize any possibility of contamination. Only the extractors are exposed to air during cleaning, while the rest of the system is flushed between batches. These stringent and exacting production methods also allow us to provide products without preservatives or alcohol. The honey used is tested to be free of nitrofuran and chloramphenicol to further ensure the purity and safety of these products.

As with all Plum Flower® products, our liquid extracts are third party laboratory tested for microbial and heavy metal contamination and meet all of our rigorous quality control standards.

Capsule Manufacturing
A fine selection of Chinese herbal supplements is available in capsule form in the Plum Flower® brand. These capsules are prepared in the U.S. using a combination of Plum Flower® 5:1 Extract Powders and Plum Flower® unsulfured herb powders. The capsules used are vegetarian except for Tartarian Buckwheat and Gingko Biloba, which are encapsulated in gelatin capsules. Tartarian Buckwheat Capsules and Gingko Biloba Capsules also contain standardized extracts of some of their active ingredients for a more targeted product. Encapsulation service is also offered to licensed practitioners through our Prescription Service.

Infusion Manufacturing
Infusions are herbal extracts of single herbs or formulas that have been condensed into a granule form with sugar. The amount of sugar ranges from 7–40% depending upon the formula. This medium makes them more palatable, easy to administer, and simple to reconstitute into a tea when mixed with hot water. The manufacturing process that is used is comparable to the Plum Flower® 5:1 Concentrated Extract Powders. Many of the infusions offered by Mayway come from the Guangzhou Qixing Pharmaceutical Co. Ltd., an internationally GMP certified manufacturer and the proud producer of Star Ring® Brand.

External Use Manufacturing
A selection of plasters, liniments, ointments and creams and are distributed by Mayway Corp., that we do not import directly, so manufacturing information is limited. The only manufacturing information available for these products is printed on or contained with the product itself.

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