Traditional Chinese medicine (TCM) formulaparticles are a series of formula particles made from TCM decocting piecesthrough extraction, concentration, drying and some other processes, whichcombines modern science and technology and traditional TCM methods likedecoction and steaming. As a result, they keep the property, flavor and functionof TCM decocting pieces, as well as stable and reliable quality. It meets theneed of prescription adjustment and diagnosis and treatment based on an overallanalysis of the illness and patients' condition

Product description

●  Guide researches and production according toTCM theory

●  Use water as a solvent to extract allingredients of herbs

●  Choose appropriate production technologyaccording to individual characteristics of each herb

●  Extract essential oil from herbs to preservetheir flavor

●  Use low-temperature concentration and instantdrying to reduce damage of heat-sensitive components

●  Administer strict quality control system toensure accurate dosage and stable quality

● Heavy metals,pesticide residues, aflatoxin and other harmful substances all meetinternational standards

●  Clean, boiling-free, portable and easy totake

Ultra-finely grounded decocting pieces areobtained after grounding herbs according to physics principles. As no dregs areremoved, there is no significant reduction of dosage. The preparation offormula particles, however, is based on the boiling technology of decoction,which uses water as a main solvent in extracting all ingredients and removingdregs or other useless components. As a result, they have clinical advantageslike small dosage, easy absorption and quick effect.

Comparing with TCM formula particles, herbwater has weak concentration if it is produced by drug-decocting machine, whichholds low efficiency of exaction. The machine, which boils all herbs together,cannot adjust processes according to the characteristics of each drug, so thetraditional decoction methods are unnable to be applied, like change of boilingsequence, gentle heat, high heat, melting by heat and so on. For example, decoctingpangolin scales takes 20 hours, whereas decocting mankshood pieces needs 6 hours;herbs with essential oil will lose a lot of oil during decoction, and the herbwater is rapid to deteriorate, difficult to store, and inconvenient to carry.

At present, disordered kinds of ready-preparedChinese medicine, whose sources and quality vary widely, coexist in market. Traditionalpills and powder are directly obtained from grinding herbs.As form of traditonalChinese medicine, modern ready-prepared Chinese medicine, however, also includesuch new forms of TCM as extraction and purification. The prescription of ready-preparedChinese medicines is fixed with limited indications; its clinical applicationremains comparatively fixed regardless of different conditions of patients. TCMformula particles, on the other hand, are modern decocting pieces which enabletraditional herbs to be applied individually. They help TCM doctors prescribemedicine and adjust dosage according to the conditions of each patient, whichminimize the side effect of drugs while treating diseases.

TCM formula particles are produced based ondecoction requirements of TCM. Their basic processes, adjusted according toindividual kind of herbs, include medicinal herb selection, processing,extraction, concentration, drying, granulating, packaging and test.

The shelf life of TCM formula particles isthree years.

The stability of drugs includes their physical,chemical and microbial stability. Physical stability refers to the change ofdrug stability due to physical changes, such as moisture absorption, adhesion,discoloration and melting of granules. Microbial stability changes when drugsdeteriorate because of bacteria, molds or other microorganisms. Chemicalstability changes because external factors affect drugs, or because the drugsand other ingredients of preparations produce chemical reactions. The mainchemical changes include oxidation, hydrolysis, reduction and photolysis etc.

To decide the shelf life of TCM formulaparticles, stress test and accelerated test should be performed first, whichwas followed by sample investigation at room temperature.

Stress test may be performed to research thesensitivity of drugs to light, heat, humidity, and air. As is proposed inCollection of Guiding Principles on Pre-clinical Research of New Drugs by Bureauof Drug Administration of Ministry of Health, new drugs and their preparationneed be exposed to the conditions of air, strong light irradiation, hightemperature and humidity before their application for clinical test. During theexposure, sample drugs several times to observe the changes of theirappearance, content and some related quality indicators. Test items should alsobe chosen based on the kinds of preparation besides the examination of degradationproducts. Raw materials of drugs used in test should be spreaded to the allowedthickness, and the packaging of preparations should be removed in order tounderstand the inherent nature of drugs and provide information for storage,prescription and processing conditions. The appropriate storage conditions aredecided according to the results of these tests.

During accelerated test, strong stress isimposed on medicine within a short time in order to accelerate its reactions;then its shelf life can be calculated by using some certain methods. Since reactionrate of most drugs accelerates significantly with increasing heat, temperatureis usually selected as strong stress.

During sample investigation at roomtemperature, samples are stored at room temperature in sample chamber withtheir factory packaging; then sample and test them in different time todetermine the changes of their quality indicators. If no obvious change happensin three years, samples should continue to be stored in order to providedetailed information of their stability. Based on the results of investigation,the storage conditions and shelf life of unstable drugs will be decidedaccordingly.

The price of formula particles is about 30~ 40% higher than that of decocting pieces based on converted specifications.The raw materials of the formula particles are selected from the decoctingpieces that meet pharmacopoeia standards, and then go through aseries of industrial processes and whole-process quality control. It is thereforeunderstandable that the price of TCM formula particles is somewhat higher than thatof decocting pieces. Although the products of the formula particles share thesame scope and methods with the decocting pieces in clinical application, theformer has become a new distinct variety rather than a form of decocting pieces.They overshadow decocting pieces by their stable quality, reliable effectiveness,safety, convenience and sanitation.

Prices of TCM formula particles depend onthose of raw materials and production processes. General speaking, theproduction processes of the same kind of medicine - flowers, roots, for example- are similar, which results in similar production cost. Therefore, prices ofraw materials of the same kind of medicine significantly affect prices of theproducts. For instance, the production of each bag of herbal roots -that is 10gof decocting pieces - costs RMB 0.20 yuan. If raw materials of some kind take RMB0.60 yuan, then its product will be charged about RMB 0.80 yuan. Compared with originaldecocting pieces, the price of its particles only increases slightly. On theother hand, the price of products increases greatly if the raw materials of themedicine cost only RMB 0.10 yuan.

Traditionally, people have becomeaccustomed to and accepted the taste of TCM decoction. There is also a sayinggoing among them which says "A good medicine tastes bitter". In fact,Chinese medicine itself has five tastes: pungent, sweet, sour, bitter andsalty. So bitterness is not the only taste of different kinds of decoction; itis just the fixed impression of most people on TCM tastes. Generally speaking,the soup of TCM formula particles, whose flavor is relatively pure, cannottaste worse than traditional decoction. Besides, the small dosage of TCMformula particles avoids unbearable bitterness for patients. For those who arenot forbidden taking sugar, they can add a certain amount of sugar into themedicine. Moreover, we're now developing some seasoning which serves similarrole as coffee mate.

1,Usage: take one dose of drug prescribedby your doctor, cut each bag along its reserved incision, pour the medicineinto one cup, wet it with a little of boiling water and then add 250 ml more(about two-thirds of a cup), stir it until the medicine is dissolved, and placethe solution to let it cool or warm. Take it once respectively in the morningand in the evening. Before taking it in the evening, add some hot water intothe solution or simply heat it to increase its temperature.

2, Notes: (1), Be sure to use boiling water(90-100℃).

(2) After adding some water, stir thesolution for 0.5 ~1 minute until it is fully dissolved.

(3) Water must be sufficient.

(4), Some precious crude medicines are undissolvablebecause they are ultra-finely grounded at first and then used as medicine. Shakeit with water before taking.

Some kinds of formula particles areinsoluble or partially insoluble, or just slowly dissolved.  Such phenomena appear for two reasons:

(1) Some particles - like fritillary bulb,rhizoma gastrodiae, scorpion, centipede, Chinese eaglewood, panax quinquefoliumand panax notoginseng - are made from herbs through micronization, so they aresimilar to powder with insolubility and precipitation.

(2), Some seed or root products - like plantainseed, semen cuscutae, pinellia tuber - produce cloudy phenomenon or floccule duringdissolution, especially when the medicine liquid is cool. This is because someingredients in the products dissolve in relatively hot liquid and condense inrelative cool solution.

Being difficult to dissolve, which isfrequently described as insolubility by patients, is mainly resulted fromimproper preparation, such as using water with too low temperature or mixinginsufficiently.

Why do very few patients produce internalheat after taking formula particles?

Internal heat refers to the dryness,discomfort or pain of throat which occurs after some patients take TCM. Thesymptoms appear for the following reasons:

(1) Patients themselves have hyperactivityof fire due to yin deficiency, and so produce internal heat after taking somehot-property medicine.

(2) Spraying, drying, and other heatingprocesses are involved in the production of TCM formula particles. According toTCM theory, drugs will become a little hotter after being fried or heated, andso cause very few patients to produce internal heat.

(3) In their clinical practice, doctorsshould adjust prescription according to specific conditions of patients, whichwill extinguish internal heat quickly.

The phenomena of internal heat mainly focusin southern regions, such as Guangdong, Guangxi, Hong Kong, etc.

Most of TCM formula particles only containoriginal ingredients, except for those who are difficult to form particles,which may therefore contain less than 5% of biological polymers. Because manyraw materials of drugs contain starchy ingredients, people with diabetes shouldfollow doctor's instructions when considering taking these drugs.

Academic debate never disappears inhistory. Without it, science will stop developing. But the academic debate ofsingle or mixed decoction becomes a key factor that even now TCM formula particleshave not seen their proper development. The view held by some people that onlymixed decoction is consistent with TCM theory, which is a misconception,because the essence of TCM prescription is choosing and combining major, minor,adjuvant and envoy drugs according to causes and symptoms of diseases as wellas TCM theory, rather than mixed decoction. Although TCM formula particlesadopt single decoction, they still prescribe drugs according to patient'sconditions, which does not violate the essence of TCM:

(1) Mixed decoction is not the only way.Eighteen Clashes and Nineteen Incompatibilities of TCM tradition are typicalexamples of single decoction.

(2) Modern pharmacology has confirmed thatthe precipitation between alkaloid and tannic acid reduces medicinal effect.

(3) The drug forms of pills, powder, pelletadopted by the ancients are all single decoction, rather than mixed decoction.

(4) The attenuation of herbs happens duringprocessing. Decoction is not reliable for attenuation.

In all, researches aiming at theinteraction of ingredients during single or mixed decoction do not comply withTCM theory. It's also the reason why no development has been made in complexprescription research for several decades.

In addition, as one of the top researchissues of the State Administration of TCM, the comparison of clinical effect of10 classic prescriptions between mixed and single decoction demonstrated thattherapeutic effects of TCM formula particles and decoctions are basically thesame.