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Technology Articles

Ⅰ. Decocting difference between single Chinese herbal extracts and TCM decoction pieces

1. Objective and pertinent view on the function of decocting process
   Some prescriptions may generate some new ingredients after being decocted, such as coordinated complexes, molecular composites, products of chemical kinetics and so on. Only through a process from quantitative change to qualitative change, these new ingredients may increase efficacy, decrease efficacy, promote solubility, reduce toxicity or modify the whole prescription.
   However, in most cases, the amount of new ingredients is small, which can only collaborate or boost the efficacy and cannot affect the therapeutic effect of the original prescription. Moreover, the property of the newly generated compound is unstable, which cannot boost the efficacy and may reduce the whole efficacy of the prescription to some extent.
2. Rules of decocting process and TCM formula
   • Decocting process and formula requirements
     Decocting is not the rigid index of compound formula. Without decocting, some famous
     preparations can also be generated, such as Zhuge Xingjun Powders, Liuyi Powders, Ermiao Pills, Sanmiao Pills, Simiao Pills, Wuzi Yanzong Pills, Angong Niuhuang Pills, Zixue Pills, Zhibao Pills and so on.
   • Decocting process and the theory of the unique importance of chemical ingredients
     During the decocting process, the reaction processes and reaction products are uncertain, unstable, unpredictable and uncontrollable. If people go after the chemical reaction between compound medicines alone, it will definitely make the studies on TCM preparations fall into a dilemma. Thus, the theory of the unique importance of chemical ingredients is dangerous.
   • Decocting process and treatment based on syndrome differentiation, modification according to symptoms
     Formula adjustment together with amount adjustment: If the therapeutic effect of the whole prescription lies in the amount of some chemical components, the increase or decrease of some herbs in the prescription is impossible to guarantee the generation of new ingredients and maintain the equivalent amount. It violates with the treatment based on syndrome differentiation and modification according to symptoms.
     Amount adjustment without formula adjustment: The diversity and uncertainty of TCM
     prescriptions are also reflected by the increase or decrease of dosage. If there are chemical changes in the combined decocting process, the changes of TCM decoction pieces and the amount of ingredients may directly affect the results of chemical reactions. Thus, it is impossible to keep the new ingredients of chemical reactions constant.
   • Decocting process and efficacy
     Powders are the mixture of grinded medicinal materials. Pills are produced with grinded medicinal materials through bonding by water or honey. No decocting process is involved, thus there is no new chemical ingredient generated. However, from the clinical efficacy, different dosage forms of the same Chinese herbal compound may be used to treat the same kind of disease. It indicates that the effect of compound does not rely on the new ingredient generated in decocting process or no new ingredient is generated during the decocting process or even there is new ingredient, but it has no effect. Otherwise, only decoction can take effect, while pills and powders have no
     effect in clinic.
   • Report of separated decocting and combined decocting
     The study reports of separated decocting and combined decocting may be concluded as ‘one
     mainstream and several directions’.
     One mainstream: The mainstream holds that the efficacy of separated decocting and combined decocting is equal to or slightly higher than that of combined decocting. For instance, the study of Guangzhou University of Chinese Medicine indicates that the anti-inflammation, analgesic effect and safety of Paeoniae Radix Alba Single Chinese Herbal Extracts are higher than those of Paeoniae Radix Alba Decoction, while the difference in immunity enhancement and equivalent dose is not significant. The study of Hubei University of Chinese Medicine indicates that the content of hesperidin in Erchen Soup Formula Granules is slightly higher than that in the traditional decoction. The study of Chengdu University of TCM indicates that the efficacy of Chuanxiong Chatiao Powders constituted by single Chinese herbal extracts is exact. Compared with the TCM
     decoction pieces, the difference in the clinical efficacy of the single Chinese herbal extracts on 60 patients with headache caused by external contraction of wind evil is not significant. The study of Nanjing University of Chinese Medicine indicates that the efficacy of Traditional Banxie Xiexin Decoction and single Chinese herbal extracts is basically the same. Both of them can relieve pain, excrete gall-bladder, reduce serum bilirubin and increase bile flow.
     Several directions: There are slight differences in the products of chemical reactions and some treatment indicators and there are many manifestations. For instance, the study on the separated decocting and combined decocting of ephedra and earthworm conducted by School of Pharmacy of SJTU and Research Institute of Chinese Medicine of Shanghai University of Traditional Chinese Medicine indicates that with ephedrine and pseudoephedrine as indicators, the combined decocting is superior to separated decocting with total amino acids as indicators, the separated decocting is superior to combined decocting. West China School of Pharmacy Sichuan University has performed qualitative comparison by thin-layer chromatography on the formula granules and combined decoction of Wumo Decoction and Sini Powders and quantitative comparison by high performance liquid chromatography on paeoniflorin. The results indicate that the liposoluble components (petroleum ether extracts) and water-soluble components (n-butyl alcohol extracts) are basically the same. The contents of paeoniflorin in the separated decoction and combined decoction are slightly different. The diversified differences indicate that the explanation on the mechanism of Chinese herbal compound with one or some chemical indicators is partial.

Ⅱ. How do single Chinese herbal extracts stay the same with traditional decoctions

1. The feed intake is the TCM decoction pieces, which keeps the flavor and channel tropism of the single Chinese herbal extracts unchanged.
2. The TCM decoctions are decocted with water and the single Chinese herbal extracts are extracted with water as the solvent.
3. The basic theory of TCM is followed to extract the active ingredients or index ingredients in the TCM decoction pieces. As for the varieties of which the active ingredients cannot be determined, the ‘whole ingredient’ is extracted to reserve the ingredient characteristic of decoctions and keep the multiple effect of a single herb.
4. Different extraction techniques are used according to the properties of different herbs (those varieties which are not suitable to decoct or the products which are often grinded for use are directly powdered through modern micronization technique).
5. The single Chinese herbal extracts should not only control the consistency of a single variety, but also ensure the consistency of granules and decoctions. For compound prescription, the method of simulating the decoction reaction system and clinical verification is used.

Ⅲ. Selection and obtainment of medicinal materials 999 Single Chinese Herbal Extracts

1. The quality of medicinal materials is controlled from the source. The quality of 999 Single Chinese Herbal Extracts is controlled from the source. According to Research Guide of Single Chinese Herbal Extracts and Chinese Pharmacopoeia of 2010 Edition, medicinal materials records in the standards issued by the Ministry of Health and the local standards, the raw medicinal materials are selected from the nationally approved sources and places of origin at the harvest seasons. The quality of medicinal materials is controlled from the source.
2. Standardized procurement. The medicinal materials of 999 Single Chinese Herbal Extracts are provided from GAP planting bases. Other medicinal materials are all procured according to origins, harvest seasons and pharmacopoeia requirements. All medicinal materials are strictly inspected before warehousing.

Ⅳ. Feeding principle of single Chinese herbal extracts

The Production and Research Practice of Chinese Herbal Extracts (Trial) issued by China Food and Drug Administration and State Administration of Traditional Chinese Medicine stipulates that the feeding intake of single Chinese herbal extracts should be the decoction pieces prepared through the traditional techniques. It is to maintain the same active ingredients, property and flavor, function and efficacy with the TCM decoction pieces and to closely combine with the TCM theory.

Ⅴ. Specific to different varieties, how do 999 Single Chinese Herbal Extracts utilize different production techniques

1. Plant morphology characteristic: It mainly refers to the medical parts, such as roots, stems, leaves, flowers, fruits, seeds and entire grasses. There are large differences in the quality between different parts or between the same part of different varieties. Thus, different technique parameters are selected. For instance, Glycyrrhizae Radix et Rhizoma and Arnebiar Radix both belong to taproot medicinal materials, but there are large different in the quality. Glycyrrhizae Radix et Rhizoma is solid and hard to break up. It is difficult for solvent to immerse. Thus, the soaking time and extracting time are long. Arnebiar Radix is light and soft and easy to break up. Thus, it is not suitable for soaking and decocting too long.
2. Chemical component characteristic: It mainly refers to volatile components, heat sensitive components, oligosaccharides, greases and so on.
   • Varieties containing volatile components: Zingiberis Rhizoma, Chrysanthemi Flos, Schizonepetae Herba and so on. Volatile oils should be extracted.
   • Varieties containing oligosaccharides: Rehmanniae Radix, Codonopsis Radix, Asparagi Radix and so on. The components are easy to leach, so they are not suitable for soaking and decocting too long.
     Because of thermoplasticity, the drying temperature should not be too high.
   • Varieties containing starches: Dioscoreae Rhizome, Coicis Semen and so on. Because starches are easy to gelatinize after being heated, it is bad for active ingredients to leach. It is suitable for soaking for a long time and decocting for a short time. Starches are easy to agglomerate at high concentration, which will affect spray drying. Thus, the relative density of the extract should not be too high.
   • Varieties rich in greases: Cannabis Semen, Pruni Semen and so on. Because greases are hydrophobic components, it is bad for other components to leach and it will affect the drying of extracts. Thus, degreasing is necessary before the extraction.

Ⅵ. How do 999 Single Chinese Herbal Extracts ensure the content of volatile components

1. For the varieties requiring volatile oil assay stipulated by Chinese Pharmacopoeia, standards of the Ministry of Health and local standards, the dual-extraction method is adopted. Volatile oils (β- CD included) are extracted by steam distillation and other components are extracted by water extraction. The extracts are combined. It reserves the volatile oils to the maximum extent. For instance, Amomi Fructus and Amomum Cardamomum shall be extracted by this method.
2. For other varieties with aromatic smell and acrid flavor, such as Schizonepetae Herba, Saposhnikovia Radix and so on, because the content of volatile oils is low, the extracting time and temperature should be reduced to ensure the content of volatile components.

Ⅶ. How are the quality standards for 999 Single Chinese Herbal Extracts made

1. Identification study: The authenticity of the single Chinese herbal extracts is identified through the types of chemical components. The common methods include thin-layer chromatography, high performance liquid chromatography, ultraviolet spectroscopy, specific chemical reaction and so on. Based on a large number of experimental studies, one or several identification methods which have strong reproducibility and specificity are selected. Negative control, standard control and medicinal material control are required.
2. Assay study: The quality of the single Chinese herbal extracts is specified through the content of index components. The common methods include thin-layer chromatography scanning, high performance liquid chromatography, ultraviolet spectroscopy, volumetric method and so on.
   Based on a large number of experimental studies, one or several determination methods which have high stability, high precision, high reproducibility and high reliability are selected. It is based on the determination of 10 batches of samples and 20 data.
3. Stability study: It is to investigate the influence on the chemical, physical and biological stability of the single Chinese herbal extracts by various factors. Sample observation is used to detect the character, index component content and microbial limit of the single Chinese herbal extracts regularly (3-6 months) in order to determine the shelf-life.

Ⅷ. How long is the shelf-life of 999 Single Chinese Herbal Extracts

The shelf-life of 999 Single Chinese Herbal Extracts is 3-5 years. The shelf-life is determined according to the results of stability test. It is determined through investigating the influence on chemical, physical and biological stability by temperature, moisture and other factors.

1. Sample observation: Samples are stored for half a year, one year, two years or longer at room temperature. The chemical, physical and biological stability is tested regularly. The test results are analyzed and summarized to determine the shelf-life. This method fits the actual storage conditions and has high reliability. However, it will cost a long time, especially the drugs which are slow in changes.
2. Chemical kinetics: It is to predict the shelf-life through simulating the kinetic reaction that is most similar to the test drug. Because the storage environment is different from the actual conditions, this method can only be used as reference. It had better combine with sample observation to have mutual control.
   The shelf-life of 999 Single Chinese Herbal Extracts is determined by the aforementioned two methods.

Ⅸ. Requirements on storage conditions of 999 Single Chinese Herbal Extracts

The requirements on storage conditions of 999 Single Chinese Herbal Extracts are relatively low.
They are stored in a cool and ventilated place, avoiding exposure, high-temperature and moisture.
There is no special requirement.

Ⅹ. What are the excipients added during the production process of 999 Single
Chinese Herbal Extracts

In order to keep the original taste and flavor of the TCM, CR Sanjiu tries its best not to add preservative and excipient during the production process of 999 Single Chinese Herbal Extracts.
As for the TCM containing saccharides and polysaccharides, a small amount of excipient is added during the granulation process. No excipient is added in other steps. The used excipients are soluble dextrin and lactose which meet the standards of Chinese Pharmacopeia. Lactose is 100% soluble in water.

Ⅺ. Why do some single Chinese herbal extracts agglomerate

999 Single Chinese Herbal Extracts are ‘original’ TCM without any additives. A small part will agglomerate due to their own viscosity; it is normal and will not affect the efficacy. The agglomerated content will be dissolved through boiling and stirring for a while.

Ⅻ. Why are some single Chinese herbal extracts hard to dissolve or undissolvable

1. The TCM decoction contains solution, suspension, emulsion and colloid. The suspension, emulsion and colloid all contain different degrees of ‘undissolved substances’. These ‘undissolved substances’ are all medicinal components.
2. Some valuable medicinal materials are powdered to used as drugs and hard to dissolve.
3. It may be caused by wrong dissolving method, such as the water temperature is low or the stirring is insufficient.

ⅩⅠⅠⅠ. Which kind of varieties of 999 Single Chinese Herbal Extracts use the preparation method of powdering

For some valuable, animal and extraction-sensitive TCM varieties, the preparation method of powdering is used, such as Notoginseng Radix et Rhizoma Powders, Draconis Sanguis, Aquilariae Lignum Resinuatum Powders, Fritillariae Cirrhosae Bulbus Powders, Indigo Naturalis Powders, Rhei Radix et Rhizoma and so on.

ⅩⅣ. Why there is difference in color and taste between different batches

It is caused by the different drying temperature of each batch of medicinal materials. The delivered single Chinese herbal extracts are qualified products and the quality is guaranteed. Please be assured to take.

ⅩⅤ. Application of modern analysis techniques in the identification of medicinal materials

The identification of medicinal materials is mainly to identify the authenticity, purity and quality. Since 1990s, CR Sanjiu Quality Center has applied modern analysis techniques to identify traditional Chinese medicinal materials. In Volume One of Chinese Pharmacopoeia of 2005 Edition, thin-layer chromatography can be used for identifying 1523 items and assaying 45 items; high performance liquid chromatography for assaying 479 varieties and 518 items; gas chromatography for identifying and assaying 47 varieties. Fingerprint chromatography is mainly used for the varieties of which the active ingredients or index components are systematic, thorough and clear. Fingerprint chromatography can be applied to 237 varieties, accounting for 40.9% of the recorded varieties.

ⅩⅥ. TCM fingerprint chromatogram

TCM fingerprint chromatogram refers to the common peak chromatogram that can mark the characteristics of the TCM after the appropriate treatment through analysis means. Within certain ranges, the TCM fingerprint chromatogram can basically reflect the general view of the TCM, enhancing the quality control index from the determination of a single component to the detection of the internal quality. It can be used to identify the authenticity and evaluate the quality uniformity and tability of the medicinal materials, semi-finished products and finished products. Fingerprints can reflect the differences caused by the origins and harvest seasons.
The fingerprint chromatogram is used to set up the quality standards for Chinese herbal extracts and control the quality of Chinese herbal extracts. It can be used to comprehensively evaluate the product quality and overall control the whole substances, which is real, stable and consistent.

Application Articles

Ⅰ. Application scope of single Chinese herbal extracts

The single Chinese herbal extracts are applicable to the specific diseases and other diseases that can be treated by TCM decoction pieces. They can be taken orally, used for fuming and washing, clystering and wet compressing or used as patches, nourishments and health care products.
They can be used just after dissolution. It is fit for emergencies, officer workers, migrant workers, students, business travelers, tourists, disables and the elderly.

Ⅱ. Directions of taking single Chinese herbal extracts

Pour a daily dose of single Chinese herbal extracts into a cup. Soak it with a small amount of warm water, then stir approximately. Add boiled water to about 300ml and stir till the solids are fully dissolved. Stand still and let it cool down to warm. Take it at a time or divided it into two portions and take it in morning and evening (follow the doctor’s advice). Heat the solution or add hot water when taking in the evening. Children’s dosage, use directions and use for fuming and washing, clystering and wet compressing or used as patches should follow doctor’s advice.

Ⅲ. What are the advantages of single Chinese herbal extracts bring to hospitals

1. They enrich the pharmaceutical composition, satisfy patients’ choices and enhance patients’ satisfaction to hospitals.
2. They are fit for emergencies, officer workers, migrant workers, students, business travelers, tourists, disables and the elderly.
3. They can attract patients to visit hospitals, expand the clinical applications of drugs and increase the income of hospitals.
4. They enhance the modernization of pharmacies, make the management convenient and save manpower and material resources.
5. No decoction room, medicinal materials warehouse and relevant equipment is needed. The
   expenditure of hospitals is saved.

Ⅳ. What are the advantages of single Chinese herbal extracts bring to clinicians

1. The single Chinese herbal extracts fully follow the basic TCM theories and fully exert the advantages of TCM.
2. The standards for drug quality are strict and the safety is high.
3. They meet the application demands on TCM of ER physicians and pediatricians, enhancing the emergency capacity of TCM.
4. The efficacy is stable and is good for reflecting the curative intent, increasing cure rate and enhancing popularity.
5. The efficacy is stable, which is convenient for clinical curative effect observation and experience summary and shortens the cycle of experience summary.
6. They are convenient for scientific research projects and the components are stable, which is good for obtaining the scientific and objective results.
7. The product quality is consistent, enhancing the reproducibility and reliability of scientific researches.
8. The index components are objectified. The mechanism of drugs can be specifically studied to find new therapeutic effects.
9. They can satisfy the different demands of patients and enhance patients’ satisfaction to clinicians.

Ⅴ. What are the advantages of single Chinese herbal extracts bring to patients

1. The safety and efficacy are more assured, which is beneficial to the relief and cure of diseases.
   The quality of single Chinese herbal extracts is strictly controlled. The indexes of heavy metals, pesticide residues, microorganism and chemical pollution are strictly detected. The safety is high and the efficacy is more assured.
2. They can shorten the course of treatment, save medical expenses and reduce patients’ burden.
   The single Chinese herbal extracts have strong potency and high efficacy, and they are easy to be absorbed. They can help physicians to master the most appropriate treatment opportunity. They are beneficial to shortening the course of treatment, enhancing response rate and saving medical costs.
3. The single Chinese herbal extracts are small and light, which is convenient to carry and store. The shelf-life is long.
4. The single Chinese herbal extracts can be directly dissolved for use. The volume is largely reduced.
5. The invisible wastes caused by uncertainties during the decocting process are avoided and the utilization ratio of TCM is increased.
6. They can meet the demands of officer workers, students, migrant workers, business traveler and tourists, keeping the promptness and continuity of TCM.
7. They are especially suitable for special population whose self-care capability is poor and disables.
8. The problem of spending a lot of time in waiting and the difficulty in ‘taking medicine’ are improved.
9. The health care and treatment service of TCM can be enjoyed by more people.