Production and Quality Control

Production Technology

Planting of Raw Medicinal Materials

In accordance with the principles of genuine place of origin, correct growing environment and no pollution, CR Sanjiu has established GAP plant bases in 10 provinces across the country. In these bases, more than 300 kinds of different herbs are grown under conditions which heavy metals and pesticide residues are effectively controlled and effectiveness of raw medicinal materials is assured.

Identification of Traditional Chinese Medicinal Materials

In order to determine the authenticity and quality, the identification of traditional Chinese medicinal materials includes species  dentificationand quality identification. According to the standards in Chinese Pharmacopoeia, CR Sanjiu has set up strict enterprise standards. Through origin identification, character identification, microscopic identification, physical and chemical identification, CR Sanjiu ensures that the varieties of the medicinal materials are consistent with Chinese Pharmacopoeia.

Preparation of Traditional Chinese Medicinal Materials

The preparation of traditional Chinese medicinal materials is the crystallization of thousand years’ experience in using TCM and is a feature of TCM.

Extraction

The standard method for preparing extracts is established based on the traditional decoctions. According to different medicinal materials, the soaking time, water amount, extraction times, extraction duration and other technological parameters are strictly studied through  rthogonal test with the index component content, extraction amount, extract and specific chromatogram as indicators.

Concentration

The comprehensive assessment is conducted with the change in index component content and the change in similarity of specific  hromatogram before and after concentration as the indicators. The vacuum, temperature, time of concentration and the relative density of extracted liquors are analyzed to establish the concentration parameters and determine the appropriate concentration method.

Drying

According to the specific characteristics of different medicinal materials, the characteristics of dry powders, the change in index component content and the change in similarity of specific chromatogram before and after drying are studied to select and optimize the technological parameters of the drying method. Now, the common drying methods are spray drying, vacuum drying and ambient pressure drying.

Granulation

Products are granulated through dry granulation (tabletting, crushing and granulation). Excipients are not added during the granulation. If necessary, the type and amount of excipients must be investigated respectively. The granulated products have good mobility, are not easy to absorb moisture and are convenient to store.

Packaging

999 Single Chinese Herbal Extracts are packaged into sachets or bottles. As for sachets, the products are packed in aluminum plastic films, which have beautiful appearance and good sealing. It is easy to carry. The bottles corollary use with the modern intelligent TCM pharmacy
which varieties of different particles uniformly mixed and divided into other measurement encapsulated in a separate case. Patients take
great convenience to carry and store.

Quality Inspection of Finished Products

The quality inspection of finished products is the last guarantee for controlling qualified products. The inspection includes the determination of characters, granularity, water, solubility, content uniformity, heavy metals, pesticide residues, microbial limit and content.

Storage and Delivery

After careful package, the single Chinese herbal extracts are tagged with a uniform bar code and sent to an assigned warehouse. The warehousing and delivery are controlled by computer barcode management system, avoiding the errors occurred during stocking and delivering.

Production Technology Example of Special Species

Menthae Haplocalycis Herba

The method of decocting with water is used. The volatile oil is collected during the decocting process. The decocting liquid is depressurized, concentrated and spray dried. Meanwhile, the aromatic water collected during the decocting process is extracted again to collect the volatile oil. The volatile oil is combined with that collected during the decocting process. β-cyclodextrin (β-CD) is included. The mixture is dried at low
temperature. The inclusion compound of volatile oil and β-CD is mixed with the spray-dried powder of TCM decoction pieces. The mixture is granulated through dry granulation.

Production Process

Three-stage Quality Control