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Specification of Design
1. Overview
Injection is widely used in the Chinese market. Its demand is constantly rising. The traditional Chinese medicine injections have more huge market potential. This Specification is for the design of ship SHLI. This object as detoxification, for the common cold, fever, cough and sore throat, has a good effect. It is a daily ordinary medicine. The annual output of 10 million bottles SHLI has just meet market with demand, and reduces the cost.
According to "Chinese Pharmacopoeia" process requirements, honeysuckle, forsythia and Scutellaria are using as raw materials, to cut and grind in this design. The Scutellaria and honeysuckle, forsythia extract respectively. Using the ingredients as a concentration of 2mol/L hydrochloric acid，40% sodium hydroxide solution, and ethanol. Prepare Scutellaria extracts and honeysuckle, forsythia extract. And then dilute the extracted materials. At last, canning production as 10 ml bottle with SHLI. The main component is bacilli, chromogenic acid and Forsythia. Working for 300 days. Make bottles a day.
2. Process Calculation
Process calculations include material balance, heat balance and equipment selection.
A. According to the scale of production, calculated the demand for ampoules.
B. Scutellaria is purified by acid-base many times. The final product was dried to obtain an extract. Honeysuckle and forsythia is by concentrating and alcohol distilling to obtain concentrated dosing. According to Chinese Pharmacopoeia’s content requirements, calculating the material balance for these two process routes to determine the daily demand for traditional Chinese medicine raw materials.
C. Ethanol as a solvent of Chinese herbal medicines in this design is high demanded. And industrial ethanol is expensive. Therefore, the use of recycled ethanol is necessary. According to "Chemical Process Design Manual" designed water - ethanol distillation column, distillated ethanol and obtain 95% ethanol.
D. According to the material balance content and the process requirements, selecting equipment, and to determine the number of equipment units.
E. In order to ensure the extraction of traditional Chinese medicine, choosing the centrifuges to make sure the main ingredient completed precipitation. While the dissolving tank, stirring blades were designed to make Chinese the main ingredient is completely dissolved.
F. Compare the purified water system, and select equipment preliminary.
G. According to production needs, select device for ampoule linkage
H. Calculate for the heat, to know the overall process energy generated by consumption generally.
3. The Part of Non-Technical Design
After completing the three count content， design the ship by using the data above. All designed according to current GMP standards and "Chemical Process Design Manual" requirements.
A. Area was pided by cleanliness requirements in this design. Concentration layer is A grade cleanliness area and finished packing area is B grade cleanliness area.
B. People are the largest pollution for cleanliness workshop. This design implements flow, logistics persion.
C. For using space efficiently, this design is a rectangular floor workshop, and production area of 51.5m × 22.5m. As required, the floor for the distillation column and material handling using potential difference need to heighten.
D. Depending on the temperature and humidity clean room requirements, design pressure, and the corresponding air supply system, air conditioning system.