New technology and equipment for production of traditional Chinese medicine oral liquid
At present, the domestic Chinese medicine oral liquid preparation process still needs improvement, mainly in the formulation of the bacteria test and the clarity index is unqualified, the drug active ingredient loss is serious, the energy consumption is high, and the production cycle is long. Tannins, resins, starches, pectins, mucilages, pigments, etc. in traditional Chinese medicine oral liquids are often removed as impurities in the preparation, but due to current production technology limitations, some impurities have not been removed, during the placement process. The finished product will precipitate. The production of traditional Chinese medicine oral liquid mainly adopts water extraction and alcohol precipitation method or percolation method. Water extraction and alcohol precipitation method The effective components of various drugs (flavonoids, saponins, alkaloids, organic acids) have a primary alcohol deposition loss rate of about 10% to 15% ; and the bee milk concentrate produced by the percolation method, according to Tianjin The Institute of Pharmaceutical Research determined that the content of ginsenoside in the traditional Chinese medicine solution prepared by a factory was 0.194 mg/10 ml , and the amount was only 0.039 mg/10 ml when the finished product was filled , accounting for only 20.1% of the formula content , most of which was Lost during freezing and filtration.
   The high molecular impurities in the liquid of the Chinese medicine have a hydrophilic group and a hydrophobic base, and the aqueous solution is a colloidal solution, which is the main reason for product precipitation. The development of membrane separation technology provides a new method for removing high molecular impurities in Chinese medicine oral liquid. Ultrafiltration is the ideal unit operation of large and small molecules in solution. Generally, the relative molecular mass of the traditional Chinese medicine component is small, and the relative molecular mass of the ineffective component is large. Therefore, the ultrafiltration method can be used to remove the polymer impurity without losing the active ingredient of the drug. Due to the high turbidity and high viscosity of traditional Chinese medicine extracts, the application of ultrafiltration in traditional Chinese medicine oral liquid is still in the experimental exploration stage. The technology and equipment experts who have not applied to industrial production have selected appropriate ultrafiltration membranes according to the molecular properties of saponins. The ultrafiltration device TUOL-1 oral liquid filtration device was designed and manufactured to keep the filtration rate of the liquid and the external force of the membrane small, so that the ultrafiltration membrane with weak strength can be applied to the production of Chinese medicine oral liquid. And applied to production for many years, take good results.
1 . Production process and equipment
1.1 Process: The new process is: extract → filtration → liquid preparation → ultrafiltration → potting.
   This process was applied to the production of bee milk oral liquid to replace the original freezing and standing process. The original process is: tincture → semi-finished product preparation ( stands for 15 days below 5 °C ) → filtration → finished product preparation → ( stands for 15 days below 5 °C ) → filtration → re-filtration → can seal.
1.2 New process characteristics: 1 The finished product liquid is not precipitated externally; 2 Energy and ethanol are saved, the production efficiency is improved , and the product cost is reduced; 3 The active ingredient with more drugs is retained, and the drug effect ingredients and formula of the finished drug liquid are saved. Consistent.
1.3 Equipment performance: Ultrafiltration equipment TUOL-1 oral liquid filtration performance indicators: 1 processing capacity: 50 ~ 30L / h ( 0.5 ~ 30,000 / hour); 2 operating pressure: ≤ 0.1Mpa ; 3 operating temperature: 5 ° C ~ 40 ℃; ④ resistance pH range: 3 ~ 11 (40 ℃) .
1.4 Ultrafiltration flux: In the production of bee milk essence oral liquid, the relationship between the flow rate and time of the finished drug solution obtained by ultrafiltration is shown in Fig. 1. Generally, the production task can be completed in 3~5h .
1.5 Equipment cleaning 5 Equipment cleaning: Membrane cleaning and regeneration is the key to the successful application of membrane separation technology. This process uses warm water to wash out the residual bee milk in the module, and wash the membrane with distilled water with 0.7% cleaning agent. Then use the external pressure type operation, backwash the membrane until there is no foreign matter, and the distilled water after the Zui uses the internal pressure type to rinse the membrane. The cleaning effect is shown in Figure 2 .
2 . Results and discussion
   The production practice proves that the quality of the bee milk product produced by the above new technology and equipment is significantly higher than the original process (Tables 1 and 2 ), and the preparation has no precipitation after 20 months. The content of ginsenoside and 10-HDA in the finished product is consistent with the formula. (Table 2 ).
  As shown in Table 1 , the purpose of removing the bacteria, impurities and clarifying the liquid can be achieved by the process, and the finished liquid is not precipitated for a long time.
   Table 1 Quality analysis of bee milk products produced by the new process
                                                  New craft products                            Quality Standard
   Relative volume mass ( 20 °C ) 1.15~1.20 1.15~1.20
   Ethanol content ( 20 °C ) ≤1.0% ≤2.0%
bacteria    Check                                     No cell                       ≤100 a bacteria, molds ≤100 months
≤0 a pathogen
   Table 2 The results of the determination of the active ingredient content of the bee concentrate
Bee milk concentrate          Original process          New Technology
Ginsenoside ( mg/10mL ) 0.147 0.015 0.155
10-HAD 0.299 0.133 0.2712
   Determination method of ginsenoside content: Take a certain amount of sample, dilute under reduced pressure, add water to deep solution, alkalinize, extract with n-butanol, wash with water, concentrate to dryness, and add methanol as sample solution. The spot was placed on a high-performance silica gel G plate, developed with a CAMAG expansion groove, scanned with a Shimadzu CS-901 thin layer scanner, and a standard curve was prepared according to the reference ginsenoside Re measurement to calculate the ginsenoside content in the sample solution.
Bee milk concentrate          Original process          New Technology
Ginsenoside ( mg/10mL ) 0.147 0.015 0.155
10-HAD 0.299 0.133 0.2712
   Determination method of ginsenoside content: Take a certain amount of sample, dilute under reduced pressure, add water to deep solution, alkalinize, extract with n-butanol, wash with water, concentrate to dryness, and add methanol as sample solution. The spot was placed on a high-performance silica gel G plate, developed with a CAMAG expansion groove, scanned with a Shimadzu CS-901 thin layer scanner, and a standard curve was prepared according to the reference ginsenoside Re measurement to calculate the ginsenoside content in the sample solution.
Determination of 10-HDA content: Take a certain amount of sample, acidify with hydrochloric acid, add diatomaceous earth to form a uniform dispersion, extract, deepen, add ethyl acetate into a sample solution, and use CAMAG IV automatic spotting device to The high-performance silica gel GF254 thin-layer plate was used to scan with a CS-9000 thin - layer scanner, and the standard curve drawn by the 10-HDA measurement of the reference substance was summarized to calculate the content of 10-HDA in the sample solution .
   As shown in Table 2 , the new process has almost no loss of medicinal ingredients, while the original process indicates that the effective component loss rate is higher than 80% . Since the medicinal ingredients and the formula of the new process finished liquid are basically the same, the efficacy is better ensured. At the same time, the removal of the non-medical component of the polymeric viscous substance further stabilizes the quality of the liquid, accelerates the absorption of the drug, and improves the efficacy.
   The use of the process can save the precipitation process of the chemical solution in the traditional process, and save the energy and ethanol, improve the production efficiency, and realize continuous production. The method is applicable not only to an oral liquid produced by the percolation method represented by the bee milk oral liquid, but also to an oral liquid produced by the water extraction and alcohol precipitation method.
3 . in conclusion
   Experiments show that the new process of Chinese medicine oral liquid production is simple, the production cycle is shortened, continuous production can be realized, and many problems in intermittent production are avoided. If the process is widely used in production, it will help to improve the competitiveness of traditional Chinese medicine preparations in the international market.
Note: This information is from the network and is only used for technical communication.
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