Abstract: The prescription of pudi blue anti-inflammatory granules originates from the "Pudi blue anti-inflammatory tablets" on page 187 of the 3rd volume of the "Ministry Standards" of human medicine, which is made of skullcap, dandelion, kudidine and plate blue root four-flavor medicinal herbs by extraction, which has the effect of clearing heat, detoxification, anti-inflammation and swelling, and is used for the treatment of cough and asthma evidence induced by chicken infectious bronchitis. In this paper, the pharmaceutical research, pharmacological research and clinical research of Pudilan are elaborated separately.
Livestock breeding is facing more and more diseases, of which viral diseases are mainly vaccine prevention, once the disease occurs, it can only be treated symptomatically, or culled; bacterial diseases are mainly treated with antibiotics, long-term, large-dose, and even irregular antibacterial drugs are used, and clinically resistant bacteria are widespread. Detoxification and detoxification chinese medicines have good prevention and treatment effects on viruses, bacteria and mixed infectious diseases.
The traditional farming model of "relying on antibiotics to improve efficiency" faces many hazards:
(1) Decreased immune function of animals; (2) Threats to animal and human health by drug-resistant bacteria; (3) Drug residues in livestock and poultry products endanger human health. Modern healthy life is challenged by the traditional breeding model, food sampling antibiotics are many problems, veterinary antibiotics through food will enter the human body. Chinese medicine originates from nature, and 40% of commonly used Chinese medicines are homologous varieties of medicine and food, which is in line with the development trend of green aquaculture. In the context of food safety, Chinese medicine is a combination of traditional Chinese medicines for poultry heat detoxification and detoxification, which can effectively prevent and control viral and bacterial diseases with the highest incidence in breeding.
Among the proprietary Chinese medicines of human medicine detoxification and detoxification, pudilan preparation is the fourth type of new antipyretic and antiviral products in the market after Banlan root, shuanghuanglian and Qingkailing. Researchers in 9 groups, including Liu and Ma, found that pudilan preparations were safe and effective in the treatment of upper respiratory tract infections, and 4 groups of researchers, such as Chongshi and Zhang, confirmed that pudilan anti-inflammatory oral liquid had significant efficacy in the treatment of acute tonsillitis. Pudi blue preparation is one of the most effective formulas in the antipyretic and detoxification traditional Chinese medicine formula, with accurate efficacy and high cost performance.
In this paper, the pharmaceutical-process, pharmacology, and clinical aspects of pudi blue granules are studied separately, which provides a basis for the research and development of pudi blue granules.
1. Pharmaceutical research
1.1 Process research
Pudi blue is made of skullcap, dandelion, bitter dipterine, plate blue root four flavor herbs through extraction, the raw materials in this study according to the drug characteristics are warm boiled, decoction, to ensure that the active ingredients of the drug are not destroyed. Multiple decoctions ensure that the high content of active ingredients is fully released. The olamine extraction process solves the traditional crushing process to reduce the water dissolving capacity of drugs, and filters out the invalid ingredients such as starch, sugar, cellulose, mucilage, chlorophyll, gum and other invalid ingredients contained in traditional Chinese medicine. By concentrating and purifying the active ingredients into granule forms that can both drink water and mix, it is effectively ensured that the efficacy of the drug is maximized and the operation and use are simplified (Fig. 1).
Figure 1. The process route of pudi blue granules
1.2 Stability studies
Three batches of pilot products were placed in a stability test chamber with a temperature of 40±2 °C, a relative humidity of 75±5%, and a quality inspection for 6 consecutive months. The resulting characteristics, identification, moisture and content of the indicators all conformed to the relevant provisions of the pudi blue anti-inflammatory granule quality standards (draft) and the general provisions of the appendix granule preparations of the Chinese Veterinary Pharmacopoeia. Among them, the moisture and content did not change significantly during the 6-month period, which initially showed that the stability of this product was good. Three batches of pilot products were placed in the sample room for 18 consecutive months of quality inspection, and the resulting characteristics, identification, moisture and content indicators all met the relevant provisions under the quality standards (draft) of Pudilan anti-inflammatory granules and the appendix of the Chinese Veterinary Pharmacopoeia under the general rules of granule preparations.
Long-term stability tests continue to be examined.
2. Pharmacological research
2.1 In vitro bacteriostatic test Pudi blue anti-inflammatory granule aqueous solution has different degrees of inhibition effect on Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, and Candida albicans, and the lowest inhibitory concentrations of MIC are 6.25, 25, 100, 12.5 mg raw drug / mL, respectively.
2.2 In vivo bacteriostatic test to observe the effect of puddy blue anti-inflammatory granules on the death of mice caused by intraperitoneal injection of Staphylococcus aureus. Results The mortality rate of the blank group was 90%, the mortality rate of the control group was 30%, and the mortality rate of the high-end and low dose mice of the pudilan anti-inflammatory granule was 20%, 30% and 50%, respectively. It shows that this product has a protective effect on the death of model mice.
2.3 Antipyretic test to observe the effect of this product on the increase in body temperature of rats caused by 2,4-dinitrophenol. The results had a good antipyretic effect on the elevated body temperature of the model rats, and there were significant differences between the high and medium dose groups and the model group.
2.4 Anti-inflammatory test Pudi blue anti-inflammatory granules can significantly inhibit the ear swelling of mice caused by xylene.
2.5 Acute toxicity test Pudilan anti-inflammatory granules failed to detect LD50. The maximum dosage is 360 g of raw drug / kg, which is equivalent to 75 times the dose of 4.8 g of raw drug / kg in mice, and the mice are healthy and lively after 7 days of gastric filling, and none of them die. After 7 days of execution, the autopsy did not see abnormal changes in internal organs. It shows that there is no acute toxicity of pudilan anti-inflammatory granules.
2.6 Long-term toxicity test There were no abnormal changes in the general conditions, behavioral activities, feces, etc. of rats who received continuous gastric administration for 30 days and stopped the drug for 2 weeks; none of the animals in each group had any causal toxic reactions and deaths related to the drug. Most of the indicators such as hematology, blood biochemistry and pathological examination of animals in each drug delivery group were within the normal range, except for the individual indicators such as small dose WBC and lymphocyte classification, which were significantly different from the control group, and the rest were not significant compared with the control group. It showed that there was no toxic reaction to SD rats in the high, medium and low dose groups of pudilan anti-inflammatory granules for 1 month, no obvious effect on animal weight, hematology, blood biochemistry and so on, and no obvious pathological damage to major organs or tissues such as heart, liver and kidney.
3. Clinical research
To establish a chicken cough and asthma model, the clinical administration dose of pudilan anti-inflammatory granules for infectious bronchitis in chickens was: add 4 g per 1 L of water for 5 days. With 1, 3, 5, 10 times the clinically recommended dose, continuous medication for 5 days, the test chickens did not see any toxic symptoms during the observation period, the mental state was good, the diet was normal, that is, the test chickens could be well tolerated after administration. The blood routine and blood biochemical indicators of chickens in each experimental group were changed within the normal range, indicating that there was no adverse effect on the physiological and biochemical function of chickens. No gross eye and histologic pathological changes were seen in the chicken liver and kidney test, and no obvious toxic side effects were found. Comprehensive analysis of various detection indicators showed that pudilan anti-inflammatory granules are safe for clinical application at the recommended dose (4 g per 1 L of water, continuous use for 5 days). The cure rates of the high, medium and low dose groups were 90%, 86.9% and 80%, respectively, and the effective rates were 96.7%, 93.3% and 86.7%, respectively. The relative weight gain rates of the high, medium and low dose groups were 90.87%, 96.52% and 91.55%, respectively, and the relative weight gain rates were the highest in the medium dose group. According to the therapeutic effect of pudilan anti-inflammatory granules and the change of chicken weight, combined with the comprehensive consideration of drug costs and other factors, the recommended dose of pudilan anti-inflammatory granules for the treatment of infectious bronchitis in chickens is: add 4 g per 1 L of water for 5 days.
Summary and discussion
Many seemingly normal healthy pigs, after the blood test blue ear will show positive, the disease at the same time dissection of piglet kidneys can see many white bad spots, these are the incubation period virus caused by the sub-health state of the pig herd: there is no obvious disease on the surface, but the immune system is suppressed by the virus, its own resistance is low, once infected by foreign pathogens, it will erupt on a large scale, bringing huge economic losses to the pig farm. Jiangxi New Century Minxing Animal Health Products Co., Ltd. production of Pudi blue granules have a unique formula in the market, belongs to the national three types of new veterinary drugs, for the virus has high efficiency, multi-layer granular plasmid process, to ensure the product active ingredient content, easy to use, good palatability, can meet the needs of the majority of farmers to prevent and control multiple diseases. By using pudi blue granules, the hidden virus of piglets is purified and the sub-health status of piglets in the farm is improved. Improves autoimmunity and reduces the incidence of pig herds.
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