New-generation synthetic pulmonary surfactant preparation and clinical application thereof
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A pulmonary surfactant and preparation technology, applied in the field of new-generation synthetic pulmonary surfactant, can solve the problems of poor stability and low activity of fully synthetic PS preparations, achieve stable and long-lasting curative effect, increase in vitro surface activity, and improve blood oxygen level. Effect
Pending Publication Date: 2022-03-11
BEIJING SHUANGHE RUNCHUANG TECH CO LTD
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Problems solved by technology
[0016] The present invention is devoted to the development of new prescriptions to solve the shortcomings of low activity and poor stability of fully synthetic PS preparations currently under development
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Embodiment 1
[0050] According to the information corresponding to Example 1 in the above table, add all the materials into ethanol (95%, v / v) at 35-45°C, stir until dissolved, and filter while hot; add a buffer solution (tris or Phosphate, sodium chloride, calcium chloride, etc.) (pH = 7.0 ± 0.5), stir quickly until uniform, and remove the organic solvent by circular dialysis or nanofiltration until the solvent residue meets the requirements of the relevant regulations of the Chinese Pharmacopoeia.
[0051] Detect the pH and content of the medicinal solution, supplement the buffer solution according to the test results, and adjust the pH to the specified level (pH=7.0±0.5) if necessary. When necessary, appropriate filtration or other means can be used to remove microorganisms in the liquid medicine.
[0052] Quantitative filling into borosilicate glass control injection bottles (or other pharmaceutical packaging materials) to prepare PS preparations.
Embodiment 2
[0054] According to the information corresponding to Example 2 in the above table, add all the materials into isopropanol (90%, v / v) at 35-45° C., stir until dissolved, and filter while hot; add the buffer solution ( tris or phosphate, sodium chloride, calcium chloride, etc.), stir rapidly until uniform, remove the organic solvent by gradient centrifugation, freeze-dry, and moderately pulverize (or micronize) to obtain the PS preparation.
Embodiment 3
[0056] According to the information corresponding to Example 3 in the above table, all the materials were added into the acidified methanol-chloroform solution kept at 35-45° C., stirred evenly, and filtered.
[0057] After blowing dry with nitrogen gas, oscillate evenly with a buffer solution (tris or phosphate, etc.), and quantitatively dispense into a suspension dosage form. It can also be freeze-dried to produce a freeze-dried product.
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Abstract
The invention relates to a fully synthetic pulmonary surfactant (PS) preparation as well as a composition, a preparation method and application thereof. Specifically, the invention provides a PS preparation with a brand new formula. The invention also provides a method for preparing the PS preparation. The invention also provides a pharmaceutical composition containing the PS preparation. The PS preparation provided by the invention has the characteristics of high surface activity and lasting drug effect, and has sufficient in-vitro surface tension and animal pharmacodynamic model support. The fully-synthesized PS preparation can obviously improve the in-vitro surface activity, the blood oxygen level, lung compliance and the like of animal pharmacodynamic experiments are obviously improved, and the fully-synthesized PS preparation has a more stable and lasting curative effect. The total synthesis PS preparation can be clinically used for treating and preventing diseases related to pulmonary surfactant deficiency or dysfunction, such as neonatal respiratory distress syndrome NRDS, secondary respiratory distress syndrome ARDS, and PS deficiency or dysfunction induced by severe pneumonia, meconium inhalation syndrome, new crown pneumonia, chronic obstructive pulmonary disease and the like.
Description
technical field [0001] The invention relates to the field of biomedicine, and specifically relates to a new generation of synthetic pulmonary surfactant, a preparation containing the synthetic pulmonary surfactant and its clinical application. Background technique [0002] Pulmonary surfactant (PS) is a naturally occurring surface active substance whose main components are various phospholipids and four surfactant proteins (SP-A, SP-B, SP-C and SP -D). [0003] PS deficiency or dysfunction is the main cause of respiratory distress syndrome (Respiratory Distress Syndrome, RDS) in premature infants, and it is also one of the causes of secondary respiratory distress syndrome (Acute Respiratory Distress Syndrome, ARDS). In addition, acute lung injury induced by chronic obstructive pulmonary disease (COPD), meconium aspiration syndrome (MAS), severe pneumonia, and new coronary pneumonia is often accompanied by PS deficiency or dysfunction . [0004] Since the 1990s, a variety ...
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