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CN-121977678-A - Detection method for intestinal flora capsule filling quantity difference and application of detection method in preparation of capsule preparation for accurate intestinal flora transplantation

CN121977678ACN 121977678 ACN121977678 ACN 121977678ACN-121977678-A

Abstract

The invention belongs to the technical field of biology, and discloses a detection method for the difference of the filling amount of capsules of intestinal flora and application of the detection method in preparation of capsule preparations for accurate intestinal flora transplantation. The composition provided by the invention specifically comprises petroleum ether and an organic polar solvent with a polarity index of 3.5-5 and a boiling point of 60-90 ℃, and an elution system with a specific polarity gradient is formed by the petroleum ether and the organic solvent together, and the elution system can effectively remove residues which are adhered to the inner wall of a capsule shell and are difficult to remove, so that a more accurate detection result of the difference of the loading amount is obtained, and the composition has very good application prospect in detecting the difference of the loading amount of an intestinal flora capsule.

Inventors

  • XU WEI
  • LIN HAO
  • HE JIANQUAN
  • LIN ZHENXIONG
  • ZHANG BANGZHOU
  • XIAO CHUANXING

Assignees

  • 厦门承葛生物科技有限公司

Dates

Publication Date
20260505
Application Date
20260129

Claims (10)

  1. 1. The application of the composition in detecting the difference of the intestinal flora capsule loading amount is characterized in that the composition comprises petroleum ether and an organic polar solvent in a volume ratio of 1 (1-5), wherein the polarity index of the organic polar solvent is 3.5-5, and the boiling point of the organic polar solvent is 60-90 ℃.
  2. 2. Use of a composition according to claim 1 for the detection of differences in the dosage of capsules of the intestinal flora, wherein the organic polar solvent is selected from one or more of ethylene dichloride, ethyl acetate, isopropanol, methyl ethyl ketone and chloroform.
  3. 3. Use of a composition according to claim 1 for detecting differences in the dosage of capsules of intestinal flora, wherein the organic polar solvent is isopropanol and/or ethyl acetate.
  4. 4. A detection method of the filling quantity difference of an intestinal flora capsule is characterized by comprising the steps of S1, obtaining the mass M Total (S) of the intestinal flora capsule, S2, forming a primary opening on the intestinal flora capsule and extruding the content to finish removing the content, S3, forming a secondary opening on the intestinal flora capsule to expose the inner wall of the intestinal flora capsule, flushing and centrifuging the intestinal flora capsule to finish cleaning the inner wall of a capsule shell to obtain the capsule shell, S4, taking the capsule shell, drying the capsule shell to obtain the mass M Shell and shell of the capsule shell, and calculating the filling quantity based on M Total (S) and M Shell and shell ; In the step S3, the intestinal flora capsules are washed by adopting a composite eluent in the washing treatment, wherein the composite eluent comprises petroleum ether and an organic polar solvent in a volume ratio of 1 (1-5), the polarity index of the organic polar solvent is 3-5, and the boiling point of the organic polar solvent is 60-90 ℃.
  5. 5. The method for detecting a difference in the capsule contents of an intestinal flora according to claim 4, wherein the processing means used for the removal of the contents and the cleaning of the inner wall of the capsule is a capsule processing means comprising: The grating plate is used for placing and fixing the intestinal flora capsules, and is provided with at least two mounting holes matched with the shapes of the intestinal flora capsules; the multi-connected cylinder extrusion tool is used for realizing extrusion of the intestinal flora capsules and comprises a mounting plate and extrusion cylinders, wherein the extrusion cylinders are arranged on the mounting plate and correspond to the mounting holes on the grating plates one by one, and the diameter of each extrusion cylinder is smaller than the aperture of each mounting hole.
  6. 6. The method for detecting a difference in the filling amount of a capsule of intestinal flora according to claim 4, wherein in the step S2, the method for forming the primary opening comprises the steps of performing annular cutting on one end of the capsule of intestinal flora by using a blade to form the primary opening, and the distance between the position of the annular cutting and the end of the capsule of intestinal flora is 1 mm-2 mm.
  7. 7. The method for detecting a difference in intestinal flora capsules according to claim 4, wherein in step S3, the number of times of the washing treatment is1 to 10.
  8. 8. The method according to claim 4, wherein in step S3, the rotational speed of the centrifugation is 800rpm to 1200rpm for 5S to 15S.
  9. 9. The method for detecting a difference in intestinal flora capsules according to claim 4, wherein in step S4, the drying treatment is performed at a temperature of 30 ℃ to 45 ℃ for 5min to 20min.
  10. 10. Use of the composition according to any one of claims 1 to 3 or the method for detecting differences in the encapsulated intestinal flora according to any one of claims 4 to 9 in the preparation of a capsule formulation for accurate intestinal flora transplantation.

Description

Detection method for intestinal flora capsule filling quantity difference and application of detection method in preparation of capsule preparation for accurate intestinal flora transplantation Technical Field The invention belongs to the technical field of biology, and particularly relates to a detection method for a difference of intestinal flora capsule filling amount and application of the detection method in preparation of a capsule preparation for accurate intestinal flora transplantation. Background The biological product of intestinal flora refers to a biological preparation taking intestinal flora as a core raw material, and the content of the biological preparation is complex and mainly comprises active flora, a protective agent and various organic matters derived from feces. The preparation is usually encapsulated by adopting a capsule dosage form, and the difference of the encapsulation amount is a key detection item for ensuring the accurate dosage and stable quality of the capsule. At present, the method specified in the general rule 0103 of the fourth edition of Chinese pharmacopoeia 2020 is mainly adopted to detect the difference of the filling amount of the capsules, and specifically the method comprises the steps of taking 20 capsules of a sample, precisely weighing each capsule, pouring out the content, cleaning the capsule shell of soft capsules or hard capsules with semi-solid or liquid content by using volatile solvents such as diethyl ether, volatilizing the solvent at a ventilation position, precisely weighing the capsule shell, and calculating the filling amount of each capsule. However, as the content of the intestinal flora capsule contains a large amount of yellow residues with stronger polarity, and the adopted capsule shell is of a double-layer structure with easily-adhered outer layers and easily-adhered inner layers, detection by adopting a method in Chinese pharmacopoeia has the following problems that firstly, the traditional volatile solvents such as diethyl ether and the like can effectively dissolve and elute organic components with stronger polarity in the content, a large amount of yellow residues still adhere to the inner wall of the capsule shell after cleaning, and secondly, the existence of the residues can lead to lower content finally measured, and significant errors are introduced, so that the quality control requirements of the special preparation cannot be met because the quality of the product cannot be truly reflected by the process level and quality condition of the product due to the difference detection result, and the existence of the residues has larger limitation. Disclosure of Invention The invention aims to solve the problems that the existing capsule filling quantity difference detection method is not capable of effectively removing contents in an intestinal flora capsule, and the accuracy, reliability and stability of a measurement result are not ideal, and provides application of a composition in the intestinal flora capsule filling quantity difference detection. The second object of the present invention is to provide a method for detecting differences in the amount of capsules of intestinal flora. The third object of the present invention is to provide the use of the above-mentioned composition or the method for detecting the difference in the encapsulated content of intestinal flora in the preparation of a capsule preparation for accurate intestinal flora transplantation. The composition provided by the invention is particularly applied to detection of the difference of the intestinal flora capsule loading quantity, and comprises petroleum ether and an organic polar solvent in a volume ratio of 1 (1-5), wherein the polarity index of the organic polar solvent is 3.5-5, and the boiling point of the organic polar solvent is 60-90 ℃. Further, the organic polar solvent is selected from one or more of ethylene dichloride, ethyl acetate, isopropyl alcohol, methyl ethyl ketone and chloroform. Further, the organic polar solvent is isopropanol and/or ethyl acetate. The method for detecting the difference of the filling amount of the intestinal flora capsules comprises the steps of S1, obtaining the mass M Total (S) of the intestinal flora capsules, S2, forming a primary opening on the intestinal flora capsules and extruding the content to remove the content, S3, forming a secondary opening on the intestinal flora capsules to expose the inner walls of the intestinal flora capsules, washing the inner walls of the intestinal flora capsules to obtain capsules, S4, drying the capsules to obtain the mass M Shell and shell of the capsules, and calculating the filling amount based on the M Total (S) and the M Shell and shell , wherein in the step S3, the intestinal flora capsules are washed by adopting a composite eluent, the composite eluent comprises petroleum ether and an organic polar solvent with the volume ratio of 1 (1-5), the polar index of the or