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Compound bile enteric capsule based on low temperature and negative pressure and preparation method thereof

A technology of low-temperature negative pressure and enteric-coated capsules, which is applied in capsule delivery, pharmaceutical formulations, and medical preparations containing active ingredients. Restoring the effect of enterohepatic recirculation

Pending Publication Date: 2019-07-12
THE FIRST AFFILIATED HOSPITAL OF MEDICAL COLLEGE OF XIAN JIAOTONG UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the direct oral administration of concentrated bile has great damage to the gastric mucosa, and the traditional high-temperature drying method may damage the active ingredients of bile, and ordinary capsules loaded with bile dry powder can be melted in the stomach, which cannot simulate normal human bile at 12 Physiological environment for intestinal release

Method used

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  • Compound bile enteric capsule based on low temperature and negative pressure and preparation method thereof
  • Compound bile enteric capsule based on low temperature and negative pressure and preparation method thereof
  • Compound bile enteric capsule based on low temperature and negative pressure and preparation method thereof

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preparation example Construction

[0027] The invention discloses a preparation method of compound bile enteric-coated capsules based on low-temperature negative pressure, which comprises the following steps:

[0028] Step 1. Collect the bile fluid drained from patients with obstructive jaundice; currently, the bile drained from patients with obstructive jaundice is discarded, and the present invention collects the bile drained from patients with obstructive jaundice that have been discarded;

[0029] Step 2. Screen the collected bile fluid drained from patients with obstructive jaundice: filter the collected bile drained from patients with obstructive jaundice with 80-120 mesh to remove impurities and suspended solids; At 4°C, the activity of bile components can be maintained to the greatest extent.

[0030] Step 3. Put the filtered bile liquid in a negative pressure drying box for low-temperature negative-pressure drying, wherein the low-temperature negative-pressure drying temperature is 70-85°C, the low-tem...

Embodiment 1

[0037] Step 1. Collect the bile fluid drained from patients with obstructive jaundice;

[0038] Step 2. Sieve the collected bile drained from patients with obstructive jaundice: filter the collected bile drained from patients with obstructive jaundice with a 100-mesh mesh to remove impurities and suspended solids; ensure 4°C from transportation to filtration , to maintain the activity of bile components to the greatest extent.

[0039] Step 3. Put the filtered bile liquid in a negative pressure drying box for low-temperature negative-pressure drying, wherein the low-temperature negative-pressure drying temperature is 75°C, the low-temperature negative-pressure drying pressure is 35mbar, The time is 24 hours, and bile crystals are prepared;

[0040] Step 4, collect the dried bile crystals, grind them into powder, and prepare bile dry powder; then add pancreatin powder and mix, and can put it into enteric-coated capsules; wherein, the mass-volume ratio of pancreatin powder to b...

Embodiment 2

[0045] Step 1. Collect the bile fluid drained from patients with obstructive jaundice;

[0046] Step 2. Sieve the collected bile drained from patients with obstructive jaundice: filter the collected bile drained from patients with obstructive jaundice with an 80-mesh mesh to remove impurities and suspended solids; ensure 4°C from transportation to filtration , to maintain the activity of bile components to the greatest extent.

[0047] Step 3. Put the filtered bile liquid in a negative pressure drying box for low-temperature negative-pressure drying, wherein the low-temperature negative-pressure drying temperature is 85°C, the low-temperature negative-pressure drying pressure is 20mbar, and the low-temperature negative-pressure drying The time is 28 hours, and bile crystals are prepared;

[0048] Step 4, collect the dried bile crystals, grind them into powder, and prepare bile dry powder; then add pancreatin powder and mix, and can put it into enteric-coated capsules; wherein, ...

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Abstract

The invention discloses a compound bile enteric capsule based on low temperature and negative pressure and a preparation method thereof. The preparation method comprises the following steps that externally drained waste bile liquid of an obstructive jaundice patient is collected; the collected bile liquid is preliminarily screened and filtered; the screened and filtered bile liquid is placed in anegative-pressure is drying box to be subjected to low-temperature negative-pressure drying; dried bile crystals are collected and ground into powder physically, pancreatin in a proper proportion is added to be fully mixed, and the mixture is contained in the enteric capsule; the compound bile enteric capsule is placed in a sterile bottle and is sealed and stored, and the compound bile enteric capsule based on low temperature and negative pressure is prepared. According to the compound bile enteric capsule prepared through the preparation method, active ingredients in bile can be reserved to the maximum extent while the drying efficiency is guaranteed, and the added pancreatin can assist the digestion function to the maximum extent. According to the enteric capsule, irrigation to gastric mucosa can be reduced, and the bile can play a role in the intestinal tract better.

Description

technical field [0001] The invention belongs to the technical field of drug research and development, and in particular relates to a low-temperature negative pressure-based compound bile enteric-coated capsule and a preparation method thereof. Background technique [0002] Obstructive jaundice is mainly caused by malignant tumors (including cholangiocarcinoma, gallbladder cancer, pancreatic cancer, duodenal cancer and other malignant diseases) and some benign space-occupying, etc., directly invading or indirectly compressing the bile duct, causing cholestasis and liver function damage A series of systemic pathophysiological changes, such as decreased protein synthesis, are common clinical diseases in hepatobiliary surgery. Percutaneous transhepatic cholangial drainage (PTCD) is a commonly used palliative treatment method for relieving malignant biliary obstruction. It is widely used clinically because of its small trauma, safety and reliability. However, postoperative PTCD ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/54A61K9/48A61P1/04A61P1/16A61K35/413
CPCA61K35/413A61K38/54A61K9/4808A61P1/04A61P1/16A61K2300/00
Inventor 贾庆安廖侠肖雪莲张梅
Owner THE FIRST AFFILIATED HOSPITAL OF MEDICAL COLLEGE OF XIAN JIAOTONG UNIV
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