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Traditional Chinese medicine for soothing liver, regulating qi and promoting bile flow and preparation method and quality standard thereof

A technology of soothing the liver and regulating qi and traditional Chinese medicine, which is applied in traditional Chinese medicine soft capsules. The GC method is used to detect the drug field, which can solve the problems of long production cycle, excessive disintegration time, and low disintegration time, and achieve high production controllability and high production efficiency. The effect of short cycle and reasonable process

Inactive Publication Date: 2011-07-13
秦皇岛润青制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] There are still deficiencies in the above-mentioned soft capsules, for example, the disintegration time exceeds the standard due to the hardening of the capsule skin during the storage period. Even if it meets the minimum national limit, the lower disintegration time is beneficial to the curative effect, and the process of pressing into pills is unreasonable. Leading to difficult production control and long production cycle; the quality of the peppermint oil used is not fixed

Method used

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  • Traditional Chinese medicine for soothing liver, regulating qi and promoting bile flow and preparation method and quality standard thereof
  • Traditional Chinese medicine for soothing liver, regulating qi and promoting bile flow and preparation method and quality standard thereof
  • Traditional Chinese medicine for soothing liver, regulating qi and promoting bile flow and preparation method and quality standard thereof

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Effect test

Embodiment 1

[0033] Embodiment 1, the preparation of soft capsule

[0034] Pharmaceutical composition peppermint oil 100g refined corn oil 200g

[0035] Capsule skin gelatin 1000g: glycerin 400g: water 1000g: polyethylene glycol (400) 50g

[0036] method

[0037] (1) Preparation of gelatin solution Take gelatin, PEG400, glycerin, and water according to the proportion, add them to the interlayer material tank, heat at 65±5°C to make it melt, and become the glue for later use;

[0038] (2) Ingredients are taken by weighing peppermint oil and refined corn oil according to the prescription amount, and stirred to mix evenly;

[0039] (3) Pressing into pellets, connecting the insulated gelatin slurry barrel with the soft capsule machine, putting the contents of the soft capsules into the hopper, and adjusting the pellet pressing parameters (the temperature of the plastic box is 49°C; the temperature of the spray body is 37°C; the temperature of the tape is 0.7mm ;Rolling speed: 2.2r / min), fir...

Embodiment 2

[0043] Pharmaceutical composition peppermint oil 100g refined corn oil 100g

[0044] Capsule skin gelatin 800g: glycerin 200g: water 800g: polyethylene glycol (400) 20g

[0045] method

[0046] (1) Preparation of gelatin solution Take gelatin, PEG400, glycerin, and water according to the proportion, add it to the interlayer material tank, heat at 65±5°C to melt it, and prepare it as glue for later use;

[0047] (2) Ingredients Weigh peppermint oil and refined corn oil according to the prescription amount, stir to mix evenly;

[0048](3) Press into pills, connect the heat-preserved gelatin slurry barrel with the soft capsule machine, put the contents of the soft capsules into the hopper, and adjust the pellet pressing parameters (the temperature of the plastic box is 50°C; the temperature of the spray body is 38°C; the temperature of the tape is 0.7mm ;Rolling speed: 2.2r / min), first adjust the thickness and uniformity of the rubber, and then adjust the outlet according to th...

Embodiment 3

[0050] Pharmaceutical composition Peppermint oil 100g Refined corn oil 300g

[0051] Capsule gelatin 1200g: glycerin 600g: water 1200g: polyethylene glycol (400) 100g

[0052] method

[0053] (1) Preparation of gelatin solution Take gelatin, PEG400, glycerin, and water according to the proportion, add it to the interlayer material tank, heat at 65±5°C to melt it, and prepare it as glue for later use;

[0054] (2) Ingredients Weigh peppermint oil and refined corn oil according to the prescription amount, stir to mix evenly;

[0055] (3) Press into pills, connect the heat-preserved gelatin slurry barrel with the soft capsule machine, put the contents of the soft capsules into the hopper, and adjust the pellet pressing parameters (the temperature of the plastic box is 49°C; the temperature of the spray body is 38°C; the temperature of the tape is 0.8mm ;Rolling speed: 2.4r / min), first adjust the thickness and uniformity of the rubber, and then adjust the outlet according to the...

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Abstract

The invention discloses a traditional Chinese medicine soft capsule for soothing the liver, regulating qi and promoting bile flow, a preparation method of the soft capsule, and a GC (gas chromatography) method for detecting the soft capsule. The pharmaceutical composition disclosed by the invention is prepared from peppermint oil and refined corn oil according to the ratio of 1:(1-3), and a capsule shell is prepared from gelatin, glycerol, water and polyethylene glycol according to the ratio of (0.8-1.2):(0.2-0.6):(0.8-1.2):(0.02-1). The invention also provides a preparation method of the soft capsule and a GC method for measuring the content of menthol in the soft capsule. The clinical test of the traditional Chinese medicine soft capsule disclosed by the invention shows that the total efficiency reaches 98.7%, the capsule shell is nearly not hardened in the storage period, the disintegration time does not exceed 16 minutes, the pill pressing process is reasonable, the production controllability is high, the production cycle is short, and the quality of the used peppermint oil is controllable.

Description

technical field [0001] The invention belongs to the field of traditional Chinese medicine, and relates to a traditional Chinese medicine soft capsule for soothing the liver, regulating qi and promoting gallbladder, a preparation method of the medicine, and a method for detecting the medicine by GC. Background technique [0002] Chronic cholecystitis and cholelithiasis mostly belong to the syndromes of "rib pain", "abdominal pain" and "jaundice" in traditional Chinese medicine, and are mostly caused by stagnation of liver, stagnation of qi, and accumulation of dampness and heat in the liver and gallbladder. Gallbladder and pain relief. Danshu Capsules mainly treat chronic calculous cholecystitis, chronic cholecystitis and gallstone stagnation of the liver and gallbladder. [0003] Danshu Capsules are mainly used for chronic calculous cholecystitis, chronic cholecystitis and gallstone stagnation of the liver and gallbladder, damp-heat stomach stagnation syndrome, its raw mate...

Claims

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Application Information

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IPC IPC(8): A61K36/899A61K9/48A61K47/42G01N30/36A61P1/16
Inventor 佟雪松
Owner 秦皇岛润青制药有限公司
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