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Sample treatment method in industrial production of oral solid preparation medicines

A sample processing and solid preparation technology, which is applied in the field of pharmaceutical preparations and quality control, can solve the problems of affecting quality, not accurately reflecting the actual mixing degree of intermediate products, and not paying attention, so as to achieve the effect of avoiding changes

Pending Publication Date: 2021-01-08
SHIJIAZHUANG DONGFANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The results are as follows: the content uniformity measured in the laboratory may not accurately reflect the actual mixing degree of the intermediate products in the production workshop, giving false positive or false negative test results, making intermediate products with quality defects enter the subsequent process and affecting the final product quality. Quality of products
[0006] However, for a long time, the field has not paid attention to the sample processing method after sampling in the industrial production of oral solid dosage forms

Method used

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  • Sample treatment method in industrial production of oral solid preparation medicines
  • Sample treatment method in industrial production of oral solid preparation medicines
  • Sample treatment method in industrial production of oral solid preparation medicines

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0069] Example 1 Selection of sampling bags

[0070] Take PE bags with a length of 200 mm, a width of 150 mm, and a single film thickness of 70, 80, 90, 100, 110, 20, 130, and 140 microns, respectively. The length is 200 mm, and the width is 150 mm. 110, 20, 130, 140 micron PVC bags, 200mm long, 150mm wide, PP bags with single film thickness of 70, 80, 90, 100, 110, 20, 130, 140 micron, add 50g starch to each bag. After adding the starch, place it in a vacuum packaging machine for vacuuming to -0.08MPa (displayed by the vacuum packaging machine), observe whether there is a rupture, and make a record. Then heat seal at 120°C for 5 seconds, observe the sealing condition of the bag immediately after the heat sealing is completed, and make a record. The results are shown in Table 1.

[0071] Table 1 Integrity and sealing of different sampling bags

[0072]

[0073]

[0074] The above results show that the PE material bag shows good thermoplasticity and strength, and the...

Embodiment 2

[0075] Example 2 A sample processing method in the industrial production of compound polyethylene glycol electrolyte powder

[0076] Weigh 60kg of polyethylene glycol 4000, 10kg of anhydrous sodium sulfate, 2.5kg of sodium chloride, 1.5kg of potassium chloride, 2.7kg of sodium bicarbonate and 0.1kg of sodium saccharin. Pass all materials through a 60-mesh sieve, add the sieved polyethylene glycol 4000, sodium chloride, potassium chloride, sodium bicarbonate, anhydrous sodium sulfate and sodium saccharin into the lifting mixer, and turn on the mixer at a speed of 10rpm / min, the forward mixing time is 20min, and the reverse mixing time is 20min, the intermediate product to be tested is obtained, and the content uniformity is tested by sampling.

[0077] Each sampling is about 100g, the bulk density of the sample is 0.7g / ml, and the calculated volume of 100g sample is about 143ml. Based on the calculation that the filling volume is 1 / 3 to 2 / 3 of the volume of the PE ziplock b...

Embodiment 3

[0085] Example 3 A sample processing method in the industrial production of Qianggan Capsules:

[0086]Sample 1: Weigh 250g capillary, 125g isatidis, 125g angelica, 125g white peony root, 250g salvia miltiorrhiza, 125g turmeric, 250g astragalus, 125g codonopsis, 125g alisma, 125g sealwort, 125g rehmannia, 125g yam, 100g hawthorn, Liushenqu 100g, Gentiana 100g and Licorice 100g. The above sixteen flavors are decocted three times with water, 1.5 hours for the first time, 1.0 hours for the second and third times, combined decoction, filtered, and the filtrate is added with ammonia test solution to adjust the pH value to 8, filtered, and the filtrate is concentrated under reduced pressure to Thick paste with a relative density of 1.15-1.25 (75°C), dried below 75°C, crushed, added appropriate amount of starch, placed in a mixer, the mixing speed is 6rpm / min, the forward mixing time is 15min, and the reverse mixing time is 15min. (total mixing 30min).

[0087] Sample 2: Weigh 25...

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Abstract

The invention provides a sample treatment method in industrial production of oral solid preparation medicines. The sample treatment method comprises the following steps: (1) preparing a sampling bag;(2) sampling; (3) fixing a sample; (4) detecting the sample. The method can basically ensure that the sampled sample is not disturbed and keep the original state before sampling, so that the content uniformity detection result can reflect the real mixing degree of an intermediate product. The treatment method of the present invention is particularly suitable for process control of oral solid formulations comprising a small amount of highly active components.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations and quality control, in particular to a sample processing method in the industrial production of oral solid preparation medicines. Background technique [0002] There are many kinds of oral solid preparations, including powders, granules, tablets, capsules, pills, etc. Although the dosage forms are different, the production process generally includes raw materials (active components and excipients) quality assessment, crushing, sieving, mixing, preparation Molding, packaging and other links. Among them, the mixing process is an important link in the production of oral solid preparations. Whether the mixing is uniform or not directly affects the product quality, especially for preparations containing small amounts of active ingredients. If the mixing is uneven, it will directly affect the effectiveness and safety of the patient's medication. [0003] Mixing refers to the operation proce...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N1/28
CPCG01N1/28
Inventor 马旭伟李朋飞李召红王黎颖姜洋
Owner SHIJIAZHUANG DONGFANG PHARMA
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