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Cholagogic pain-relieving capsule as well as preparation method and quality test and control method thereof

A pain-relieving capsule and choleretic technology, applied in the field of drugs for cholecystitis and the treatment of acute and chronic hepatitis, can solve the problems of drug selectivity affecting compliance, long heating time of extract, affecting drug absorption, etc. Reliable curative effect and the effect of improving drug concentration

Inactive Publication Date: 2009-09-09
YUNNAN YONGZITANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Lidan Zhitong Tablets have been on the market for more than 10 years, and the feedback has been good, but the existing problems have gradually emerged: (1) The prescription is small, resulting in a large dosage, 6 tablets each time, three times a day, which affects the patient's ability to take medicine. compliance and selectivity to the drug; (2) in order to cover up its bitterness, the bare tablet is coated with sugar, and the drug dissolves slowly, which prolongs the disintegration time and affects the drug absorption; (3) the preparation method is limited to Under the conditions of the year, it was concentrated at room temperature, and the extract was heated for a long time and the temperature was high, which may lead to changes in the composition of the drug; (4) the amount of excipients was large; (5) there was only one color reaction in the quality control, and the specificity was not strong. Difficulty controlling drug quality

Method used

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  • Cholagogic pain-relieving capsule as well as preparation method and quality test and control method thereof
  • Cholagogic pain-relieving capsule as well as preparation method and quality test and control method thereof
  • Cholagogic pain-relieving capsule as well as preparation method and quality test and control method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] The raw material medicine that makes capsule active ingredient of the present invention consists of: Bupleurum (stir-fry) 120g, red peony root 120g, Fructus aurantii (stir-fry) 120g, Radix Glycyrrhizae 60g Capillary root 200g, Corydalis Corydalis (stir-fry) 200g, Atractylodes 120g, Toosendan ( Fried) 200g, Agrimony 300g, Banlangen 200g, Dandelion 300g and Turmeric 200g. Crush it into a coarse powder, add water and decoct three times, the first time for 2 hours, the second time and the third time each for 1.5 hours, combine the decoction, filter, and concentrate the filtrate under reduced pressure to a thick liquid with a relative density of 1.35-1.37 (60°C). Paste, add appropriate amount of auxiliary material starch, dry, crush, add appropriate amount of starch and magnesium stearate, mix well, put into capsules; Finally, add an appropriate amount of magnesium stearate, mix evenly, and pack into capsules to make 1000 capsules to obtain the required choleretic pain relie...

Embodiment 2

[0043] The optimization method of the water decoction process is: take the prescription medicinal material amount (2140g) that makes 1000 capsules, add water in multiples according to the table, the number of times (three times) of each decoction, and the time (2 hours, 1.5 hours, 1.5 hours) The same, and adjust the water content of each obtained dry extract to be almost the same, the test data are shown in Table 1.

[0044] Table 1.

[0045]

[0046] The method for determining the content of naringin in Table 1 is the HPLC method. Table 1 shows that, taking the total solids as an indicator, the more water is added, the more dry paste will be obtained. For example, taking the final total extraction amount of naringin as an indicator, adding 8 to 10 times the amount of water is enough, and 8 times , 10 times and 12 times the water extraction results are not much different.

Embodiment 3

[0048] ——Test data of three batches of pilot production

[0049] *Amplify 10 times according to the prescription quantity, and produce three batches of products according to the above-mentioned manufacturing method, and the test data are shown in the table.

[0050] batch number

[0051] Relative density of extract (80℃)

[0052] The above three batches of finished products have been inspected: properties, identification, water content, disintegration time limit, weight difference, content determination and microbial inspection are all qualified (according to the self-made quality standard draft and the relevant provisions of the appendix of "Chinese Pharmacopoeia").

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Abstract

The invention discloses a cholagogic pain-relieving capsule as well as a preparation method and a quality test and control method thereof. In the invention, the existing cholagogic pain-relieving tablets are improved significantly by adding prescription dosage, adopting reduced pressure low temperature concentration technology or reduced pressure low temperature concentration plus spray drying, reducing moisture in the extract to increase the medicament concentration, thus satisfying the requirement for the medicament preparation and optimizing the preparation technique. Meanwhile, the invention also provides a qualitative and quantitative method for product quality test and control, wherein TLC method is selected for authenticating five drugs, HPLC method is adopted for detecting the content of naringin, thus the cholagogic pain-relieving capsule is secure and effective and has controllable quality.

Description

technical field [0001] The invention relates to a medicine for treating acute and chronic hepatitis and cholecystitis, more specifically, a Chinese patent medicine prepared from Chinese herbal medicines. At the same time, the invention also relates to a preparation method and a quality control method of the medicine. Background technique [0002] As we all know, acute and chronic hepatitis and cholecystitis are refractory common diseases, frequently-occurring diseases, and great harm to human health, so active treatment must be given. There are many kinds of medicines for the treatment of Chinese and Western medicine. The treatment of chronic hepatitis and cholecystitis by Western medicine is mainly based on anti-inflammation, anti-infection, and immune enhancement. However, traditional Chinese medicine has much richer treatment methods for acute and chronic hepatitis and cholecystitis, which are mainly reflected in the two treatment principles of "diagnostic treatment" and...

Claims

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Application Information

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IPC IPC(8): A61K36/9066A61K9/48A61P1/16G01N30/36G01N30/90
Inventor 朱明浩郑金丹
Owner YUNNAN YONGZITANG PHARMA
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