Gongxuening soft capsule, its preparing method and sue

Abstract

The present invention relates to a Chinese patent medicine preparation and its preparation method. In particular, it relates to a Gongxuening soft capsule and its preparation method. Said invention uses polyethylene glycol 200, polyethylene glycol 400, polyethylene glycol 600 or polyethylene glycol 800 as dispersion agent, and utilizes said dispersion agent to completely dissolve the Chinese medicinal material Chinese Paris rhizome extract so as to obtain capsule solution. Said invention can greatly raise bioavailability of medicine and its therapeutic effect.

Description

technical field

[0001] The invention relates to a Chinese patent medicine preparation and a preparation method thereof, in particular to Gongxuening soft capsules, a preparation method thereof and an application thereof. Background technique

[0002] The current preparation of Gongxuening is hard capsule preparation or tablet, which is processed from the extract of Chonglou, and the active ingredients in the extract are saponin, diosgenin and pinanogenin. Gongxuening Capsule has the effects of cooling blood to stop bleeding, clearing heat and dehumidification, uterine contraction and hemostasis, removing blood stasis and relieving pain, anti-inflammatory and analgesic, etc. Etc. blood-heat syndrome, and chronic pelvic inflammatory disease caused by damp-heat stasis, low abdominal pain, lumbosacral pain, leucorrhea and other gynecological diseases. Gongxuening capsules or tablets are pure traditional Chinese medicine preparations, without hormones, quick onset, strong effect...

Examples

Embodiment 1-6

[0051] The preparation of embodiment 1-6 Gongxuening soft capsule

[0052] See Table 2 for the composition and related parameters of Gongxuening Soft Capsules in Examples 1-6.

[0053] The preparation method is as follows: 1) take 20kg of eucalyptus, grind it into coarse powder, add four times the amount of 70% ethanol, and reflux extraction for 3 times, the first time is 5 hours, the second time is 4 hours, the third time is 3 hours, and the extracts are combined , filtered, the filtrate decompressed and reclaimed ethanol to make a thick paste, added water to dissolve the paste, let it stand overnight, centrifuged with a disc centrifuge, took the centrifugate, dried, and pulverized to obtain the dry extract of Chonglou extract; 2) with Glycerol: gelatin: water (0.5:1:0.9) ratio of the preparation of the capsule skin; 3) according to the prescription, take the dry paste powder of Chonglou, put it in the mixing tank, add polyethylene glycol 400, glycerin, stir and mix evenly, a...

Embodiment 7 Embodiment 1-3

[0055] The long-term stability investigation of embodiment 7 embodiment 1-3 Gongxuening soft capsule

[0056] The Gongxuening soft capsules obtained in Examples 1-3 are packaged in aluminum-plastic blisters, and placed in 0,3 And after 6 months, inspect the following indicators month by month, and compare the results with those before placement to observe its stability.

[0057] Stability investigation Observation of properties, identification, inspection, water content, content, microbial inspection and other indicators, the test method refers to the method under the corresponding item in the first appendix of "Pharmacopoeia of the People's Republic of China" in 2005. The requirements for each indicator are:

[0058] 1) Properties: It is a soft capsule preparation, and the content is a tan viscous liquid with a bitter taste;

[0059] 2) Identification item: Thin-layer chromatography identification of Chonglou;

[0060] 3) The disintegration time limit should be <1 hour;

...

Embodiment 8 Embodiment 1-3

[0071] The accelerated stability investigation of embodiment 8 embodiment 1-3 Gongxuening soft capsule

[0072] The Gongxuening soft capsules obtained in Examples 1-3 are packaged in aluminum-plastic blisters, and placed in 0, 1 , After 2, 3 and 6 months, inspect the following indicators month by month, and compare the results with those before placement to observe its stability.

[0073] Stability investigation Observation of properties, identification, inspection, water content, content, microbial inspection and other indicators, the test method refers to the method under the corresponding item in the first appendix of "Pharmacopoeia of the People's Republic of China" in 2005. The requirements for each indicator are:

[0074] 1) Properties: It is a soft capsule preparation, and the content is a tan viscous liquid with a bitter taste;

[0075] 2) Identification item: Thin-layer chromatography identification of Chonglou;

[0076] 3) The disintegration time limit should be <...

technical field

[0001] The invention relates to a Chinese patent medicine preparation and a preparation method thereof, in particular to Gongxuening soft capsules, a preparation method thereof and an application thereof. Background technique

[0002] The current preparation of Gongxuening is hard capsule preparation or tablet, which is processed from the extract of Chonglou, and the active ingredients in the extract are saponin, diosgenin and pinanogenin. Gongxuening Capsule has the effects of cooling blood to stop bleeding, clearing heat and dehumidification, uterine contraction and hemostasis, removing blood stasis and relieving pain, anti-inflammatory and analgesic, etc. Etc. blood-heat syndrome, and chronic pelvic inflammatory disease caused by damp-heat stasis, low abdominal pain, lumbosacral pain, leucorrhea and other gynecological diseases. Gongxuening capsules or tablets are pure traditional Chinese medicine preparations, without hormones, quick onset, strong effect...

Examples

Embodiment 1-6

[0051] The preparation of embodiment 1-6 Gongxuening soft capsule

[0052] See Table 2 for the composition and related parameters of Gongxuening Soft Capsules in Examples 1-6.

[0053] The preparation method is as follows: 1) take 20kg of eucalyptus, grind it into coarse powder, add four times the amount of 70% ethanol, and reflux extraction for 3 times, the first time is 5 hours, the second time is 4 hours, the third time is 3 hours, and the extracts are combined , filtered, the filtrate decompressed and reclaimed ethanol to make a thick paste, added water to dissolve the paste, let it stand overnight, centrifuged with a disc centrifuge, took the centrifugate, dried, and pulverized to obtain the dry extract of Chonglou extract; 2) with Glycerol: gelatin: water (0.5:1:0.9) ratio of the preparation of the capsule skin; 3) according to the prescription, take the dry paste powder of Chonglou, put it in the mixing tank, add polyethylene glycol 400, glycerin, stir and mix evenly, a...

Embodiment 7 Embodiment 1-3

[0055] The long-term stability investigation of embodiment 7 embodiment 1-3 Gongxuening soft capsule

[0056] The Gongxuening soft capsules obtained in Examples 1-3 are packaged in aluminum-plastic blisters, and placed in 0,3 And after 6 months, inspect the following indicators month by month, and compare the results with those before placement to observe its stability.

[0057] Stability investigation Observation of properties, identification, inspection, water content, content, microbial inspection and other indicators, the test method refers to the method under the corresponding item in the first appendix of "Pharmacopoeia of the People's Republic of China" in 2005. The requirements for each indicator are:

[0058] 1) Properties: It is a soft capsule preparation, and the content is a tan viscous liquid with a bitter taste;

[0059] 2) Identification item: Thin-layer chromatography identification of Chonglou;

[0060] 3) The disintegration time limit should be <1 hour;

...

Embodiment 8 Embodiment 1-3

[0071] The accelerated stability investigation of embodiment 8 embodiment 1-3 Gongxuening soft capsule

[0072] The Gongxuening soft capsules obtained in Examples 1-3 are packaged in aluminum-plastic blisters, and placed in 0, 1 , After 2, 3 and 6 months, inspect the following indicators month by month, and compare the results with those before placement to observe its stability.

[0073] Stability investigation Observation of properties, identification, inspection, water content, content, microbial inspection and other indicators, the test method refers to the method under the corresponding item in the first appendix of "Pharmacopoeia of the People's Republic of China" in 2005. The requirements for each indicator are:

[0074] 1) Properties: It is a soft capsule preparation, and the content is a tan viscous liquid with a bitter taste;

[0075] 2) Identification item: Thin-layer chromatography identification of Chonglou;

[0076] 3) The disintegration time limit should be <...