Pharmaceutical formulations with the raw material containing panax, ophiopogon root and schisandra fruit, processes for their preparation, the raw material and the quality control method for the prepa

A pharmaceutical preparation, the technology of Schisandra chinensis, applied in the quality control of raw materials ginseng, Schisandra chinensis, and Ophiopogon japonicus, can solve problems such as difficulty in ensuring safety and stability, excessive dosage, and difficulty in finding safe and effective quality control methods for injections, etc.

Inactive Publication Date: 2008-02-06
天津市轩宏医药技术有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] When the traditional Chinese medicine compound prescription is used for oral administration, if all kinds of ingredients in the prescription that can produce pharmacological effects are fully retained in the finished preparation, the original efficacy of the prescription can be better preserved, but there are often excessive dosages. big problem
[0010] When the Chinese medicine compound is made into injections, if we try our best to keep all the ingredients that can produce pharmacological effects in the prescription, the prepared injections will either retain too many impurities, and bring in various risks of uncontrollable impurities during injection administration. It is difficult to find a safe and effective quality control method for the prepared injection, and it is difficult to guarantee the safety and stability; or the production process of separating and purifying each monomer component is extremely complicated, the cost is extremely high, and it has no practical significance

Method used

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  • Pharmaceutical formulations with the raw material containing panax, ophiopogon root and schisandra fruit, processes for their preparation, the raw material and the quality control method for the prepa
  • Pharmaceutical formulations with the raw material containing panax, ophiopogon root and schisandra fruit, processes for their preparation, the raw material and the quality control method for the prepa

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0306] prescription:

[0307] Prescription 1

Prescription 2

Prescription 3

Ginseng (red ginseng / raw ginseng)

1000g

Ginseng (red ginseng / raw ginseng)

950g

Ginseng (red ginseng / raw ginseng)

1100g

Ophiopogon japonicus

3120g

Ophiopogon japonicus

3200g

Ophiopogon japonicus

3000g

Schisandra

1560g

Schisandra

1520g

Schisandra

1510g

starch

275g

starch

297g

starch

319g

powdered sugar

137.5g

Dextrin

115.5g

lactose

93.5g

microcrystalline cellulose

110g

microcrystalline cellulose

110g

microcrystalline cellulose

110g

Sodium carboxymethyl starch

27.5g

Sodium carboxymethyl starch

27.5g

Sodium carboxymethyl starch

27.5g

95% ethanol

Appropriate amount

95% ethanol

Appropriate amount

95% ethanol

Appropriate amount

...

Embodiment 2

[0328] prescription:

[0329] Prescription 4

Prescription 5

Prescription 6

Prescription 7

Prescription 8

Ginseng (red ginseng)

500g

1000g

1000g

1000g

2000g

Ophiopogon japonicus

1560g

3120g

3120g

3120g

6240g

Schisandra

780g

1560g

1560g

1560g

3120g

Add purified water or

water for injection to

5000ml

5000ml

10000ml

20000ml

20000ml

production

1000 Oral Liquids

[0330] Prescription 9

Prescription 10

Prescription 11

Prescription 12

Prescription 13

Ginseng (red ginseng)

500g

1000g

1000g

1000g

2000g

Ophiopogon japonicus

1560g

3120g

3120g

3120g

6240g

Schisandra

780g

1560g

1560g

1560g

3120g

Add water for injection to

5000ml

...

Embodiment 3

[0356] prescription:

[0357] Prescription 29

Prescription 30

Ginseng (red ginseng)

1000g

1000g

Ophiopogon japonicus

3120g

3120g

Schisandra

1560g

1560g

Mannitol

290g

300g

Add water for injection to

3000ml

3000ml

production

1000 vials of freeze-dried preparations for injection

[0358] Preparation:

[0359] (1) Processing of ginseng: slice ginseng, add 6 times the amount respectively (for the first time because it is a dry medicinal material, add 1 times more amount) 70% ethanol reflux extraction 2 times, each 2 hours, combine the extracts, (filter ), recover ethanol from the medicinal solution until there is no alcohol smell, adjust the concentration of the medicinal solution to 1.5g of ginseng crude drug per 1ml, add 1 times the amount of water-saturated n-butanol for extraction 6 times, combine the n-butanol solution, and recover Add n-butanol unt...

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Abstract

The present invention relates to a medicine preparation with raw material comprising gen-seng, RADIX OPHIOPOGONIS and schizan drin and relates to the methods of preparing and quality control of the invention as well as relates to the quality control method of the raw material comprising gen-seng, radix ophiopogonis and schizan drin. The present invention comprises saponins content of gen-seng, amylase content of gen-seng, saponins content of radix ophiopogonis and neolignan content of schizan drin. Each unit dosage of preparation comprises Rg1 and Re for 0.08 mg-12 mg, polysaccharide of gen-seng for 1mg-460mg, general saponins for 5 mg-800 mg and Schisandrin for 0.036mg-6mg. a medicine functioning as cooperation can be or can not be added in the present invention which can be any acceptable medicine preparation type comprising oral taking solid preparation, oral taking semi-solid preparation, oral taking liquid preparation and injection. The present invention also provides the quality control method of gen-seng, RADIX OPHIOPOGONIS and schizan drin as well as the quality control method of the present invention.

Description

technical field [0001] The invention belongs to the field of medicines, and specifically relates to a pharmaceutical preparation containing ginseng, radices japonicus and schisandra in its raw materials, a preparation method, a quality control method, and a quality control method for the raw materials of ginseng, radix radix and schisandra. Background technique [0002] The ancient prescription "Shengmaisan" is composed of ginseng, Ophiopogon japonicus, and Schisandra chinensis. It has the effects of nourishing qi and nourishing yin, and restoring the pulse. It is mainly used for palpitations, shortness of breath, cold limbs, sweating, and pulse. Desperate. [0003] Modern medical research has proved that the drug has the effect of dilating blood vessels and increasing coronary blood flow, and can be used to treat cardiovascular diseases such as myocardial infarction, cardiogenic shock, and septic shock. [0004] Ginseng contains saponins, polysaccharides, β-elemene, panaxy...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/8968A61K9/08A61K9/10A61K9/14A61K9/16A61K9/19A61K9/20A61K9/48A61P9/02A61P9/10G01N30/90G01N30/02G01N33/15
Inventor 吴良信章晓骅孔志云陈宝玉艾劼
Owner 天津市轩宏医药技术有限公司
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