CN1679841A - Powder injection of sarcandra and its making method - Google Patents

Powder injection of sarcandra and its making method Download PDF

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Publication number
CN1679841A
CN1679841A CNA2005100420437A CN200510042043A CN1679841A CN 1679841 A CN1679841 A CN 1679841A CN A2005100420437 A CNA2005100420437 A CN A2005100420437A CN 200510042043 A CN200510042043 A CN 200510042043A CN 1679841 A CN1679841 A CN 1679841A
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China
Prior art keywords
filtrate
amount
injection
add
precipitation
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CNA2005100420437A
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Chinese (zh)
Inventor
肖广常
张颖
孙锦光
王淑娟
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HENGRUI MEDICAL SCIENCE AND TECHNOLOGY DEVELOPMENT Co Ltd SHANDONG PROVINCE
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HENGRUI MEDICAL SCIENCE AND TECHNOLOGY DEVELOPMENT Co Ltd SHANDONG PROVINCE
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Priority to CNA2005100420437A priority Critical patent/CN1679841A/en
Publication of CN1679841A publication Critical patent/CN1679841A/en
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    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Medicinal Preparation (AREA)

Abstract

A powder injection for treating pneumonia, appendicitis, cellular tissue inflammation, bacterial dysentery, tumors, etc is prepared from glabrous sarcandra herb through extracting, mixing it with cosolvent and excipient and freeze drying.

Description

Powder injection of sarcandra and preparation method thereof
(1) technical field
The present invention relates to a kind of powder injection of sarcandra and preparation method thereof, belong to medical technical field.
(2) background technology
Herba Sarcandrae (having another name called Herba Pileae Scriptae, Ramulus Sambuci Williamsii, Herba Pileae Scriptae) is a conventional Chinese medicine, is the herb of Chloranthaceae plant plait Corallium Japonicum Kishinouye (Sarcandraglabra Thunb).Be perennial herb or undershrub, high 50~120 centimetres.Root manure is big, and stem is grown thickly, and joint obviously.The Pharmacopoeia of the People's Republic of China 2000 version (one one) is recorded it and is used as legal medical material.Herba Sarcandrae bitter in the mouth, suffering, property are put down, and be slightly poisonous, has effects such as antiinflammatory, heat clearing away, detoxifcation and relaxing muscles and tendons to promote blood circulation.The Herba Sarcandrae clinical practice is very extensive, especially respiratory tract and gastral diseases associated with inflammation is had curative effect preferably, also often is applied to promote union of fracture, antitumor, immunomodulating and analgesia etc.The dosage form of the present domestic listing of Herba Sarcandrae has solid preparation and injection, its antiinflammatory, heat clearing away, detoxifcation and relaxing muscles and tendons to promote blood circulation and antineoplastic curative effect more and more obtain the approval of extensive patients, yet phenomenons such as the muddiness that usually occurs in the Chinese medicine injection, precipitation, influence the quality of product, thereby influenced the treatment curative effect of medicine.
(3) summary of the invention
The present invention has avoided the deficiency of above-mentioned technology, and a kind of powder injection of sarcandra and preparation method thereof is provided.
The invention provides a kind of powder injection of sarcandra, prepare: get Herba Sarcandrae, decoct with water secondary by following method, filter, filtrate concentrates, and adds the ethanol precipitation secondary, reclaim ethanol and concentrated, add the egg protein solution of proper amount of fresh preparation, stir, make precipitation, cold preservation filters, filtrate is boiled, and filters, and filtrate adds ethanol, make that to contain amount of alcohol be 75%, place precipitation, filter, filtrate recycling ethanol, it is an amount of to add the injection water, adds cosolvent, excipient, stir, water for injection is supplied in dissolving again, regulate pH value to 4.0~7.0, add pin with charcoal after stirring at room, filtering decarbonization, fine straining.Filtrate is through spraying drying or lyophilization, promptly.
Above-mentioned cosolvent is selected from one or more in sodium sulfite, sodium sulfite, sodium pyrosulfite, Tween 80, the glycerol.Molecular weight gets final product by this area normal ranges.
Above-mentioned excipient is selected from one or more in mannitol, lactose, glycine, sorbitol, low molecular dextran, glucose, sucrose, the hydrolysis gel.Molecular weight gets final product by this area normal ranges.
The invention provides a kind of preparation method of powder injection of sarcandra, this method comprises the step of following order:
1) get Herba Sarcandrae, decoct with water secondary, each 2 hours, collecting decoction filtered, and it is 1.33 (70 ℃) that filtrate is concentrated into relative density;
2) get above-mentioned filtrate and add the ethanol precipitation secondary, make for the first time that to contain the alcohol amount be 70%, containing the alcohol amount for the second time is 80%, each cold preservation 48 hours filters, and filtrate recycling ethanol also is concentrated into every 1ml and contains crude drug 10g, the egg protein solution that adds the proper amount of fresh preparation stirs, and makes precipitation, cold preservation 48 hours filters, and filtrate is boiled, excessive egg protein is solidified, filter, filtrate adds ethanol, make that to contain amount of alcohol be 75%, place precipitation, filter Herba Sarcandrae extract;
3) said extracted thing, cosolvent, excipient are closed place container, it is an amount of to add the injection water, and stirring and dissolving is supplied water for injection, regulates pH value to 4.0~7.0, add pin with charcoal after stirring at room, filtering decarbonization, fine straining.Spray-dried or the lyophilization of filtrate, promptly.
The main chemical compositions that contains in the Chinese medicinal material of sarcandra glaber is phenols, tannin, flavonoid glycoside, coumarin, volatile oil and lactone etc.At present, isolated effective ingredient has 30 from Herba Sarcandrae, comprise 13 of sesquialter glycosides, 9 of flavonoid glycosides, 2 of organic acids, 3 of Coumarinses, and 3 of other compounds, as: Fumaric acid, linalyl acetate, succinic acid, atractylene lactone, coumarin, lactone flavonoid glycoside, different ash tree pyridine etc.Wherein the linalyl acetate in the volatile oil has very strong direct killing effect to tumor cell, and organic acid mixture such as Fumaric acid and succinic acid have stronger antibacterial and anti-inflammation functions, be the main active of Herba Sarcandrae performance anti-inflammation, the atractylene lactone in the sesquialter glycoside also has certain antibacterial and anti-inflammation functions simultaneously.
Compared with prior art this product has overcome phenomenons such as the muddiness that usually occurs in the injection, precipitation, and it is stable to obtain the quality of the pharmaceutical preparations, drug safety, convenience.
Powder injection of sarcandra of the present invention has heat-clearing and toxic substances removing, dispersing swelling and dissipating binds.Be used for pneumonia due to the hyperactivity of toxic heat, appendicitis, cellulitis, bacillary dysentery, abscess, unite tumors such as being used for digestive tract cancer, cancer of pancreas, hepatocarcinoma with ZHONGJIEFENG PIAN.
(4) specific embodiment
Embodiment 1
Get Herba Sarcandrae 1000g, decoct with water secondary, each 2 hours, collecting decoction filters, and it is 1.33 (70 ℃) that filtrate is concentrated into relative density, add the ethanol precipitation secondary, make for the first time that to contain the alcohol amount be 70%, containing the alcohol amount for the second time is 80%, each cold preservation 48 hours filters, and filtrate recycling ethanol also is concentrated into every 1ml and contains crude drug 10g, the egg protein solution that adds the proper amount of fresh preparation stirs, and makes precipitation, cold preservation 48 hours filters, and filtrate is boiled, excessive egg protein is solidified, filter, filtrate adds ethanol, makes that to contain amount of alcohol be 75%, place precipitation, filter, filtrate recycling ethanol gets Herba Sarcandrae extract.Herba Sarcandrae extract, mannitol 100g, Tween 80 10g are closed again and place container, it is an amount of to add the injection water, stirring and dissolving, add injection and be diluted with water to 1000ml, regulate pH value to 7.0, add pin with charcoal after stirring at room, filtering decarbonization, fine straining, filtrate is sub-packed in the 2ml sterilization cillin bottle, lyophilization, tamponade, gland, promptly.
Embodiment 2
Get Herba Sarcandrae 5000g, decoct with water secondary, each 2 hours, collecting decoction filters, and it is 1.33 (70 ℃) that filtrate is concentrated into relative density, add the ethanol precipitation secondary, make for the first time that to contain the alcohol amount be 70%, containing the alcohol amount for the second time is 80%, each cold preservation 48 hours filters, and filtrate recycling ethanol also is concentrated into every 1ml and contains crude drug 50g, the egg protein solution that adds the proper amount of fresh preparation stirs, and makes precipitation, cold preservation 48 hours filters, and filtrate is boiled, excessive egg protein is solidified, filter, filtrate adds ethanol, make that to contain amount of alcohol be 75%, place precipitation, filter, filtrate recycling ethanol, it is an amount of to add the injection water, cold preservation 24 hours, filter, filtrate is regulated pH value to 9.0 with caustic lye of soda, and adding that active carbon makes is 0.05% concentration, boils 30 minutes, filter, get Herba Sarcandrae extract.Again Herba Sarcandrae extract, glycine 80g, sodium sulfite 10g are closed and place container, it is an amount of to add the injection water, stirring and dissolving, add injection and be diluted with water to 1000ml, regulate pH value to 6.0, add pin with charcoal after stirring at room, filtering decarbonization, fine straining, the spray-dried powder injection of sarcandra that promptly gets of filtrate.
Embodiment 3
Get Herba Sarcandrae 10000g, decoct with water secondary, each 2 hours, collecting decoction filters, and it is 1.33 (70 ℃) that filtrate is concentrated into relative density, add the ethanol precipitation secondary, make for the first time that to contain the alcohol amount be 70%, containing the alcohol amount for the second time is 80%, each cold preservation 48 hours filters, and filtrate recycling ethanol also is concentrated into every 1ml and contains crude drug 100g, the egg protein solution that adds the proper amount of fresh preparation stirs, and makes precipitation, cold preservation 48 hours filters, and filtrate is boiled, excessive egg protein is solidified, filter, filtrate adds ethanol, make that to contain amount of alcohol be 75%, place precipitation, filter, filtrate recycling ethanol, it is an amount of to add the injection water, cold preservation 24 hours, filter, get Herba Sarcandrae extract.Herba Sarcandrae extract, lactose 20g, sodium pyrosulfite 8g are closed again and place container, it is an amount of to add the injection water, stirring and dissolving, add injection and be diluted with water to 1000ml, regulate pH value to 5.0, add pin with charcoal after stirring at room, filtering decarbonization, fine straining, filtrate is sub-packed in the 4ml sterilization cillin bottle, lyophilization, tamponade, gland, promptly.
Pharmacodynamic test of active extract
The present invention has carried out the research of aspects such as anti-inflammation, antitumor, and result of study shows:
1) Herba Sarcandrae has direct inhibitory action external to antibacterial, the minimum bacteria concentration of facing upward to bacillus pyocyaneus and staphylococcus aureus is respectively 0.6% and 1.3%, to Hemolytic streptococcus and colibacillary minimum inhibitory concentration is 2.5%, and experimental result shows that Herba Sarcandrae can reduce the mortality rate of mice Staphylococcus aureus bacteremia in the body.
2) Herba Sarcandrae can improve mice carbon clearance index, improves the phagocytic function of mice nonspecific immunity reticuloendothelial system.Powder injection of sarcandra also can increase the weight of the spleen and the thymus of tumor-bearing mice, increases tumor-bearing mice peripheral leukocytes number, improves immunologic function.
Toxicological test
Powder injection of sarcandra has been carried out toxicological study, the result shows, mice is measured through intravenous injection LD50 and belongs to nontoxic scope, the mouse sperm deformity test, mouse marrow cell micro nuclear test, Salmonella reversion test is all negative, and mutagenicity is found at the end, and human liver renal function, blood pressure, pulse etc. are not all had obvious damage.

Claims (4)

1, the present invention is a kind of powder injection of sarcandra, it is characterized in that this injectable powder is prepared by following method: get Herba Sarcandrae, decoct with water secondary, filter, filtrate concentrates, and adds the ethanol precipitation secondary, reclaim ethanol and concentrated, add the egg protein solution of proper amount of fresh preparation, stir, make precipitation, cold preservation filters, filtrate is boiled, and filters, and filtrate adds ethanol, make that to contain amount of alcohol be 75%, place precipitation, filter, filtrate recycling ethanol, it is an amount of to add the injection water, adds cosolvent, excipient, stir, water for injection is supplied in dissolving again, regulate pH value to 4.0~7.0, add pin with charcoal after stirring at room, filtering decarbonization, fine straining, the spray-dried or lyophilization of filtrate, promptly.
2, powder injection of sarcandra as claimed in claim 1 is characterized in that described cosolvent is selected from one or more in sodium sulfite, sodium sulfite, sodium pyrosulfite, Tween 80, the glycerol.
3, powder injection of sarcandra as claimed in claim 1 is characterized in that described excipient is one or more in mannitol, lactose, glycine, sorbitol, low molecular dextran, glucose, sucrose, the hydrolysis gel.
4, the described powder injection of sarcandra preparation method of claim 1 comprises that step is as follows:
1) get Herba Sarcandrae, decoct with water secondary, each 2 hours, collecting decoction filtered, and it is 1.33 (70 ℃) that filtrate is concentrated into relative density;
2) get above-mentioned filtrate and add the ethanol precipitation secondary, make for the first time that to contain the alcohol amount be 70%, containing the alcohol amount for the second time is 80%, each cold preservation 48 hours filters, and filtrate recycling ethanol also is concentrated into every 1ml and contains crude drug 10g, the egg protein solution that adds the proper amount of fresh preparation stirs, and makes precipitation, cold preservation 48 hours filters, and filtrate is boiled, excessive egg protein is solidified, filter, filtrate adds ethanol, make that to contain amount of alcohol be 75%, place precipitation, filter Herba Sarcandrae extract;
3) said extracted thing, cosolvent, excipient are closed place container, it is an amount of to add the injection water, and stirring and dissolving is supplied water for injection, regulate pH value to 4.0~7.0, add pin with charcoal after stirring at room, filtering decarbonization, fine straining, the spray-dried or lyophilization of filtrate, promptly.
CNA2005100420437A 2005-01-21 2005-01-21 Powder injection of sarcandra and its making method Pending CN1679841A (en)

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Application Number Priority Date Filing Date Title
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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN100374105C (en) * 2005-12-13 2008-03-12 南京虹桥医药技术研究所 Glabrous sarcandra herb lyophilized powder for injection, its high-dose injection and preparing method
CN102462711A (en) * 2011-09-19 2012-05-23 江西天施康中药股份有限公司 Glabrous sarcandra herb injection and preparation method thereof
CN102988432A (en) * 2012-12-11 2013-03-27 广东新峰药业股份有限公司 Preparation method of traditional Chinese medicine aqueous solution for antibiosis, antiphlogosis and antitumor

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN100374105C (en) * 2005-12-13 2008-03-12 南京虹桥医药技术研究所 Glabrous sarcandra herb lyophilized powder for injection, its high-dose injection and preparing method
CN102462711A (en) * 2011-09-19 2012-05-23 江西天施康中药股份有限公司 Glabrous sarcandra herb injection and preparation method thereof
CN102988432A (en) * 2012-12-11 2013-03-27 广东新峰药业股份有限公司 Preparation method of traditional Chinese medicine aqueous solution for antibiosis, antiphlogosis and antitumor

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