CN1695676A - Method for preparing powder of red sage root with high content in use for administration through vein - Google Patents
Method for preparing powder of red sage root with high content in use for administration through vein Download PDFInfo
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- CN1695676A CN1695676A CN 200510010016 CN200510010016A CN1695676A CN 1695676 A CN1695676 A CN 1695676A CN 200510010016 CN200510010016 CN 200510010016 CN 200510010016 A CN200510010016 A CN 200510010016A CN 1695676 A CN1695676 A CN 1695676A
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- danshensu
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- radix salviae
- salviae miltiorrhizae
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Abstract
A powder injection with high content of danshensu for intravenous injecting is prepared from red sage root through decocting three times, collecting decoction, filtering, concentrating, dissolving in water, filtering, regulating pH=6-9, heat treating, cold storage, ultrafiltering and drying.
Description
Technical field:
The invention belongs to medicine and make the field, be specifically related to a kind of preparation technology of Radix Salviae Miltiorrhizae for injection powder.
Background technology:
Radix Salviae Miltiorrhizae is a conventional Chinese medicine simply, another name Arisaema balansae Engl., Radix Salviae Miltiorrhizae, Herba Wedeliae Wallichii root etc., this be because of its medicinal root be aubergine so.The traditional Chinese medical science is thought, its bitter in the mouth cold nature has promoting blood circulation to restore menstrual flow, effects such as the silt pain relieving of dispelling, the relieving restlessness that clears away heart-fire, removing heat from blood eliminating carbuncle, is applicable to blood stasis, heat in blood, blood stasis hold concurrently the various diseases due to becoming silted up of heat or heat in blood of holding concurrently.Radix Salviae Miltiorrhizae whole nation demand is bigger, is one of the most frequently used clinically medicine, occupies critical role in Chinese crude drug.Radix Salviae Miltiorrhizae not only has the effect of blood circulation promoting and blood stasis dispelling, and multiple diseases such as treatment coronary heart disease, hepatitis, vasculitis and neurasthenia are all had new curative effect, also has a considerable amount of outlets.Be nearly hundred kinds of the products of raw material production with the Radix Salviae Miltiorrhizae, kind surplus the production dosage form has 10 is so the development and utilization of Radix Salviae Miltiorrhizae has good development prospect.Radix Salviae Miltiorrhizae for injection is a kind of treatment coronary heart disease, anginal medicine commonly used clinically, and Radix Salviae Miltiorrhizae has two to mainly contain effective constituent: water-soluble components danshensu and liposoluble constituent TANSHINONES, danshensu are treatment cardiovascular diseases's main pharmacodynamics compositions.Content of Danshensu is very low in traditional Danshen root injection, is about about 3% (accounting for the total amount of shape admittedly ratio).
Summary of the invention:
In order to solve the low shortcoming of content of Danshensu in traditional Danshen root injection, the invention provides the preparation method of the high Radix Salviae Miltiorrhizae powder of a kind of content of Danshensu that is used for intravenously administrable, it is achieved in that a, red rooted salvia is decocted with water three times, merge decoction liquor, filter, decoction liquor is condensed into cream; B, wash condensed cream twice, make pure content reach 40~90%, filter, be condensed into cream with ethanol alcohol; The mastic that c, the b step that is dissolved in water obtain, the addition of water are 3~8 times of paste volume, filter; D, be 6~9, under 90~130 ℃ of conditions, heat-treated 15~90 minutes that cold preservation is 12~48 hours then with aqueous slkali regulator solution pH value; E, carry out hyperfiltration treatment with ultrafilter membrane; F, collect filtrate, filtrate is dried to powder, obtain content of Danshensu and be 8~15% Radix Salviae Miltiorrhizae powder.Because danshensu can the microcirculation improvement obstacle, improve dysbolismus due to the cell hypoxic-ischemic, can coronary artery dilator, the isolated coronary that the antagonism propranolol causes is shunk, generation has certain inhibitory action to malonaldehyde, can be used for atherosclerotic control, significant anticoagulation is arranged, experimental results show that danshensu has the outer thrombosis of antibody, antiplatelet aggregation function (ADP induces), in anti-, outer blood coagulation system function, reduce platelet and promote the effect that fibrin (former) is degraded, have obvious inhibition platelet to discharge the effect of vaso-excitor material, so in Danshen root injection, use gained Radix Salviae Miltiorrhizae powder of the present invention as the main pharmacodynamics composition, treat coronary heart disease clinically, angina pectoris has tangible curative effect, and drug effect is increased significantly.The present invention is by increasing heat treatment process, makes content of Danshensu bring up to 8~15% by traditional 3%, and content of Danshensu improves more than 2.5 times.This method is easy, environmental protection, technical process are simple, does not need special installation, and safety, easy operating and carry out quality control are with low cost, gained content of Danshensu height, and stable performance is fit to large-scale industrial production.
The specific embodiment:
The specific embodiment one: present embodiment is achieved in that a, water carries: red rooted salvia is decocted with water three times, merge decoction liquor, filter, decoction liquor is condensed into cream; B, precipitate with ethanol: wash condensed cream twice with ethanol alcohol, make pure content reach 40~90%, filter, be condensed into cream; The mastic that c, the b step that is dissolved in water obtain, the addition of water are 3~8 times of paste volume, filter; D, be 6~9, under 90~130 ℃ of conditions, heat-treated 15~90 minutes that cold preservation is 12~48 hours then with aqueous slkali regulator solution pH value; E, carry out hyperfiltration treatment with ultrafilter membrane; F, collect filtrate, filtrate is dried to powder, obtain content of Danshensu and be 8~15% Radix Salviae Miltiorrhizae powder.Present embodiment adopts the HPLC method to detect content of Danshensu, and every performance of danshensu all detects according to this area conventional sense method, and specific targets are as follows:
Content: 8~15%;
Character: fine powder;
Color: yellowish-brown or brown;
Loss on drying :≤5%;
Heavy metal :≤10PPM;
The complete conformance with standard of above-mentioned every performance indications.
The specific embodiment two: present embodiment is achieved in that a, gets red rooted salvia, decocts with water three times, and wherein the addition of water is 6~12 times of medical material weight, and decocting time is 30~120 minutes, merges decoction liquor, filters, and decoction liquor is condensed into cream; B, wash condensed cream twice, make to contain the alcohol amount and reach 40~90%, filter, be condensed into cream with ethanol alcohol; The mastic that c, the b step that is dissolved in water obtain, the addition of water are 3~8 times of mastic weight, filter; D, be 6~9 with sodium hydroxide solution regulator solution pH value, heat treatment is 15~90 minutes under 90~130 ℃ of conditions, and cold preservation is 12~48 hours then; E, be that 10000~100000 high molecular weight membrane carries out hyperfiltration treatment with molecular weight; F, collect filtrate, adopt freeze-drying or spray drying method that filtrate is dried to powder, obtain content of Danshensu and be 8~15% Radix Salviae Miltiorrhizae powder.
The specific embodiment three: present embodiment is achieved in that a, gets the 1kg red rooted salvia, the decocting that adds 10,8,8 times respectively boils three times, and each decocting time was respectively 90,60,60 minutes, merges decoction liquor, filter, decoction liquor is concentrated into proportion 1.081.10 (50 ℃); B, wash twice, make to contain the alcohol amount and reach 80%, filter, be concentrated into proportion 1.081.10 (50 ℃) with ethanol alcohol; C, in the concentrated solution that the b step obtains, add 6 times of amount distilled water, it is fully dissolved, filter; D, be 8 with 10% sodium hydroxide solution regulator solution pH value, heat treatment is 90 minutes under 120 ℃ of conditions, and cold preservation is 24 hours then; E, be that 30000 ultrafilter membrane carries out hyperfiltration treatment with molecular weight; F, collection filtrate are carried out lyophilization or spray drying, make the pale brown color solid drugs powder that meets the intravenous drip requirement.Adopt the HPLC method to detect content of Danshensu, content of Danshensu is 8~15% in the finished product.Every performance indications such as the content of present embodiment products obtained therefrom, character, color, loss on drying, heavy metal meet the requirements fully.
The specific embodiment four: present embodiment is achieved in that a, gets the 1kg red rooted salvia, the decocting that adds 12,8,6 times respectively boils three times, and each decocting time was respectively 120,90,60 minutes, merges decoction liquor, filter, it is 1.10~1.12 (50 ℃) that decoction liquor is concentrated into proportion; B, wash twice with ethanol alcohol, make to contain the alcohol amount and reach 75%, filter, concentrated proportion is 1.10~1.12 (50 ℃); C, in the concentrated solution that the b step obtains, add 8 times of amount distilled water, it is fully dissolved, filter; D, be 9 with 20% sodium hydroxide solution regulator solution pH value, heat treatment is 90 minutes under 100 ℃ of conditions, and cold preservation is 48 hours then; E, be that 50000 ultrafilter membrane carries out hyperfiltration treatment with molecular weight; F, collection filtrate adopt freeze-drying with the filtrate drying.Adopt the HPLC method to detect content of Danshensu, content of Danshensu is 8~15% in the finished product.Every performance indications such as the content of present embodiment products obtained therefrom, character, color, loss on drying, heavy metal meet the requirements fully.
Claims (4)
1, is used for the preparation method of the high Radix Salviae Miltiorrhizae powder of the content of Danshensu of intravenously administrable, it is characterized in that it is achieved in that a, red rooted salvia is decocted with water three times, merge decoction liquor, filter, decoction liquor is condensed into cream; B, wash condensed cream twice, make pure content reach 40~90%, filter, be condensed into cream with ethanol alcohol; The mastic that c, the b step that is dissolved in water obtain, the addition of water are 3~8 times of paste volume, filter; D, be 6~9, under 90~130 ℃ of conditions, heat-treated 15~90 minutes that cold preservation is 12~48 hours then with aqueous slkali regulator solution pH value; E, carry out hyperfiltration treatment with ultrafilter membrane; F, collect filtrate, filtrate is dried to powder, obtain content of Danshensu and be 8~15% Radix Salviae Miltiorrhizae powder.
2, the preparation method of the Radix Salviae Miltiorrhizae powder that the content of Danshensu that is used for intravenously administrable according to claim 1 is high is characterized in that described aqueous slkali is a sodium hydroxide solution.
3, the preparation method of the Radix Salviae Miltiorrhizae powder that the content of Danshensu that is used for intravenously administrable according to claim 1 is high, the molecular weight that it is characterized in that described ultrafilter membrane is 10000~100000.
4, the preparation method of the Radix Salviae Miltiorrhizae powder that the content of Danshensu that is used for intravenously administrable according to claim 1 is high, the method that it is characterized in that filtrate is dried to powder is freeze-drying or spray drying method.
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101633616B (en) * | 2009-08-14 | 2012-10-03 | 贵州拜特制药有限公司 | Preparation method and medicinal application of tanshinol |
CN103405500A (en) * | 2013-07-31 | 2013-11-27 | 哈药集团中药二厂 | Preparation method of radix salviae miltiorrhizae freeze-dried powder for intravenous injection |
CN105461548A (en) * | 2015-12-22 | 2016-04-06 | 贵州景峰注射剂有限公司 | Method converting danshinolic acid B into tanshinol |
Family Cites Families (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1559469A (en) * | 2004-02-27 | 2005-01-05 | 北京乾露春科技有限公司 | Prepn. method for freezing-drying powder injection for treating cardiovascular disease |
-
2005
- 2005-05-24 CN CNB2005100100161A patent/CN100372549C/en active Active
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101633616B (en) * | 2009-08-14 | 2012-10-03 | 贵州拜特制药有限公司 | Preparation method and medicinal application of tanshinol |
CN103405500A (en) * | 2013-07-31 | 2013-11-27 | 哈药集团中药二厂 | Preparation method of radix salviae miltiorrhizae freeze-dried powder for intravenous injection |
CN105461548A (en) * | 2015-12-22 | 2016-04-06 | 贵州景峰注射剂有限公司 | Method converting danshinolic acid B into tanshinol |
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CN100372549C (en) | 2008-03-05 |
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Effective date of registration: 20211223 Address after: 150000 room a307-169, building 20, innovation and entrepreneurship Plaza, science and technology innovation city, high tech Industrial Development Zone, Harbin, Heilongjiang Province (178 Xiuyue Street) Patentee after: Harbin Pharmaceutical Group traditional Chinese Medicine Co.,Ltd. Address before: 150078 No. 243 Airport Road, Daoli District, Heilongjiang, Harbin Patentee before: The Second Chinese Medicine Factory, Harbin Pharmaceutical Group Co.,Ltd. |