CN102872171A - Method for preparing radix isatidis injection - Google Patents
Method for preparing radix isatidis injection Download PDFInfo
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- CN102872171A CN102872171A CN2012104276295A CN201210427629A CN102872171A CN 102872171 A CN102872171 A CN 102872171A CN 2012104276295 A CN2012104276295 A CN 2012104276295A CN 201210427629 A CN201210427629 A CN 201210427629A CN 102872171 A CN102872171 A CN 102872171A
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Abstract
A method for preparing radix isatidis injection comprises carrying out the following steps on radix isatidis medicinal materials, such as extracting, alcohol precipitation, ammonia precipitation, water precipitation, mixing and sterilization. The water precipitation is operated by three times of special combined water precipitation operation, and other technological steps are matched with the water precipitation to eliminate the problem that medicines are easy to produce a trace of settlings, so that stability of product quality is improved and a quality guarantee period of a product can reach up to 24 months; and synchronously, observation for 36 months shows that the radix isatidis injection provided by the invention does not only accord with a provision on the 171th page in twentyth volume in the traditional Chinese medicine prescription preparation based on a drug standard in Ministry of Public Health, and the liquid medicine does not have a trace of settlings in a storage process, so that percent of pass of a foreign matter batch is 100%. The problem that 5% to 7% of products can produce a trace of settlings at different time segments due to the products prepared by the preparation method provided by a national standard by batches. Controllability and durability of a product preparation technology are improved and stability and safety of the medicines are improved.
Description
Technical field
The invention belongs to the processing technique of Chinese herbs field, relate to the preparation method of Radix Isatidis injection.
Background technology
Radix Isatidis is the root of cruciferae isatis drying, Radix Isatidis injection be by Radix Isatidis through extract, behind the purification, the Chinese medicine injection of being processed into.Has heat-clearing and toxic substances removing, removing heat from blood sore-throat relieving, the effect of detumescence.Be mainly used in clinically tonsillitis, parotitis, laryngopharynx swelling and pain, prevent and treat the diseases such as infectious hepatitis, infantile measles.
The Radix Isatidis injection standard is recorded in the 20 the 171st page of the Sanitation Ministry medicine standard Traditional Chinese medicine historical preparation, adopted in the standard that second extraction, precipitate with ethanol, ammonia are heavy, the method for extraction and purification of twice water precipitating, the Radix Isatidis injection of the method preparation in the employing standard, in storage process, easily produce the deposit of trace, cause product visible foreign matters check against regulation, by batch, the different periods has respectively 5%～7% product can produce the negligible deposition thing in storage process.Not only caused certain economic loss to manufacturing enterprise, also administrable has brought safely hidden danger.
Summary of the invention
The object of the present invention is to provide a kind of preparation method of Radix Isatidis injection, the Radix Isatidis injection end product quality that this preparation method obtains is stable, period of storage is grown, produced without any deposit at storage-life.
The objective of the invention is to be achieved through the following technical solutions:
A kind of preparation method of Radix Isatidis injection, comprise the extraction to chromatogram of Radix Isatidis, precipitate with ethanol, ammonia is heavy, water precipitating, preparation and sterilization steps, it is characterized in that: described water precipitating step is at first to carry out 2/3 water precipitating: the heavy gained extractum of ammonia is sent in the settling tank, adding purified water to medicinal liquid weight is 2/3 of crude drug weight, it is airtight after the logical cold water of interlayer makes medicinal liquid be cooled to 2～10 ℃, left standstill 24～30 hours at 2～10 ℃, get supernatant and serve as a contrast filter paper filtering with the plate filter folder, filtrate is sent in the decompression concentrator, and being evaporated to relative density is 1.08～1.13(60 ℃ of survey) extractum;
Carry out again 1/2 water precipitating: described 2/3 water precipitating gained extractum is sent in the settling tank, adding purified water to medicinal liquid weight is 1/2 of crude drug weight, it is airtight after the logical cold water of interlayer makes medicinal liquid be cooled to 2～10 ℃, left standstill 24～30 hours at 2～10 ℃, getting supernatant is the filtering with microporous membrane of 0.65 μ m with plate filter folder lining aperture, filtrate is sent in the decompression concentrator, and being evaporated to relative density is 1.06～1.10(60 ℃ of survey) extractum;
Then carry out 5/3 water precipitating: described 1/2 water precipitating gained extractum is sent in the settling tank, adding purified water to medicinal liquid weight is 5/3 of crude drug weight, stir, filter, filtrate is airtight after being cooled to 2～10 ℃, left standstill 24 hours at 2～10 ℃, get supernatant, via hole diameter is that 0.65 μ m filter filters, filtrate is regulated pH value 7.0～7.4 with the 0.01g/ml sodium hydroxide solution, airtight after being cooled to 2～10 ℃, left standstill 24～30 hours at 2～10 ℃, getting supernatant is that 0.65 μ m micropore filter filters with the aperture.
Specifically, the preparation method of above-mentioned Radix Isatidis injection, carry out as follows:
1, medical material pre-treatment: get chromatogram of Radix Isatidis, it is first the stainless steel mesh of 2～3mm with the aperture, sieve dedust soil is sorted out impurity and the medical material of going mouldy is arranged, and wipes out fibrous root, the reed head of medical material again, cutting growth 1.5cm～2cm section shape, upper medicine-washing machine cleans 2 times with drinking water first, again with purified water spray drip washing 10 minutes, drain, again 40～60 ℃ of oven dry;
2, extract: get the Radix Isatidis 600kg after the oven dry, add in the extraction pot, add purified water and decoct secondary, add for the first time the purified water that accounts for 6 times of weight of chromatogram of Radix Isatidis, decocted 2 hours, add for the second time the purified water that accounts for 4 times of weight of chromatogram of Radix Isatidis, decocted 1.5 hours, merge decocting liquid twice, be cooled to 20～25 ℃, left standstill 4～6 hours, through the clean textile filter-cloth filtering of plate filter folder lining folder, in time change clean textile filter cloth, filtrate is sent into decompression concentrator, and to be concentrated into relative density be 1.18～1.22(60 ℃ of survey) extractum;
3, precipitate with ethanol: previous step gained extractum is sent in the Alcohol-settling tank, slowly add 95% (ml/ml) ethanol, and the limit edged stirs and to make that to contain the alcohol amount be 70%～71% (ml/ml), the logical cold water of interlayer is down to 2～10 ℃ with the alcohol deposit fluid temperature, left standstill 48 hours at 2～10 ℃ after airtight, get supernatant and filter through the plate filter of folder lining filter paper, filtrate is sent in the extraction pot, Recycled ethanol is to without behind the alcohol flavor, and continuing to be evaporated to relative density is 1.14～1.20(60 ℃ of survey) extractum;
4, ammonia is heavy reaches except ammonia: previous step gained extractum is sent in the settling tank, inject water to 1000000～1200000ml, regulate pH value 8.0～8.5 with ammonia, it is airtight after the logical cold water of interlayer makes medicinal liquid be cooled to 2～10 ℃, 2～10 ℃ leave standstill 24～30 hours after, get supernatant and filter with the plate filter of folder lining filter paper, filtrate adds evanescence of heat ammonia, and continuing to be concentrated into relative density is 1.12～1.16(60 ℃ of survey) extractum;
5,2/3 water precipitating: previous step gained extractum is sent in the settling tank, adding purified water to medicinal liquid weight is 2/3 of crude drug weight, be 400kg, it is airtight after the logical cold water of interlayer makes medicinal liquid be cooled to 2～10 ℃, left standstill 24～30 hours at 2～10 ℃, get supernatant with plate filter folder lining filter paper filtering, filtrate is sent in the decompression concentrator, and being evaporated to relative density is 1.08～1.13(60 ℃ of survey) extractum;
6,1/2 water precipitating: previous step gained extractum is sent in the settling tank, adding purified water to medicinal liquid weight is that 1/2 of crude drug weight is 300kg, it is airtight after the logical cold water of interlayer makes medicinal liquid be cooled to 2～10 ℃, left standstill 24～30 hours at 2～10 ℃, getting supernatant is the filtering with microporous membrane of 0.65 μ m with plate filter folder lining aperture, filtrate is sent in the decompression concentrator, and being evaporated to relative density is 1.06～1.10(60 ℃ of survey) extractum;
7,5/3 water precipitating: previous step gained extractum is sent in the settling tank, adding purified water to medicinal liquid weight is 5/3 of crude drug weight, stirs, and filters, filtrate is airtight after being cooled to 2～10 ℃, left standstill 24 hours at 2～10 ℃, get supernatant, via hole diameter is that 0.65 μ m filter filters, filtrate is regulated pH value 7.0～7.4 with the 0.01g/ml sodium hydroxide solution, airtight after being cooled to 2～10 ℃, left standstill 24～30 hours at 2～10 ℃, getting supernatant is that 0.65 μ m micropore filter filters with the aperture;
8, preparation and embedding: get above-mentioned filtrate and be heated to 20～30 ℃, regulate pH value 6.8～7.2 with the 0.01g/ml sodium hydroxide solution, add 6000g mannitol, stirring makes it dissolving, injects water to 1200000ml, and via hole diameter is after the filter of 0.22 μ m filters, filter through the mesopore fabric filter again, the terminal via hole diameter is to adopt aseptic filling technology fill, sealing after the sterilizing filter of 0.22 μ m filters, and is filled in the clean glass ampule of 2ml every fill 2.10～2.15ml;
9. sterilization: the medicine behind the above-mentioned filling and sealing propped up send in the water-bath type sterilizing leak detector in 100 ℃ of water-bath sterilizations 30 minutes, leak detection and get final product.
The present invention has following beneficial effect:
The present invention has taked distinctive three combination type water precipitating operation, cooperates other processing step to eliminate medicine easy problem that produces the negligible deposition thing in storage process, and stability, the shelf life of products of improving the quality of products are 24 months; Simultaneously, the observation through 36 months shows, the Radix Isatidis injection that adopts the inventive method to make, not only meet the 20 the 171st page of regulation of the Sanitation Ministry medicine standard Traditional Chinese medicine historical preparation, and medicinal liquid is in storage process, and all without the negligible deposition deposits yields, visible foreign matters batch qualification rate is 100%.Solved by the prepared product of the method for making of national Specification by batch, the different periods has respectively 5%～7% product can produce the problem of negligible deposition thing in storage process.Improve controllability and the ruggedness of product preparation process, improved stability and the safety of medicine.
The specific embodiment
In order more clearly to explain the present invention, below the invention will be further described, below be described as better embodiment of the present invention, can not do any restriction to protection scope of the present invention.
A kind of preparation method of Radix Isatidis injection, concrete steps are as follows:
One, preparation in batches: 1200000ml;
Two, clean medical material recipe quantity: 600kg;
Three, preparation method:
1, medical material pre-treatment: get chromatogram of Radix Isatidis, it is first the stainless steel mesh of 2～3mm with the aperture, sieve dedust soil, sort out impurity and the medical material of going mouldy is arranged, wipe out again fibrous root, the reed head of medical material, cutting growth 1.5cm～2cm section shape, upper medicine-washing machine, clean 2 times with drinking water first, with purified water spray drip washing 10 minutes, drain again.Again 40～60 ℃ of oven dry.
2, extract: get the Radix Isatidis 600kg after the oven dry, add in the extraction pot, add purified water and decoct secondary, add for the first time the purified water that accounts for 6 times of weight of chromatogram of Radix Isatidis, decocted 2 hours, add for the second time the purified water that accounts for 4 times of weight of chromatogram of Radix Isatidis, decocted 1.5 hours, merge decocting liquid twice, be cooled to 20～25 ℃, left standstill 4～6 hours, through the clean textile filter-cloth filtering of plate filter folder lining folder, in time change in case of necessity clean textile filter cloth, filtrate is sent into decompression concentrator, and to be concentrated into relative density be 1.18～1.22(60 ℃ of survey) extractum.
3, precipitate with ethanol: previous step extractum is sent in the Alcohol-settling tank, slowly add 95% (ml/ml) ethanol, and the limit edged stirs and to make that to contain the alcohol amount be 70%～71% (ml/ml), the logical cold water of interlayer is down to 2～10 ℃ with the alcohol deposit fluid temperature, left standstill 48 hours at 2～10 ℃ after airtight, get supernatant and filter through the plate filter of folder lining filter paper, filtrate is sent in the extraction pot, Recycled ethanol is to without behind the alcohol flavor, and continuing to be evaporated to relative density is 1.14～1.20(60 ℃ of survey) extractum.
4, ammonia is heavy reaches except ammonia: previous step extractum is sent in the settling tank, inject water to 1000000～1200000ml, regulate pH value 8.0～8.5 with ammonia, it is airtight after the logical cold water of interlayer makes medicinal liquid be cooled to 2～10 ℃, 2～10 ℃ leave standstill 24～30 hours after, get supernatant and filter with the plate filter of folder lining filter paper, filtrate adds evanescence of heat ammonia, and continuing to be concentrated into relative density is 1.12～1.16(60 ℃ of survey) extractum.
5,2/3 water precipitating: previous step extractum is sent in the settling tank, adding purified water to medicinal liquid weight is 2/3 of crude drug weight, be 400kg, it is airtight after the logical cold water of interlayer makes medicinal liquid be cooled to 2～10 ℃, left standstill 24～30 hours at 2～10 ℃, get supernatant with plate filter folder lining filter paper filtering, filtrate is sent in the decompression concentrator, and being evaporated to relative density is 1.08～1.13(60 ℃ of survey) extractum.
6,1/2 water precipitating: previous step extractum is sent in the settling tank, adding purified water to medicinal liquid weight is that 1/2 of crude drug weight is 300kg, it is airtight after the logical cold water of interlayer makes medicinal liquid be cooled to 2～10 ℃, left standstill 24～30 hours at 2～10 ℃, getting supernatant is the filtering with microporous membrane of 0.65 μ m with plate filter folder lining aperture, filtrate is sent in the decompression concentrator, and being evaporated to relative density is 1.06～1.10(60 ℃ of survey) extractum.
7,5/3 water precipitating: previous step extractum is sent in the settling tank, inject water to 1000000ml, stir, filter, filtrate is airtight after being cooled to 2～10 ℃, left standstill 24 hours at 2～10 ℃, get supernatant, via hole diameter is that 0.65 μ m filter filters, filtrate is regulated pH value 7.0～7.4 with the 0.01g/ml sodium hydroxide solution, airtight after being cooled to 2～10 ℃, left standstill 24～30 hours at 2～10 ℃, getting supernatant is that 0.65 μ m micropore filter filters with the aperture.
8, preparation and embedding: get above-mentioned filtrate and be heated to 20～30 ℃, regulate pH value 6.8～7.2 with the 0.01g/ml sodium hydroxide solution, add 6000g mannitol, stirring makes it dissolving, injects water to 1200000ml, and via hole diameter is after the filter of 0.22 μ m filters, filter through the mesopore fabric filter again, the terminal via hole diameter is to adopt aseptic filling technology fill, sealing after the filter of 0.22 μ m filters, and is filled in the clean glass ampule of 2ml every fill 2.10～2.15ml.
9. sterilization: the medicine behind the above-mentioned filling and sealing propped up send in the water-bath type sterilizing leak detector in 100 ℃ of water-bath sterilizations 30 minutes, leak detection and get final product.
The Radix Isatidis injection constant product quality that above-mentioned preparation method makes is excellent, shelf life of products is 24 months; Simultaneously, the observation through 36 months shows, not only meets the regulation of the 20 the 171st page of the Sanitation Ministry medicine standard Traditional Chinese medicine historical preparation, and medicinal liquid is in storage process, and all without the negligible deposition deposits yields, visible foreign matters batch qualification rate is up to 100%.
Claims (2)
1. the preparation method of a Radix Isatidis injection, comprise the extraction to chromatogram of Radix Isatidis, precipitate with ethanol, ammonia is heavy, water precipitating, preparation and sterilization steps, it is characterized in that: described water precipitating step is at first to carry out 2/3 water precipitating: the heavy gained extractum of ammonia is sent in the settling tank, adding purified water to medicinal liquid weight is 2/3 of crude drug weight, it is airtight after the logical cold water of interlayer makes medicinal liquid be cooled to 2～10 ℃, left standstill 24～30 hours at 2～10 ℃, get supernatant and serve as a contrast filter paper filtering with the plate filter folder, filtrate is sent in the decompression concentrator, and being evaporated to relative density is 1.08～1.13(60 ℃ of survey) extractum;
Carry out again 1/2 water precipitating: described 2/3 water precipitating gained extractum is sent in the settling tank, adding purified water to medicinal liquid weight is 1/2 of crude drug weight, it is airtight after the logical cold water of interlayer makes medicinal liquid be cooled to 2～10 ℃, left standstill 24～30 hours at 2～10 ℃, getting supernatant is the filtering with microporous membrane of 0.65 μ m with plate filter folder lining aperture, filtrate is sent in the decompression concentrator, and being evaporated to relative density is 1.06～1.10(60 ℃ of survey) extractum;
Then carry out 5/3 water precipitating: described 1/2 water precipitating gained extractum is sent in the settling tank, adding purified water to medicinal liquid weight is 5/3 of crude drug weight, stir, filter, filtrate is airtight after being cooled to 2～10 ℃, left standstill 24 hours at 2～10 ℃, get supernatant, via hole diameter is that 0.65 μ m filter filters, filtrate is regulated pH value 7.0～7.4 with the 0.01g/ml sodium hydroxide solution, airtight after being cooled to 2～10 ℃, left standstill 24～30 hours at 2～10 ℃, getting supernatant is that 0.65 μ m micropore filter filters with the aperture.
2. the preparation method of a Radix Isatidis injection is characterized in that, carries out as follows:
(1), medical material pre-treatment: get chromatogram of Radix Isatidis, it is first the stainless steel mesh of 2～3mm with the aperture, sieve dedust soil is sorted out impurity and the medical material of going mouldy is arranged, and wipes out fibrous root, the reed head of medical material again, cutting growth 1.5cm～2cm section shape, upper medicine-washing machine cleans 2 times with drinking water first, again with purified water spray drip washing 10 minutes, drain, again 40～60 ℃ of oven dry;
(2), extract: get the Radix Isatidis 600kg after the oven dry, add in the extraction pot, add purified water and decoct secondary, add for the first time the purified water that accounts for 6 times of weight of chromatogram of Radix Isatidis, decocted 2 hours, add for the second time the purified water that accounts for 4 times of weight of chromatogram of Radix Isatidis, decocted 1.5 hours, merge decocting liquid twice, be cooled to 20～25 ℃, left standstill 4～6 hours, through the clean textile filter-cloth filtering of plate filter folder lining folder, in time change clean textile filter cloth, filtrate is sent into decompression concentrator, and to be concentrated into relative density be 1.18～1.22(60 ℃ of survey) extractum;
(3), precipitate with ethanol: previous step gained extractum is sent in the Alcohol-settling tank, slowly add 95% (ml/ml) ethanol, and the limit edged stirs and to make that to contain the alcohol amount be 70%～71% (ml/ml), the logical cold water of interlayer is down to 2～10 ℃ with the alcohol deposit fluid temperature, left standstill 48 hours at 2～10 ℃ after airtight, get supernatant and filter through the plate filter of folder lining filter paper, filtrate is sent in the extraction pot, Recycled ethanol is to without behind the alcohol flavor, and continuing to be evaporated to relative density is 1.14～1.20(60 ℃ of survey) extractum;
(4), ammonia is heavy reaches except ammonia: previous step gained extractum is sent in the settling tank, inject water to 1000000～1200000ml, regulate pH value 8.0～8.5 with ammonia, it is airtight after the logical cold water of interlayer makes medicinal liquid be cooled to 2～10 ℃, 2～10 ℃ leave standstill 24～30 hours after, get supernatant and filter with the plate filter of folder lining filter paper, filtrate adds evanescence of heat ammonia, and continuing to be concentrated into relative density is 1.12～1.16(60 ℃ of survey) extractum;
(5), 2/3 water precipitating: previous step gained extractum is sent in the settling tank, adding purified water to medicinal liquid weight is 2/3 of crude drug weight, be 400kg, it is airtight after the logical cold water of interlayer makes medicinal liquid be cooled to 2～10 ℃, left standstill 24～30 hours at 2～10 ℃, get supernatant with plate filter folder lining filter paper filtering, filtrate is sent in the decompression concentrator, and being evaporated to relative density is 1.08～1.13(60 ℃ of survey) extractum;
(6), 1/2 water precipitating: previous step gained extractum is sent in the settling tank, adding purified water to medicinal liquid weight is that 1/2 of crude drug weight is 300kg, it is airtight after the logical cold water of interlayer makes medicinal liquid be cooled to 2～10 ℃, left standstill 24～30 hours at 2～10 ℃, getting supernatant is the filtering with microporous membrane of 0.65 μ m with plate filter folder lining aperture, filtrate is sent in the decompression concentrator, and being evaporated to relative density is 1.06～1.10(60 ℃ of survey) extractum;
(7), 5/3 water precipitating: previous step gained extractum is sent in the settling tank, adding purified water to medicinal liquid weight is 5/3 of crude drug weight, stirs, and filters, filtrate is airtight after being cooled to 2～10 ℃, left standstill 24 hours at 2～10 ℃, get supernatant, via hole diameter is that 0.65 μ m filter filters, filtrate is regulated pH value 7.0～7.4 with the 0.01g/ml sodium hydroxide solution, airtight after being cooled to 2～10 ℃, left standstill 24～30 hours at 2～10 ℃, getting supernatant is that 0.65 μ m micropore filter filters with the aperture;
(8), preparation and embedding: get above-mentioned filtrate and be heated to 20～30 ℃, regulate pH value 6.8～7.2 with the 0.01g/ml sodium hydroxide solution, add 6000g mannitol, stirring makes it dissolving, injects water to 1200000ml, and via hole diameter is after the filter of 0.22 μ m filters, filter through the mesopore fabric filter again, the terminal via hole diameter is to adopt aseptic filling technology fill, sealing after the sterilizing filter of 0.22 μ m filters, and is filled in the clean glass ampule of 2ml every fill 2.10～2.15ml;
(9), sterilization: the medicine behind the above-mentioned filling and sealing propped up send in the water-bath type sterilizing leak detector in 100 ℃ of water-bath sterilizations 30 minutes, leak detection and get final product.
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1453033A (en) * | 2003-05-19 | 2003-11-05 | 吴梅春 | Freeze dried isatis root powder for injection and its prepn |
| CN1751700A (en) * | 2005-08-08 | 2006-03-29 | 北京阜康仁生物制药科技有限公司 | Novel administration route of isatis root injection for relieving internal heat, and prepn. technique and application thereof |
| CN1833667A (en) * | 2006-04-12 | 2006-09-20 | 烟台市中医医院 | Natural indigo ketone oral liquor or injection and usage |
-
2012
- 2012-10-30 CN CN2012104276295A patent/CN102872171A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1453033A (en) * | 2003-05-19 | 2003-11-05 | 吴梅春 | Freeze dried isatis root powder for injection and its prepn |
| CN1751700A (en) * | 2005-08-08 | 2006-03-29 | 北京阜康仁生物制药科技有限公司 | Novel administration route of isatis root injection for relieving internal heat, and prepn. technique and application thereof |
| CN1833667A (en) * | 2006-04-12 | 2006-09-20 | 烟台市中医医院 | Natural indigo ketone oral liquor or injection and usage |
Non-Patent Citations (2)
| Title |
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| 丁海昕等: "板蓝根注射液制备工艺的研究", 《齐鲁药事》 * |
| 吴俊伟等: "板蓝根注射液制备工艺的改进", 《中国兽药杂志》 * |
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