Ziyuglycoside self-emulsifying drug delivery system preparation
A delivery system, the technology of Sangui saponin, applied in the field of preparation of Sangui saponin self-emulsifying drug delivery system, can solve the problems of slow onset of action, low quality standard, lack of pharmacokinetic parameters, etc., and achieve stable quality and reasonable process Feasible effect
Active Publication Date: 2018-02-06
ZUNYI MEDICAL UNIVERSITY
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Problems solved by technology
Currently on the market, Diyu Shengbai Tablets is a prescription preparation developed from a single herb Burnet as a raw material, which has a significant inhibitory effect on the decrease in the number of peripheral blood leukocytes caused by radiotherapy and chemotherapy, but there are many problems restricting its clinical application and development. , such as unclear material basis and mechanism of action, lack of pharmacokinetic parameters, slow onset of action, limited dose of drug effect, 60 mg is the maximum daily dose, low quality standards and other serious problems, making this variety unable to enter the first-line clinical practice Variety, failed as a blockbuster drug for myelosuppression
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[0026] The present invention is described in further detail below:
[0027] A self-emulsifying drug delivery system of burnet saponin, comprising the following components, the percentage by weight of which is composed of:
[0028] Oil phase: 0.05%-0.25%;
[0029] Surfactant: 0.45%-0.65%;
[0030] Co-surfactant: 0.1%-0.3%; the balance is mainly Saponin of Burnet.
[0031] The preparation method of the saponin of Burnet includes the following steps:
[0032] step one:
[0033] Take 1 kg of Burnet decoction pieces, crush them properly, add 8 times the amount of 90% ethanol to reflux and extract twice, each time for 1.5 hours, filter, combine the two extracts, let stand and let cool, add 10% NaOH solution to adjust the pH to 12-14, let it stand overnight, centrifuge to remove the precipitate, and filter the filtrate to obtain the supernatant;
[0034] Step two:
[0035] Concentrate the supernatant obtained in step 1 under reduced pressure, add water to ethanol concentration ...
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Abstract
The invention discloses a ziyuglycoside self-emulsifying drug delivery system which is prepared from the following components in weight percentage: 0.05% to 0.25% of oil phase, 0.45% to 0.65% of surface active agent, 0.1% to 0.3% of cosurfactant and the rest of a main material ziyuglycoside. The ziyuglycoside self-emulsifying drug delivery system disclosed by the invention is established for the first time and has the advantages of reasonable and practical technology and stable quality.
Description
technical field [0001] The invention relates to a self-emulsifying drug delivery system, in particular to the preparation of a burnet saponin self-emulsifying drug delivery system. Background technique [0002] Chemoradiation, as the main means of tumor treatment, has serious side effects such as bone marrow suppression. It often leads to a decrease in the number of peripheral blood cells in patients and a decrease in immune function. Improving the tolerance of cancer patients to chemoradiotherapy drugs and reducing the risk of "secondary cancer" caused by myelosuppression has become an urgent problem to be solved in the course of radiotherapy and chemotherapy. Currently on the market, Diyu Shengbai Tablets is a prescription preparation developed from a single herb Burnet as a raw material, which has a significant inhibitory effect on the decrease in the number of peripheral blood leukocytes caused by radiotherapy and chemotherapy, but there are many problems restricting it...
Claims
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IPC IPC(8): A61K9/00A61K9/107A61K31/704A61K47/26A61K47/10A61K47/14A61P7/00A61P7/06
CPCA61K9/00A61K9/107A61K31/704A61K47/10A61K47/14A61K47/26A61K2236/333A61K2236/39A61K2236/53
Inventor 熊永爱曾艳
Owner ZUNYI MEDICAL UNIVERSITY