CN-122005735-A - Gekko Swinhonis series Chinese medicinal preparation containing 3kD ultrafiltration process and its preparation method

Abstract

The invention discloses a gecko series Chinese medicinal preparation containing 3kD ultrafiltration technology and a preparation method thereof, wherein gecko is taken as a core raw material, water extraction and 3kD ultrafiltration are carried out to remove impurities and pyrogen, and small molecular active peptides are enriched, so that the gecko series Chinese medicinal preparation can be prepared into syrup, oral liquid, tablets, capsules, injection, freeze-dried powder injection, external preparations and other full-dosage products, has multiple effects of resisting tumor, rheumatism, dredging collaterals, stroke, relieving cough, resolving hard mass, regulating immunity and the like, has simple process, is safe and stable, can be industrially produced, and is suitable for wide clinical application.

Inventors

• CHEN JUN

Assignees

• 陈俊

Dates

Publication Date

20260512

Application Date

20260317

Claims (5)

1. 1. A gecko series traditional Chinese medicine preparation containing a 3 kDa ultrafiltration process is characterized by being prepared from the following raw materials, by weight, 30-80 parts of dry gecko, 0-40 parts of compatible traditional Chinese medicine, 100-400 parts of medicinal auxiliary materials, 0-3 parts of transdermal enhancer and a proper amount of purified water or injection water, wherein an ultrafiltration membrane with a molecular weight cut-off of 2.5 kDa-3.5 kDa is adopted for normal-temperature ultrafiltration, the ultrafiltration pressure is 0.12-0.18 MPa, the temperature is 25-40 ℃, the removal rate of macromolecular impurities and pyrogen after ultrafiltration is more than or equal to 70%, the enrichment rate of micromolecular active peptides with a molecular weight of less than 3 kDa is more than or equal to 40%, and the preparation is any one of syrup, oral liquid, tablets, capsules, granules, powder, injection, freeze-dried powder injection and external transdermal preparation.
2. 2. The gecko-series Chinese medicinal preparation according to claim 1, wherein the compatible Chinese medicines are selected from one or more of radix Angelicae Pubescentis, radix Saposhnikoviae, radix Achyranthis bidentatae, herba Scutellariae Barbatae, herba Hedyotidis Diffusae, radix astragali, herba Houttuyniae, bulbus Fritillariae Thunbergii, radix Glehniae, herba Artemisiae Scopariae, radix Curcumae, carapax Trionycis, radix Salviae Miltiorrhizae, rhizoma Chuanxiong, radix Stemonae, radix Asteris, and radix Ophiopogonis.
3. 3. The gecko-series Chinese medicinal preparation according to claim 1, wherein the series preparation comprises any one or more of rheumatism-dredging type, general anti-cancer and stasis-dissipating type, lung cancer-dedicated type, liver cancer-dedicated type, vein-relaxing restoration type, stasis-dissipating and cough-relieving type, gecko polysaccharide peptide type, nano gecko type and external transdermal type.
4. 4. A method for preparing the gecko series of traditional Chinese medicine preparations according to any one of claims 1-3, characterized by comprising the following steps: (1) Cleaning and crushing raw materials, and adding 8-10 times of purified water or water for injection for soaking for 1-2 hours; (2) Heating, decocting and extracting for 2 times, wherein the first time is 1.5-2 hours, the second time is 1 hour, mixing decoctions, and filtering; (3) Ultrafiltering the filtrate with 2.5 kDa-3.5 kDa ultrafilter membrane at normal temperature to remove macromolecular impurities and pyrogen, and enriching small molecular active peptide less than 3 kDa; (4) Concentrating the ultrafiltration permeate under reduced pressure to obtain fluid extract or extractum with the relative density of 1.10-1.22 at 60 ℃; (5) Adding medicinal adjuvants, mixing, and making into corresponding dosage forms by conventional method; (6) Constant volume, filtering, packaging, and sterilizing; the method does not adopt enzymolysis, alcohol precipitation and macroporous resin adsorption as core purification steps.
5. 5. The use of a gecko-series of Chinese herbal preparations according to any one of claims 1-3 for the preparation of a medicament for the treatment of rheumatalgia, malignant tumors, lung cancer, liver cancer, stroke sequelae, chronic cough, pulmonary nodules, external use for detumescence and analgesia, characterized in that the medicament achieves efficacy by enriching gecko-derived <3 kDa small molecule active peptides.

Description

Gekko Swinhonis series Chinese medicinal preparation containing 3kD ultrafiltration process and its preparation method The ultrafiltration technology is a key technology for modern separation and purification of animal medicines and traditional Chinese medicines, wherein a 3kD ultrafiltration membrane can accurately cut off substances with the molecular weight of about 3000Da, and has irreplaceable advantages in the aspects of active peptide enrichment, macromolecular impurity removal, preparation clarifying, impurity removal, pyrogen removal and the like. At present, 3kD ultrafiltration is widely applied to the separation of micromolecular active peptides of animal medicines such as pilose antler, deer blood, turtle shell, american cockroach and the like, and the purification of polysaccharide and clarification of extract of traditional Chinese medicines such as red ginseng, pilose asiabell root, astragalus and the like. In the field of animal medicines, 3kD ultrafiltration is a core means for obtaining <3kDa anticancer, immunity and vein relaxing active peptide, can remarkably improve the purity and stability of medicinal components, is suitable for preparing oral preparations and injection, and in the field of traditional Chinese medicines, 3kD ultrafiltration can effectively remove impurities such as tannins, pigments, colloids, pyrogens and the like, thereby improving the quality and safety of the traditional Chinese medicine preparation. However, in the prior art, the development of 3kD ultrafiltration series preparation processes and products aiming at gecko medicine sources is still less, and particularly, a gecko preparation system integrating multiple indications and multiple dosage forms (syrup, oral solid preparation, injection and external preparation) has not been reported in a system, and has larger innovation and application space. Compared with the prior art, the invention has outstanding substantial characteristics and obvious progress, the traditional gecko related traditional Chinese medicine is mainly concentrated in a single extract, a single formulation or a single indication, enzymolysis, alcohol precipitation and complex purification processes are usually adopted, the impurity removal, pyrogen removal and micromolecular peptide enrichment are synchronously completed without combining a system with 3kD ultrafiltration, and all formulations such as syrup, oral liquid, tablets, capsules, particles, injection, freeze-dried powder injection, external transdermal and the like are not covered at the same time, so that multi-indication integrated series preparations such as rheumatism, tumor, lung cancer, liver cancer, apoplexy, cough relieving, stasis dissipating, immune regulation and the like are not formed. The invention adopts simple water extraction and 3kD normal temperature ultrafiltration technology, does not need enzymolysis and alcohol precipitation, can effectively remove macromolecular impurities and pyrogen, can be used for oral preparations, can meet the production requirement of injection, integrates nine-large efficacy series and full dosage form coverage, has simple and convenient technology, low cost, high safety and wide application range, has obvious innovation in the modernization field of traditional Chinese medicine animal medicine preparations, is different from the prior art, and does not have completely consistent patent literature. The formula comprises 30-80 parts of dry gecko, 0-40 parts of compatible traditional Chinese medicine, 100-400 parts of honey/rock sugar/glycerol/pharmaceutical auxiliary materials, 0-3 parts of transdermal agent and a proper amount of purified water/water for injection. The compatible Chinese medicine is one or more selected from radix Angelicae Pubescentis, radix Saposhnikoviae, achyranthis radix, herba Scutellariae Barbatae, herba Hedyotidis Diffusae, radix astragali, herba Houttuyniae, bulbus Fritillariae Thunbergii, radix Glehniae, herba Artemisiae Scopariae, radix Curcumae, carapax Trionycis, saviae Miltiorrhizae radix, rhizoma Ligustici Chuanxiong, radix Stemonae, radix Asteris, and radix Ophiopogonis. The preparation method comprises the steps of 1, cleaning raw materials, crushing, adding 8-10 times of purified water or injection water, soaking for 1-2 hours, 2, heating, decocting for 2 times, 1.5-2 hours for the first time, merging decoction, filtering, 3, carrying out normal-temperature ultrafiltration on filtrate by adopting a 3kD ultrafiltration membrane at the pressure of 0.12-0.18 MPa and the temperature of 25-40 ℃, removing macromolecular proteins, polysaccharides, pigments, colloids, pyrogens and other impurities, enriching small molecular active peptides with the concentration of less than 3kDa, 4, concentrating the ultrafiltration permeate under reduced pressure to fluid extract or extractum with the relative density of 1.10-1.22 at the temperature of 60 ℃,5, adding corresponding pharmaceutic adjuvants, stirring, dis