Method for extracting and purifying lysimachia capillipes saponin B from schisandra propinqua

Abstract

The invention discloses a method for extracting and purifying lysimachia capillipes saponin B. The lysimachia capillipes saponin B is prepared from the following components in parts by mass: 100 parts of schisandra chinensis, 0.05 to 0.8 part of mannitol, 0.01 to 0.3 part of sodium hydroxide, 0.01 to 0.3 part of maleic acid, 0.03 to 0.5 part of propylene glycol and 400 to 4000 parts of water for injection. Meanwhile, the invention further discloses a preparation method of the method for extracting and purifying the lysimachia capillipes saponin B in the schisandra propinqua. According to the present invention, the formula design is scientific, the whole formula preparation is rigorous through the stabilizer propylene glycol, the cosolvent mannitol and the pH regulator sodium hydroxide and the maleic acid, the by-products are as few as possible, and the multi-stage temperature control sterilization mode is adopted to effectively inactivate the bacteria possibly existing in the mixed liquid so as to achieve the injection quality standard.

Description

Technical Field

[0001] The invention belongs to the field of medicine, and particularly relates to an extraction and purification method of scutellaria baicalensis saponin B in osmanthus fragrans and a preparation method thereof. Background Art

[0002] Quinine is a quinoline derivative that can bind to the DNA of malarial parasites to form a complex, inhibit DNA replication and RNA transcription, and thus inhibit the protein synthesis of the protozoa. Its effect is weaker than that of chloroquine. In addition, quinine can reduce the oxygen consumption of malarial parasites, inhibit the phosphorylase in malarial parasites and interfere with their sugar metabolism. Quinine also causes malarial pigment aggregation, but it develops slowly, rarely forms large clumps, and is often accompanied by cell death. Electron microscopy observation shows that the nucleus and outer membrane of the protozoa are swollen, and there are small vacuoles. The blood cell particles aggregate in the small vacuoles, which is different from the pigment aggregation of chloroquine. In the blood, a certain concentration of quinine can cause premature rupture of parasitized red blood cells, thereby preventing the maturation of schizonts. This product is ineffective in the irritation stage, and a long course of treatment can cure malignant malaria, but it has no direct effect on the gametocytes of malignant malaria, so it cannot interrupt transmission. The extraction and purification method of fine-stemmed vanilla saponin B in Manshanxiang is a colorless or slightly yellow clear liquid, which is mainly used to treat cerebral malaria and other severe malignant malaria. The traditional method for extracting and purifying vanilla saponin B from Rhizoma Cibotii has a complicated preparation process, and the pyrogen and bacterial content are easily exceeded, which no longer meets the increasingly rigorous standard control. Summary of the invention

[0003] Purpose of the invention: The purpose of the present invention is to provide a method for extracting and purifying vanillin B from Fructus Amomi, in view of the shortcomings of the prior art.

[0004] Another object of the present invention is to provide a preparation method for extracting and purifying the above-mentioned vanillin saponin B from the Fructus Amomi.

[0005] Technical solution: In order to achieve the above-mentioned invention objectives, the present invention is specifically implemented as follows: a method for extracting and purifying the fine-stemmed vanilla saponin B in Fructus Amomi, comprising the following components in parts by weight: 100 parts of Fructus Amomi, 0.05-0.8 parts of mannitol, 0.01-0.3 parts of sodium hydroxide, 0.01-0.3 parts of maleic acid, 0.03-0.5 parts of propylene glycol and 400-4000 parts of water for injection.

[0006] In a preferred embodiment, the method for extracting and purifying vanillin B from Fructus Ampelopsis Ribotii consists of the following components in parts by mass: 100 parts of Fructus Ampelopsis Ribotii, 0.2 parts of mannitol, 0.05 parts of sodium hydroxide, 0.03 parts of maleic acid, 0.1 parts of propylene glycol and 2000 parts of water for injection.

[0007] The method for preparing the above-mentioned method for extracting and purifying the fine-stemmed vanilla saponin B from the osmanthus sinensis comprises the following steps: (1) Take each component according to the formula and set aside; (2) Mix 50-70% of the total amount of water for injection with mannitol for 20-40 minutes; (3) dissolving the osmanthus fragrans in the solution obtained in step (2) and mixing for no less than 30 minutes; (4) Take 0.05-0.1% of the mass of the activated carbon particles of the Manshanxiang and sterilize them at high temperature, controlling the temperature to not less than 80°C for 1-2 hours; (5) Mixing the solution obtained in step (3) with activated carbon, sodium hydroxide, maleic acid, propylene glycol, and remaining water for injection, and centrifuging for more than 30 minutes in a centrifuge; (6) Aseptically filtering the mixed solution obtained in step (5) to remove the activated carbon particles added in the previous step, and canning as needed; (7) The canned mixed liquid is sterilized at multiple stages of high temperature. The first stage is to raise the temperature to 50-55°C for 40-60 minutes. The second stage is to raise the temperature to 65-70°C for 20-40 minutes. The third stage is to raise the temperature to 80-85°C for 15-20 minutes. The mixture is then cooled to room temperature.

[0008] Wherein, the steps (2) to (6) are performed in an environment not higher than 25°C, preferably at a temperature of 15-20°C.

[0009] Beneficial effects: Compared with the traditional technology, the present invention has the following advantages: (1) Scientific formula design, using stabilizer propylene glycol, co-solvent mannitol, and pH adjusters sodium hydroxide and maleic acid to make the entire formula preparation more rigorous and produce as few by-products as possible; (2) In the present invention, the activated carbon particles are sterilized before being added. Since the activated carbon is not sterilized at high temperature when it is subsequently added to the mixed solution, and the mixed solution is easily affected by heat sources and bacteria, the activated carbon particles are sterilized at high temperature first to prevent the introduction of influencing factors when the activated carbon particles are added; (3) In the present invention, the raw materials are directly sterilized at high temperature after being added to the mixed liquid, thereby avoiding the need for pre-sterilization of the raw materials and saving energy without affecting the quality of the finished product; (4) The present invention adopts a multi-stage temperature control sterilization method to effectively inactivate bacteria that may exist in the mixed solution, thereby meeting the quality standards of the injection solution. DETAILED DESCRIPTION Example 1

[0010] The invention discloses a method for extracting and purifying vanillin B from Rhizoma Cyperi. The method comprises the following components in parts by weight: 100 parts of Rhizoma Cyperi, 0.05 parts of mannitol, 0.01 parts of sodium hydroxide, 0.01 parts of maleic acid, 0.03 parts of propylene glycol and 400 parts of water for injection. Example 2

[0011] The invention discloses a method for extracting and purifying vanillin B from Rhizoma Cyperi. The method comprises the following components in parts by weight: 100 parts of Rhizoma Cyperi, 0.8 parts of mannitol, 0.3 parts of sodium hydroxide, 0.3 parts of maleic acid, 0.5 parts of propylene glycol and 4000 parts of water for injection. Example 3

[0012] The invention discloses a method for extracting and purifying vanillin B from Rhizoma Cyperi. The method comprises the following components in parts by weight: 100 parts of Rhizoma Cyperi, 0.2 parts of mannitol, 0.08 parts of sodium hydroxide, 0.05 parts of maleic acid, 0.3 parts of propylene glycol and 1800 parts of water for injection. Example 4

[0013] The invention discloses a method for extracting and purifying vanillin B from Rhizoma Cyperi. The method comprises the following components in parts by weight: 100 parts of Rhizoma Cyperi, 0.6 parts of mannitol, 0.2 parts of sodium hydroxide, 0.1 parts of maleic acid, 0.4 parts of propylene glycol and 3500 parts of water for injection. Example 5

[0014] The invention discloses a method for extracting and purifying vanillin B in Rhizoma Cyperi, which comprises the following components in parts by weight: 100 parts of Rhizoma Cyperi, 0.1 parts of mannitol, 0.05 parts of sodium hydroxide, 0.08 parts of maleic acid, 0.1 parts of propylene glycol and 1000 parts of water for injection. Example 6

[0015] The method for extracting and purifying the fine-stemmed vanilla saponin B in the preparation of the method comprises: taking each component according to the formula amount for use; taking 50-70% of the total amount of water for injection and mixing with mannitol for 20-40 minutes; dissolving the osmanthus fragrans in the solution obtained in step (2) and mixing for not less than 30 minutes; taking 0.05-0.1% of the mass of the osmanthus fragrans activated carbon particles for high temperature sterilization, controlling the temperature to not less than 80°C, and continuing for 1-2 hours; mixing the solution obtained in step (3) with activated carbon, sodium hydroxide, maleic acid, propylene glycol, The remaining water for injection is mixed and centrifuged for more than 30 minutes in a centrifuge; the mixed solution obtained in step (5) is aseptically filtered to remove the activated carbon particles added in the previous step, and canned as needed; the canned mixed solution is sterilized at multiple stages, with the first stage raising the temperature to 50-55°C and heating for 40-60 minutes, the second stage raising the temperature to 65-70°C and heating for 20-40 minutes, and the third stage raising the temperature to 80-85°C and heating for 15-20 minutes, and then cooling to room temperature.

Claims

1. A method for extracting and purifying vanilla saponin B from Rhizoma Cibotii, characterized in that: The following steps are involved: (1) Take each component according to the formula and set aside; (2) Mix 50-70% of the total amount of water for injection with mannitol for 20-40 minutes; (3) dissolving the osmanthus fragrans in the solution obtained in step (2) and mixing for no less than 30 minutes; (4) Take 0.05-0.1% of the mass of the activated carbon particles of the Manshanxiang and sterilize them at high temperature, controlling the temperature to not less than 80°C for 1-2 hours; (5) Mixing the solution obtained in step (3) with activated carbon, sodium hydroxide, maleic acid, propylene glycol, and remaining water for injection, and centrifuging for more than 30 minutes in a centrifuge; (6) Aseptically filtering the mixed solution obtained in step (5) to remove the activated carbon particles added in the previous step, and canning as needed; (7) The canned mixed liquid is sterilized at multiple stages of high temperature. The first stage is to raise the temperature to 50-55°C for 40-60 minutes. The second stage is to raise the temperature to 65-70°C for 20-40 minutes. The third stage is to raise the temperature to 80-85°C for 15-20 minutes. The mixture is then cooled to room temperature.

2. The method for extracting and purifying the scutellaria baicalensis saponin B from the Herba Corydalis affine according to claim 1, characterized in that: The steps (2) to (6) are performed in an environment not higher than 25°C.