Method for processing ixeris sonchifolia for ixeris sonchifolia injection in producing area

Abstract

The invention discloses a production area processing method of ixeris denticulata for ixeris sonchifolia hance injection, and belongs to the field of production area processing of traditional Chinese medicinal materials. On the basis of a harvesting, processing and storage method of the Chinese medicinal material production quality management specifications, the production reality and the physicochemical properties of effective components of the ixeris denticulata are combined, and the ixeris denticulata hance injection is prepared. Influences of harvesting, producing area processing and storage methods of the Ixeris denticulata medicinal materials on the content of total phenolic acids and total flavonoids of the active ingredients of the Ixeris denticulata medicinal materials are studied, the practical production problem that the quality of the Ixeris denticulata medicinal materials is unstable is effectively solved, and in the Ixeris denticulata processed in the producing area, the content of the total phenolic acids and the content of the total flavonoids are remarkably improved, and the quality of the Ixeris denticulata medicinal materials is improved. Compared with the prior art, the content of polymeric tannins, phenolic acids, pathogenic bacteria, other sensitizing substances and the like is remarkably reduced, the accelerated stability research lasts for 6 months, the long-term stability research lasts for 24 months, the quality is stable, and reference is provided for construction of a GAP base of the traditional Chinese medicinal material Ixeris denticulata for the ixeris sonchifolia hance injection and formulation of SOP of the GAP base.

Description

Technical Field

[0001] The invention relates to a method for processing clematis nephrodisiac for kudiezi injection, and belongs to the field of processing of traditional Chinese medicines. Background Art

[0002] The chemical composition of Ixeris sonchifolia (Bge_) Hance, a plant of the Asteraceae family, is complex, mainly containing phenolic acids, flavonoids, organic acids, sesquiterpene lactones and triterpene saponins. In addition, it also contains sterols, coumarins, lignans, vitamins, amino acids, sugars and other compounds. It is the main raw material for the intravenous Chinese medicine injection, Ixeris sonchifolia injection.

[0003] Current research results show that the medicinal material basis for the treatment of coronary heart disease and cerebral infarction is flavonoids and phenolic acid compounds. The monomer compounds chicoric acid, luteolin, apigenin, (-) 3,4-dihydroxycaffeoyltartaric acid, etc. are the main pharmacologically active ingredients in Kudiezi injection, and are also important chemical components for quality standard detection and control.

[0004] In recent years, in the investigation of the resources of the raw medicinal materials of Ilex classipes, the quality research and the production investigation of related enterprises, it was found that its quality is closely related to its harvesting period, processing method, storage method and time, which directly affects the quality of the raw medicinal materials. Ilex classipes has always been used as wild products for medicinal purposes. After collecting the medicinal materials, the farmers would tie them up and hang them on the forks of trees on the hillside or in front of or behind the house to dry naturally in the shade or in the sun.

[0005] At present, the production of Ilex cerasifera is to bundle it after harvesting, dry it in the sun or in the shade, and then pack it and place it in the medicinal material warehouse, but there are serious quality problems:

[0006] (1) The total phenolic acid and total flavonoid contents were sometimes qualified and sometimes unqualified, resulting in poor batch stability of the quality of the raw materials of Sophora flavescens and a significant increase in the cost of purchasing raw materials.

[0007] (2) After being stored for a period of time (0.5 years), the medicinal materials are prone to mold and deterioration from the inside out, becoming unqualified raw materials and causing serious economic losses.

[0008] (3) The content of total phenolic acid and total flavonoids decreased, even to the point of being unqualified. The main reason for the mold and deterioration of the original medicinal materials was the processing and packaging methods of the medicinal materials.

[0009] (4) Kudiezi injection is a small-volume injection of traditional Chinese medicine for intravenous use. It has high requirements for safety, effectiveness and quality controllability, and has allergic reactions during clinical use: skin flushing, rash, itching, dyspnea, breathlessness, palpitations, cyanosis, hypotension, anaphylactic shock, etc. These adverse reactions are related to the processing quality of the medicinal materials used in production. Summary of the invention

[0010] In view of this, the present invention provides a processing method of Ilex claspingii for Kudiezi injection, based on the harvesting, processing and storage methods of "Quality Management Standard for Production of Chinese Medicinal Materials", combined with the actual production and the physicochemical properties of the effective ingredients of Ilex claspingii, the effects of processing and storage methods of different origins of Ilex claspingii medicinal materials on the total phenolic acid and total flavonoids contents of its active ingredients are studied, aiming to determine the most scientific origin processing method and storage method for the production of Ilex claspingii medicinal materials, effectively solve the actual production problem of unstable quality of Ilex claspingii medicinal materials, and provide a reference for the construction of the GAP base of Ilex claspingii, a Chinese medicinal material for Kudiezi injection, and the formulation of its SOP.

[0011] In order to achieve the above object, the present invention adopts the following technical solution:

[0012] A method for processing clematis oleraceus for kudiezi injection at the place of origin, comprising the following steps:

[0013] (1) cutting the above-ground part of the cleistochete in full bloom, removing foreign matter, drying in the field until it is wilted, and tying;

[0014] (2) the bundled oleander is piled up for enzymatic hydrolysis, and then air-dried again after enzymatic hydrolysis until the surface is dry, and then cut into sections;

[0015] (3) drying the cut nephrolepis chinensis by air-drying until the moisture content is 6.0-10.0%;

[0016] (4) vacuum packing the dried Ilex nemorosa segments.

[0017] On the basis of the above technical solution, the present invention further defines the solution as follows:

[0018] Furthermore, in step (1), the above-ground portion is the portion above 5 to 10 cm from the ground;

[0019] Removing impurities means removing dry rotten leaves, weeds and sand;

[0020] The field drying time is 1 to 3 days, until the moisture content is reduced by 30 to 40%;

[0021] The bundling specification is 10-15kg / bundle.

[0022] Furthermore, in step (2), the temperature of the stacking enzymolysis is 30 to 50° C., the time is 12 to 72 hours, the paving thickness is 0.3 to 1.0 meter, and preferably, the time is 24 to 48 hours;

[0023] The length of the cut section is 1.0 to 10.0 cm;

[0024] The temperature of the secondary drying is 60 to 120° C., and the time is 0.5 to 4.0 hours.

[0025] Furthermore, the temperature of the forced air drying in step (3) is 60 to 120° C., preferably 100 to 110° C., the time is 0.5 to 4.0 hours, preferably 0.5 to 1.0 hour, and the paving thickness is 15 to 30 cm.

[0026] Furthermore, in step (4), the vacuum packaging is performed by vacuum pumping for 5 to 20 seconds, the packaging is three-layer packaging, and the packaging specification is 5.0 to 50.0 kg.

[0027] Furthermore, in step (4), the three-layer packaging is composed of a highly breathable non-woven fabric layer, a dense aluminum-plastic film layer, and a woven bag layer from the inside to the outside.

[0028] The contents of total phenolic acid and total flavonoids in the processed Ilex classipes from the above-mentioned origins are significantly increased, about 90% higher than those of the prior art. Studies have shown that flavonoid components represented by luteolin and apigenin and phenolic acid components represented by chicoric acid are the main active ingredients of Ilex classipes, and are also the main medicinal material basis for the treatment of coronary heart disease, angina pectoris, cerebral infarction and other diseases in Ilex classipes injection. At the same time, the contents of polymerized tannins, phenolic acids, pathogenic bacteria and other allergenic substances are significantly reduced. The accelerated stability study was 6 months and the long-term stability study was 24 months, and the quality was stable, meeting the internal control quality standard requirements for the direct production of Ilex classipes injection.

[0029] The present invention also provides the use of the origin processing method of the above-mentioned Ilex classipes in the preparation of Ilex kudiezi Chinese patent medicine, such as the use of the method in the preparation of Ilex kudiezi injection and / or decoction pieces.

[0030] The beneficial effects of the present invention are:

[0031] Compared with the traditional processing technology at the production site, the processing method of the invention can effectively improve the content of total flavonoids and total phenolic acid, a medicinal active substance in the medicinal material of Sophora flavescens after the processing technologies of harvesting, airing, stacking enzymolysis, cutting, drying and vacuum packaging of Sophora flavescens, and has a significant effect on improving the quality of Sophora flavescens decoction pieces used in the production of Kudiezi injection.

[0032] In addition, the production site processing techniques such as harvesting, cleaning, stacking enzymatic hydrolysis, cutting, drying and vacuum packaging have been successively carried out to standardize the process to the maximum extent, determine the process parameters, improve the quality of medicinal materials, batch stability, qualification and safety, and improve the quality of raw materials used in the production of Kudiezi injection. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1 is the standard curve of luteolin;

[0034] Figure 2 is the total phenolic acid detection wavelength of the present invention;

[0035] Figure 3 This is the standard curve of chicoric acid. DETAILED DESCRIPTION

[0036] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0037] Example 1

[0038] Harvesting and drying technology of clematis oleraceus

[0039] Every May to June, cut the above-ground part of the clasping dahliae at full flowering period (60-70% of flowers are in bloom), cut it 5-10 cm above the ground, remove impurities, and dry it in the field for 1-3 days until it is wilted and soft. At the same time, the moisture is reduced by 30-40%, and the flowers are 80-90% in bloom. Bundle the clasping dahliae, each bundle weighs 5-15 kg.

[0040] Example 2

[0041] Enzymatic hydrolysis technology of piled up Ilex nephrolepis

[0042] The bundled clematis oleracea is orderly stacked on the shelf of the temperature-controlled room, the thickness of the medicinal materials is 0.3-1.0 meters, the temperature range is 30-50° C., the humidity range is 80-90%, and the temperature is gradually increased and the time is controlled by enzymolysis for 12-72 hours to obtain the clematis oleracea after enzymolysis;

[0043] Example 3

[0044] Drying process after cutting

[0045] Temperature-controlled air blast rapid drying, drying temperature is 60-120°C, drying time is 0.5-4.0 hours, moisture is 6.0-10.0%.

[0046] Example 4

[0047] Vacuum packaging process

[0048] Fully automatic vacuum packaging machine, each bag is 5 to 50kg, and then vacuum packaging is carried out. The vacuum extraction time is 5 to 20 seconds. It uses three layers of high-quality and low-cost packaging materials of different materials: the inner layer is a highly breathable non-woven fabric protective layer, the middle layer is a dense aluminum-plastic film, and the outer layer is a waterproof woven bag.

[0049] Example 5

[0050] Screening test of processing technology at origin

[0051] 1. Determination method of total flavonoids and total phenolic acids in Sophora flavescens

[0052] 1.1. Determination method of total flavonoids in Sophora flavescens

[0053] 1.1.1 Determination of the maximum absorption wavelength

[0054] Accurately weigh an appropriate amount of luteolin reference substance dried to constant weight, dissolve it with methanol to prepare a solution containing 0.128 mg / ml luteolin in a 10 ml volumetric flask, add 0.3 ml of 5% sodium nitrite solution, shake well, and let it stand for 6 minutes. Add 0.3 ml of 10% aluminum nitrate solution, shake well, let it stand for 6 minutes, then add 4 ml of 1 mol / L sodium hydroxide solution, dilute to the scale with 60% ethanol, shake well, let it stand for 10 minutes, prepare a blank solution in the same way, scan at 300-800 nm, and measure the maximum absorption wavelength.

[0055] Take another 0.5g of Sophora flavescens, extract with methanol and prepare a solution of a certain concentration in a 10ml volumetric flask, add 0.3ml of 5% sodium nitrite solution, shake well, and leave for 6min. Add 0.3ml of 10% aluminum nitrate solution, shake well, and leave for 6min, then add 4ml of 1mol / L sodium hydroxide solution, dilute to the scale with 60% ethanol, shake well, and leave for 10min. Prepare a blank solution in the same way, scan at 300-800nm, and measure the maximum absorption wavelength.

[0056] The results showed that both the luteolin reference substance and the sample had maximum absorption at 505 nm, so 505 nm was selected as the measurement wavelength.

[0057] 1.1.2. Preparation of standard curve

[0058] Accurately weigh an appropriate amount of luteolin reference substance dried to constant weight, dissolve it in methanol and prepare a solution containing 0.128 mg / ml luteolin, accurately measure 1.0, 2.0, 3.0, 4.0, and 5.0 ml of the solution, place them in 10 ml volumetric bottles, add 0.3 ml of 5% sodium nitrite solution, shake well, and let it stand for 6 minutes. Add 0.3 ml of 10% aluminum nitrate solution, shake well, let it stand for 6 minutes, then add 4 ml of 1 mol / L sodium hydroxide solution, dilute to the scale with 60% ethanol, shake well, and let it stand for 10 minutes. Prepare a blank solution in the same way, and measure the absorbance at a wavelength of 505 nm according to (Appendix to the 2020 edition of the Chinese Pharmacopoeia).

[0059] Table 1 Determination results of luteolin standard curve

[0060] Solution concentration (μg / ml) 12.8 25.6 38.4 51.2 64.0 Absorbance value 0.135 0.276 0.397 0.489 0.584

[0061] The standard curve is drawn with concentration as the horizontal axis and absorbance as the vertical axis. After linear regression, the regression equation is:

[0062] A=0.868C+0.0429,r=0.9900,it can be seen that luteolin has a good linear relationship in the concentration range of 12.8~64.0μg / ml. Figure 1 shown.

[0063] 1.1.3 Preparation of test solution

[0064] Take 0.5 g of Sophora flavescens and 50 ml of methanol, reflux extraction for 1.0 h, accurately weigh, accurately measure 5.0 ml, put it in a 50 ml volumetric flask, add methanol solution to the scale, and the test solution is obtained.

[0065] 1.1.4. Method of content determination

[0066] Accurately measure 3.0 ml of the test solution of Sophora flavescens in a 10 ml volumetric flask, add 0.3 ml of 5% sodium nitrite solution, shake well, and let stand for 6 minutes. Add 0.3 ml of 10% aluminum nitrate solution, shake well, let stand for 6 minutes, then add 4 ml of 1 mol / L sodium hydroxide solution, dilute to the scale with 60% ethanol, shake well, and let stand for 10 minutes. Prepare a blank solution in the same way, measure the absorbance at a wavelength of 505 nm according to (Appendix to the 2020 edition of the Chinese Pharmacopoeia), and calculate the content of total flavonoids according to the standard curve.

[0067] 1.2. Determination of total phenolic acids in Sophora flavescens

[0068] 1.2.1 Determination of detection wavelength

[0069] Weigh appropriate amounts of chicoric acid reference substance and this product, prepare them according to the methods under reference substance solution and test solution, use 50% ethanol as blank solvent, scan in the wavelength range of 200-500nm, and the results are shown in the figure. The results show that this product has maximum absorption at 328nm wavelength, and the blank solvent has almost no absorption at this wavelength. The results are shown in the figure. Therefore, the wavelength of 328nm is selected as the measurement wavelength, which has strong selectivity. Figure 2 shown.

[0070] 1.2.2 Linear relationship test

[0071] Accurately weigh 0.00192 g of chicoric acid reference substance, place it in a 10 ml volumetric flask, add an appropriate amount of 50% ethanol, shake to dissolve, add 50% ethanol to dilute to the scale, and shake well; accurately measure 2.5 ml, place it in a 10 ml volumetric flask, add 50% ethanol to dilute to the scale, and shake well; accurately measure 0.5 ml, 1.0 ml, 1.5 ml, 2.0 ml, 2.5 ml, and 3.0 ml of the above solution, respectively place them in 10 ml volumetric flasks, add water to dilute to the scale, shake well, take the above solutions, respectively measure the absorbance at a wavelength of 328 nm, calculate the regression equation, and the results are as shown in the following table.

[0072] Table 2 Results of linear relationship test for content determination

[0073] Volume(ml) 0.5 1.0 1.5 2.0 2.5 3.0 Concentration (mg / ml) 0.0024 0.0048 0.0071 0.095 0.0119 0.0143 Absorbance 0.188 0.377 0.561 0.749 0.929 1.118

[0074] The standard curve was drawn with concentration as the horizontal axis and absorbance as the vertical axis, and the regression equation was obtained: y = 77.46946x + 0.00826, r = 0.99971. The results showed that the absorbance of the chicoric acid reference substance showed a good linear relationship with the concentration in the range of 2.4 to 14.3 μg / ml. Figure 3 shown.

[0075] 1.2.3 Preparation of reference solution

[0076] Take about 8 mg of chicoric acid reference substance, accurately weigh it, place it in a 10 ml volumetric flask, add 50% ethanol to the scale; accurately measure 1 ml, place it in a 100 ml volumetric flask, add 50% ethanol to the scale, shake well, and you have it.

[0077] 1.2.4 Preparation of test solution

[0078] Accurately measure 0.5 g of this product, extract with 50 ml of 50% ethanol under reflux for 1.0 h, take 10 ml of the extract, recover to dryness under reduced pressure at 60°C, add 5 ml of water to the residue to dissolve it, let it cool, pass it through 15 g of a treated AB-8 macroporous resin column (inner diameter 1.5 cm, column height about 12 cm), elute with water, collect the eluate to the scale in a 100 ml volumetric flask, shake well, accurately measure 5 ml, add it to a 100 ml volumetric flask, add 5 ml of anhydrous ethanol, add water to the scale, shake well, and you have it.

[0079] 1.2.5. Determination method

[0080] Take the reference solution and the test solution respectively, measure the absorbance at a wavelength of 328nm according to the UV-visible spectrophotometry (Appendix of the 2020 edition of the Chinese Pharmacopoeia), and calculate the result.

[0081] 2. Research on the harvesting and drying technology of Ilex oleraceus

[0082] From mid-May to late June every year, during the peak flowering period (60-70% of the flowers are in bloom), the above-ground part of the clasping dahliae is harvested and cut at a height of 5-10 cm from the ground. Impurities such as dry rotten leaves and weeds are removed and dried in the field for 1-3 days until it is wilted and soft. At the same time, the moisture is reduced by 30-40% and the flowers are 80-90% in bloom. The clasping dahliae are then bundled, with each bundle weighing 5-15 kg.

[0083] 2.1. Determination of the height of the above-ground part

[0084] The total flavonoids and total phenolic acid contents were used as the criteria for determining the cutting height. The results are shown in Tables 3 and 4.

[0085] Table 3 Sample content determination results (n = 3)

[0086] sample Height from ground (cm) Total flavonoids (%) Total phenolic acid (%) 1 2 5.3 7.3 2 5 7.6 12.2 3 10 8.2 13.6

[0087] The above data show that the content of total flavonoids and total phenolic acids is low in the part of Sophora flavescens below 5 cm from the ground, so it is best to cut it at a height of 5 to 10 cm from the ground, and the content of total flavonoids and total phenolic acids is higher.

[0088] 2.2 Determination of drying time

[0089] Table 4 Sample content determination results (n = 3)

[0090] sample Drying time (days) Total flavonoids (%) Total phenolic acid (%) 1 0 3.6 4.2 2 1 8.3 7.3 3 2 10.6 12.2 4 3 11.2 13.6

[0091] The above data show that the total flavonoids and total phenolic acid contents of Sophora flavescens increased significantly when it was directly dried after harvest. Therefore, it is advisable to dry it in the field for 1 to 3 days after harvesting, and the total flavonoids and total phenolic acid contents will be basically stable after 2 to 3 days of drying.

[0092] 3. Study on the enzymatic hydrolysis technology of Ilex oleraceus

[0093] 3.1. Determination of the enzymatic hydrolysis temperature

[0094] The bundled clematis oleracea is orderly stacked on the shelf of the temperature-controlled room, the thickness of the medicinal materials is 0.5-0.8 meters, the temperature range is 30-60° C., the humidity range is: 90%, and the temperature is gradually increased and the time is controlled by enzymolysis, and the time is 12-72 hours, so as to obtain the clematis oleracea after enzymolysis;

[0095] Total flavonoids, total phenolic acids and 90% ethanol hot extract were used as indicators and as the basis for determining the enzymatic hydrolysis process parameters. The results are shown in Tables 5 and 6.

[0096] Table 5 Sample measurement results (n=3)

[0097] sample Enzymatic hydrolysis temperature (℃) Total flavonoids (%) Total phenolic acid (%) Extract (%) 1 30 10.6 12.2 8.0 2 40 14.3 15.3 11.2 3 50 18.6 20.2 14.5 4 60 20.2 22.6 15.3

[0098] The above data show that when the enzymatic hydrolysis temperature is higher than 50℃, the contents of total flavonoids and total phenolic acids are basically stable. Therefore, the optimal stacking enzymatic hydrolysis temperature is determined to be 40-50℃, and the content after enzymatic hydrolysis increases by nearly 1 times, and the 90% ethanol hot extract increases by nearly 0.9 times.

[0099] 3.2 Determination of stacking enzymatic hydrolysis time

[0100] The bundled clematis oleracea are orderly stacked on the shelves of the temperature-controlled room, the thickness of the medicinal materials is 0.5-0.8 meters, the temperature range is 40-50 DEG C, the humidity is 90%, and the temperature is gradually increased and the time-controlled enzymolysis is carried out for 12-72 hours to obtain the clematis oleracea after enzymolysis.

[0101] Table 6 Sample measurement results (n=3)

[0102] sample Enzymatic hydrolysis time (h) Total flavonoids (%) Total phenolic acid (%) Extract (%) 1 12 10.4 11.2 10.3 2 24 14.5 15.6 12.5 3 48 18.2 19.8 18.9 4 72 20.2 22.1 20.7

[0103] The above data show that when the enzymatic hydrolysis temperature is 40-50℃ and the enzymatic hydrolysis time exceeds 48h, the increase in the measured total flavonoids and total phenolic acid contents is no longer significant. Therefore, the optimal stacking enzymatic hydrolysis time is determined to be 24-48h, and the measured components and extracts after enzymatic hydrolysis increased by nearly 1 times.

[0104] 4. Research on drying process after cutting

[0105] Temperature-controlled blast rapid drying, gradient drying temperature of 60-120°C, drying time of 0.5-4.0 hours, moisture of 6.0-10.0%.

[0106] Taking total flavonoids, total phenolic acids, harmful microorganisms, etc. as evaluation indicators, the material was dried to a moisture content of 6.0-10.0%, and the optimal drying temperature was studied and determined. The results are shown in Table 7 below.

[0107] Table 7 Sample research results (n=3)

[0108]

[0109] The above data show that the drying temperature is above 100°C and below 120°C, which can simultaneously meet the basic requirements of killing harmful microorganisms and maintaining a moisture content of 6.0-10.0%, and no significant changes were observed in the measured components total flavonoids and total phenolic acids.

[0110] 5. Research on vacuum packaging technology

[0111] 5.1. Fully automatic vacuum packaging machine, 5-50kg per package, and then vacuum packaging. The vacuum pumping time is 5-20 seconds. When the vacuum gauge of the vacuum pump shows a vacuum degree below -0.08 and the pointer remains stable for 10 seconds, the vacuum pumping can be stopped and the bag can be sealed immediately.

[0112] 5.2. Use three layers of packaging materials with different materials of good quality and low price: the inner layer is a highly breathable non-woven protective layer, the middle layer is a dense aluminum-plastic film, and the outer layer is a waterproof woven bag.

[0113] 6. Comparative study on stability

[0114] 6.1. Research basis: Accelerated stability test and long-term stability test in the “Guidelines for Drug Stability Studies”.

[0115] 6.2. Research samples:

[0116] 6.2.1. Ilex nephrolepis processed from traditional production areas: packaging specification: 10.0 kg, referred to as Ilex nephrolepis 1;

[0117] 6.2.2. The clematis vesiculosus processed by the patented origin processing method: referred to as clematis vesiculosus 2.

[0118] 6.3. Testing indicators: total flavonoids, total phenolic acid, moisture, etc.

[0119] 6.4. Research methods: The drug stability test chamber was placed at a controlled temperature of 40°C and RH of 75% for 6 months; the ordinary Chinese medicinal materials warehouse was placed at room temperature for 24 months.

[0120] 6.5. The research results are shown in Tables 8 and 9 below.

[0121] Table 8 Results of accelerated stability study of samples

[0122]

[0123]

[0124] The research data in the table above show that:

[0125] (1) The clematis claspingii processed from the patented origin has high content of total flavonoids and total phenolic acids, which is nearly 1 times higher than that of the clematis claspingii processed from the traditional origin.

[0126] (2) The accelerated stability test for 6 months showed that the traditional samples failed to meet the test criteria within 1 month and had slight (visible to the naked eye) mold.

[0127] (3) The samples processed in the origin of this patent showed basically unchanged total flavonoids and total phenolic acid content in the accelerated stability study for 6 months, which completely solved the problem of mold and deterioration of Ilex clerestoris due to high temperature and high humidity, significantly improved the quality of Ilex clerestoris, and fully met the requirements for the preparation of Ilex clerestoris injection.

[0128] Table 9 Results of long-term stability study of samples

[0129]

[0130] The data in the above table show that:

[0131] (1) The clematis claspingii processed from the patented origin has high content of total flavonoids and total phenolic acids, which is nearly 1 times higher than that of the clematis claspingii processed from the traditional origin.

[0132] (2) Moreover, a long-term 24-month stability study has shown that traditional samples have unqualified test indicators and a small amount of mold within 6 months of storage.

[0133] (3) The samples processed in the origin of this patent completely solved the problem of mildew and deterioration of Ilex oleraceus due to high temperature and high humidity in summer, significantly improved the quality of Ilex oleraceus, and directly improved the quality of Ilex oleraceus injection product.

[0134] In summary, the processing methods of the origin of Ilex classipes were innovatively studied, including the processes of harvesting and drying, stacking enzymatic hydrolysis, cutting and drying, and vacuum packaging. The product quality and stability of Ilex classipes were improved, and the total flavonoids and total phenolic acids, the medicinal active ingredients, were increased by about 90%, respectively, solving the problem of multiple batches of unqualified quality and mold and deterioration of medicinal materials processed in traditional origins. At the same time, the processing methods at the origin were standardized to provide high-quality Chinese medicinal materials for the production of safer and more effective Ilex classipes injection, truly realizing the goal of "good medicinal materials, good medicine".

Claims

1. A method for processing the origin of Ilex nephrodisiac for Ilex nephrodisiac injection, characterized in that: Here are the steps: (1) cutting the above-ground part of the cleistochete in full bloom, removing foreign matter, drying in the field until it is wilted, and tying; (2) the bundled oleander is piled up for enzymatic hydrolysis, and then air-dried again after enzymatic hydrolysis until the surface is dry, and then cut into sections; (3) drying the cut nephrolepis chinensis by air-drying until the moisture content is 6.0-10.0%; (4) vacuum packing the dried Sophora flavescens.

2. The origin processing method according to claim 1, characterized in that: In step (1), the above-ground part refers to the part above 5 to 10 cm from the ground; Impurities removal includes dry rotten leaves, weeds and sand.

3. The origin processing method according to claim 1, characterized in that: The drying time in the field in step (1) is 1 to 3 days, and the drying time is until the moisture content is reduced by 30 to 40%; The bundling specification is 10-15kg / bundle.

4. The origin processing method according to claim 1, characterized in that: In step (2), the temperature of the stacking enzymolysis is 30 to 50° C., the time is 12 to 72 hours, and the paving thickness is 0.3 to 1.0 m; The length of the cut section is 1.0 to 10.0 cm; The temperature of the secondary drying is 60 to 120° C., and the time is 0.5 to 4.0 hours.

5. The origin processing method according to claim 4, characterized in that: The time for stacking enzymatic hydrolysis is 24 to 48 hours.

6. The origin processing method according to claim 1, characterized in that: The temperature of step (3) blast drying is 60-120° C., the time is 0.5-4.0 hours, and the paving thickness is 15-30 cm.

7. The origin processing method according to claim 6, characterized in that: The temperature of the blast drying is 100 to 110° C., and the time is 0.5 to 1.0 hour.

8. The origin processing method according to claim 1, characterized in that: The vacuum packaging in step (4) is performed by vacuum pumping for 5 to 20 seconds, the packaging is three-layer packaging, and the packaging specification is 5.0 to 50.0 kg.

9. The origin processing method according to claim 7, characterized in that: The three-layer packaging from inside to outside is composed of a highly breathable non-woven fabric layer, a dense aluminum-plastic film layer, and a woven bag layer.

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