Screening method of activated carbon for production of shenqi fuzheng injection
By using mid-infrared spectroscopy detection and calculation formula to screen activated carbon, the problem of large quality differences between activated carbon batches in the production of Shenqi Fuzheng Injection was solved, achieving accurate quality control and cost-effectiveness.
Patent Information
- Application Number
- CN202411736038.5
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2024-11-29
- Publication Date
- 2025-10-17
- Estimated Expiration
- 2044-11-29
AI Technical Summary
In the production of Shenqi Fuzheng Injection, the production process of activated carbon lacks objective quantitative standards, resulting in large quality differences between batches, affecting product quality control and fluctuations in the content of active ingredients.
Mid-infrared spectroscopy was used to detect the transmittance of activated carbon. The amount of each index component of Shenqi Fuzheng Injection adsorbed by unit activated carbon was predicted by a calculation formula. Preset thresholds were set to screen out activated carbon that met the standards.
It provides an accurate quantitative quality control standard for activated carbon, solves the problem of large differences between batches, is low-cost, fast, and accurately predicts results, and is suitable for the industrial production of Shenqi Fuzheng Injection.
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Abstract
Description
TECHNICAL FIELD
[0001] The application relates to the technical field of medicines, in particular to a screening method of activated carbon for production of Shenqi Fuzheng injection. BACKGROUND
[0002] The activated carbon has strong adsorption capacity for pyrogen, and has the functions of decolorization and filtration aid, and is therefore widely used in the production of injections to remove pyrogen and decolorize. The Shenqi Fuzheng injection is a national new medicine of the second category of traditional Chinese medicines which was put into the market by Limin Pharmaceutical Factory of Lizhu Group in 1999. The injection is prepared from traditional medicines radix ginseng and astragalus root by a water extraction and alcohol precipitation process, is a traditional Chinese medicine limpid large volume injection, has the effect of tonifying qi and strengthening body resistance, and is mainly used for treating tumor diseases.
[0003] At present, in the actual production process of the product, the production process of the activated carbon is relatively extensive, objective quantitative standards are lacked, and there is a big quality difference between batches. Under this condition, the adsorption of the activated carbon can cause the content of effective components in the Shenqi Fuzheng injection to fluctuate, which is not conducive to the quality control of the product and can cause the product to be unqualified when used improperly. Therefore, the enterprise urgently needs a characterization method of the activated carbon to establish a quantitative method of the related properties of the activated carbon, to formulate a quality control standard and to indicate the selection of the activated carbon, so as to solve the problem of the big quality difference between batches of the activated carbon. SUMMARY
[0004] Therefore, it is necessary to provide a screening method of activated carbon for production of Shenqi Fuzheng injection, which has relatively accurate prediction results and can provide more effective quantitative quality control standards of the activated carbon, so as to indicate the selection of the activated carbon and solve the problem of the big difference between batches.
[0005] The technical scheme of the application is as follows:
[0006] The application provides a screening method of activated carbon for production of Shenqi Fuzheng injection, which comprises the following steps:
[0007] The activated carbon is subjected to mid-infrared spectrum detection to obtain the transmittance at a preset wave number;
[0008] The transmittance at the preset wave number is pretreated to obtain the corrected transmittance at the preset wave number;
[0009] According to a calculation formula, the prediction value of the amount of each index component of the Shenqi Fuzheng injection adsorbed by unit activated carbon is calculated from the transmittance and the corrected transmittance at the preset wave number, and a preset threshold value of the amount of each index component of the Shenqi Fuzheng injection adsorbed by unit activated carbon is set;
[0010] The prediction value and the preset threshold value are compared, and the activated carbon for production of the Shenqi Fuzheng injection is screened according to the comparison result;
[0011] The index components are calycosin glycosides, adenine, adenosine and astragaloside IV.
[0012] In one embodiment, the preset wave number is a specific wave number of activated carbon in the mid-infrared spectrum.
[0013] Optionally, the preset wave number is 1560±5cm -1 , 2325±5cm -1 , 3050±5cm -1 and 3445±5cm -1 .
[0014] In one embodiment, the step of preprocessing the transmittance at the preset wave number includes: subtracting the transmittance at 4000±5cm -1 from the transmittance at the preset wave number to obtain the corrected transmittance at the preset wave number.
[0015] In one embodiment, the calculation formula of the predicted value of the amount of calycosin glycosides adsorbed by unit activated carbon is as shown in the following formula (1):
[0016]
[0017] Among them, represents the predicted value of the amount of calycosin glycosides adsorbed by unit activated carbon (mg / g), represents the corrected transmittance at 1560±5cm -1 (%).
[0018] In one embodiment, the calculation formula of the predicted value of the amount of adenine adsorbed by unit activated carbon is as shown in the following formula (2):
[0019]
[0020] Among them, represents the predicted value of the amount of adenine adsorbed by unit activated carbon (mg / g), represents the transmittance at 1560±5cm -1 (%).
[0021] In one embodiment, the calculation formula of the predicted value of the amount of adenosine adsorbed by unit activated carbon is as shown in the following formula (3):
[0022]
[0023] Among them, represents the predicted value of the amount of adenosine adsorbed by unit activated carbon (mg / g), represents the transmittance at 1560±5cm -1 (%), represents the transmittance at 2325±5cm-1 the corrected transmittance (%) at 3050±5 cm
[0024] In one of the embodiments, the calculation formula of the predicted value of the amount of astragaloside A adsorbed by unit activated carbon is shown in the following formula (4):
[0025]
[0026] wherein, the predicted value of the amount of astragaloside A adsorbed by unit activated carbon (mg / g), and respectively represent the corrected transmittance (%) at 3050±5 cm -1 and 3442±5 cm -1 .
[0027] In one of the embodiments, the step of screening activated carbon for the production of Shenqi Fuzheng injection according to the comparison result comprises:
[0028] comparing the predicted values with the preset threshold value, and screening activated carbon with all the predicted values within the preset threshold value as activated carbon for the production of Shenqi Fuzheng injection.
[0029] In one of the embodiments, the preset threshold value of the amount of calycosin-7-glucoside adsorbed by unit activated carbon is 20 mg / g-60 mg / g; and / or
[0030] The preset threshold value of the amount of adenine adsorbed by unit activated carbon is 5 mg / g-30 mg / g.
[0031] In one of the embodiments, the preset threshold value of the amount of adenosine adsorbed by unit activated carbon is 10 mg / g-40 mg / g; and / or
[0032] The preset threshold value of the amount of astragaloside A adsorbed by unit activated carbon is 50 mg / g-165 mg / g.
[0033] Compared with the prior art, the present application has the following beneficial effects:
[0034] The present application establishes a technology for quantitatively predicting the equilibrium adsorption amount of index components by activated carbon based on mid-infrared spectrum for Shenqi Fuzheng system, which has the advantages of good prediction effect, provides more effective quantitative quality standard of activated carbon, thereby indicating the selection of activated carbon, and solving the problem of large batch difference. At the same time, compared with directly using activated carbon for adsorption when producing Shenqi Fuzheng injection, the technical scheme of the present application has lower cost, faster speed, and is more green and accurate in prediction result, which can provide a new method for screening activated carbon for the industrial production of Shenqi Fuzheng injection. DETAILED DESCRIPTION
[0035] The present application is further described in connection with the following embodiments. The present application can be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and fully convey the scope of the application to others skilled in the art.
[0036] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in the description of the application herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.
[0037] Unless otherwise indicated, or unless the context clearly indicates otherwise, the terms or phrases used in this application have the following meanings:
[0038] The percentage content involved in the present application, if not specified, means mass percentage for solid-liquid mixing and solid-solid mixing, and means volume percentage for liquid-liquid mixing.
[0039] As used herein, "one or more" means any one, any two, or any two or more of the recited items.
[0040] As used herein, the alternative scope of "and / or", "or / and", "and / or" includes any one of two or more related recited items, and also includes any and all combinations of the related recited items, which includes any two related recited items, any more related recited items, or a combination of all related recited items. (It should be noted that when at least three items are connected by at least two conjunctions selected from "and / or", "or / and", "and / or", it should be understood that in the present application, the technical solution undoubtedly includes the technical solution connected by "logical and", and also undoubtedly includes the technical solution connected by "logical or". For example, "A and / or B" includes three parallel solutions of A, B and A+B. For another example, the technical solution of "A, and / or, B, and / or, C, and / or, D" includes any one of A, B, C and D (i.e. the technical solution connected by "logical or"), and also includes any and all combinations of A, B, C and D, i.e. includes the combination of any two or any three of A, B, C and D, and also includes the four-item combination of A, B, C and D (i.e. the technical solution connected by "logical and").)
[0041] As used herein, "further", "furthermore", "in particular", and the like are used to describe purposes, indicating differences in content, but should not be understood as limiting the scope of protection of the present application.
[0042] In the present document, "first aspect", "second aspect", "third aspect", "fourth aspect" and the like are only for the purpose of description, and cannot be understood as indicating or implying relative importance or quantity, nor can it be understood as implicitly indicating the importance or quantity of the technical features indicated. In addition, "first", "second", "third", "fourth" and the like only serve the purpose of non-exhaustive enumeration description, and should be understood as not constituting a closed limitation on the quantity. Therefore, the features limited by "first", "second" can explicitly or implicitly include at least one of the features. In the description of the present application, the meaning of "multiple" is at least two, such as two, three, etc., unless otherwise specifically limited. In the description of the present application, the meaning of "several" is at least one, such as one, two, etc., unless otherwise specifically limited.
[0043] In the present application, when a numerical interval is involved, unless otherwise specified, the above numerical interval is considered to be continuous and includes the minimum value and the maximum value of the range, and every value between such minimum value and maximum value. Further, when the range refers to an integer, every integer between the minimum value and the maximum value of the range is included. In addition, when multiple ranges are provided to describe a feature or a characteristic, the ranges can be combined. In other words, unless otherwise indicated, all ranges disclosed herein should be understood to include any and all sub-ranges subsumed therein.
[0044] Specifically, only some numerical ranges are specifically disclosed herein. However, any lower limit can be combined with any upper limit to form a range not explicitly recited; and any lower limit can be combined with other lower limits to form a range not explicitly recited, and similarly any upper limit can be combined with any other upper limit to form a range not explicitly recited. In addition, each individually disclosed point or single numerical value can itself be combined as a lower limit or an upper limit with any other point or single numerical value or with other lower limits or upper limits to form a range not explicitly recited. The use of numerical ranges using endpoints includes all numbers within that range and any range that would exist between the numbers in that range, e.g. 1 to 5 includes 1, 1.1, 1.3, 1.5, 2, 2.75, 3, 3.80, 4, and 5, etc.
[0045] In the present application, the percentage content involved, unless otherwise specified, refers to mass percentage for solid-liquid mixing and solid-solid mixing, and refers to volume percentage for liquid-liquid mixing.
[0046] In the present application, the percentage concentration involved, unless otherwise specified, refers to the final concentration. The final concentration refers to the proportion of the added ingredient in the system after the ingredient is added.
[0047] The temperature parameters in the present application, if not particularly limited, allow both constant temperature treatment and treatment within a certain temperature range. The constant temperature treatment allows temperature fluctuations within the accuracy range controlled by the instrument. Fluctuations within the range of, for example, ±5°C, ±2°C, ±1°C, ±0.5°C, ±0.4°C, ±0.3°C, ±0.2°C, ±0.1°C are allowed. The normal temperature or room temperature in the present application refers to no temperature control operation, and generally refers to 4°C to 35°C, preferably 20±5°C.
[0048] Currently reported characterization methods of activated carbon mainly include three kinds: the first kind of activated carbon routine indicators mainly include iodine adsorption value, methylene blue adsorption value, phenol adsorption value, etc., and the detection method is carried out according to the corresponding national standard. The second kind adopts nitrogen isothermal adsorption method, and the specific surface area and porosity analyzer is used to detect the pore structure parameters such as specific surface area, pore volume and average pore diameter of activated carbon. The third kind adopts Fourier transform infrared spectrometer to detect the mid-infrared spectrum of activated carbon, and the test wave band is 400~4000 cm -1 Although there are many reports on the application of activated carbon in traditional Chinese medicine injections and the characterization methods of related structures, there are still few reports on the quantitative relationship between the characterization information of activated carbon and its adsorption performance. And most of the related characterization information has weak correlation with the adsorption amount of the index components of the Shenqi Fuzheng system, so it is necessary to establish a new method to establish the relationship between the characterization information of activated carbon and the adsorption amount of the index components of the Shenqi Fuzheng system, so as to select activated carbon according to the relationship.
[0049] The characterization method of mid-infrared spectrum has the advantages of green, low cost and fast detection speed, based on which, the technical personnel of the present application found through a large amount of research that the surface chemical properties of activated carbon can be characterized by measuring the mid-infrared spectrum of activated carbon, and the prediction value of the adsorption amount of the index components of the Shenqi Fuzheng system of activated carbon can be calculated according to the calculation formula of different index components by using the transmittance and the corrected transmittance at a specific wave number after pretreatment of the spectrum data. At the same time, the method for quantitatively predicting the adsorption amount of the index components of the Shenqi Fuzheng system of activated carbon based on the mid-infrared spectrum established by the present application has the advantage of good prediction effect, and provides a quantitative quality standard of activated carbon, so as to indicate the selection of activated carbon and solve the problem of large batch difference.
[0050] The present application provides a screening method for activated carbon for the production of Shenqi Fuzheng injection, comprising the following steps:
[0051] The mid-infrared spectrum of the activated carbon is detected to obtain the transmittance at a preset wave number;
[0052] The transmittance at the preset wave number is pretreated to obtain the corrected transmittance at the preset wave number;
[0053] According to the calculation formula, the prediction value of the amount of each index component of the Shenqifuzheng injection adsorbed by the unit activated carbon is calculated by the transmittance at the preset wave number and the corrected transmittance, and the preset threshold value of the amount of each index component of the Shenqifuzheng injection adsorbed by the unit activated carbon is set.
[0054] The prediction value is compared with the preset threshold value, and the activated carbon for producing the Shenqifuzheng injection is screened according to the comparison result.
[0055] The index components are calycosin glycosides, adenine, adenosine and astragaloside A.
[0056] In some examples, the preset wave number is a specific wave number of infrared spectrum in the activated carbon.
[0057] In some examples, the preset wave number is 1560±5cm -1 , 2325±5cm -1 , 3050±5cm -1 and 3442±5cm -1 . Understandably, the preset wave number includes but is not limited to 1555cm -1 , 1560cm -1 , 1565cm -1 , 2320cm -1 , 2325cm -1 , 2330cm -1 , 3045cm -1 , 3050cm -1 , 3055cm -1 , 3437cm -1 , 3442cm -1 and 3447cm -1 . Further, the preset wave number is 1560cm -1 , 2325cm -1 , 3050cm -1 and 3442cm -1 .
[0058] In some examples, the step of preprocessing the transmittance at the preset wave number includes subtracting the transmittance at 4000±5cm -1 from the transmittance at the preset wave number to obtain the corrected transmittance at the preset wave number. Further, the step of preprocessing the transmittance at the preset wave number includes subtracting the transmittance at 4000cm -1 from the transmittance at the preset wave number to obtain the corrected transmittance at the preset wave number.
[0059] In some examples, the calculation formula of the prediction value of the amount of calycosin glycosides adsorbed by the unit activated carbon is shown in the following formula (1):
[0060]
[0061] wherein, represents a predicted value (mg / g) of the amount of calycosin glycoside adsorbed per unit of activated carbon, represents a corrected transmittance (%) at 1560±5 cm -1
[0062] In some examples, a formula for calculating a predicted value of the amount of adenine adsorbed per unit of activated carbon is shown in Equation (2) below:
[0063]
[0064] wherein, represents a predicted value (mg / g) of the amount of adenine adsorbed per unit of activated carbon, represents a transmittance (%) at 1560±5 cm -1
[0065] In some examples, a formula for calculating a predicted value of the amount of adenosine adsorbed per unit of activated carbon is shown in Equation (3) below:
[0066]
[0067] wherein, represents a predicted value (mg / g) of the amount of adenosine adsorbed per unit of activated carbon, represents a transmittance (%) at 1560±5 cm -1 represents a corrected transmittance (%) at 2325±5 cm -1
[0068] In some examples, a formula for calculating a predicted value of the amount of astragaloside IV adsorbed per unit of activated carbon is shown in Equation (4) below:
[0069]
[0070] wherein, represents a predicted value (mg / g) of the amount of astragaloside IV adsorbed per unit of activated carbon, and represent corrected transmittances (%) at 3050±5 cm -1 and 3442±5 cm -1
[0071] Specifically, the index component quantity refers to the mass of the index component balanced by the activated carbon per unit. The spectral data preprocessing, specific wave number selection and index component quantity calculation formula of the present application are technical innovations, which can effectively utilize the mid-infrared spectral data to predict the index component quantity of the Shenqi Fuzheng system adsorbed by the activated carbon, so as to indicate the selection of the activated carbon.
[0072] In some examples, the step of screening the activated carbon for the production of the Shenqi Fuzheng injection according to the comparison result comprises:
[0073] The predicted values are compared with the preset threshold value, and the activated carbon with all the predicted values within the preset threshold value range is screened as the activated carbon for the production of the Shenqi Fuzheng injection.
[0074] In some examples, the preset threshold value of the calycosin glycoside adsorbed by the activated carbon per unit is 20 mg / g to 60 mg / g. It can be understood that the preset threshold value of the calycosin glycoside adsorbed by the activated carbon per unit includes but is not limited to 20 mg / g, 30 mg / g, 40 mg / g, 50 mg / g and 60 mg / g.
[0075] In some examples, the preset threshold value of the adenine adsorbed by the activated carbon per unit is 5 mg / g to 30 mg / g. It can be understood that the preset threshold value of the adenine adsorbed by the activated carbon per unit includes but is not limited to 5 mg / g, 10 mg / g, 15 mg / g, 20 mg / g, 25 mg / g and 30 mg / g.
[0076] In some examples, the preset threshold value of the adenosine adsorbed by the activated carbon per unit is 10 mg / g to 40 mg / g. It can be understood that the preset threshold value of the adenosine adsorbed by the activated carbon per unit includes but is not limited to 10 mg / g, 20 mg / g, 30 mg / g and 40 mg / g.
[0077] In some examples, the preset threshold value of the astragaloside IV adsorbed by the activated carbon per unit is 50 mg / g to 165 mg / g. It can be understood that the preset threshold value of the astragaloside IV adsorbed by the activated carbon per unit includes but is not limited to 50 mg / g, 70 mg / g, 90 mg / g, 110 mg / g, 130 mg / g, 150 mg / g and 165 mg / g.
[0078] The following is further illustrated in combination with specific examples. The raw materials involved in the following specific examples, if not specifically stated, can be sourced from the market; the instruments used, if not specifically stated, can be sourced from the market; the processes involved, if not specifically stated, are conventionally selected by those skilled in the art.
[0079] The mid-infrared spectrometer (NICOLET iS50 FT-IR, Thermo Scientific) was used to collect the infrared spectrum of the sample, and the spectral parameters were as follows: the spectral collection range was 4000~400cm -1 , the resolution was 4cm -1 , the number of spectral scans was 32 times / s, each sample was sampled in parallel three times, and each tablet was scanned twice.
[0080] The calculation formula used in calculating the predicted value of the amount of each index component of the Shenqifuzheng system adsorbed by the unit activated carbon in Examples 1-3 is as follows: calycosin glycosides are formula (1), adenine is formula (2), adenosine is formula (3), and astragaloside A is formula (4).
[0081]
[0082]
[0083]
[0084]
[0085] Among them, , , and represent the predicted value (mg / g) of the amount of calycosin glycosides, adenine, adenosine, and astragaloside A adsorbed by the unit activated carbon, respectively, represents the transmittance (%) at 1560cm -1 , , , and represent the corrected transmittance (%) at 1560cm -1 , 2325cm -1 , 3050cm -1 , and 3442cm -1 .
[0086] The method for obtaining the experimental value of the amount of each index component in the activated carbon in Examples 1-3 is as follows: the activated carbon is subjected to adsorption experiment according to the small test process of Shenqifuzheng injection, the index component content is detected at intervals, the kinetic equation is fitted according to the detection value, and thus the experimental value of the amount of each index component is obtained. Specifically as follows:
[0087] Take 25mL of Shenqi extract, dilute it 20 times with purified water, mix well, and get Shenqifuzheng diluent.
[0088] Take 0.107 g of activated carbon and add it to the Shenqi Fuzheng dilution. Stir at room temperature at a stirring speed of 250 r / min. Take samples every 10 minutes, filter the samples through a 0.22 μm filter, and collect the samples for index component content detection.
[0089] The content detection methods of the index components are as follows:
[0090] (1) Adenine, adenosine, and calycosin detection method
[0091] Chromatographic conditions and system suitability test: use octadecylsilane-bonded silica gel as the filler (Waters Atlantis T3, 100 mm x 2.1 mm, 3 μm); use 0.05% formic acid aqueous solution as mobile phase A and acetonitrile as mobile phase B; the elution gradient is shown in Table 1; the detection wavelength is 260 nm; the column temperature is 30°C; and the flow rate is 0.25 mL / min.
[0092] Table 1 Elution gradient of mobile phase
[0093]
[0094] Preparation of test sample solution:
[0095] Shenqi Fuzheng dilution before activated carbon adsorption: take the test sample, filter it, and obtain it.
[0096] Shenqi Fuzheng dilution after activated carbon adsorption: take the test sample, filter it, and obtain it.
[0097] Determination method: precisely take 5 μL of the test sample solution, inject it into the liquid chromatograph, and determine it.
[0098] (2) Astragaloside detection method
[0099] Chromatographic conditions and system suitability test: use octadecylsilane-bonded silica gel as the filler (chromatographic column ZORBAX SB-C18 250 mm x 4.6 mm, 5 μm); the mobile phase is 0.2% formic acid-water (A) and acetonitrile (B); the column temperature is 30°C; the flow rate is 0.8 mL / min, the ELSD atomization temperature is 30°C; the drift tube temperature is 80°C; the nitrogen flow rate is 1.6 L / min; and the evaporative light scattering detector is detected according to the gradient elution in Table 2.
[0100] Table 2 Elution gradient of mobile phase
[0101]
[0102] Preparation of test solution: the solid phase extraction column was activated, i.e. the C18 solid phase extraction column was treated with 12 mL of methanol and 12 mL of purified water in sequence. 12 mL of activated carbon adsorption solution was taken, 0.5 mL of ammonia was added, and the mixture was centrifuged and mixed uniformly for standby. The activated carbon adsorption solution was added to the activated solid phase extraction column and adsorbed for 30 minutes. Then, the column was washed with water for 3 column volumes, and then eluted with methanol until the color of the eluent no longer changed, and the methanol eluent was collected. The methanol eluent was evaporated to dryness in a water bath, and 1 mL of methanol was added for dissolution, thereby obtaining the test solution.
[0103] Determination method: 10 μL of the standard solution and the test solution was precisely taken respectively and injected into the liquid chromatograph for determination.
[0104] Specifically, the kinetic equation used is the pseudo-first-order kinetic equation, i.e. equation (1):
[0105]
[0106] where k1 is the pseudo-first-order adsorption rate constant (min -1 ), q e is the activated carbon adsorption amount at equilibrium time (mg / g), and q t is the activated carbon adsorption amount at time t (mg / g). The activated carbon adsorption experimental data of the index components were non-linearly fitted by using the pseudo-first-order kinetic equation, and the kinetic parameters q e , i.e. the experimental value of the amount of the index component, were calculated.
[0107] The following is a specific example.
[0108] Example 1
[0109] A certain amount of activated carbon with batch number 230705 provided by Limin Pharmaceutical Factory of Lizhu Group was mixed with dry KBr (potassium bromide) powder of spectral purity at a mass ratio of 1:100, and then pressed and sent to a mid-infrared spectrometer for detection, with a test waveband of 400-4000 cm -1 . The transmittance at a specific wave number was obtained by testing, and the corrected transmittance was obtained by subtracting 4000 cm -1 . The transmittance and the corrected transmittance at the specific wave number are shown in Table 3.
[0110] Table 3 Transmittance and corrected transmittance at specific wave number of batch number 230705
[0111]
[0112] The amount of index components of Shengmai Fuzheng system adsorbed by activated carbon was calculated according to the transmittance and the corrected transmittance at the specific wave number, and the prediction results of the amounts of each index component and the results obtained by experiment are shown in Table 4.
[0113] Table 4 Predicted and experimental results of each index component quantity of batch number 230705
[0114]
[0115] From the relative deviation of each index component, except for poor prediction of adenine, other index components showed good prediction effect. According to the proposed activated carbon optimization method, the calycosin glycoside index quantity of this batch of activated carbon exceeds the threshold range (> 60 mg / g), so this batch of activated carbon is not selected for adsorption.
[0116] Example 2
[0117] Take the activated carbon provided by Lijiu Group Limin Pharmaceutical Factory with batch number 230706, mix the activated carbon sample with spectrally pure dry KBr powder at a mass ratio of 1:100, press, and then send it to the mid-infrared spectrometer for detection. The test wave band is 400-4000 cm -1 . The transmittance at a specific wave number is obtained, and then 4000 cm -1 is subtracted to obtain the corrected transmittance. The transmittance and corrected transmittance at a specific wave number are shown in Table 5.
[0118] Table 5 Transmittance and corrected transmittance at a specific wave number of batch number 230706
[0119]
[0120] According to the transmittance and corrected transmittance at a specific wave number, the activated carbon adsorption of the Shenqifuzheng system index component quantity is calculated, and the prediction results of each index component quantity and the experimental results are shown in Table 6.
[0121] Table 6 Predicted and experimental results of each index component quantity of batch number 230706
[0122]
[0123] From the relative deviation of each index component, all index components showed good prediction effect, and the highest relative deviation was also below 5%. According to the proposed activated carbon optimization method, the index component quantity of this batch of activated carbon is within the preset threshold, so this batch of activated carbon is selected for adsorption.
[0124] Example 3
[0125] Take the activated carbon provided by Lijiu Group Limin Pharmaceutical Factory with batch number 230807, mix the activated carbon sample with spectrally pure dry KBr powder at a mass ratio of 1:100, press, and then send it to the mid-infrared spectrometer for detection. The test wave band is 400-4000 cm -1 . The transmittance at a specific wave number is obtained, and then 4000 cm-1 The corrected transmittance was obtained. The transmittance and the corrected transmittance at specific wave numbers are shown in Table 7.
[0126] Table 7 Transmittance and corrected transmittance at specific wave numbers of batch 230807
[0127]
[0128] The active carbon adsorption of the active ingredient of the ginseng supporting system was calculated according to the transmittance and the corrected transmittance at specific wave numbers. The predicted results of each active ingredient and the experimental results are shown in Table 8.
[0129] Table 8 Predicted and experimental results of each active ingredient of batch 230807
[0130]
[0131] From the relative deviation of each active ingredient, all the active ingredients showed good prediction effect, and the highest relative deviation was also below 5%. According to the proposed active carbon optimization method, the active carbon of this batch exceeded the threshold range (>165 mg / g) of the active ingredient of astragaloside IV, so this batch of active carbon was not selected for adsorption.
[0132] The technical features of the above-described embodiments can be combined in any manner. In order to make the description simple, all possible combinations of the technical features in the above-described embodiments are not described, but as long as the combinations of the technical features do not exist, they should be considered as the scope of the present disclosure.
[0133] The above-described embodiments only express several embodiments of the present application, and the description is more specific and detailed, but it should not be understood as a limitation on the scope of the patent application. It should be noted that for ordinary skilled in the art, without departing from the concept of the present application, a number of modifications and improvements can be made, which are within the scope of the present application. Therefore, the scope of the patent protection of the present application should be subject to the appended claims, and the description can be used to explain the content of the claims.
Claims
1. A method for screening activated carbon for the production of Shenqi Fuzheng Injection, characterized in that: The following steps are involved: Perform mid-infrared spectroscopy on the activated carbon to obtain the transmittance at the preset wave number; Preprocessing the transmittance at the preset wavenumber to obtain a corrected transmittance at the preset wavenumber; According to the calculation formula, the predicted value of the amount of each indicator component of Shenqi Fuzheng Injection adsorbed per unit activated carbon is calculated by the transmittance and corrected transmittance at the preset wave number, and the preset threshold value of the amount of each indicator component of Shenqi Fuzheng Injection adsorbed per unit activated carbon is set; Compare the predicted value with the preset threshold value, and select activated carbon for the production of Shenqi Fuzheng Injection based on the comparison results; The index components are isoflavone glycosides, adenine, adenosine and astragaloside IV; the preset wave number is the specific wave number of activated carbon in the mid-infrared spectrum; the preset wave number is 1560±5cm -1 、2325±5cm -1 、3050±5cm -1 and 3442±5cm -1 ; The calculation formula for the predicted value of the amount of isoflavone glycosides adsorbed per unit activated carbon is shown in the following formula (1): , in, represents the predicted value of the amount of isoflavone glycosides adsorbed per unit activated carbon (mg / g), Represents 1560±5cm -1 Corrected transmittance under (%); The calculation formula for the predicted value of the amount of adenine adsorbed per unit activated carbon is shown in the following formula (2): , in, represents the predicted value of the amount of adenine adsorbed by unit activated carbon (mg / g), Represents 1560±5cm -1 Transmittance under (%); The calculation formula for the predicted value of the amount of adenosine adsorbed per unit activated carbon is shown in the following formula (3): , in, represents the predicted value of adenosine adsorption per unit activated carbon (mg / g), Represents 1560±5cm -1 Transmittance under % Represents 2325±5 cm -1 Corrected transmittance under (%); The calculation formula for the predicted value of the amount of astragaloside IV adsorbed by unit activated carbon is shown in the following formula (4): , in, represents the predicted value of astragaloside IV adsorbed per unit activated carbon (mg / g), and Representing 3050±5cm respectively -1 and 3442±5cm -1 Corrected transmittance (%) under .
2. The method for screening activated carbon for the production of Shenqi Fuzheng Injection according to claim 1, characterized in that: The step of pre-processing the transmittance at the preset wave number includes: subtracting 4000±5cm from the transmittance at the preset wave number; -1 The transmittance under the preset wave number is obtained.
3. The method for screening activated carbon for the production of Shenqi Fuzheng Injection according to claim 1, characterized in that: The step of pre-processing the transmittance at the preset wave number includes: subtracting 4000 cm from the transmittance at the preset wave number; -1 The transmittance under the preset wave number is obtained.
4. The method for screening activated carbon for the production of Shenqi Fuzheng Injection according to claim 1, characterized in that: The preset wave number is 1560 cm -1 、2325cm -1 、3050cm -1 and 3442cm -1 .
5. The method for screening activated carbon for use in the production of Shenqi Fuzheng Injection according to any one of claims 1 to 4, characterized in that: The steps for screening activated carbon for the production of Shenqi Fuzheng Injection based on the comparison results include: The predicted values are compared with the preset thresholds, and activated carbons whose predicted values are all within the preset thresholds are selected as activated carbons for the production of Shenqi Fuzheng Injection.
6. The method for screening activated carbon for the production of Shenqi Fuzheng Injection according to claim 5, characterized in that: The preset threshold value of the amount of calycosin adsorbed per unit activated carbon is 20 mg / g to 60 mg / g; and / or The preset threshold value of adenine adsorption per unit activated carbon is 5 mg / g~30 mg / g.
7. The method for screening activated carbon for the production of Shenqi Fuzheng Injection according to claim 5, characterized in that: The preset threshold value of adenosine adsorption per unit activated carbon is 10mg / g~40mg / g; and / or The preset threshold value of astragaloside IV adsorption per unit activated carbon is 50 mg / g~165 mg / g.
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