CN111658708A

CN111658708A - Composition for improving anemia symptoms and preparation method and application thereof

Info

Publication number: CN111658708A
Application number: CN202010582239.XA
Authority: CN
Inventors: 侯国如; 宫秀秀; 梁善芳; 蔡宇忆
Original assignee: Zhuhai Baode Runsheng Health Technology Co ltd
Current assignee: Zhuhai Baode Runsheng Health Technology Co ltd
Priority date: 2020-06-23
Filing date: 2020-06-23
Publication date: 2020-09-15

Abstract

The invention belongs to the field of traditional Chinese medicines, and discloses a composition for improving anemia symptoms, and a preparation method and application thereof. The composition for improving anemia symptoms is mainly prepared from the following raw material components: jujube, donkey-hide gelatin, ferrous salt, angelica, ginseng and medlar. Furthermore, the raw materials of the composition also comprise white paeony root. According to the composition, the Chinese angelica, the ginseng and the medlar are introduced on the basis of the raw materials of the Chinese date, the donkey-hide gelatin and the ferrous salt, so that the prepared composition has a remarkable effect of improving anemia symptoms; the raw material of white paeony root is further introduced, so that the anemia treatment effect of the composition can be further improved. The raw materials of the composition are traditional Chinese medicines, and the composition has no obvious side effect on human bodies after being taken for a long time.

Description

Composition for improving anemia symptoms and preparation method and application thereof

Technical Field

The invention belongs to the field of traditional Chinese medicines, and particularly relates to a composition for improving anemia symptoms, and a preparation method and application thereof.

Background

Anemia (anemia) refers to a common clinical condition in humans in which the peripheral red blood cell volume is reduced below the lower limit of the normal range. Because of the complexity of hematocrit measurements, hemoglobin (Hb) concentrations are often used instead clinically. Generally, adult male Hb <120g/L, adult female (non-pregnant) Hb <110g/L, and pregnant woman Hb <100g/L are considered anemias.

Anemia is classified differently based on different clinical features. Such as: acute anemia and chronic anemia are classified according to the rate of anemia progression; classifying large cell anemia, normal cell anemia, and small cell hypopigmented anemia according to red blood cell morphology; mild, moderate, severe and very severe anemia are classified according to hemoglobin concentration; according to the myelored hyperplasia, the hyperplastic anemia (such as hemolytic anemia, iron deficiency anemia, megaloblastic anemia and the like) and the hypoplastic anemia (such as aplastic anemia) are divided

The clinical manifestations of anemia are influenced by the etiology of anemia, the degree of decline of the oxygen carrying capacity of blood, the degree of decline of blood volume, the rate of anemia occurrence, and the compensatory and tolerable abilities of the blood, circulation, respiration systems, etc. The earliest symptoms are dizziness, hypodynamia and drowsiness; while the most common, prominent sign is pale complexion. In the prior art, a lot of medicines for treating anemia exist, but the general defects are that the treatment effect is poor, for example, long-term medicine taking is needed, anemia symptoms are easy to recover after medicine stopping, but side effects are obviously aggravated if some western medicines are taken for a long time. The existing traditional Chinese medicines for treating anemia are poor in efficacy and need to be further improved.

Therefore, it is desirable to provide a Chinese medicinal composition for improving anemia symptoms, which is remarkably effective and has no significant side effects even if taken for a long time.

Disclosure of Invention

The present invention is directed to solving at least one of the problems of the prior art described above. Therefore, the invention provides a composition for improving anemia symptoms, a preparation method and application thereof, wherein the composition can obviously improve the anemia symptoms and has no obvious side effect even if the composition is taken for a long time.

A composition for improving anemia symptoms is mainly prepared from the following raw materials: jujube, donkey-hide gelatin, ferrous salt, angelica, ginseng and medlar.

Preferably, the raw materials of the composition also comprise white paeony root.

Preferably, the jujube is jujube and/or red jujube.

Preferably, the ferrous salt is at least one of ferrous lactate, ferrous gluconate, ferrous fumarate or ferrous fumarate.

Preferably, the composition further comprises an adjuvant.

Preferably, the auxiliary material is at least one selected from sorbitol, erythritol, amino acid, potassium sorbate, essence or sucralose.

Preferably, the amino acid is glycine.

Preferably, the raw materials of the composition further comprise a solvent.

Preferably, the solvent is water.

Preferably, the composition for improving anemia symptoms is mainly prepared from the following raw materials in parts by weight: 400 parts of jujube, 30-80 parts of donkey-hide gelatin, 0.5-3 parts of ferrous salt, 30-100 parts of angelica, 30-100 parts of ginseng and 200 parts of medlar.

Further preferably, the composition for improving anemia symptoms is mainly prepared from the following raw materials in parts by weight: 200 portions of jujube, 50-80 portions of donkey-hide gelatin, 1-2 portions of ferrite, 40-60 portions of angelica, 40-80 portions of ginseng and 120 portions of medlar.

Preferably, the composition also comprises 60-150 parts of raw material white paeony root; further preferably, the composition also comprises 80-120 parts of raw material white paeony root.

Preferably, the composition for improving anemia symptoms is mainly prepared from the following raw materials in parts by weight: 200-250 parts of jujube, 50-80 parts of donkey-hide gelatin, 1-2 parts of ferrite, 40-60 parts of angelica, 40-80 parts of ginseng, 120-180 parts of medlar and 80-120 parts of white paeony root.

Preferably, the composition also comprises 60-100 parts of auxiliary materials.

Preferably, the composition further comprises 30-60 parts of sorbitol; further preferably, the composition further comprises 40-50 parts by weight of sorbitol.

Preferably, the composition further comprises 10-35 parts of erythritol; further preferably, the composition further comprises 20-30 parts of erythritol by weight.

Preferably, the composition also comprises 0.01 to 1.5 parts of amino acid; further preferably, the composition further comprises 0.5-1 part of amino acid by weight.

Preferably, the composition further comprises 0.1 to 0.8 part by weight of potassium sorbate; further preferably, the composition further comprises 0.3-0.5 part of potassium sorbate in parts by weight.

Preferably, the composition further comprises 0.1-1 part of essence according to the parts by weight; further preferably, the composition further comprises 0.3-0.75 part of essence according to parts by weight.

Preferably, the composition further comprises 0.1-1 part of sucralose by weight; further preferably, the composition further comprises 0.3-0.5 part of sucralose according to parts by weight.

A method for preparing a composition for improving anemia symptoms, comprising the steps of:

(1) mixing fructus Jujubae, colla Corii Asini, radix Angelicae sinensis, Ginseng radix, and fructus Lycii with solvent, decocting, filtering, collecting filtrate, and concentrating to obtain concentrate;

(2) adding water into colla Corii Asini, decocting, melting by heat, making colla Corii Asini solution, centrifuging, collecting centrifugate, mixing with the concentrate obtained in step (1), adding ferrous salt, stirring, and mixing to obtain the composition.

Preferably, in the step (1), the mass of the solvent is 10-15 times of the total mass of the raw materials including the jujube, the donkey-hide gelatin, the ferrous salt, the angelica, the ginseng and the medlar.

Preferably, in the step (1), the decocting times are 2-5 times, and each time is 1-2 hours. Mixing the filtrates, and concentrating.

Preferably, in the step (1), the vacuum degree of the concentration is-0.06 to-0.08 MPa, and the temperature is 60-70 ℃.

Preferably, in step (1), the concentrate has a density of 1.15 to 1.18g/cm³。

Preferably, in step (2), the centrifugate is refrigerated and then centrifuged, and the centrifugate is mixed with the concentrate prepared in step (1).

Preferably, in the step (2), after the ferrous salt is added, the auxiliary materials and the solvent are also added, the volume is constant, the mixture is stirred and mixed, the mixture is refrigerated (at 2-6 ℃), and then the mixture is kept stand and centrifuged, and the centrifugate is taken out, filled and sterilized to prepare the composition.

More preferably, the solvent is water, and the volume is up to 1000 mL.

Preferably, the filling specification is performed as required, for example 20 mL/bottle.

Preferably, the sterilization is carried out at a temperature of 116 ℃ for 40 minutes.

Preferably, the composition prepared in step (2) is stored in a cool and dry environment.

The medicine comprises the composition and auxiliary materials.

Preferably, the medicament further comprises an excipient.

Preferably, the medicament is any pharmaceutically acceptable dosage form; preferably, the dosage form is selected from oral liquid, tablet, powder or capsule.

The composition disclosed by the invention is applied to preparation of a medicine for treating anemia.

Compared with the prior art, the invention has the following beneficial effects:

(1) according to the composition, the Chinese angelica, the ginseng and the medlar are introduced on the basis of the raw materials of the Chinese date, the donkey-hide gelatin and the ferrous salt, so that the prepared composition has a remarkable effect of improving anemia symptoms.

(2) The raw material of white paeony root is further introduced into the composition disclosed by the invention, so that the anemia treatment effect of the composition can be further improved.

(3) The raw materials of the composition are traditional Chinese medicines, and the composition has no obvious side effect on a human body after being taken for a long time.

Detailed Description

In order to make the technical solutions of the present invention more apparent to those skilled in the art, the following examples are given for illustration. It should be noted that the following examples are not intended to limit the scope of the claimed invention.

The starting materials, reagents or apparatuses used in the following examples are conventionally commercially available or can be obtained by conventionally known methods, unless otherwise specified.

Example 1: preparation of composition for improving anemia symptoms

The composition for improving anemia symptoms is 1000mL in volume and mainly prepared from the following raw materials in parts by weight: 250 parts of jujube, 50 parts of donkey-hide gelatin, 1.35 parts of ferrous lactate, 50 parts of angelica, 50 parts of ginseng, 150 parts of medlar and 100 parts of white paeony root; auxiliary materials: 50 parts of sorbitol, 30 parts of erythritol, 1 part of glycine, 0.5 part of potassium sorbate, 0.75 part of essence and 0.5 part of sucralose; solvent: and (3) water.

(1) mixing fructus Jujubae, colla Corii Asini, radix Angelicae sinensis, Ginseng radix, fructus Lycii, and radix Paeoniae alba with 10 times of water, decocting for 2 times and 2 hr each time, filtering (mesh number of filtering screen is 200 mesh), mixing filtrates, concentrating at 65 deg.C under vacuum degree of-0.06-0.08 MPa to obtain concentrate with density of 1.17g/cm³And is ready for use;

(2) adding water with the mass of 10 times of the donkey-hide gelatin, decocting (the time is 8 hours), melting to prepare donkey-hide gelatin liquid, centrifuging, taking centrifugate, filtering by a filter screen with 200 meshes, refrigerating, centrifuging again, taking centrifugate, mixing with the concentrate prepared in the step (1), then adding ferrous lactate, sorbitol, erythritol, glycine, potassium sorbate, essence and sucralose, adding water to a constant volume of 1000mL, stirring, mixing, filling, wherein the filling specification is 10 mL/bottle, sterilizing, and keeping the temperature at 116 ℃ for 40 minutes to prepare the composition for improving the symptoms of anemia.

Example 2: preparation of composition for improving anemia symptoms

The composition for improving anemia symptoms is 1000mL in volume and mainly prepared from the following raw materials in parts by weight: 200 parts of jujube, 80 parts of donkey-hide gelatin, 2 parts of ferrous lactate, 60 parts of angelica, 80 parts of ginseng, 120 parts of medlar and 80 parts of white peony root; auxiliary materials: 30 parts of sorbitol, 10 parts of erythritol, 1.5 parts of glycine, 0.6 part of potassium sorbate, 0.5 part of essence and 0.6 part of sucralose; solvent: and (3) water.

(1) mixing fructus Jujubae, colla Corii Asini, radix Angelicae sinensis, Ginseng radix, fructus Lycii, and radix Paeoniae alba with 12 times of water, decocting for 3 times and 2 hr each time, filtering (mesh number of filtering screen is 200 mesh), mixing filtrates, concentrating at 60 deg.C under vacuum degree of-0.06-0.08 MPa to obtain concentrate with density of 1.18g/cm³And is ready for use;

(2) adding water with the mass of 10 times of the donkey-hide gelatin into the donkey-hide gelatin, decocting the donkey-hide gelatin for 7 hours, melting the donkey-hide gelatin to prepare donkey-hide gelatin solution, centrifuging the donkey-hide gelatin solution to obtain centrifugate, filtering the centrifugate by a filter screen with 200 meshes, refrigerating the donkey-hide gelatin solution, centrifuging the centrifugate again to obtain centrifugate, mixing the centrifugate with the concentrate prepared in the step (1), then adding ferrous lactate, sorbitol, erythritol, glycine, potassium sorbate, essence and sucralose into the mixture, adding water to the mixture to a constant volume of 1000mL, stirring and mixing the mixture, filling the mixture into a bottle with the specification of 20mL per bottle, sterilizing the mixture, and keeping the mixture at the temperature of 116.

Example 3: preparation of composition for improving anemia symptoms

The composition for improving anemia symptoms is 1000mL in volume and mainly prepared from the following raw materials in parts by weight: 300 parts of jujube, 80 parts of donkey-hide gelatin, 2 parts of ferrous gluconate, 100 parts of angelica, 60 parts of ginseng, 180 parts of medlar and 150 parts of white peony root; auxiliary materials: 30 parts of sorbitol, 10 parts of erythritol, 1.5 parts of glycine, 0.6 part of potassium sorbate, 0.5 part of essence and 0.6 part of sucralose; solvent: and (3) water.

(2) adding water with the mass of 10 times of the donkey-hide gelatin, decocting (the time is 7 hours), melting to prepare donkey-hide gelatin liquid, centrifuging, taking centrifugate, filtering by a filter screen with 200 meshes, refrigerating, centrifuging again, taking centrifugate, mixing with the concentrate prepared in the step (1), then adding ferrous gluconate, sorbitol, erythritol, glycine, potassium sorbate, essence and sucralose, adding water to a constant volume of 1000mL, stirring and mixing, filling, wherein the filling specification is 20 mL/bottle, sterilizing and sterilizing, wherein the temperature is kept at 116 ℃ for 40 minutes, so that the composition for improving the symptom of anemia is prepared.

Example 4: preparation of composition for improving anemia symptoms

Example 4 differs from example 1 in that the composition is prepared without the use of the raw material white peony root, and the remaining components and preparation are the same as in example 1.

Example 5: preparation of composition for improving anemia symptoms

The composition for improving anemia symptoms is 1000mL in volume and mainly prepared from the following raw materials in parts by weight: 350 parts of jujube, 70 parts of donkey-hide gelatin, 1.5 parts of ferrous fumarate, 90 parts of angelica, 60 parts of ginseng, 150 parts of medlar and 140 parts of white paeony root; auxiliary materials: 30 parts of sorbitol, 10 parts of erythritol, 1.5 parts of glycine, 0.6 part of potassium sorbate, 0.5 part of essence and 0.6 part of sucralose; solvent: and (3) water.

The procedure for the preparation of example 5 was the same as in example 1.

Comparative example 1

Comparative example 1 is different from example 1 in that the composition is prepared without using ginseng and lycium barbarum, and the remaining components and preparation process are the same as example 1.

Product effectiveness testing

1. Animal testing

1.1. Sample preparation: the composition prepared in example 1, the composition prepared in example 4, the composition prepared in comparative example 1, and deionized water.

1.2. Animals: the experiment selects 74 clean SD male rats (a strain of rats which are widely used for pharmacological, toxicological and pharmacodynamic experiments) provided by Shanghai Slek laboratory animals, Limited liability company, and the weight of the SD male rats is 40-50 g. License number: SCXK (Shanghai) No. 2012-0002.

1.3. A breeding environment: the SPF animal laboratory of Fujian province disease control center has the following license numbers: SYXK (min) 2012-; feeding with low-iron feed (provided by Cupresso Biotech, Inc., Guangzhou); the formula of the low-iron feed comprises: corn starch G/kg, egg white protein 200.0G/kg, sucrose 100.0G/kg, corn oil 70.0G/kg, cellulose 50.0G/kg, mixed mineral salt AIN-93G-MX 35.0G/kg, mixed vitamin AIN-93G-VX 10.0G/kg, L-cystine 3.0G/kg, choline chloride 2.5G/kg.

1.4. Testing an instrument: an electronic balance, an yapei blood cell analyzer, and a 930N fluorescence spectrophotometer.

1.5. Dosage and test substance preparation: test 3 test groups were set, namely test group 1 (taking the composition prepared in example 1), test group 2 (taking the composition prepared in example 4), test group 3 (taking the composition prepared in comparative example 1), and taking a dosage of 20.0mL/kg BW (20.0 mL of drug per kg of body weight), and the model control group was given an equivalent amount of deionized water.

1.6. Experimental methods

1.6.1. Establishing a rat model of iron deficiency anemia: healthy weaning SD male rats 74 are selected to be fed with low-iron feed and deionized water after being adapted for 4 days in experimental environment, a stainless steel cage and a feeding tank are adopted, part of rats are selected every week from 3 weeks to test hemoglobin (Hb), and when Hb of most animals is lower than 100g/L, the weight and Hb of all rats are tested.

1.6.2. Recovery experiments: 40 rats with Hb <100g/L were selected as experimental animals, and were randomly divided into a model control group and 3 test groups according to Hb level and body weight of anemia rats, each group was 10, each group was continuously fed with a low iron diet, the test groups were test group 1 (taking the composition prepared in example 1), test group 2 (the composition prepared in example 4), and test group 3 (the composition prepared in comparative example 1), the model control group was administered with an equal amount of ionized water, weighed weekly, and after 32 days of continuous administration, body weight, hemoglobin, hematocrit, and free protoporphyrin in erythrocytes were measured.

1.7. And (3) data statistics: multiple sets of experimental data were analyzed for one-way anova with SPSS software. Through the homogeneity of variance test, the experimental data with the same variance is subjected to statistical analysis by adopting an LSD method (least significant difference method), and the experimental data with the different variance or the abnormal variance is subjected to variable conversion and then is subjected to statistics.

1.8. Results

1.8.1. Rat body weight before and after the test

The body weights of the rats in each group before and after the test are counted, and the results are shown in table 1, and as can be seen from table 1, the body weights of the rats in the test groups 1-3 after the test are all larger than that of the model control group, but the difference is not statistically significant (P is larger than 0.05).

Table 1: effect on body weight of anemic rats: (

g)

Group of	Before testing	P value	After the test	P value
					Model control group	310±14	/	450±23	/
Test group 1	302±20	0.985	465±42	0.397
					Test group 2	308±19	0.566	454±36	0.265
Test group 3	305±10	0.580	469±19	0.784

1.8.2. Effect on hemoglobin of anemic rats

The hemoglobin content of the rats in each group before and after the test is counted, and the results are shown in table 2, and as can be seen from table 2, the hemoglobin concentration of the rats in the test groups 1-3 is higher than that of the model control group after the test, wherein the hemoglobin concentration of the rats in the test groups 1-2 is higher than that of the rat in the test group 3, and the difference has statistical significance (P is less than 0.05).

Table 2: effect on hemoglobin (Hb) in anemic rats: (

g/L)

Group of	Before testing	P value	After the test	P value	Value of rise
						Model control group	76.6±3.8	/	91.1±5.8	/	14.5±8.5
Test group 1	76.1±6.7	0.871	147.0±8.5	0.000	70.9±8.4
						Test group 2	76.2±7.5	0.752	146.7±6.8	0.000	70.5±5.9
Test group 3	76.4±5.5	0.811	137.4±5.6	0.015	61.1±6.8

1.8.3. Influence on hematocrit and free protoporphyrin content of anemic rats

The haematocrit and the free protoporphyrin content of the rats in each group before and after the test are counted, the results are shown in table 3, and as can be seen from table 3, the haematocrit of the rats in the test groups 1-2 is higher than that of the rat in the test group 3 and the model control group, and the difference has statistical significance (P is less than 0.05); the content of free protoporphyrin in the rat erythrocytes of the test group 1-2 is lower than that of the test group 3 and the model control group, and the difference has statistical significance (P is less than 0.05).

Table 3: has effects on hemangiocrit (Hct) and erythrocyte free protoporphyrin (FEP) of anemic rat

Group of	Packed cell volume (%)	P value	Erythrocyte free protoporphyrin (μ g/L)	P value
					Model control group	52.3±6.2	/	668.0±65.2	/
Test group 1	82.9±6.5	0.000	371.5±30.1	0.000
					Test group 2	81.3±3.8	0.000	379.8±22.4	0.000
Test group 3	77.2±4.9	0.047	452.5±40.8	0.037

In summary, the following steps: after a rat model with iron deficiency anemia is established, a tested sample is given for 32 days, the hemoglobin concentration of rats in the test group 1-2 is higher than that of a model control group, the differences have statistical significance (P is less than 0.01), and the front and back rising amplitudes are more than 70 g/L; the hematocrit of the rats in the test groups 1-2 is higher than that of the rats in the model control group and the test group 3, and the difference has statistical significance (P is less than 0.01); the content of free protoporphyrin in the red blood cells of the rats in the test groups 1-2 is lower than that of the control group of the model, and the differences have statistical significance (P is less than 0.01). The composition prepared by the embodiment of the invention has the function of improving iron deficiency anemia.

2. Human body test

2.1. Test object

The test substance: the recommended dosage of the composition prepared in example 1 is 2 times per day for an adult, and 1 bottle (10 mL/bottle) for each time.

Subject: women with normal physical examination, age range of 18-55 years and hemoglobin content of less than 120g/L are selected, and women in gestation period and lactation period are excluded.

2.2. Testing instrument

Atomic absorption spectrophotometer, fluorescence spectrophotometer, Hb1002 hemoglobin determination apparatus, microcentrifuge for hematocrit, 125I-serum ferritin radioimmunoassay kit, and FT-630 gamma-counter.

2.3. Test method

The subjects, 120 women, were divided into a control group (60) administered with an equal amount of placebo and a test group (60) administered with an equal amount of the composition prepared in example 1. Control group 2 during the test period test group 1 persons did not take the test substance as specified or did not wish to take the 2 nd blood sample, and were excluded as specified, and no statistics were included in the results. The average age (42.8 + -3.2) of the control group, the average height (157.2 + -3.1) cm, the average weight (58.1 + -4.3) kg, the average age (40.1 + -2.1) of the test group, the average height (158.0 + -3.4) cm, the average weight (59.5 + -2.3) kg, and the average age, height, and weight of the two women were not statistically significant. The samples were taken orally in the test group and the placebo was taken orally in the control group in the same external package, and the dosage was 2 times/day, 1 bottle (10 mL/bottle) each time, and the observation was carried out for 30 days. At the end of the test, the subjects still suffering from anemia in the test and control groups were re-dosed with the sample for a course of 30 days.

Results the data were compared using SPSS13.0 software for a t-test.

2.4. Test indexes and results

2.4.1. Hemoglobin: the control group and the test group are tested before and after the test by adopting a cyaniding high-iron method, the blood of the ring finger is taken by a quantitative capillary tube of 10 mu L and is put into a plastic tube containing 2.5mL of a potassium ferricyanide reagent, the vibration is carried out fully, the blood is dissolved completely, after being placed for 15min in a dark place, the measurement is carried out by a hemoglobin meter, and the standard and the reference substance of the hemoglobin are simultaneously measured, and the result is shown in Table 4.

Table 4: for hemoglobin contentThe influence of (a) (g/L,

)

group of	Before testing	After the test	Difference value	P value (in group)
					Control group	111.2±3.2	113.9±2.8	2.7±1.2	P＞0.05
Test group	112.7±4.1	126.7±5.1	14.1±2.4	P＜0.01
					P value (between groups)	P＞0.05	P＜0.01	P＜0.01

As can be seen from Table 4, the hemoglobin content difference between the control group and the test group before the test is not statistically significant (P > 0.05), and the hemoglobin content of the test group after the test is significantly higher than that of the control group (P < 0.01). The hemoglobin content of the test group after the test is obviously increased (P is less than 0.01) compared with that before the test. The difference of the hemoglobin increase of the test group before and after the test is obviously higher than that of the control group (P is less than 0.01). The control group had an increase in hemoglobin but no statistical significance (P > 0.05).

2.4.2. Hematocrit: for the control group and the test group, blood was taken through a 9. mu.L quantitative capillary before and after the test, one end was sealed with a rubber cement, and the measurement was carried out by a hematocrit measuring instrument, and the results were read after 2min while measuring the reference standard blood sample. The results are shown in Table 5.

Table 5: effect on hematocrit (%,

)

group of	Before testing	After the test	Difference value	P value (in group)
					Control group	31.2±2.5	31.9±1.9	0.7±1.8	P＞0.05
Test ofGroup of	31.9±1.5	36.7±2.7	4.8±3.2	P＜0.01
					P value (between groups)	P＞0.05	P＜0.01	P＜0.01

As can be seen from Table 5, the difference between the hematocrit of the control group and the test group before the test was not statistically significant (P > 0.05), and the hematocrit of the test group after the test was significantly higher than that of the control group (P < 0.01). The hematocrit of the test group after the test was significantly increased (P < 0.01) compared to the hematocrit before the test, and the hematocrit of the control group after the test was not significantly increased (P > 0.05) compared to the hematocrit before the test. The increase difference of the hematocrit of the test group is obviously higher than that of the control group (P < 0.01).

2.4.3. Red blood cell free protoporphyrin: for the control group and the test group, whole blood was dropped on a special filter paper before and after the test, and after drying, stored in a refrigerator at 4 ℃ for standby (time not more than 2 months). During the determination, a filter paper with blood drops is driven into a glass test tube by a puncher, a diatomite solution with the mass fraction of 2% is added, the glass test tube is put into a refrigerator at 4 ℃ for overnight elution, a mixed solution of ethyl acetate and glacial acetic acid (the ratio is 4: 1) is added for extraction, after centrifugation for 10min, 0.5mol/L hydrochloric acid is added into a supernatant, oscillation centrifugation is carried out, and a lower layer liquid is taken to be determined by a fluorescence spectrophotometer. The results are shown in Table 6.

Table 6: the effect on the free protoporphyrin content of erythrocytes (μ g/dl,

)

group of	Before testing	After the test	Difference value	P value (in group)
					Control group	65.4±9.5	61.9±12.9	-3.5±18.8	P＞0.05
Test group	67.2±11.7	23.6±18.4	-43.6±23.2	P＜0.01
					P value (between groups)	P＞0.05	P＜0.01	P＜0.01

As can be seen from Table 6, the difference between the content of free protoporphyrin in erythrocytes of the control group and the test group before the test was not statistically significant (P > 0.05), and the content of free protoporphyrin in erythrocytes of the test group after the test was significantly lower than that of the control group (P < 0.01). The content of the free protoporphyrin of the red blood cells in the test group after the test is obviously lower than that before the test (P is less than 0.01), and the content of the free protoporphyrin of the red blood cells in the control group after the test is not obviously reduced. The difference in the decrease in free protoporphyrin of the erythrocytes in the test group was significantly higher than in the control group (P < 0.01).

2.4.4. Serum ferritin: before and after the test, 50 mu L of serum is taken, ferritin antibody and 125I-ferritin are added, the mixture is fully and uniformly mixed, the mixture is incubated for 1h at 37 ℃, a separation reagent is added, the mixture is fully shaken up, the mixture is placed at room temperature for 15min, 3500r/min is centrifuged for 15min, the supernatant is discarded, and a gamma-counter is used for counting the precipitation. The results are shown in Table 7.

Table 7: the effect on serum ferritin content (mg/L,

)

group of	Before testing	After the test	Difference value	P value (in group)
					Control group	54.2±26.7	57.9±32.4	3.7±23.9	P＞0.05
Test group	56.1±35.7	83.5±38.6	27.4±30.1	P＜0.01
					P value (between groups)	P＞0.05	P＜0.01	P＜0.01

As can be seen from Table 7, the difference between the serum ferritin content of the control group and the test group before the test is not statistically significant (P > 0.05), and the serum ferritin content and the increase value of the serum ferritin content of the test group after the test are both significantly higher than those of the control group (P < 0.01). The serum ferritin content of the test group is obviously increased (P is less than 0.01) after the test compared with that before the test, the serum ferritin content of the control group is not obviously changed (P is more than 0.05) after the test compared with that before the test, and the increase value of the serum ferritin content of the test group is obviously higher than that of the control group (P is less than 0.01).

In summary, the oral administration of the composition of example 1 of the present invention for 30 days can significantly increase the hemoglobin content, the red blood cell pressure and the serum ferritin level of the women with anemia, and significantly decrease the content of free protoporphyrin in red blood cells, which indicates that the composition of example 1 can effectively improve nutritional anemia in women. And during taking, the compliance of a subject is better, adverse reactions such as nausea, vomiting, gastrointestinal discomfort and the like are not found, and the composition is proved to have the characteristics of good effect, small side effect and the like.

Claims

1. A composition characterized by being prepared from the following raw materials: jujube, donkey-hide gelatin, ferrous salt, angelica, ginseng and medlar.

2. The composition of claim 1, wherein the material of the composition further comprises white peony root.

3. The composition according to claim 1, which is prepared from the following raw materials in parts by weight: 400 parts of jujube, 30-80 parts of donkey-hide gelatin, 0.5-3 parts of ferrous salt, 30-100 parts of angelica, 30-100 parts of ginseng and 200 parts of medlar.

4. The composition according to claim 2, which is prepared from the following raw materials in parts by weight: 200-250 parts of jujube, 50-80 parts of donkey-hide gelatin, 1-2 parts of ferrite, 40-60 parts of angelica, 40-80 parts of ginseng, 120-180 parts of medlar and 80-120 parts of white paeony root.

5. A method of preparing a composition comprising the steps of:

(2) dissolving colla Corii Asini in solvent, decocting, melting by heating to obtain colla Corii Asini solution, centrifuging, collecting centrifugate, mixing with the concentrate obtained in step (1), adding ferrous salt, and stirring to obtain the composition of any one of claims 1-4.

6. The method according to claim 5, wherein in the step (1), the density of the concentrate is 1.15 to 1.18g/cm³。

7. A medicament comprising the composition of any one of claims 1 to 4 and an adjuvant.

8. The medicament of claim 7, further comprising an excipient.

9. The medicament of claim 7 or 8, wherein the medicament is in any pharmaceutically acceptable dosage form; preferably, the dosage form is selected from oral liquid, tablet, powder or capsule.

10. Use of a composition according to any one of claims 1 to 4 in the manufacture of a medicament for the treatment of anemia.