Zhenqi blood-enriching oral liquid

Abstract

The invention relates to the field of blood-enriching oral liquid, in particular to Zhenqi blood-enriching oral liquid. Sheep placentas, pearls, red ginseng, Chinese wolfberry fruits, astragalus membranaceus, radix angelicae, coix seeds, fresh ginger, Chinese dates, black beans, angelica sinensis, radix puerariae and Chinese herbaceous peony are used as functional component raw materials. The sheep placenta is hydrolyzed by pancreatin to obtain hydrolysate rich in protein, polypeptide, amino acid, collagen, female progestational hormone and the like, and the palatability of the oral liquid is improved through deodorization and decoloration treatment of activated carbon. Neutral protease is firstly added into pearls for enzymolysis, then hydrochloric acid is added for hydrolysis, and protein is converted into a water-soluble component with smaller molecular weight. The pearl hydrolysate is good in water solubility, high in absorptivity and rich in active substances. Soybean isoflavone contained in the black beans is similar to estrogen secreted by a human body in structure. Paeonia lactiflora has the functions of dredging channels and promoting blood circulation. And the other nine blood-enriching traditional Chinese medicines are mutually coordinated to achieve the purposes of nourishing yin and blood, enriching blood and soothing nerves. Qi and blood are effectively regulated, and hypomenorrhea and thin menstruation are treated.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of blood tonifying oral liquid, in particular to a kind of precious blood tonifying oral liquid. BACKGROUND

[0002] Oligomenorrhea and polymenorrhea are common clinical symptoms, with an incidence of about 70%. Due to the delay of childbearing age, the increase of mental and psychological pressure, unhealthy lifestyle and chronic diseases, and other factors, the number of patients with oligomenorrhea or polymenorrhea is increasing, especially among young people. Oligomenorrhea and polymenorrhea can seriously affect the physical and mental health of patients, and some patients with oligomenorrhea or polymenorrhea have an increased risk of endometrial hyperplasia under the long-term stimulation of estrogen and limited protection of progesterone. Therefore, the management of oligomenorrhea and polymenorrhea not only plays an important role in improving the quality of life and health of patients, but also can protect the reproductive capacity of patients.

[0003] The existing precious blood tonifying oral liquid is a pure traditional Chinese medicine preparation, which is suitable for dizziness, pale complexion, fatigue and other symptoms caused by deficiency of qi and blood. The precious blood tonifying oral liquid mainly contains sheep placenta, pearl, red ginseng, medlar, astragalus, angelica, baizhi, yiyiren, ginger, jujube. These traditional Chinese medicines have high biological activity and play an important role in tonifying qi and blood. Previous studies have confirmed the effectiveness and safety of precious blood tonifying oral liquid in treating anemia patients, but its improvement on oligomenorrhea and polymenorrhea has not been reported. SUMMARY

[0004] In view of the problems in the background art, a kind of precious blood tonifying oral liquid is proposed.

[0005] The present application proposes a kind of precious blood tonifying oral liquid, which is suitable for improving oligomenorrhea and polymenorrhea. According to the formula proportion, the raw materials of effective components in the oral liquid are as follows: sheep placenta 30-31 parts, pearl 2-3 parts, red ginseng 4-5 parts, medlar 4-5 parts, astragalus 10-11 parts, baizhi 5-6 parts, yiyiren 2-3 parts, ginger 1-2 parts, jujube 2-3 parts, black beans 3-4 parts, angelica 3-4 parts, gualou 1-2 parts and peony 1-2 parts.

[0006] Preferably, it also includes 10-20 parts of flavoring agent; the flavoring agent is concentrated fruit juice of any one or more fruits of strawberry, banana, apricot, pear, apple, loquat, cherry, banana, longan or lychee.

[0007] Preferably, the preparation method is as follows:

[0008] S1, preparing sheep placenta enzyme solution: after freeze-drying treatment of sheep placenta, hydrolyze with trypsin, dissociate protein, and prepare enzyme solution semi-finished product, then use activated carbon to remove odor and decolorize the sheep placenta enzyme solution, filter to obtain sheep placenta enzyme solution;

[0009] S2, preparing pearl enzyme-acid hydrolysate: after crushing the pearl, first add neutral protease to hydrolyze the protein, then add hydrochloric acid to hydrolyze the protein into water-soluble components with smaller molecular weight, and filter to obtain pearl enzyme-acid hydrolysate;

[0010] S3, red ginseng, medlar, astragalus, baizhi, coix seed, ginger, jujube, black bean, angelica, radix puerariae and peony are ground into powder and then boiled with water to obtain a separation liquid by filtration;

[0011] S4, the separation liquid, the sheep placenta enzyme hydrolysate, the pearl enzyme-acid hydrolysate and the flavoring agent are mixed, water is added to 1000ml, and the product is obtained by refrigeration, filtration, filling and sterilization.

[0012] Preferably, the specific steps of S1 are as follows: the sheep placenta is washed and processed into particles of 80-200 mesh and water content less than 90%; freeze-drying treatment is performed at about-30℃; 3 times the amount of water is added, the pH is adjusted to 7.5, the temperature is adjusted to 50℃, and trypsin is added for hydrolysis for 4 hours to obtain an enzyme hydrolysate semi-finished product; under the conditions of a temperature of 70℃ and a pH of 11, activated carbon is used to remove odor and color from the sheep placenta enzyme hydrolysate, the amount of activated carbon used is 2.0%, and the decolorization time is 60 minutes; after filtration, the sheep placenta enzyme hydrolysate is obtained.

[0013] Preferably, the specific steps of S2 are as follows: the pearl is crushed into 100 mesh fine powder, a small amount of water is added for boiling in a water bath, and stirring is performed to obtain a pearl slurry; the temperature is lowered to 40℃, neutral protease is added for reaction for 3-6 hours for enzyme hydrolysis; the temperature is raised to 90℃, and 6 mol / L hydrochloric acid is added for hydrolysis for 2 hours; after filtration, the filtrate is combined to obtain an enzyme-acid hydrolysate.

[0014] Preferably, the specific steps of S3 are as follows: 5 times and 3 times the amount of water is added to the mixed powder of red ginseng, medlar, astragalus, baizhi, coix seed, ginger, jujube, black bean, angelica, radix puerariae and peony for boiling twice, each time for 2 hours; centrifugal separation is performed to obtain a separation liquid.

[0015] Preferably, the pearl and astragalus blood tonifying oral liquid is used in combination with progesterone to improve oligomenorrhea and menorrhagia.

[0016] Compared with the prior art, the present application has the beneficial technical effects that: the precious blood supplementing oral liquid in the present application takes sheep placenta, pearl, red ginseng, medlar, astragalus, baizhi, yiyiren, ginger, jujube, black bean, angelica, gualou and peony as functional component raw materials. The sheep placenta is hydrolyzed by adding trypsin to obtain a hydrolysate rich in protein, polypeptide, amino acid, collagen, estrogen and progesterone, cytokine and trace element, and then the hydrolysate is treated by activated carbon to remove odor and color, thereby improving the palatability of the oral liquid. The pearl is first subjected to enzymatic hydrolysis by adding neutral protease to dissociate protein, and then subjected to hydrolysis by adding hydrochloric acid to convert the protein into water-soluble components with smaller molecular weight. The obtained pearl enzyme-acid hydrolysate has good water solubility, high absorption rate and is rich in active substances. The soybean isoflavone contained in the black bean is similar in structure to the estrogen secreted by the human body. The peony has the functions of dredging meridians and promoting blood circulation. The other nine blood supplementing traditional Chinese medicines are used as adjuvants to achieve the purpose of nourishing yin and blood, blood supplementing and spirit tranquilization. The blood is effectively regulated, and the oligomenorrhea and menometrorrhagia are treated. BRIEF DESCRIPTION OF DRAWINGS

[0017] Figure 1 Graph for blood loss evaluation in Example Five;

[0018] Figure 2 Flow chart for the study of the combination of the precious blood supplementing oral liquid and the progesterone capsule in Example Five;

[0019] Figure 3 Comparison graph of the TCMSSs of the menstruation of the patients in the three groups at each follow-up treatment in Example Five;

[0020] Figure 4 Comparison graph of the PBAC scores of the patients in the three groups at each follow-up treatment in Example Five. DETAILED DESCRIPTION

[0021] Example One

[0022] The precious blood supplementing oral liquid proposed in the present embodiment contains the following raw materials as effective components according to the formula proportion: 30 parts of sheep placenta, 2 parts of pearl, 4 parts of red ginseng, 4 parts of medlar, 10 parts of astragalus, 5 parts of baizhi, 2 parts of yiyiren, 1 part of ginger, 2 parts of jujube, 3 parts of black bean, 3 parts of angelica, 1 part of gualou and 1 part of peony.

[0023] It is further explained that 10 parts of a flavoring agent are further included. The flavoring agent is concentrated fruit juice of any one or more of strawberry, banana, apricot, pear, apple, loquat, cherry, banana, longan or lychee.

[0024] Example Two

[0025] The rare Qisheng blood supplement oral liquid according to the formula proportion, the raw material of the effective component in the oral liquid is: 31 parts of sheep placenta, 3 parts of pearl, 5 parts of red ginseng, 5 parts of medlar, 11 parts of astragalus, 6 parts of baizhi, 3 parts of yiyiren, 2 parts of ginger, 3 parts of jujube, 4 parts of black beans, 4 parts of angelica, 2 parts of kudzu root and 2 parts of peony.

[0026] It should be further pointed out that, 20 parts of flavoring agent; flavoring agent is strawberry, banana, apricot, pear, apple, loquat, cherry, banana, longan or litchi concentrate juice of any one or more fruits.

[0027] Example three

[0028] The rare Qisheng blood supplement oral liquid according to the formula proportion, the raw material of the effective component in the oral liquid is: 31 parts of sheep placenta, 3 parts of pearl, 5 parts of red ginseng, 5 parts of medlar, 11 parts of astragalus, 6 parts of baizhi, 3 parts of yiyiren, 2 parts of ginger, 3 parts of jujube, 4 parts of black beans, 4 parts of angelica, 2 parts of kudzu root and 2 parts of peony.

[0029] It should be further pointed out that, 20 parts of flavoring agent; flavoring agent is strawberry, banana, apricot, pear, apple, loquat, cherry, banana, longan or litchi concentrate juice of any one or more fruits.

[0030] Example four

[0031] The rare Qisheng blood supplement oral liquid preparation method according to the present embodiment, the steps are as follows:

[0032] S1, preparation of sheep placenta enzyme solution: sheep placenta is washed, and is treated into 80-200 mesh, water content less than 90% granules; freeze-drying treatment at about-30 DEG C; add 3 times the amount of water, adjust pH to 7.5, temperature is 50 DEG C, add trypsin hydrolysis 4 hours, filter to prepare enzyme solution semi-finished product, under the condition of temperature is 70 DEG C, pH is 11, using activated carbon to remove odor and decolorization of sheep placenta enzyme solution, activated carbon dosage is 2.0%, decolorization time is 60 min, after filtration, the sheep placenta enzyme solution is obtained.

[0033] S2, preparation of pearl enzyme-acid hydrolysis solution: pearl is crushed into 100 mesh fine powder, add a small amount of water bath boiling, stirring to get pearl powder slurry, cooling to 40 DEG C, add neutral protease reaction 3-6 hours for enzymolysis, temperature rises to 90 DEG C, with 6 mol / L hydrochloric acid hydrolysis, heat preservation 2 hours, filtration, combined filtrate to prepare enzyme-acid hydrolysis solution.

[0034] S3, red ginseng, medlar, astragalus, baizhi, yiyiren, ginger, jujube, black beans, angelica, kudzu root and peony mixed powder respectively add 5 times, 3 times water decoction twice, 2 hours each time, centrifugal separation, get separation liquid.

[0035] S4, the separation liquid, the sheep placenta enzymatic hydrolysate, the pearl enzyme-acid hydrolysate, the flavoring agent are mixed, and water is added to 1000ml, and after cold storage, filtration, filling, sterilization, the finished product is obtained.

[0036] Example Five

[0037] The present embodiment proposes an application of the precious blood supplement oral liquid. The precious blood supplement oral liquid is used in combination with progesterone to improve oligomenorrhea and polymenorrhea.

[0038] To study the above application, the present embodiment further expands the related experiments of the combination of the precious blood supplement oral liquid and progesterone.

[0039] Experimental method: 96 patients with menstrual disorders were randomly divided into three groups of the precious blood supplement oral liquid (ZQ), progesterone capsules (PG) or combination of traditional Chinese and Western medicine (COM), with a ratio of 1:1:1. The graphic loss of blood scale and the TCM syndrome score of menstruation were recorded at the baseline after the start of treatment, 1 month and 3 months. The differences in 36 short-term health survey scores and safety indicators were compared at the baseline and after 3 months of treatment.

[0040] The inclusion criteria are as follows: patients aged 25 to 40, patients with oligomenorrhea and / or polymenorrhea (i.e. patients meeting all the above diagnostic criteria), and patients who provide informed consent and voluntarily participate in the study.

[0041] The exclusion criteria are as follows: patients with ovarian dysfunction due to ovarian surgery, patients with a history of radiotherapy and chemotherapy for malignant tumors, patients taking hormones or immunosuppressive drugs, patients with severe or unstable physical diseases that may affect the efficacy of drugs or the conduct of the trial, patients with an allergic reaction or serious adverse reactions to the drugs used in the trial, patients with breast cancer or other sex hormone-dependent malignant tumors or first-degree relatives with breast cancer, patients with a history of thromboembolic disease or a tendency to thrombosis, patients who have used drug regulation of menstruation in the past 3 months, patients with drug abuse or dependence (alcohol or drugs) in the past 3 months, heavy smokers (20 or more cigarettes per day), and patients who meet the inclusion criteria but cannot follow the doctor's advice, judge the efficacy or lack sufficient data to evaluate the efficacy.

[0042] Grouping and intervention measures: 96 patients with oligomenorrhea and polymenorrhea were randomly divided into the precious blood supplement oral liquid group (ZQ group, 10ml of the precious blood supplement oral liquid, bid), the progesterone capsule group (PG group, 200mg of progesterone capsules, qd for 10 consecutive days in a cycle), and the combination of traditional Chinese and Western medicine group (COM group, 10ml of the precious blood supplement oral liquid, bid, and 200mg of progesterone capsules, qd for 10 days in a cycle), with a ratio of 1:1:1. The treatment cycle was 3 months.

[0043] Sample size estimation: The sample size was calculated based on Traditional Chinese Medicine Syndrome Score (TCMSS). The estimated TCMSS decrease was 4.95 ± 1.18 for ZQ group, 3.03 ± 1.48 for PG group, and 5.50 ± 2.13 for COM group. Alpha was 5% (two-sided), power was 80%, and 24 patients were needed per group; considering a dropout rate of 15%, 90 patients were needed.

[0044] Randomization: The randomization sequence was created using SAS 9.4 (SAS Institute, Inc, Cary, NC) in a 1:1:1 ratio (block size of 6). The researchers sealed each randomized numbered intervention assignment information in a separate opaque envelope and administered accordingly.

[0045] Primary and secondary endpoints:

[0046] (1) Overall clinical efficacy

[0047] The overall clinical efficacy was defined according to the New Guide to Clinical Research in Chinese Medicine, the Criteria for Diagnosis and Efficacy of Chinese Medicine Diseases, and the Diagnostic Criteria for Menstrual Disorders in Gynecology. The overall clinical efficacy was divided into four levels: recovery, significant effect, effectiveness, and no effect.

[0048] Recovery: Recovery refers to the restoration of menstrual blood loss (MBL), duration of bleeding, and the length and regularity of the patient's menstrual cycle. The characteristics of recovery also include the disappearance of other symptoms, with a cure index of ≥95%.

[0049] Significant effect: Significant effect refers to the restoration of the menstrual cycle to 28 ± 7 days, an increase in menstrual blood volume to more than 30 milliliters, or an increase in the duration of bleeding within 7 days after recovery. Significant effect also manifests as the disappearance or alleviation of other symptoms, with a treatment efficacy index between 95% and 70%.

[0050] Effective: Effective refers to the improvement in MBL, duration of bleeding, length and regularity of the menstrual cycle, and other symptoms compared to baseline. The effectiveness index for effectiveness is between 70% and 30%.

[0051] No effect: No effect refers to the lack of improvement in menstrual flow, duration of bleeding, and menstrual period after treatment. In addition, the efficacy index is less than 30% (efficacy index = [TCMSS before treatment - TCMSS after treatment] / TCMSS before treatment * 100%).

[0052] (2) Menstrual TCMSS:

[0053] The menstrual TCMSS was determined according to the New Guide to Clinical Research in Chinese Medicine and the Criteria for Diagnosis and Efficacy of Chinese Medicine Diseases. The menstrual TCMSS includes primary symptoms and secondary symptoms. A lower score indicates a better assessment of menstrual health.

[0054] The primary symptom was classified as 0 (menstruation normal, blood bright red), 2 (MBL amount 20-30 mL, duration of bleeding 2-3 days, normal menstrual cycle duration <3 months, blood dark red), 4 (MBL amount <20 mL, duration of bleeding 1-2 days, menstrual cycle lengthened to 35 days to 2 months, blood dark red), 6 (spot bleeding, duration of bleeding <1 day, menstrual cycle lengthened to 3-5 months, blood water dark red) according to the severity of the symptoms. The secondary symptoms were classified as 0 (no symptoms), 1 (occasional symptoms), 2 (symptoms frequent but life normal), and 3 (symptoms frequent and life affected). Patients were asked to compare the descriptions of the primary and secondary symptoms on a scale and record the total TCMSSs immediately after the menstrual cycle ended.

[0055] (3) Blood loss assessment chart (PBAC)

[0056] Patients were asked to record the number of sanitary napkins used and the degree of blood penetration in the chart. Mild was defined as blood area occupying 1 / 3 of the entire sanitary napkin. Moderate was defined as blood area occupying 1 / 3-3 / 5 of the entire sanitary napkin. Severe was defined as the entire sanitary napkin being stained with blood. Mild, moderate, and severe bloodstains on the sanitary napkin were scored as 1 point, 5 points, and 20 points, respectively. Each small clot was scored one point and each large clot was scored five points. Figure 1

[0057] Secondary endpoints

[0058] (1) 36-item short-form health survey (SF-36): SF-36 contains 36 items. The second item is used to assess the patient's health changes in the past year, and the other 35 items assess the patient's physical and mental health status through eight dimensions. The higher the score, the better the quality of life.

[0059] (2) Sex hormones: Fasting blood samples were collected from patients at baseline and 3 months after treatment. Sex hormone levels were collected on day 2 and day 3 of the menstrual cycle from regularly menstruating women or any day from amenorrhea patients. Blood indices were measured using chemiluminescence immunoassay (CLIA) and Beckman Coulter DXI 800 (Beckman Coolter Inc. Brea, CA, USA).

[0060] (3) Endometrium: Endometrial thickness was monitored by transvaginal ultrasound on days 1-3 after menstruation.

[0061] Safety monitoring: Fasting blood samples were collected at baseline and 3 months after treatment. Safety indicators such as complete blood count and liver and kidney function were collected on days 2-3 of the menstrual cycle from regularly menstruating women or any day from amenorrhea patients. As previously described, blood indices were measured using CLIA. Reactions or adverse events (including serious reactions) were monitored.​

[0062] Statistical analysis: All statistical analyses were performed using SPSS software version 25.0 (IBM Inc., Somers, NY, USA).

[0063] Normally distributed results are expressed as mean ± standard deviation and skewed distribution results are expressed as median (interquartile range). Differences between treatment groups were tested using one-way analysis of variance for normally distributed data and Kruskal-Wallis analysis for skewed distribution data. Comparisons within the same group were performed using paired t-tests for normally distributed data and Wilcoxon signed-rank tests for skewed data. Categorical data were analyzed using chi-square tests. Statistical significance was set at P < 0.050.

[0064] result

[0065] 1. Study Participants and Baseline Characteristics

[0066] At the beginning of the study, there were 32 patients in each group, and 84 patients completed the entire experiment. There were 21 patients in the ZQ group, 32 patients in the PG group, and 31 patients in the COM group ( Figure 2 ), and the dropout rate was 12.5% ​​(12 / 96). There were no significant differences in age or body mass index between the groups (Table 1).

[0067] Table 1: Patient characteristics at baseline

[0068]

[0069] Note: BIM is body mass index

[0070] 2. Overall clinical efficacy

[0071] We calculated the total clinical efficacy of the three groups of patients at different treatment times. When comparing the total clinical efficacy of 3 months of treatment with that of 1 month of treatment, we found significant differences among the three groups (P = 0.007). In addition, pairwise comparisons showed that the efficacy of the COM group was significantly higher than that of the ZQ group and the PG group (P = 0.021 and 0.005, respectively) (Tables 2-3). After 3 months of treatment, the total clinical efficacy of the COM group was higher than that of the ZQ group and the PG group, with no statistical significance (P > 0.05) (Table 4).

[0072] Table 2: Comparison of clinical efficacy among the three groups of patients after 3 months of treatment and 1 month of treatment

[0073]

[0074] Table 3: Paired comparison of the total efficacy of the three groups after 3 months of treatment and 1 month of treatment

[0075]

[0076] Table 4: Clinical efficacy of three groups of treatment for 3 months compared to baseline

[0077]

[0078] 3. Improvement of menstrual TCMSSs

[0079] We compared the menstrual TCMSSs of the three groups in different cycles and found that each of the three groups had significant differences in different cycles (PZQ<0.001, PPG=0.001, PCOM<0.001); therefore, we used the Wilcoxon signed rank test for paired comparison of all groups, respectively. The results showed that TCMSS1 (P=0.027) and TCMSS3 (P<0.001) of ZQ group were significantly lower than TCMSS0. Similar differences were observed in PG group (P1=0.041; P3<0.001, respectively). In the COM group, TCMSS1 (P=0.003) and TCMSS3 (P<0.001) were significantly lower than TCMSS0, and the decrease between TCMSS3 and TCMSS1 was also statistically significant (P=0.018) (Table 5, Figure 3 ). No significant differences were observed between the three groups at baseline and 1 month after treatment (PO=0.526, P1=0.663), while the three groups had significant differences at baseline treatment and 3 months after treatment (P3=0.023). Paired comparison showed that the TCMSSs of the COM group were significantly lower than those of the ZQ group (P=0.019) and the PG group (P=0.025) (Table 5, Figure 3 ).

[0080] Table 5: Menstrual TCMSSs of the three groups at each treatment follow-up

[0081]

[0082] *P<0.05, **P<0.01 compared with baseline of the same group; #P<0.05 compared with 1 month after treatment. At 3 months of treatment, 0P<0.05 compared with the COM group. Figure 3 *P<0.05, **P<0.01 compared with baseline of the same group; #P<0.05 compared with 1 month after treatment. At 3 months of treatment, 0P<0.05 compared with the COM group.

[0083] 4. Improvement of menstrual blood volume

[0084] The PBAC scores of ZQ and PG groups were significantly different before and after treatment (PZQ=0.247, PPG=0.528), but the PBAC scores of COM group were not significantly different (P=0.005). Wilcoxon signed rank test showed that there was only difference between PBAC3 and PBAC1 (P=0.004), and the PBAC3 scores were significantly different among the three groups (P>0.05) (Table 6, Figure 4 ).

[0085] Table 6: PBAC scores of the three groups of patients at each follow-up

[0086]

[0087] Note: **P<0.01, compared with the same group after 1 month of treatment in Table 6. Figure 4 Note: **P<0.01, compared with the same group after 1 month of treatment in Table 6.

[0088] 5. Secondary endpoints

[0089] 1) SF-36 scores: After 3 months of treatment, the SF-36 scores of all three groups were significantly higher than at baseline (PZQ=0.02, PPG=0.049, PCOM=0.001), and no significant differences were found among the three groups at each follow-up (Table 7).

[0090] 2) Sex hormone levels and endometrial thickness: After 3 months of treatment, there were no significant changes in sex hormone levels and endometrial thickness in each group, and there were no differences among the groups at each follow-up (Table 7). We further selected patients with reduced ovarian reserve (basal follicle-stimulating hormone (FS day) for two consecutive menstrual cycles, 10 IU / L) in the three groups. The study found that in the COM group, one patient's FSH was significantly reduced (21.38 IU / L vs. 6.88 IU / L), and another patient's FSH increased after 3 months of treatment (13.1 IU / L vs. 16.74 IU / L). The ZQ group (n=5, 14.41±5.30 vs. 8.02±1.92) and the PG group (n=8, 14.53±8.13 vs. 7.05±2.08) showed a downward trend.

[0091] Table 7: Secondary endpoints of the three groups at baseline and after 3 months of treatment

[0092]

[0093] Note: FSH follicle-stimulating hormone; LH: luteinizing hormone; E2: estradiol; AMH: anti-Mullerian hormone; SF-36: MOS Short Form Health Survey. *P<0.05, **P<0.01, compared with baseline.

[0094] The above results show that, compared with Zhenqibu Xueliao oral liquid or progesterone monotherapy for treating oligomenorrhea and menoxenia, Zhenqibu Xueliao oral liquid and progesterone capsule combination has better effects in total clinical efficacy, reducing TCMSSs, improving PBAC and SF-36 scores.

[0095] The Zhenqibu Xueliao oral liquid in the application takes sheep placenta, pearl, red ginseng, medlar, astragalus, baizhi, yiyiren, ginger, jujube, black bean, angelica, gualou and peony as functional component raw materials. The sheep placenta is hydrolyzed by adding trypsin to obtain a hydrolysate rich in protein, polypeptide, amino acid, collagen, estrogen and progesterone, cytokine and trace element, and then the hydrolysate is treated by activated carbon to remove odor and color, thereby improving the palatability of the oral liquid. The pearl is first subjected to enzymatic hydrolysis by adding neutral protease to dissociate protein, and then subjected to hydrolysis by adding hydrochloric acid to convert the protein into water-soluble components with smaller molecular weight. The obtained pearl enzyme-acid hydrolysate has good water solubility, high absorption rate and is rich in active substances (protein, polypeptide, polysaccharide, trace element, carotenoid and vitamin B group). The soybean isoflavone contained in the black bean is similar in structure to the estrogen secreted by the human body. The peony has the functions of dredging meridians and promoting blood circulation. The other nine blood tonifying Chinese medicinal herbs are used as adjuvants to achieve the purposes of nourishing yin and blood, tonifying blood and tranquilizing the mind. The Zhenqibu Xueliao oral liquid effectively regulates qi and blood, treats oligomenorrhea and menoxenia.

[0096] The above has made a detailed description of the embodiments of the application in combination with the drawings, but the application is not limited thereto, and various changes can be made within the knowledge of those skilled in the art without departing from the spirit of the application.

Claims

1. A Zhenqi blood-enriching oral liquid suitable for improving oligomenorrhea and oligomenorrhea, characterized in that: According to the formula ratio, the raw materials of the active ingredients in this oral solution are: 30-31 parts of sheep placenta, 2-3 parts of pearl, 4-5 parts of red ginseng, 4-5 parts of wolfberry, 10-11 parts of astragalus, 5-6 parts of angelica, 2-3 parts of coix seed, 1-2 parts of ginger, 2-3 parts of jujube, 3-4 parts of black bean, 3-4 parts of angelica, 1-2 parts of kudzu root and 1-2 parts of peony.

2. The Zhenqi blood-enriching oral liquid according to claim 1, characterized in that: The product further comprises 10-20 parts of flavoring agent; the flavoring agent is concentrated juice of any one or more fruits selected from strawberry, banana, apricot, pear, apple, loquat, cherry, banana, longan or lychee.

3. The Zhenqi Buxue Oral Liquid according to claim 1, characterized in that The preparation method is as follows: S1. Preparing sheep placenta hydrolyzate: freeze-drying the sheep placenta and adding pancreatic enzyme to hydrolyze the placenta to dissociate the protein to prepare a semi-finished hydrolyzate, then using activated carbon to remove the fishy smell and color of the placenta hydrolyzate, and filtering to obtain the sheep placenta hydrolyzate; S2. Preparation of pearl enzyme-acid hydrolyzate: After crushing the pearls, neutral protease is added to dissociate the proteins, and then hydrochloric acid is added to hydrolyze the proteins to convert them into water-soluble components with smaller molecular weight. The pearl enzyme-acid hydrolyzate is obtained after filtration. S3, grinding red ginseng, wolfberry, astragalus, angelica, coix seed, ginger, jujube, black bean, angelica, kudzu root and peony into powder, adding water to decoct, and filtering to obtain a separated liquid; S4. Mix the separation solution, sheep placenta enzymatic hydrolyzate, pearl enzyme-acid hydrolyzate, and flavoring agent, add water to 1000 ml, refrigerate, filter, fill, and sterilize to obtain the finished product.

4. The Zhenqi blood-enriching oral liquid according to claim 3, characterized in that: The specific steps of S1 are as follows: washing the sheep placenta and processing it into 80-200 mesh particles with a water content of less than 90%; freeze-drying at about -30°C; adding 3 times the amount of water, adjusting the pH to 7.5, the temperature to 50°C, adding pancreatic enzyme to hydrolyze for 4 hours, filtering to prepare a semi-finished enzymatic hydrolyzate, and deodorizing and decolorizing the sheep placenta enzymatic hydrolyzate using activated carbon at a temperature of 70°C and a pH of 11, the activated carbon dosage being 2.0%, the decolorization time being 60 minutes, and filtering to obtain the sheep placenta enzymatic hydrolyzate.

5. The Zhenqi blood-enriching oral liquid according to claim 3, characterized in that: The specific steps of S2 are as follows: crush the pearls into 100 mesh fine powder, add a small amount of water and boil in a water bath, stir to prepare pearl powder slurry, cool to 40°C, add neutral protease and react for 3-6 hours for enzymatic hydrolysis, raise the temperature to 90°C, hydrolyze with 6 mol / L hydrochloric acid, keep warm for 2 hours, filter, and combine the filtrate to prepare enzyme-acid hydrolyzate.

6. The Zhenqi blood-enriching oral liquid according to claim 3, characterized in that: The specific steps of S3 are as follows: add 5 times and 3 times the amount of water to the mixed powder of red ginseng, wolfberry, astragalus, angelica, coix seed, ginger, jujube, black bean, angelica, kudzu root and peony respectively, and boil twice for 2 hours each time, and centrifuge to obtain a separated liquid.

7. The Zhenqi blood-enriching oral liquid according to claim 1, characterized in that: Zhenqi Buxue Oral Liquid is used in combination with progesterone to improve oligomenorrhea and infrequent menstruation.

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