Preparation method of dendrobium sanguineum plant preparation and application of dendrobium sanguineum plant preparation in gynecological endocrine diseases

Abstract

The invention provides a preparation method of a dendrobium sanguineum plant preparation and application of the dendrobium sanguineum plant preparation in gynecological endocrine diseases. The dendrobium sanguineum plant preparation is prepared from, by weight, 15-20 parts of astragalus membranaceus, 8-10 parts of dendrobium officinale, 10-12 parts of folium mori, 3-5 parts of tremella sanguineum, 8-10 parts of radix ophiopogonis, 6-8 parts of spina date seeds, 5-7 parts of allium macrostemon and 5-8 parts of gordon euryale seeds. The dendrobium sanguineum plant preparation can automatically produce gas through an enzymatic reaction, the continuous floating time of the preparation in the stomach is prolonged, the medicine is slowly released, and the bioavailability is improved. Meanwhile, the dendrobium sanguineum plant preparation has a remarkable improvement or treatment effect on various gynecological endocrine diseases such as endometriosis with insulin resistance, abnormal metrorrhagia, premature ovarian insufficiency and perimenopausal metabolic syndrome, and a new solution is provided for comprehensive treatment of complex gynecological endocrine diseases.

Description

TECHNICAL FIELD

[0001] The present application belongs to the field of modernization of traditional Chinese medicine, and particularly relates to a preparation method of a blood-ear-dendrobium plant preparation and application thereof in gynecological endocrine diseases. BACKGROUND

[0002] Gynecological endocrine diseases such as polycystic ovary syndrome (PCOS), endometriosis combined with insulin resistance (EMS-IR), abnormal uterine bleeding (DUB) and perimenopausal metabolic syndrome (PMS) have become the main burden of modern women's health. These diseases not only involve reproductive endocrine disorders, but also form a vicious cycle with systemic metabolic disorders (such as insulin resistance, chronic low-grade inflammation, oxidative stress and intestinal flora imbalance), resulting in limited efficacy and obvious side effects of existing treatment methods.

[0003] The current clinical treatment of gynecological diseases faces three core pain points: first, existing Chinese patent medicines are mostly limited to the relief of single diseases, such as Guizhifuling Capsules which are only for uterine fibroids and ovarian cysts caused by blood stasis blocking collaterals, and are difficult to cope with complex pathological states interwoven with multiple systems, such as EMS-IR; second, although hormone therapy of western medicine can inhibit lesions in the short term, it can cause oxidative stress to worsen. Clinical data shows that after using gonadotropin releasing hormone agonists (GnRH-a), the SOD activity in the serum of patients decreases by 40%; third, the vicious cycle of metabolic disorders and reproductive disorders has not been effectively blocked. For example, the risk of type 2 diabetes in PCOS patients is 4 times higher than that in the general population, and traditional treatment methods cannot simultaneously regulate reproductive endocrine and glucose and lipid metabolism.

[0004] In view of the above problems, based on the interactive regulation theory of "oxidation-reduction-endocrine-metabolism", the present application develops an innovative Chinese medicine composition with the functions of targeting pathological links and system homeostasis regulation, which is particularly suitable for treating gynecological endocrine diseases and related system dysfunction, and provides a breakthrough solution for the comprehensive treatment of complex gynecological endocrine diseases. SUMMARY

[0005] In view of the above technical problems, the first object of the present application is to provide a blood-ear-dendrobium plant composition.

[0006] The second object of the present application is to provide a blood-ear-dendrobium plant preparation based on the blood-ear-dendrobium plant composition and a preparation method thereof.

[0007] The third object of the present application is to provide application of the blood-ear-dendrobium plant preparation in preparing a medicine for improving or treating gynecological endocrine diseases.

[0008] Technical solution: A blood ear dendrobium plant preparation, which comprises a pharmaceutical active ingredient and a pharmaceutical excipient, wherein the pharmaceutical active ingredient is a blood ear dendrobium composition comprising the following raw material components in parts by weight: 15-20 parts of Astragalus membranaceus, 8-10 parts of Dendrobium officinale, 10-12 parts of Morus alba, 3-5 parts of blood ear, 8-10 parts of Ophiopogon japonicus, 6-8 parts of Zizyphus jujuba, 5-7 parts of Allium bakeri, and 5-8 parts of Euryale ferox; and the pharmaceutical excipient comprises the following components in parts by weight: 1.5-4 parts of microcrystalline cellulose, 18-24 parts of lactose, and 0.6-3 parts of magnesium stearate.

[0009] The preparation method of the blood ear dendrobium plant preparation described above, characterized in that it comprises the following steps:

[0010] S1. Pre-treating Astragalus membranaceus, Dendrobium officinale, Morus alba, blood ear, Ophiopogon japonicus, Zizyphus jujuba, Allium bakeri, and Euryale ferox, drying them to a constant weight, mixing them uniformly, crushing and sieving them to obtain a blood ear dendrobium composition;

[0011] S2. Dissolving phospholipid and ergosterol in a chloroform / methanol mixed solution, adding the blood ear dendrobium composition and thioglucoside described above, vortexing to mix uniformly, removing the organic solvent by rotary evaporation to form a uniform lipid film, adding PBS for hydration, ultrasonic treatment, and then spray drying after ultrafiltration and centrifugation to obtain liposomes;

[0012] S3. Adding chitosan to an acetic acid solution, stirring until completely dissolved, taking myrosinase and adding it to PBS, slowly dripping the chitosan solution into the PBS, ultrasonic treatment in an ice bath to obtain a mixed solution, dissolving sodium tripolyphosphate in water, dripping it into the mixed solution while continuously stirring, washing the precipitate obtained after centrifugation with PBS, and spray drying to obtain myrosinase microspheres;

[0013] S4. Mixing the liposomes and myrosinase microspheres, adding microcrystalline cellulose, lactose, and magnesium stearate, and mixing them uniformly to obtain the blood ear dendrobium plant preparation.

[0014] Preferably, the phospholipid in step S2 is any one or more of Antarctic krill phosphatidylcholine, Antarctic krill phosphatidylethanolamine, Antarctic krill phosphatidylserine, and Antarctic krill phosphatidylinositol.

[0015] Preferably, the thioglucoside in step S2 includes but is not limited to raphanus glucosinolate and myrosin.

[0016] Preferably, the mass ratio of phospholipid, ergosterol, and thioglucoside in step S2 is 4.4-5.5:1-1.8:0.8-1.5.

[0017] Preferably, the volume ratio of chloroform and methanol in step S2 is 2-2.5:1-2.

[0018] As preferred, the temperature of the rotary evaporation in step S2 is 40-50℃, and the rotation speed of the rotary evaporation is 120-180 rpm.

[0019] As preferred, the temperature of the hydration in step S2 is 50-60℃, and the time of the hydration is 30-60 min.

[0020] As preferred, the power of the ultrasonic in step S2 is 200-220 W, and the time of the ultrasonic is 5-8 min.

[0021] As preferred, the rotation speed of the centrifugation in step S2 is 10000-12000 x g, and the time of the centrifugation is 15-25 min.

[0022] As preferred, the chitosan in step S3 is low molecular weight chitosan, and the molecular weight is 50-150 kDa.

[0023] As preferred, the source of the myrosinase in step S3 includes but is not limited to the seeds, roots, stems or leaves of broccoli, cauliflower, radish, Brussels sprouts or rape.

[0024] As preferred, the mass ratio of the chitosan, myrosinase and sodium triphosphate in step S3 is 20-30:1-2.5:8-14.

[0025] As preferred, the rotation speed of the stirring in step S3 is 300-600 rpm, and the time of the stirring is 20-40 min.

[0026] As preferred, the rotation speed of the centrifugation in step S3 is 5000-7000 x g, and the time of the centrifugation is 10-20 min.

[0027] The above blood dendrobium plant preparation is used for preparing a medicine for improving or treating gynecological endocrine diseases, and the gynecological endocrine diseases include endometriosis combined with insulin resistance, abnormal uterine bleeding, premature ovarian failure and perimenopausal metabolic syndrome.

[0028] The dosage form of the above medicine for improving or treating gynecological endocrine diseases is a tablet, a pill, a capsule, a powder or a granule.

[0029] Beneficial effects:

[0030] 1. The blood-ear dendrobium plant preparation prepared by the present application triggers an enzymatic reaction in the stomach environment, realizes self-gas production, makes the preparation continuously float in the stomach, prolongs the retention time of the pharmaceutical ingredients in the stomach, and at the same time maintains the controlled release of the drug, overcoming the defects of short retention time in the stomach and low bioavailability of traditional oral preparations. The blood-ear dendrobium plant preparation and the thioglycoside substrate are co-embedded, the myrosinase is microencapsulated alone, and the thioglycoside substrate is isolated in space to avoid pre-reaction between the two during delivery, thereby ensuring that the enzymatic reaction is triggered only in the stomach. When the preparation reaches the stomach, gastric juice releases myrosinase and thioglycoside, and the two undergo enzymatic reaction to produce CO2 in situ, making the preparation density decrease and float on the surface of the gastric juice, realizing the continuous floating in the stomach for 16 h and the drug release of more than 85% within 24 h.

[0031] 2. The blood-ear dendrobium plant preparation prepared by the present application has significant advantages compared with conventional stomach floating preparations. The traditional carbonate gas production system is easily affected by individual gastric acid secretion and gastric emptying speed, has short gas production duration and large floating time fluctuation, and excessive carbonate may cause stomach discomfort. In contrast, the enzymatic gas production system of the present application generates CO2 gas by enzyme catalysis of specific substrate to make the preparation continuously float, which has the following advantages:

[0032] (1) Strong substrate specificity: the high selective combination of myrosinase and thioglycoside substrate avoids non-target reactions and reduces the interference of by-products;

[0033] (2) Controllable gas production rate: the release rate of enzyme and substrate can be controlled by adjusting the enzyme load, substrate ratio or embedding wall material ratio, prolonging the floating time to 16 h;

[0034] (3) High biocompatibility: myrosinase derived from Brassicaceae plants and thioglycoside substrate are usually safe, avoiding the risk of electrolyte disturbance of carbonate. DETAILED DESCRIPTION

[0035] The present application will be further described below in conjunction with examples, and the following examples are an explanation of the present application, but the present application is not limited to the following examples:

[0036] Example 1

[0037] This example is the preparation of the blood-ear dendrobium plant preparation, which includes the following steps:

[0038] S1. Raw material pretreatment: Take honey and water and mix them evenly according to a mass ratio of 1:1, then add Astragalus and stir until uniform, soak for 2 hours, fry at 100°C for 40 minutes, dry at 90°C for 45 minutes, and reserve; freeze-dry fresh Dendrobium officinale, and reserve; pick mulberry leaves after frost, microwave them to fix the color, dry them at 100°C for 40 minutes, and reserve; dry blood-ear at 60°C for 2 hours, and micronize it (D90≤15 μm), and reserve; soak Ophiopogon japonicus in water, add water fly realgar powder according to a mass ratio of 40:1, stir until uniform, and dry at 60°C for 12 hours, and reserve; soak spina date at 30°C in warm water for 10 hours to promote germination, and dry at 55°C for 12 hours, and reserve; soak Allium bakeri in vinegar for 3 days, and dry at 55°C for 12 hours, and reserve; roast Euryale ferox bran until it is slightly yellow, and dry at 60°C for 10 hours, and reserve;

[0039] S2. Prepare blood-ear and Dendrobium officinale composition: mix 20 parts of Astragalus, 10 parts of Dendrobium officinale, 10 parts of mulberry leaves, 5 parts of blood-ear, 8 parts of Ophiopogon japonicus, 8 parts of spina date, 7 parts of Allium bakeri, and 5 parts of Euryale ferox, and grind them through a 60-mesh sieve, and reserve;

[0040] S3. Prepare liposomes: weigh 5.4 g of Antarctic krill phosphatidylethanolamine and 1.2 g of ergosterol, and dissolve them in a chloroform / methanol mixed solution (2:1, v / v), add the above blood-ear and Dendrobium officinale composition and 1.5 g of glucoraphanin, vortex to mix, remove the organic solvent by rotary evaporation at 40°C and 150 rpm, form a uniform lipid film, add 5 mL of PBS (pH 7.4), hydrate at 55°C for 30 minutes, treat with ultrasonic waves at 200 W for 5 minutes (on for 5 s / off for 5 s, ice bath), ultrafiltrate, centrifuge at 10,000 x g for 20 minutes, and spray dry to prepare liposomes;

[0041] S4. Prepare myristicinase microspheres: weigh 100 mg of low-molecular-weight chitosan, add 10 mL of 1% acetic acid solution, and stir until completely dissolved; take 5 mg of myristicinase, add 1 mL of PBS (pH 5.0), and slowly drop into the chitosan solution, and prepare a mixed solution by ultrasonic treatment at 50 W for 30 s in an ice bath; weigh 50 mg of sodium triphosphate, add 10 mL of water, and drop into the mixed solution at a speed of 1 mL / min by using a syringe pump, stir at 500 rpm for 30 minutes, centrifuge at 5,000 x g for 10 minutes, wash the precipitate with PBS (pH 5.0) for 3 times, and spray dry to prepare myristicinase microspheres;

[0042] S5. Mix and press tablets: mix the liposomes and myristicinase microspheres, add 1.5 parts of microcrystalline cellulose, 18 parts of lactose, and 0.6 parts of magnesium stearate, mix them evenly, and press tablets.

[0043] Example 2

[0044] The difference between this example and Example 1 is that the blood-ear-dendrobium plant preparation in this example contains 15 parts of Astragalus, 9 parts of Dendrobium officinale, 10 parts of mulberry leaves, 3 parts of blood-ear, 10 parts of Ophiopogon, 6 parts of Semen Ziziphi Spinosae, 7 parts of Allium and 6 parts of Euryale.

[0045] Example 3

[0046] The difference between this example and Example 1 is that the addition amount of Antarctic krill phosphatidyl ethanolamine in this example is 6.9 g, the addition amount of ergosterol is 1.5 g, and the addition amount of raphanus sativus glucosinolate is 1.8 g.

[0047] Example 4

[0048] The difference between this example and Example 1 is that the addition amount of low molecular weight chitosan in this example is 175 mg, the addition amount of myrosinase is 7 mg, and the addition amount of sodium tripolyphosphate is 77 mg.

[0049] Example 5

[0050] The difference between this example and Example 1 is that the Antarctic krill phosphatidyl ethanolamine in this example is replaced by Antarctic krill phosphatidyl choline.

[0051] Example 6

[0052] The difference between this example and Example 1 is that the raphanus sativus glucosinolate in this example is replaced by sinigrin.

[0053] Comparative Example 1

[0054] The difference between this comparative example and Example 1 is that the blood-ear-dendrobium composition in this comparative example is directly compressed into tablets.

[0055] Comparative Example 2

[0056] The difference between this comparative example and Example 1 is that the blood-ear-dendrobium composition and 25 mg of NaHCO3 are mixed and then compressed into tablets in this comparative example.

[0057] Comparative Example 3

[0058] The difference between this comparative example and Example 1 is that the raphanus sativus glucosinolate in this comparative example is replaced by neoglucobrassicin.

[0059] Comparative Example 4

[0060] The difference between this comparative example and Example 1 is that the myrosinase in this comparative example is replaced by β-glucosidase.

[0061] Index test

[0062] 1. In vitro floating performance determination

[0063] The blood Dendrobium plant preparation prepared in the application was put into 900 mL of 0.1 mol / L hydrochloric acid solution, the temperature was 37±0.5℃, the rotation speed was 100 rpm, and the floating time and floating time were recorded.

[0064] Table 1: In vitro floating performance

[0065]

[0066] As shown in Table 1, compared with Comparative Examples 1-4, the blood Dendrobium plant preparations prepared in Examples 1-6 of the application can all float within 30 s, and the floating time is more than 13 h, indicating that the blood Dendrobium plant preparation prepared in the application has good floating performance.

[0067] 2. Cumulative release rate determination

[0068] Two pieces of the blood Dendrobium plant preparation prepared in the application were respectively placed in 900 mL of phosphate buffer, the temperature was 37±0.5℃, the rotation speed was 100 rpm, 5 mL of solution was taken at 12 h and 24 h and filtered with a 0.45 μm micro membrane, and the absorbance values of polysaccharides, flavonoids, saponins, alkaloids and volatile oils were detected at 490 nm, 415 nm, 550 nm, 525 nm and 255 nm, respectively, and the cumulative release rate was calculated by substituting the standard curve.

[0069] Table 2: Cumulative release rate of active ingredients

[0070]

[0071] As shown in Table 2, the blood Dendrobium plant preparations prepared in Examples 1-6 of the application are stably and continuously released within 24 h, and the release rate reaches more than 85% at 24 h, while the release rate of the blood Dendrobium plant preparations of Comparative Examples 1-4 reaches more than 80% within 12 h, and is basically completely released after 24 h, so the blood Dendrobium plant preparations prepared in Examples 1-6 of the application not only have good dissolution in the gastrointestinal tract, but also have a sustained release effect, significantly prolonging the retention time of the active ingredients in the stomach, thereby achieving a sustained and stable drug delivery effect.

[0072] Example 7

[0073] This example is the influence of the blood Dendrobium plant preparation prepared in Example 1 on polycystic ovary syndrome, including the following steps:

[0074] S1. After 3-month-old female SD rats were adaptively fed for one week, they were randomly divided into a blank control group (10) and a modeling group (50), the modeling group was injected with 0.1 mL of 60 mg / kg DHEA subcutaneously on the neck every day, and the control group was injected with 0.1 mL of sesame oil containing 10% anhydrous ethanol, for 4 weeks, vaginal smear examination was performed for 5 consecutive days to determine whether the modeling was successful;

[0075] S2. 50 rats with successful modeling were randomly divided into a model control group and a drug administration group, the drug administration group was administered with the blood and dendrobium officinale plant preparation by intraperitoneal injection, the drug administration dose was 20, 40, 80 mg / kg, and the administration was performed once every 24 hours, for a total of 4 weeks, the blank control group and the model control group were given 10 mL / kg of normal saline every day;

[0076] S3. After 4 weeks of grouping and administration, the blood was collected from the tail vein to detect the fasting insulin and blood glucose, and the insulin resistance index was calculated, and the blood was collected from the abdominal aorta after 10% chloral hydrate anesthesia to detect the levels of testosterone, estradiol and luteinizing hormone.

[0077] Comparative Example 5

[0078] The difference between this comparative example and Example 7 is that the drug used in this comparative example is chlorpheniramine.

[0079] Table 3 Various indicators of the polycystic ovary syndrome rat model

[0080]

[0081] Note: Compared with the polycystic ovary syndrome model control group, * represents P<0.05, and ** represents P<0.01.

[0082] As shown in Table 3, compared with the blank control group, the body weight, insulin resistance index (HOMA-IR), and the levels of testosterone and luteinizing hormone in the serum of the rats in the model control group were significantly increased, and the estradiol level was significantly decreased, indicating that the polycystic ovary syndrome model was successfully established. After drug intervention (Example 7 and Comparative Example 5), the body weight, insulin resistance index, and the levels of testosterone and luteinizing hormone in the serum of the rats were significantly decreased, and the estradiol level was increased, indicating that the blood and dendrobium officinale plant preparation can effectively improve the endocrine and metabolic disorders caused by polycystic ovary syndrome, and has a potential therapeutic effect on polycystic ovary syndrome.

[0083] Example 8

[0084] This example is the effect of the blood and dendrobium officinale plant preparation prepared in Example 1 on chocolate cysts with insulin resistance, which includes the following steps:

[0085] S1. After one week of adaptive feeding, 3-month-old healthy non-pregnant female SD rats were randomly divided into a blank control group (10) and a model group (50). The model group was fed with high-fat feed, and the rat endometriosis model was established. The rats were anesthetized by intraperitoneal injection of 10% chloral hydrate 0.35 g / kg, the surgical area was shaved and disinfected with iodophor, a 1.5-2 cm longitudinal incision was made 1 cm above the urethral opening on the abdominal midline, the right uterus was pulled out, the middle end of the uterus was separated and cut, the cut end was ligated, the cut uterus was cut longitudinally, washed with physiological saline, trimmed into small squares of 0.5 cm*0.5 cm, and sutured on the left ovary. No active bleeding points were found, the abdominal cavity was washed with physiological saline and penicillin solution was dropped into the abdominal cavity, and the abdominal cavity was closed layer by layer. After the operation, 0.9% physiological saline dissolved penicillin (160,000 / kg) was injected for 3 consecutive days, and normal clean feeding was carried out. On the 4th day after the operation, estradiol valerate (0.1 mg / kg) was administered by gavage, for 5 consecutive days. After 4 weeks of modeling, ultrasonic exploration was performed to check if cysts were formed in the left ovary, and blood was taken from the rat tail vein to measure fasting blood glucose. A blood glucose value > 16.7 mmol / L was considered successful modeling.

[0086] S2. 50 successfully modeled rats were randomly divided into a model control group and a drug administration group. The drug administration group was administered by gavage with blood-ear-stone-dendrobium plant preparation at a dose of 20, 40, and 80 mg / kg, once every 24 hours, for a total of 4 weeks. The blank control group and the model control group were given physiological saline 10 mL / kg per day.

[0087] S3. After 4 weeks of gavage administration, the rats were fasted for 12 hours, anesthetized with 10% chloral hydrate, and then sacrificed by abdominal aortic blood sampling. After dissection, the volume of the rat cysts was measured, and the expression of VEGF, CA125, and insulin resistance index in the serum was detected.

[0088] Comparative Example 6

[0089] The difference between this comparative example and Example 5 is that the drug used in this comparative example is leuprolide acetate.

[0090] Table 4. Various indicators of chocolate cysts with insulin resistance in rat models

[0091]

[0092] Note: Compared with the chocolate cyst model control group, * indicates P<0.05, and ** indicates P<0.01.

[0093] As shown in Table 4, compared with the blank control group, the cyst volume of the model control group rats was significantly increased, and the levels of VEGF and CA125 in serum and insulin resistance index were significantly increased, indicating that the insulin resistance model of chocolate cyst was successfully established. After drug intervention (Example 8 and Comparative Example 6), the cyst volume, serum VEGF and CA125 levels, and insulin resistance index were reduced to different degrees. With the increase of the administration dose of the blood dendrobium plant preparation (Example 7), the cyst volume, serum VEGF and CA125 levels, and insulin resistance index were all reduced, indicating that the blood dendrobium plant preparation had a definite effect on chocolate cyst with insulin resistance.

[0094] Example 9

[0095] This example is the effect of the blood dendrobium plant preparation prepared in Example 1 on perimenstrual syndrome, which includes the following steps:

[0096] S1. After adaptive feeding for 3 months, the rats were randomly divided into a blank control group (10) and a modeling group (50). The rats in the modeling group were anesthetized by intraperitoneal injection of 10% chloral hydrate 0.35 g / kg, the hair in the surgical area was cut off and disinfected with iodophor, an incision was made at a region 1-2 cm below the lowermost rib and 2 cm apart from the spine on both sides, the ovaries were found, the tissue between the ovaries and the uterus was ligated with surgical thread, the ovaries were removed, and no active bleeding points were checked. The tissue was sent into the abdominal cavity, the abdominal cavity was closed layer by layer, the wound was wiped with 0.9% normal saline to remove bloodstains, and vaginal smear examination was performed on the 5th day after the operation for 5 consecutive days to determine whether the modeling was successful.

[0097] S2. The 50 rats with successful modeling were randomly divided into a model control group and a drug administration group. The rats in the drug administration group were administered with the blood dendrobium plant preparation by intraperitoneal injection, and the administration dose was 20, 40, and 80 mg / kg. The administration was performed once every 24 hours, and the administration was performed for 4 weeks. The rats in the blank control group and the model control group were given normal saline 10 mL / kg per day.

[0098] S3. After 4 weeks of grouping and administration, the rats were fasted for 12 hours, anesthetized with 10% chloral hydrate, and then the blood was collected from the abdominal aorta to determine the levels of testosterone, estradiol, luteotropic hormone, SOD, and IL-2.

[0099] Comparative Example 7

[0100] The difference between this comparative example and Example 9 is that the drug used in this comparative example is estradiol valerate.

[0101] Table 5 Various indicators of the perimenstrual syndrome rat model

[0102]

[0103] Note: compared with the perimenopausal syndrome model control group, * means P<0.05, ** means P<0.01.

[0104] As shown in Table 5, compared with the blank control group, the estradiol level in the serum of the model control group was significantly reduced, and the luteinizing hormone level was significantly increased, indicating that the perimenopausal syndrome model was successfully established. After drug intervention (Example 9 and Comparative Example 7), the estradiol level in the serum was significantly increased, and the luteinizing hormone level was significantly decreased. In addition, the superoxide dismutase (SOD) activity was significantly enhanced, and the interleukin-2 (IL-2) level was significantly increased, indicating that the blood-ear Dendrobium plant preparation not only improved the hormone imbalance, but also may play a comprehensive treatment role by enhancing the antioxidant capacity and regulating the immune function.

[0105] The above is only the preferred embodiment of the present application, and does not limit the present application in any form. Any person skilled in the art can make many possible changes and modifications to the technical solutions of the present application, or modify equivalent embodiments, without departing from the spirit and technical solutions of the present application, by using the disclosed methods and technical contents. Therefore, any simple modification, equivalent replacement, equivalent change and modification of the above embodiments made according to the technical essence of the present application, without departing from the technical solutions of the present application, still belongs to the protection scope of the technical solutions of the present application.

Claims

1. A Dendrobium phalaenopsis plant preparation, characterized by: The blood-ear dendrobium plant preparation comprises a pharmacodynamic component and a medicinal excipient, the pharmacodynamic component is a blood-ear dendrobium composition, and the blood-ear dendrobium composition comprises the following raw material components in parts by weight: 15-20 parts of Astragalus membranaceus, 8-10 parts of Dendrobium officinale, 10-12 parts of Morus alba, 3-5 parts of blood-ear, 8-10 parts of Ophiopogon japonicus, 6-8 parts of Zizyphus jujuba, 5-7 parts of Allium bakeri and 5-8 parts of Euryale ferox; and the medicinal excipient comprises the following components in parts by weight: 1.5-4 parts of microcrystalline cellulose, 18-24 parts of lactose and 0.6-3 parts of magnesium stearate.

2. The preparation method of the blood-ear Dendrobium plant preparation according to claim 1, characterized in that, The method comprises the following steps: S1. After pretreatment, the Astragalus membranaceus, Dendrobium officinale, Morus alba, blood-ear, Ophiopogon japonicus, Zizyphus jujuba, Allium bakeri and Euryale ferox are dried to a constant weight, mixed uniformly, crushed and sieved to prepare a blood-ear dendrobium composition; S2. Phospholipid and ergosterol are dissolved in a chloroform / methanol mixed solution, and the blood-ear dendrobium composition and thioglucoside are added and mixed uniformly by vortex, and the organic solvent is removed by rotary evaporation to form a uniform lipid film, and then PBS is added for hydration, and the mixture is treated by ultrasonic wave, and then the mixture is subjected to ultrafiltration, centrifugation and spray drying to prepare liposomes; S3. Chitosan is added to an acetic acid solution and stirred until completely dissolved, and then myrosinase is added to PBS, and then the chitosan solution is slowly dripped into the mixture, and the mixture is treated by ultrasonic wave in an ice bath to prepare a mixed solution, and then sodium tripolyphosphate is dissolved in water and dripped into the mixed solution while stirring, and then the mixture is centrifuged, and the precipitate is washed with PBS, and then the mixture is spray dried to prepare myrosinase microspheres; S4. The liposomes and myrosinase microspheres are mixed, and then microcrystalline cellulose, lactose and magnesium stearate are added and mixed uniformly to prepare a blood-ear dendrobium plant preparation.

3. The method of claim 2, wherein: In step S2, the phospholipid is any one or more of Antarctic krill phosphatidylcholine, Antarctic krill phosphatidylethanolamine, Antarctic krill phosphatidylserine and Antarctic krill phosphatidylinositol.

4. The method of claim 2, wherein: In step S2, the thioglucoside includes but is not limited to raphanus sativus glucosinolate and black mustard glucosinolate.

5. The method of claim 2, wherein: In step S2, the mass ratio of phospholipid, ergosterol and thioglucoside is 4.4-5.5:1-1.8:0.8-1.5, the volume ratio of chloroform and methanol is 2-2.5:1-2, the temperature of rotary evaporation is 40-50°C, the rotation speed of rotary evaporation is 120-180 rpm, the temperature of hydration is 50-60°C, the time of hydration is 30-60 min, the power of ultrasonic wave is 200-220 W, the time of ultrasonic wave is 5-8 min, the rotation speed of centrifugation is 10 000-12 000×g, and the time of centrifugation is 15-25 min.

6. The method of claim 2, wherein: In step S3, the chitosan is low-molecular-weight chitosan, and the molecular weight of the chitosan is 50-150 kDa, and the source of the myrosinase includes but is not limited to the seeds, roots, stems or leaves of Brassica oleracea, Brassica oleracea var. botrytis, Raphanus sativus, Brassica juncea or Brassica napus.

7. The method of claim 2, wherein: In step S3, the mass ratio of chitosan, myrosinase and sodium tripolyphosphate is 20-30:1-2.5:8-14, the rotation speed of stirring is 300-600 rpm, the time of stirring is 20-40 min, the rotation speed of centrifugation is 5 000-7 000×g, and the time of centrifugation is 10-20 min.

8. The use of the blood-ear dendrobium plant preparation according to claim 1 or the blood-ear dendrobium plant preparation prepared by the preparation method of claims 2-7 in the preparation of a drug for improving or treating gynecological endocrine diseases.

9. Use according to claim 8, characterized in that: The gynecological endocrine diseases include endometriosis combined with insulin resistance, abnormal uterine bleeding, premature ovarian failure, and perimenopausal metabolic syndrome.

10. Use according to claim 8, characterized in that: The dosage form of the drug for improving or treating gynecological endocrine diseases is tablets, pills, capsules, powders, or granules.

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