CN111374990B - Placenta capsule and preparation method thereof - Google Patents

Placenta capsule and preparation method thereof Download PDF

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CN111374990B
CN111374990B CN202010245808.1A CN202010245808A CN111374990B CN 111374990 B CN111374990 B CN 111374990B CN 202010245808 A CN202010245808 A CN 202010245808A CN 111374990 B CN111374990 B CN 111374990B
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placenta
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魏伟
嵐山芮
许超
王慧琳
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Guangzhou Ruiplatinum Health Technology Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/48Reproductive organs
    • A61K35/50Placenta; Placental stem cells; Amniotic fluid; Amnion; Amniotic stem cells
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/46Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators

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Abstract

The invention provides a placenta capsule and a preparation method thereof, belonging to the technical field of fine processing of medicines. The method for preparing the placenta capsule comprises the steps of freezing and preserving the placenta, and preparing the placenta capsule after the placenta source is confirmed to be safe. The preparation method comprises cleaning and slicing the placenta after freezing preservation, slicing the placenta, adding wheat flour, freeze drying, removing flour on the surface of placenta tissue, pulverizing the placenta into powder, and encapsulating to obtain placenta capsule. The placenta tissue after freezing preservation is more beneficial to removing blood stasis and reducing the cleaning time of the placenta. The wheat flour is added in the freeze drying process, so that the freeze drying time in the freeze drying process is greatly shortened, and the production efficiency is improved. The method has simple operation steps in the preparation process, pure physical preparation, no need of enzymolysis and high temperature, and no addition of any chemical substance; and the extraction of the bioactive substances is complete and complete, the efficiency is high, and the active ingredients are easy to be absorbed.

Description

Placenta capsule and preparation method thereof
Technical Field
The invention belongs to the technical field of fine processing of medicines, and particularly relates to a placenta capsule and a preparation method thereof.
Background
The placenta (placenta) is an important organ for material exchange between a fetus and a mother, and is an intermaternal-fetal tissue-associated organ formed by the joint growth of an embryonic germ membrane and a mother's endometrium during pregnancy of a human. The placenta hominis is named as placenta hominis, and is called as placenta hominis, placenta hominis and the like.
The conventional method for preparing placenta hominis, placenta hominis or placenta capsule comprises collecting fresh placenta hominis of healthy puerpera, rinsing, removing fascia, breaking blood vessel, squeezing blood, repeatedly rinsing for several times until the placenta is clean, boiling in a pot until the placenta is floated, baking with coal fire until the placenta is foamed, loosening, and grinding into powder.
A method for preparing improved placenta powder by the chenchen dawn team of Shanxi institute of traditional Chinese medicine comprises cleaning placenta, soaking in 75% ethanol, taking out, sealing in a clean nontoxic plastic bag, freezing thoroughly (about 12h) in a refrigerator freezer at (-10 Shi 1 deg.C), taking out, slicing (about 1-2mm in thickness), placing the slices in a drying tray pre-paved with Glycyrrhrizae radix fine powder or parched rhizoma Dioscoreae fine powder, oven drying at 50 deg.C, pulverizing, filling into glass bottle or hard capsule, and sealing for use. Although this process reduces the temperature during the preparation process, the temperature during the preparation process also reaches 50 ℃, and partial loss of the active substance is also caused. In addition, the addition of ethanol in the preparation process can result in protein denaturation and active substance inactivation.
The preparation method of the placenta capsule in the patent publication No. CN107296271A comprises the following steps: (1) washing placenta after inspection and quarantine within 24 hr, removing fascia, pricking blood vessel, squeezing out blood, and repeatedly washing for several times until it is clean; (2) cutting placenta tissue into small pieces smaller than 1cm3(ii) a (3) Placing the placenta tissue obtained in the step (2) on a 80-mesh filter screen until no obvious liquid seeps out of the bottom of the filter screen; (4) flatly spreading the placenta obtained in the step (3) on a tray of an oven, setting the temperature of the oven to be 40-80 ℃, and putting the placenta into the oven to be dried for 3-5 hours; (5) putting the dried substance obtained in the step (4) into a tissue triturator, setting the rotating speed at 5000-; (6) sieving with 80 mesh sieve, and stirring the placenta powder until sieving; (7) filling the placenta powder into empty starch capsule. The preparation process is complicated, and the beneficial ingredients are lost. The preparation method has the advantages that the temperature reaches 40-80 deg.C, and the active ingredients in placenta are destroyed at high temperature.
The patent publication No. 107519206a discloses a preparation method of a human placenta lyophilized powder preparation: cleaning placenta, removing fascia and blood vessel, soaking in 10% NaCl solution for 5 hr, cutting, and homogenizing at low temperature to obtain placenta slurry; mixing with pure water, obtaining tissue and intracellular active factor by hypotonic method, stirring and extracting to obtain tissue fluid; adding 0.8-2% of yeast powder for fermentation to remove fishy smell in the product; filtering with a 30-70 μm filter membrane to obtain placenta extract; freeze drying to obtain placenta lyophilized powder; packaging with capsule shell (HPMCAS or CAP) to obtain lyophilized powder of human placenta. The method comprises the steps of performing hypotonic homogenization treatment, performing yeast fermentation to remove fishy smell, and performing freeze drying to obtain placenta active substance freeze-dried powder and form a capsule product.
Chinese patent application publication No. CN101658534 discloses a method of adding liquid nitrogen into placenta, pulverizing at 24-25 deg.c, subjecting placenta slurry to enzymolysis for 60 minutes, which takes too long, and the added protease also hydrolyzes various active substances. In the method disclosed in the chinese patent publication No. 102488713a, a large amount of small molecule active substances are lost by concentration and extraction using an ultrafiltration method with a molecular weight cut-off of 2000-l0000 Da. In addition, in the prior art, the placenta is mostly directly frozen into freeze-dried powder for eating by a freeze-drying method, and active substances pass through intestines and stomach, most of the active substances are damaged by gastric acid environment, so that the effect of active molecules is difficult to exert.
At present, no method for preparing the placenta capsule, which has the advantages of simple operation, complete and complete extraction of bioactive substances and high efficiency, is available.
Disclosure of Invention
The invention aims to overcome the defects in the prior art and provides a preparation method of placenta capsules.
Another object of the present invention is to provide the placental capsule prepared by the above preparation method.
The above object of the present invention is achieved by the following technical solutions:
a preparation method of placenta capsule comprises the following steps:
(1) freezing and storing the placenta, and simultaneously detecting viruses of the placenta;
(2) cleaning the placenta qualified by the virus detection in the step (1) with sterile water;
(3) shearing the placenta cleaned in the step (2) into 1-2 cm3Drying the small blocks in air;
(4) adding flour into the air-dried placenta tissue obtained in the step (3), and then carrying out freeze drying;
(5) removing the flour on the surface of the placenta tissue frozen and dried in the step (4), and pulverizing the residual placenta tissue into powder;
(6) and filling the placenta powder into capsules, and sterilizing at low temperature to obtain the placenta capsules.
The placenta in the step (1) is animal placenta; preferably derived from the placenta of a healthy person.
The temperature of the freezing preservation in the step (1) is-80 ℃ to-10 ℃; preferably-40 ℃.
The cryopreservation in step (1) is preferably achieved by means of a freezer.
The sterile water in the step (2) is preferably sterile purified water.
The washing in the step (2) includes an operation of washing the placental congestion with water.
The small blocks in the step (3) are preferably 5X 1X 0.3cm3
The air drying in the step (3) is realized by an air dryer; the air drying time of the air dryer is 4-8 h, and the power is 100-200W; preferably 6h, 100W.
The degree of air drying in the step (3) is preferably air drying until the moisture content of the placenta tissue is not higher than 9.1%; more preferably, the placenta is air-dried until the water content of the placenta tissue is 6-8.
The flour in the step (4) is wheat flour.
The wheat flour preferably comprises at least one of weak flour, medium flour and strong flour.
Calculating the placenta tissue and the flour in the step (4) according to the mass ratio of 50-80: 1-8; preferably 50-80: 1-3; more preferably 25: 1.
The preferable mode of adding flour into the air-dried placenta tissue in the step (4) is as follows: sprinkling flour on the surface of placenta.
The temperature of the freeze drying in the step (4) is-80 ℃ to-20 ℃, and the time of the freeze drying is 20-30 h; preferably, the temperature of the freeze drying is-80 ℃ to-20 ℃, and the time of the freeze drying is 23-28 h; more preferably, the temperature of freeze-drying is-60 deg.C and the time of freeze-drying is 24 h.
The operation of removing the flour on the surface of the placenta tissue after freeze-drying in the step (4) described in the step (5) is performed by a brush.
And (5) preparing the powder by a powder grinding machine.
The low temperature in the step (6) is 0-15 ℃; preferably 4 deg.c.
The sterilization treatment in the step (6) is irradiation sterilization treatment.
The intensity of the irradiation sterilization treatment is 9-15 kGy; preferably 10 kGy.
A placenta capsule is prepared by the above preparation method.
Compared with the prior art, the invention has the following advantages and beneficial effects:
the method for preparing the placenta capsule comprises the steps of freezing and preserving the placenta, and preparing the placenta capsule after the placenta source is confirmed to be safe. The preparation method comprises cleaning and slicing the placenta after freezing preservation, slicing the placenta, adding wheat flour, freeze drying, removing flour on the surface of placenta tissue, pulverizing the placenta into powder, and encapsulating to obtain placenta capsule. The placenta tissue after freezing preservation is more beneficial to removing blood stasis and reducing the cleaning time of the placenta. The wheat flour is added in the freeze drying process, so that the freeze drying time in the freeze drying process is greatly shortened, and the production efficiency is improved. The method has simple operation steps in the preparation process, pure physical preparation, no need of enzymolysis and high temperature, and no addition of any chemical substance; and the extraction of the bioactive substances is complete and complete, the efficiency is high, and the active ingredients are easy to be absorbed. In addition, before preparation, the placenta tissue is completely carried out according to a virus detection method of the blood product, and sterilization and disinfection treatment are carried out after preparation, so that the safety of the product is fully ensured.
Detailed Description
The present invention will be described in further detail with reference to examples, but the embodiments of the present invention are not limited thereto.
The reagents and methods used in the examples are those commonly used in the art, unless otherwise specified, and any insubstantial changes and substitutions made by those skilled in the art based on the present invention are intended to be within the scope of the invention as claimed.
First, the placenta tissue used in the present invention is clinical waste and is directly originated from the medical institution where healthy parturients are produced. The present disclosure is based on the use of fresh placental tissue, but does not directly relate to the removal or resection of placental tissue.
The placenta is derived from placenta voluntarily donated by healthy lying-in women and young health care institute of Guangdong province; wheat flour was purchased from wheat flour (grain-savory, snow-savory and delicious enriched flour) from Zhongliang group Limited.
Example 1: preparation of placenta capsule
A preparation method of placenta capsule comprises the following steps:
(1) storing the placenta of the collected healthy lying-in women in a freezer at-40 ℃, and meanwhile, conveying the sample to a umbilical cord blood hematopoietic stem cell bank of Guangdong province for virus detection;
(2) taking out placenta after virus detection is qualified, and adding sterile purified water to clean placenta extravasated blood;
(3) shearing cleaned placenta into 5 × 1 × 0.3cm pieces3The small blocks are dried for 6 hours by using an air dryer with the power of 100W until the moisture content of the placenta tissue is 6 percent;
(4) taking 500g of air-dried placenta tissue, adding 20g of wheat flour to make the surface of the placenta tissue adhered with the flour, and freeze-drying the placenta tissue in a freeze dryer at-60 ℃ for 24 hours;
(5) taking out the freeze-dried placenta tissue, removing the wheat flour on the surface of the freeze-dried placenta tissue by using a brush, and grinding the rest freeze-dried placenta tissue into powder by using a grinding machine;
(6) filling the placenta powder into capsules, and sterilizing at 4 deg.C to obtain placenta capsules meeting health food standards;
(7) the prepared placenta capsule is sent to a third party (Guangzhou gold domain medical detection center, Inc.) to detect active ingredients in the placenta.
Example 2: preparation of placenta capsule
A preparation method of placenta capsule comprises the following steps:
(1) storing the placenta of the collected healthy lying-in women in a freezer at-40 ℃, and meanwhile, conveying the sample to a umbilical cord blood hematopoietic stem cell bank of Guangdong province for virus detection;
(2) taking out placenta after virus detection is qualified, and adding sterile purified water to clean placenta extravasated blood;
(3) shearing cleaned placenta into 5 × 1 × 0.3cm pieces3The small blocks are dried for 4 hours by using an air dryer with the power of 200W until the water content of the placenta tissue is 8 percent;
(4) taking 500g of air-dried placenta tissue, adding 10g of wheat flour to make the surface of the placenta tissue adhered with the flour, and freeze-drying the placenta tissue in a freeze dryer at-20 ℃ for 28 h;
(5) taking out the freeze-dried placenta tissue, removing the wheat flour on the surface of the freeze-dried placenta tissue by using a brush, and grinding the rest freeze-dried placenta tissue into powder by using a grinding machine;
(6) filling the placenta powder into capsules, and sterilizing at 4 deg.C to obtain placenta capsules meeting health food standards;
(7) the prepared placenta capsule is sent to a third party (Guangzhou gold domain medical detection center, Inc.) to detect active ingredients in the placenta.
Example 3: preparation of placenta capsule
A preparation method of placenta capsule comprises the following steps:
(1) storing the placenta of the collected healthy lying-in women in a freezer at-50 ℃, and meanwhile, conveying the sample to a umbilical cord blood hematopoietic stem cell bank of Guangdong province for virus detection;
(2) taking out placenta after virus detection is qualified, and adding sterile purified water to clean placenta extravasated blood;
(3) shearing cleaned placenta into 5 × 1 × 0.3cm pieces3The small blocks are dried for 8 hours by using an air dryer with the power of 100W until the moisture content of the placenta tissue is 6.6 percent;
(4) taking 500g of air-dried placenta tissue, adding 30g of wheat flour to make the surface of the placenta tissue adhered with the flour, and freeze-drying the placenta tissue in a freeze dryer at-80 ℃ for 23 h;
(5) taking out the freeze-dried placenta tissue, removing the wheat flour on the surface of the freeze-dried placenta tissue by using a brush, and grinding the rest freeze-dried placenta tissue into powder by using a grinding machine;
(6) filling the placenta powder into capsules, and sterilizing at 4 deg.C to obtain placenta capsules meeting health food standards;
(7) the prepared placenta capsule is sent to a third party (Guangzhou gold domain medical detection center, Inc.) to detect active ingredients in the placenta.
Example 4: preparation of placenta capsule
A preparation method of placenta capsule comprises the following steps:
(1) storing the placenta of the collected healthy lying-in women in a freezer at-10 ℃, and meanwhile, conveying the sample to a umbilical cord blood hematopoietic stem cell bank of Guangdong province for virus detection;
(2) taking out placenta after virus detection is qualified, and adding sterile purified water to clean placenta extravasated blood;
(3) shearing cleaned placenta into 5 × 1 × 0.3cm pieces3The small blocks are dried for 6 hours by using an air dryer with the power of 150W until the moisture content of the placenta tissue is 6.9 percent;
(4) taking 800g of air-dried placenta tissue, adding 30g of wheat flour to enable the surface of the placenta tissue to be adhered with the flour, and then putting the placenta tissue into a freeze dryer to freeze-dry the placenta tissue for 25 hours at the temperature of minus 40 ℃;
(5) taking out the freeze-dried placenta tissue, removing the wheat flour on the surface of the freeze-dried placenta tissue by using a brush, and grinding the rest freeze-dried placenta tissue into powder by using a grinding machine;
(6) filling the placenta powder into capsules, and sterilizing at 4 deg.C to obtain placenta capsules meeting health food standards;
(7) the prepared placenta capsule is sent to a third party (Guangzhou gold domain medical detection center, Inc.) to detect active ingredients in the placenta.
Example 5: preparation of placenta capsule
A preparation method of placenta capsule comprises the following steps:
(1) storing the placenta of the collected healthy lying-in women in a freezer at-40 ℃, and meanwhile, conveying the sample to a umbilical cord blood hematopoietic stem cell bank of Guangdong province for virus detection;
(2) taking out placenta after virus detection is qualified, and adding sterile purified water to clean placenta extravasated blood;
(3) shearing cleaned placenta into 5 × 1 × 0.3cm pieces3The small blocks are dried for 6 hours by using an air dryer with the power of 100W until the moisture content of the placenta tissue is 6 percent;
(4) taking 600g of air-dried placenta tissue, adding 20g of wheat flour to enable the surface of the placenta tissue to be adhered with the flour, and then putting the placenta tissue into a freeze dryer to freeze-dry the placenta tissue for 26 hours at the temperature of minus 30 ℃;
(5) taking out the freeze-dried placenta tissue, removing the wheat flour on the surface of the freeze-dried placenta tissue by using a brush, and grinding the rest freeze-dried placenta tissue into powder by using a grinding machine;
(6) filling the placenta powder into capsules, and sterilizing at 4 deg.C to obtain placenta capsules meeting health food standards;
(7) the prepared placenta capsule is sent to a third party (Guangzhou gold domain medical detection center, Inc.) to detect active ingredients in the placenta.
Example 6: preparation of placenta capsule
A preparation method of placenta capsule comprises the following steps:
(1) storing the placenta of the collected healthy lying-in women in a freezer at-40 ℃, and meanwhile, conveying the sample to a umbilical cord blood hematopoietic stem cell bank of Guangdong province for virus detection;
(2) taking out placenta after virus detection is qualified, and adding sterile purified water to clean placenta extravasated blood;
(3) shearing cleaned placenta into 5 × 1 × 0.3cm pieces3The small blocks are dried for 4 hours by using an air dryer with the power of 200W until the moisture content of the placenta tissue is 7.5 percent;
(4) taking 700g of air-dried placenta tissue, adding 15g of wheat flour to enable the surface of the placenta tissue to be adhered with the flour, and then putting the placenta tissue into a freeze dryer to freeze-dry the placenta tissue for 24 hours at the temperature of minus 70 ℃;
(5) taking out the freeze-dried placenta tissue, removing the wheat flour on the surface of the freeze-dried placenta tissue by using a brush, and grinding the rest freeze-dried placenta tissue into powder by using a grinding machine;
(6) filling the placenta powder into capsules, and sterilizing at 4 deg.C to obtain placenta capsules meeting health food standards;
(7) the prepared placenta capsule is sent to a third party (Guangzhou gold domain medical detection center, Inc.) to detect active ingredients in the placenta.
Comparative example 1: comparison of effective active ingredients of placenta capsule prepared by different methods
The traditional preparation process of the human placenta comprises the following steps: washing 1500g of fresh placenta repeatedly to remove blood, boiling in boiling water for 1 hr, drying for 24 hr, grinding into powder, and storing in refrigerator at 4 deg.C.
The placenta in the placenta capsule prepared in example 1 of the present invention, the human placenta prepared by the conventional preparation process, and the fresh placenta (placenta obtained by washing with sterile purified water and extravasated blood) were all sent to Guangzhou gold domain medical testing center, Inc. for testing and analyzing the immunomodulatory active ingredients, and the content of each immunomodulatory active ingredient in each 0.05g of placenta is shown in Table 1 below.
Table 1: content comparison of effective active ingredients for regulating immunity of human placenta prepared by different processes
Figure BDA0002433952640000071
Wherein the fold refers to the ratio of the placenta prepared in example 1 to each immunoregulatory active component of placenta obtained by conventional preparation method
As can be seen from table 1 above, compared with human placenta prepared by the conventional preparation process, the placenta prepared by the method of example 1 of the present application has higher content of each immunomodulatory active ingredient; wherein, the content of the immunoglobulin IgA in the placenta prepared by the method of example 1 of the present application is 8.636 times higher than that in the placenta prepared by the traditional preparation process. Compared with fresh placenta, the method of example 1 retains at least 80% of the effective active components of immunoregulatory class in fresh placenta. The reason for this phenomenon is probably that the addition of wheat flour has a protective effect on the immunoregulatory active ingredients in the placenta, and the degradation of the active ingredients can be avoided in a low-temperature freeze-drying environment.
Comparative example 2: influence of the addition of flour on the preparation of placenta capsule
The method of preparing a disc capsule in group a1 of this comparative example 2 is substantially the same as the preparation method described in example 1, except that: wheat flour is not added in the step (4) of the group A1;
the method of preparing a disc capsule in group a2 of this comparative example 2 is substantially the same as the preparation method described in example 2, except that: wheat flour is not added in the step (4) of the group A2;
the method of preparing a disc capsule in group a3 of this comparative example 2 is substantially the same as the preparation method described in example 3, except that: wheat flour is not added in the step (4) of the group A3;
the method of preparing a disc capsule in group a4 of this comparative example 2 is substantially the same as the preparation method described in example 4, except that: wheat flour is not added in the step (4) of the group A4;
the method of preparing a disc capsule in group a5 of this comparative example 2 is substantially the same as the preparation method described in example 5, except that: wheat flour is not added in the step (4) of the group A5;
the method of preparing a disc capsule in group a6 of this comparative example 2 is substantially the same as the preparation method described in example 6, except that: wheat flour was not added in step (4) of group a 6.
Comparing examples 1-6 with comparative example 2, respectively: the freeze-drying time, the water content of the freeze-dried product, and the content of the immunomodulatory active ingredient in the finally prepared placental capsule in step (4) of groups a 1-a 6 are shown in table 2 below.
Table 2: freeze drying time, water content of freeze-dried product, and content of effective active components for regulating immunity in different processes
Figure BDA0002433952640000081
Figure BDA0002433952640000091
As can be seen from table 2 above, in order to achieve a certain water content range in the placenta tissue, the average freeze-drying time in the freeze-drying process of examples 1 to 6 was 25.33 hours, while comparative example 2: in the freeze-drying processes of groups A1-A6, the average freeze-drying time was 41.66 hours. Therefore, in the process of preparing the placenta capsule, compared with the freeze-drying time without the flour, the freeze-drying time of the placenta tissue added with the flour is averagely reduced by 16.33 hours, the working time is greatly reduced, and the working efficiency is improved. Examples 1-6 and comparative example 2, with the freeze-drying time greatly reduced after addition of flour: the water content of the freeze-dried products of the groups A1-A6 is not very different, but the whole active ingredients of the immunoregulation class are slightly improved, probably because the moisture in the placenta specimen is accelerated to evaporate after the wheat flour is added, the freeze-drying time is shortened, and the damage of the active ingredients is reduced due to the shortening of the freeze-drying time.
Comparative example 3: comparison of preparation Processes of placenta capsules
The placenta capsule of this comparative example 3 was prepared substantially in the same manner as in example 1, except that this comparative example 3 replaced wheat flour with corn starch in step (4).
Comparing the freeze-drying time in step (4) of the method of comparative example 3 and example 1, the water content of the freeze-dried product, and the content of the immunomodulatory active ingredient in the finally prepared placental capsule, the results are shown in table 3 below.
Table 3: freeze drying time in different processes, water content of freeze-dried product and content result of immunoregulation active ingredient
Example 1 Comparative example 3
Freeze drying time (h) 26 38
Water content (%) 3.2 3.25
Interferon-gamma (ng/0.05g) 1.234 1.132
Tumor necrosis factor-alpha (ng/0.05g) 0.409 0.211
Interleukin-2 (ng/0.05g) 1.43 1.231
Interleukin-6 (ng/0.05g) 0.374 0.331
Albumin (ng/0.05g) 2.7 2.591
As a result, it was found that: the product added with the corn starch is easy to adhere to the placenta tissue after freeze drying, is not easy to remove from the freeze-dried placenta tissue, and finally influences the content of the immunoregulation active ingredients in each placenta capsule.
Comparative example 4: comparison of preparation Processes of placenta capsules
The placenta capsule of this comparative example 4 was prepared substantially in the same manner as in example 1, except that the freeze-drying temperature in step (4) of this comparative example 4 was-10 ℃ and the freeze-drying time was 10 hours.
The results of comparing the water content of the placenta tissue after freeze-drying in step (4) of the method of example 4 with that of the placenta capsule finally prepared with the water content of the placenta tissue after freeze-drying in step (4) of the method of example 1 are shown in table 4 below.
Table 4: freeze drying placenta tissue with different processes, and regulating active components in placenta capsule
Example 1 Comparative example 4
Water content (%) 3.2 6.54
Interferon-gamma (ng/0.05g) 1.234 1.031
Tumor necrosis factor-alpha (ng/0.05g) 0.409 0.211
Interleukin-2 (ng/0.05g) 1.43 1.104
Interleukin-6 (ng/0.05g) 0.374 0.210
Albumin (ng/0.05g) 2.7 2.18
As a result, it was found that: the placenta obtained in comparative example 4 had a higher water content than that of example 1, and had a higher damage to the active ingredient for immunomodulation. This phenomenon may be caused by a higher water content in the placenta tissue due to a shortened lyophilization time and a too high drying temperature.
Comparative example 5: comparison of preparation Processes of placenta capsules
The placenta capsule of comparative example 5 was prepared substantially in the same manner as in example 1, except that the freeze-drying temperature in step (4) of comparative example 5 was 0 ℃ and the freeze-drying time was 35 hours, while replacing the wheat flour with corn flour.
Comparing the water content of the placenta tissue after freeze-drying in the step (4) and the content of the immunomodulatory active ingredient in the finally prepared placenta capsule in the preparation methods of comparative example 5 and example 1, the results are shown in table 5.
Table 5: freeze drying placenta tissue with different processes, and regulating active components in placenta capsule
Figure BDA0002433952640000101
Figure BDA0002433952640000111
As a result, it was found that: after freeze-drying, the water content of the placenta tissue after freeze-drying in comparative example 5 was greater than that of comparative example 1, and the immunomodulatory active ingredient in the finally prepared placenta capsule was lower than that of example 1. This may be due to the fact that corn flour is less hygroscopic than wheat flour and the water sublimation is insufficient. Meanwhile, due to the prolonging of the freeze-drying time, the active ingredients of the immune regulation class in the placenta capsule are reduced.
Comparative example 6: comparison of preparation Processes of placenta capsules
The preparation method of the placenta capsule of this comparative example 6 is substantially the same as that of example 1, except that in this comparative example 6, wheat flour is replaced with sweet potato flour (powder obtained by pulverizing sweet potatoes after sun-drying) in step (4).
The comparison between the water content of the placenta tissue after freeze-drying in the step (4) and the content of the immunomodulatory active ingredient in the finally prepared placenta capsule in the preparation methods of comparative example 6 and example 1 is shown in table 6.
Table 6: freeze drying placenta tissue with different processes, and regulating active components in placenta capsule
Example 1 Comparative example 6
Water content (%) 3.2 6.22
Interferon-gamma (ng/0.05g) 1.234 1.122
Tumor necrosis factor-alpha (ng/0.05g) 0.409 0.351
Interleukin-2 (ng/0.05g) 1.43 1.339
Interleukin-6 (ng/0.05g) 0.374 0.361
Albumin (ng/0.05g) 2.7 2.571
As a result, it was found that: after freeze-drying, the water content of the placenta tissue after freeze-drying in comparative example 6 was greater than that of comparative example 1, and the immunomodulatory active ingredient in the finally prepared placenta capsule was lower than that of example 1. The reason for this phenomenon may be that the product added with the sweet potato flour is easy to adhere to the placenta tissue after freeze drying, and is not easy to remove from the freeze-dried placenta tissue, and finally influences the content of the effective active ingredients of the immunoregulation type in each placenta capsule, and the sweet potato flour is easy to agglomerate, and is not easy to form many gaps to accelerate water sublimation, resulting in insufficient water sublimation.
The above embodiments are preferred embodiments of the present invention, but the present invention is not limited to the above embodiments, and any other changes, modifications, substitutions, combinations, and simplifications which do not depart from the spirit and principle of the present invention should be construed as equivalents thereof, and all such changes, modifications, substitutions, combinations, and simplifications are intended to be included in the scope of the present invention.

Claims (10)

1. The preparation method of the placenta capsule is characterized by comprising the following steps:
(1) freezing and storing the placenta, and simultaneously detecting viruses of the placenta;
(2) cleaning the placenta qualified by the virus detection in the step (1) with sterile water;
(3) shearing the placenta cleaned in the step (2) into 1-2 cm3Drying the small blocks in air;
(4) adding flour into the air-dried placenta tissue obtained in the step (3), and then carrying out freeze drying;
(5) removing the flour on the surface of the placenta tissue frozen and dried in the step (4), and pulverizing the residual placenta tissue into powder;
(6) filling placenta powder into capsule, and sterilizing at low temperature to obtain placenta capsule;
the air drying degree in the step (3) is air drying until the moisture content of the placenta tissue is 6-8%;
the flour in the step (4) is wheat flour;
the temperature of the freeze drying in the step (4) is-80 ℃ to-20 ℃, and the time of the freeze drying is 20-30 h.
2. The method according to claim 1, wherein the placenta in step (1) is an animal placenta.
3. The method of claim 2, wherein said animal placenta is derived from a healthy human.
4. The method according to claim 1, wherein the air-drying in the step (3) is carried out by an air-dryer; the air drying time of the air dryer is 4-8 h, and the power is 100-200W.
5. The method of claim 1, wherein the wheat flour comprises at least one of weak flour, medium flour and strong flour.
6. The preparation method of claim 1, wherein the placenta tissue and the flour in step (4) are in a mass ratio of 50-80: 1-8.
7. The preparation method of claim 6, wherein the placenta tissue and the flour are in a mass ratio of 50-80: 1-3.
8. The method for preparing the placenta hominis according to claim 1, wherein the flour is added to the air-dried placenta tissue in the step (4) by: sprinkling flour on the surface of placenta.
9. The preparation method of claim 1, wherein the temperature of the freeze drying is-80 ℃ to-20 ℃, and the time of the freeze drying is 23-28 h.
10. A placental capsule prepared by the method according to any one of claims 1 to 9.
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