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INTRODUCTION TO THE INVENTION
This invention relates to an improved process for the preparation of anti-inflammatory Drugs from human placenta.
PRIOR ART AND DRAWBACKS
It is known in published papers that human placenta possesses therepeutic uses particularly in pelvic inflammation.
Several studies have been conducted to study the antiinflammatory roles of placenta extract.
However, not much work has been done to develop a commercial process for the manufacture of anti-inflammatory drugs using human placenta.
OBJECTS OF THE INVENTION
It is therefore a principle object of the invention to propose an improved process for the preparation of anti—inflammatory Drugs from human placenta.
It is another object of this invention to propose such a process, which will be economical, reliable and have flexibility in operation.
It is a yet another object to propose such a process which will ensure high quality product effective against many
diseases.
It is a further object to propose such a process, which will produce several forms of end products, some of which can be used without any prescription or supervision or dosage.
It is thus a further object to prepare injectable to be administered unde medical supervision and lotions and gels, which can be applied as external remedies like cosmetic preparations.

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These and other objects will be more clear from the
following paragraphs, which generally state the details of the
invention.
BRIEF DESCRIPTION OF THE PROCESS OF THE INVENTION
THE INVENTED PROCESS IS CARRIED OUT IN SEVERAL STAGES.
First Stage : consists in collecting suitable human placenta under scientific conditions. This is carried out by collecting raw placenta in sterilized containers under cold conditions from hospitals. The container for the material is suitably sterilized.
The material containing containers are transported under cold conditions at temperature not exceeding 6 deg. C preferably not exceeding 5 deg.C;
Second Stage : All materials are subjected to screening and any HIV or otherwise affected materials are discarded.
Third Stage i The collected materials are stored in the sealed containers in a cold storage for 120 - 168 hours at controlled temperature of about 2-6 deg.C. Most preferred temperature is about 4 deg.C this is done to preserve the natural proteins and other valuable constituents in the placenta. Some BIOGENEOUS STIMULATORS are originated in this stage by bio-chemical process.
Fourth Stage: In this stage, the contents of each container are individually emptied on sterile surface kept cooled at low temperature properly spread and subjected to a cleaning step in which, remnants of umbilical cord, fat tissue and other unwanted material are carefully removed and discarded as a waste, which waste is separately processed to meet pollution counted requirements.

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Fifth Stage : The material found suitable for further processing is subjected to mincing operation in a suitable mechanical mincer. This operation is to be very carefully carried out and monitored.
The mincing opens up the entire material and shreds into very small pieces, thus opening up the surface area and exposing more surface area for further processing.
It is preferably carried out in a sterile condition by sterilizing the mincer and its components as well as the collection tray.
In this stage more of the protein and other valuable component are expossed and to maintain the natural values of these components, it is preferred to carry out the mincing at low temperatures. However, since the mincing is a very quick operation, the material already at the stored temperature of around 4 deg C will still be around that temperature even at the mincing stage and immediately thereafter.
The mincing stage is the crucial stage as this stage forms the basis for further successful operations.
Sixth Stage : In this stage, we immediately collected the entire minced material in cold water, preferably ice cold water and all the water soluble materials are extracted.
In a preferred example, we used 10 fold volume by weight of water for injection grade (WFI) water.
This step is at the controlled temperature conditions of less than 10 deg C and the entire contents are stored in sterile glass vessels in a cold water bath for sufficient time to ensure complete extraction of water soluble material.

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Seventh Stage : Following the cold extraction, the entire contents are subjected to a warm extraction by gradually allowing the temperature of the cold extracted matter to warm up using a hot water bath, so that the contents are raised gradually and carefully to a temperature of not over 87 deg C. It is maintained in that temperature range of 85 - 87 deg C for sufficient time until a solution is obtained. It contained all the dissolved protein and other valuable components of the placenta.
The cold and hot extractions are effected in sealed containers.
Eighth Stage : We subjected the extract with all the contents to a step of sterile filteration. Sterile condition is most important here and therefore the filter media has to be sterilised before use. (While several options of filter media are possible, it has been found that sterile cloth filter is effective and easy to operate).
Ninth Stage s The filtrate contains some water soluble long chain proteins, essential amino acids, salts, biogenic stimulators, enzymes, glycogen etc. To break the long chain proteins (for its easy availability in the body), the filtrate is subjected to a step of gradual and controlled heating to around 97 deg C using water bath and maintained for a time.
Tenth Stage : In this stage, the solution of the above step is kept in a sterile container and closed whereafter the entire contents is subjected to autoclaving at a steam pressure as necessary, generally at around 15 1bs/sq. inch at a temperature of 121 deg C for a time period as may be found necessary. This step is very important to ensure that all traces of bacteria?* are killed.

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Eleventh Stage s The autoclaved container is taken out of the autoclave and is used to prepare a desired final product. The autoclaved solution is filtered through strilized paper pulp to get a clear solution.
FINAL PRODUCTS
We have the prepared the following final products :-
a) PLACENTA LOTION
The clear solution is mixed with sufficient quantity of benzyl alcohol and a conventional preservative is added to the solution. It is then stored in sterile bottles and can be used as a lotion which is effective against vitiligo
b) PLACENTA GEL-
The clear solution mixed with benzyl alcohol is subjected to the preparation of gel in a conventional manner and stored in squazable tubes. This is useful against wound healing in burns and cuts.
c) PLACENTA INJECTABLE
The clear solution is mixed with benzyl alcohol and then subjected to a step of membrane filtration. The membrane filtered solution is filled in glass ampoules, sealed and autoclaved as before for a shorter duration of time. The ampoule is used as an injectable effective against immunotropic, antiinflammatory and would healing.

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It should be remembered that every operation has to be done under sterile conditions and at controlled temperature. If necessary, a mild washing step using sterile water can be introduced before the mincing stage to eliminate occluded blood, clots, dried remnants and others.
Dated this 31st day of May, 2000,



(K. RAJAGOPALAN)
of RAJAGOPALAN AND ASSOCIATES AGENT FOR APPLICANT.

TO
THE CONTROLLER OF PATENTS,
THE PATENT OFFICE
CALCUTTA,
There is provided a process for the preparation of anti-inflammatory drug from human placenta comprising
Collecting fresh human placenta from the hospitals and nursing homes in a sterilized containers kept at
cold conditions,
sealing the containers every time after a sample is collected,
collecting as much of the placenta as the containers can hold,
storing the containers in cold conditions,
transporting the sealed containers in cold storage van at temperature not exceeding 6 °C,
subjecting the material so transported to a step of screening for any HIV infection or otherwise affected material without losing much of the cold conditions of the material,
discarding the infected or otherwise affected material,

re-storing the approved materials in the cold containers and sealing the same,

storing the sealed containers in a cold storage at temperature below 6 °C for a period of about 4 to 8 days in order to preserve all the natural proteins and other valuable constituents contained in the placenta and to allow any self occurring bio-chemical process to complete,
/emptying the contents of each container separately on a sterile surface kept at low temperatures not exceeding 6 0 C,
subjecting the material to a cleansing step to remove any remnants of umbilical chord and fat tissue to obtain a clean placenta under sterile conditions,
quickly mincing the cleaned material at low temperatures not exceeding 6 ° C using sterilized mechanical mincer to obtain shredded material in which all the placenta is opened, collecting all the minced material in cold water and thoroughly mixing the same to enable a dissolution of the water soluble material,